Kulit orang Asia yang mengalami kronologi penuaan, mengumpul tanda-tanda penuaan yang dimediasi oleh pendedahan berpanjangan kepada sinaran ultraungu (UV).
Walaupun pelindung matahari berkesan dalam mencegah tanda-tanda penuaan, ekstrak yang kaya dengan polifenol, contohnya, ekstrak biji anggur (GSE) boleh memberikan perlindungan tambahan melalui spektrum luas aktiviti biologi.
Matlamat
Untuk mengakses keberkesanan formulasi pelindung matahari yang mengandungi ekstrak biji anggur (GSE) sebagai bahan kosmetik penting untuk penambahbaikan perubahan berkaitan usia dalam kulit penduduk Asia menggunakan teknik penilaian bukan invasif.
Kaedah
Kaedah bukan invasif digunakan untuk menilai perubahan dalam sifat biofizikal yang sepadan dengan tanda penuaan termasuk indeks melanin dan eritema, parameter warna sistem CIE L*a*b*, keanjalan, dan penghidratan kulit di bahagian bawah lengan sebelum dan selepas menggunakan pelindung matahari dengan ekstrak biji anggur (GSE) .
Untuk mengesahkan keberkesanan produk yang diuji, kami membandingkannya dengan pelindung matahari penanda aras, dan asas krim yang mengandungi sama ada penapis ekstrak biji anggur (GSE) atau UV.
Keputusan
Penggunaan pelindung matahari dua kali sehari yang mengandungi 3% ekstrak biji anggur (GSE) mengurangkan tahap melanin dan eritema dengan ketara dan meningkatkan warna kulit secara keseluruhan.
Penghidratan telah meningkat secara drastik selepas 3 jam memakai formulasi dan dikekalkan agak tinggi selama 5 jam.
Parameter keanjalan kulit, termasuk modulus Young, masa penarikan balik, dan kelikatan, bertambah baik dalam peserta semua kategori umur (35-59 tahun).
Selain itu, pelindung matahari dengan GSE, seperti yang dipuji oleh peserta, menambah baik penampilan kulit secara keseluruhan.
Kesimpulan
Potensi pengimbangan ekstrak biji anggur (GSE) pada kulit, digabungkan dengan sifat fotoprotektif penapis UV menunjukkan nilai tambah sebagai agen anti-penuaan dan terbukti keberkesanannya untuk kedua-dua kulit Asia yang berumur.
Artikel asal: https://onlinelibrary.wiley.com/doi/10.1111/jocd.14982
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Sindrom metabolik dan hasil jantung yang berkaitan dengannya merupakan beban yang besar pada sistem penjagaan kesihatan moden, dan kajian pelengkap untuk membantu dalam pengurusannya diperlukan.
Kami berhasrat untuk mengkaji kesan Al Manna atau Gum Arabic (GA) pada mereka yang mempunyai, atau berisiko, sindrom metabolik untuk mengenal pasti kesan ke atas meningkatkan parameter penyakit penting yang berkaitan dengan kardiovaskular.
Penyelidikan single-blind, randomized, placebo-controlled, telah dijalankan untuk mengenal pasti kesan suplemen GA harian ke atas faktor risiko metabolik dan kardiovaskular. Sebanyak 80 peserta secara rawak menerima 20 g GA setiap hari (n = 40) atau plasebo (1 g pektin, n = 40) selama 12 minggu. Titik akhir utama termasuk indeks antropometri badan, diet dan penilaian aktiviti fizikal, dan kimia darah (HbA1c, glukosa puasa dan lipid darah).
Daripada 80 yang mendaftar, 61 telah menyelesaikan kajian (campur tangan: 31, kawalan: 30) dengan 19 tercicir kerana pematuhan rawatan yang lemah.
Selepas 12 minggu, peserta yang menerima Al Manna atau Gum Arabic (GA) menunjukkan penurunan ketara dalam tekanan darah sistolik dan diastolik, jisim badan tanpa lemak, penggunaan tenaga dan karbohidrat, dan glukosa plasma berpuasa, serta peningkatan pengambilan serat makanan.
Mereka juga melaporkan peningkatan dalam kembung perut yang dirasakan sendiri dan kualiti pergerakan usus, serta penurunan skor selera makan berikutan penggunaan GA.
Keputusan ini menunjukkan bahawa Al Manna atau Gum Arabic (GA) boleh menjadi ubat tambahan yang selamat dan bermanfaat kepada rawatan lain bagi mereka yang mempunyai, atau berisiko mengidap sindrom metabolik.
Artikel penuh: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7826716/
The Effect of Gum Arabic (Acacia senegal) on Cardiovascular Risk Factors and Gastrointestinal Symptoms in Adults at Risk of Metabolic Syndrome: A Randomized Clinical Trial
Associated Data
Abstract
Gum Arabic (GA) is a widely-used additive in food processing, but is also historically used in a number of traditional therapies. It has been shown to have a broad range of health benefits, particularly in improving important cardiovascular risk indicators. Metabolic syndrome and its associated cardiac outcomes are a significant burden on modern healthcare systems, and complementary interventions to aid in its management are required. We aimed to examine the effect of GA on those with, or at risk of, metabolic syndrome to identify an effect on improving important disease parameters related to cardiovascular outcomes. A single-blind, randomized, placebo-controlled trial was conducted to identify the effects of daily GA supplementation on metabolic and cardiovascular risk factors. A total of 80 participants were randomized to receive 20 g of GA daily (n = 40) or placebo (1 g pectin, n = 40) for 12 weeks. Key endpoints included body-anthropometric indices, diet and physical activity assessment, and blood chemistry (HbA1c, fasting glucose, and blood lipids). Of the 80 enrolled, 61 completed the study (intervention: 31, control: 30) with 19 dropping out due to poor treatment compliance. After 12 weeks, the participants receiving the GA showed significant decreases in systolic and diastolic blood pressure, fat-free body mass, energy and carbohydrate consumption, and fasting plasma glucose, as well as increased intake of dietary fiber. They also reported improvements in self-perceived bloating and quality of bowel movements, as well as a decreased appetite score following GA consumption. These results suggest that GA could be a safe and beneficial adjunct to other treatments for those with, or at risk of, metabolic syndrome.
1. Introduction
Gum Arabic (GA) or Acacia gum is a soluble dietary fiber obtained from the stems and branches of the Acacia senegal and Acacia seyal plants, which grow mainly in the African region of Sahe in Sudan [1]. It is often associated with health benefits relevant to reducing the risk of metabolic syndrome (MetS). GA contains three different fractions of highly-branched carbohydrate structures that vary in molecular mass and protein content, which are believed to underlie its physiological effects. These are commonly known as the arabinogalactan-protein, arabinogalactan, and glycoprotein fractions [2]. However, the composition of GA may change depending on the source, climate, and soil [3]. Because of the physical properties of GA, it has been widely used in various industries including cosmetics, textiles, ceramics, pharmaceuticals and foods [4]. GA is commonly used in industrial food production as an emulsifier, a stabilizer, and a thickener due to its nondigestibility, low-solution viscosity, and safety [5]. Used as a traditional remedy for many years, several studies have described the antioxidant properties of GA and its capacity to neutralize reactive oxygen substances [6,7,8]. Research also suggests it may have an effect on lipid metabolism [9], as well as renal function [10,11,12] and satiety [13], lending support to its use as an adjunct in the prevention and treatment of metabolic syndrome. Broadly, GA appears to have a hypocholesterolemic effect, decreasing low-density lipoproteins (LDL) and very low density lipoproteins (VLDL) without affecting high-density lipoproteins (HDL) and triglycerides in animal models [6]. GA has shown potential to relieve the effects of chronic renal failure by improving creatinine clearance as well as excretion of magnesium and calcium [14]. It has also been reported to decrease blood pressure in mice, and has been shown to lower caloric intake significantly, potentially due to increased dietary-fiber intake increasing satiety [5]. This reduction in energy intake makes GA a strong candidate for adjunct weight-control therapies.
Metabolic syndrome describes a cluster of conditions including increased blood pressure, high blood glucose, excess body fat, and dyslipidemia occurring simultaneously [15]. Metabolic syndrome is one of the most significant risk factors for a wide range of noncommunicable diseases (NCDs) such as cardiovascular diseases and diabetes [16]. According to the World Health Organization (WHO), NCDs are responsible for 71 percent of deaths globally, with cardiovascular disease being the leading cause of death, followed by cancer, respiratory diseases, and diabetes [17]. Most NCDs share common behavioral risk factors such as poor diet, physical inactivity, and smoking, as well as the key MetS risk factors such as overweight, obesity, high blood sugar, and hypercholesterolemia [18]. This makes reducing the burden of MetS a key element in the prevention of NCDs [16].
Given the significant burden of MetS and its associated risk of NCDs, there is a need for novel interventions to help prevent its onset. This study aimed to investigate the effect of consuming 20 g of Gum Arabic-Acacia Senegal (GA-AS) per day based on key metabolic parameters in adults with, or at risk of, metabolic syndrome. It is the hope that the results of this study will provide insight into the dietary effects of consistent consumption of Gum Arabic-Acacia Senegal. It is hypothesized that GA-AS will provide benefits to the metabolic health of the participants with regular use and will be well tolerated by individuals taking it.
2. Materials and Methods
2.1. Study Design
The present study was a controlled, randomized, single-blind, parallel-design study comparing an intervention group receiving 20 g of GA-AS daily for 12 weeks with a control group receiving a daily placebo containing 1 g of pectin for the same period. The primary endpoints of the study were blood glucose, lipid profile, blood pressure, body composition, gastrointestinal motion, and satiety. The study was conducted at the department of Nutrition and Health, College of Food and Agriculture at United Arab Emirates University (UAEU) during the period from January to May 2018. This study was conducted according to the principles of the Helsinki declaration on human research ethics and was approved by the UAEU scientific research ethics committee (ref. no. ERH_2016_4372).
2.2. Study Participants
Participants were recruited from the UAEU (students and staff) through face-to-face interviews, email, social media, and printed advertisements on the campus and in the dormitories of the university. Participants were given both verbal and written information about the aim of the study, data to be collected, and the duration of intervention, and they were required to sign a written informed-consent form to participate in the study prior to screening.
Participants were screened for eligibility at the nutrition clinic at UAEU. Participant eligibility was based on the presence of metabolic-syndrome risk factors. Inclusion and exclusion criteria are summarized in Table 1. Risk factors assessed included waist circumference (females > 80 cm and males > 94 cm), systolic blood pressure (≥130 mm Hg), diastolic blood pressure (≥80 mm Hg), blood-fasting glucose (≥100 mg/dL), HDL cholesterol level (for female < 50 mg/dL and males < 40 mg/dL), and triglycerides level (≥150 mg/dL). Participants with more than three risk factors, or with two risk factors and one borderline, were included in the study. Participants were excluded from the study if they were smokers, pregnant women, lactating women, or were taking permanent medication.
Table 1
Nutrient composition of GA per 20 g dose.
| Nutrient | Per 20 g Dose |
|---|---|
| Energy (kcal) | 1.8 |
| Protein (g) | 0.4 |
| Carbohydrate (g) | 17.1 |
| Fat (g) | 0.02 |
| Total dietary fiber (g) | 17.1 |
| Sodium (mg) | 2.8 |
| Calcium (mg) | 214.8 |
| Magnesium (mg) | 78.0 |
| Potassium (mg) | 182.8 |
| Iron (mg) | 0.2 |
Participants were asked to complete a health-screening questionnaire that contained questions about medical conditions and medications that might influence glucose control, appetite, and energy expenditure. All participants signed an informed-consent form before taking part in the study. This study was conducted according to the guidelines in the Declaration of Helsinki. All procedures involving human subjects were approved by the United Arab Emirates University (UAEU) Scientific Research Ethics Committee.
Participants were randomly assigned to control and intervention groups via computer software, with the experimental group receiving 20 g of GA-AS powder per day and the control group receiving 1 g of placebo (pectin) powder per day for a period of 12 weeks. This dose was selected based on previous research showing metabolic effects with doses of 10–30 g per day for 4–12 weeks, with lipid effects being most significant after 5 weeks [3,13,19,20]. GA powder and placebo were provided in premeasured sachets, and participants were asked to consume the GA powder or the placebo two times per day by adding it to hot water, tea, milk, or on any meal. The nutrient composition of the study dose of Gum Arabic is presented in Table 1. Body weight (kg), height (cm), waist circumference (cm), body composition, blood glucose, blood-lipid profile, glycated hemoglobin A1c (HbA1c), and blood pressure were measured at baseline (week 0) and 12 weeks. In addition, participants were asked to complete a bowel-movement questionnaire and satiety scale at the baseline and endpoint of the study.
2.3. Research Parameters
2.3.1. Anthropometric Measurements
Body weight was recorded to the nearest 0.01 kg while the subject was wearing minimal clothes (as per local cultural requirements) and no shoes. Body composition was assessed via a bioimpedance device (InBody720, InBody, CA, USA), providing measurement of percentage body fat (%BF), fat mass (kg), and fat free mass (kg). Waist circumference was measured using measuring tapes, according to standard methods at the mid-point between inferior costal margin and superior border of the iliac crest. In obese individuals, the measurement was taken at the level of the umbilicus [21]. Body mass index (BMI) was calculated as BMI = kg/m2. All measurements were taken at baseline and after 12 weeks of intervention.
2.3.2. Diet and Physical Activity Assessment
During the study period, the participants were asked to maintain their normal lifestyle. Participants were asked to record their dietary intake at baseline (week 0) and at week 12 of the study period. Food records were taken over three days including two weekdays and one weekend day. Photographs of food with different portion sizes were used to help participants estimate the correct portion size consumed. The Food Processor® Nutrition and Fitness Software, ESHA food-analysis program (version 10.4), and the Kuwaiti Food Composition database were used to analyze the energy and nutrient contents of the consumed foods [22].
Physical activity level was assessed using the International Physical Activity Questionnaire (IPAQ) (Arabic and English versions) at baseline and week 12 [23].
2.3.3. Bowel Movement and Satiety Questionnaires
Participants were asked to answer a bowel-movement questionnaire including frequency and intensity of constipation, bloating, diarrhea, and heartburn. A satiety questionnaire with scoring points was used to assess satiety after 60 min of ingestion of either GA-AS or the placebo intervention. The questionnaires were administered at both baseline and at the end of the study (adapted from [24,25]). In the satiety questionnaire, participants answered the following questions: How did the meal (with the study treatment or placebo) you just ate make you feel? Did it satisfy your hunger, or did you feel like you needed to snack later? Then they rated their feelings of satiety for 60 min using a score of 100 [24,25].
2.3.4. Biochemical Parameters
A fasting, venous blood sample was collected (5 mL) by a certified phlebotomist at baseline and at end of the study period. Fasting blood glucose (FBG), HbA1c, serum triglyceride (TG), high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC), and total cholesterol (TC) were analyzed using Cobas C111 automated biochemical analyzer (Roche Diagnostics, Indianapolis, IN, USA). All data were collected at the laboratory facilities of the Nutrition and Health Department.
2.4. Statistical Analysis
G*Power 3.1.9.2 software was used for sample-size calculation of repeated measures ANOVA with parallel design. Power calculation identified a sample size of at least 54 participants to detect a medium-effect size (0.25) with 95% power with significance level set at 0.05. The statistical analysis was performed using SPSS version 24.0 and results presented as (Mean ± Standard Deviation). Repeated measures ANOVA was used to detect the main effects of time and group on study measures. Paired t-tests and independent t-tests were employed to compare the effect of time and groups (Control vs. Intervention), respectively. Binary data was assessed for statistical significance with the N-1 chi square test. Results were considered statistically significant at p-value < 0.05.
3. Results
The study sample consisted of 80 participants from the United Arab Emirates University, aged 18–50 years with a mean age of 25.51 ± 9.5 years, mean BMI of 33.9 ± 5.4, and with 62.3% being female. Nineteen participants dropped out of the study due to poor treatment compliance, with 61 ultimately completing the 12-week intervention. Dropouts were largely due to failure to take prescribed GA or placebo, or failure to present for follow up testing. The control group consisted of 30 participants, and the experimental group 31 (Figure 1). There were no significant differences in baseline characteristics between groups (Table 2).
Table 2
Baseline characteristics of the subjects (N = 61).
| Variable | Control (n = 30) Mean ± SD | Intervention (n = 31) Mean ± SD | p-Value |
|---|---|---|---|
| Age (years) | 25.6 ± 9.9 | 28.3 ± 11.8 | 0.452 |
| Weight (kg) | 91.7 ± 20.8 | 92.1 ± 17.4 | 0.948 |
| Height (cm) | 168.3 ± 11.6 | 164.3 ± 7.5 | 0.163 |
| BMI (kg/m2) | 31.9 ± 4.7 | 34.1 ± 5.9 | 0.174 |
| Waist circumference (cm) | 100.5 ± 16.1 | 101.2 ± 12.7 | 0.867 |
| Body Fat (%) | 39.7 ± 8.4 | 43.7 ± 7.6 | 0.088 |
| Fat free mass (kg) | 53.8 ± 14.5 | 50.9 ± 9.4 | 0.382 |
| Systolic Blood Pressure (mm Hg) | 114.8 ± 16.4 | 118.3 ± 17.0 | 0.482 |
| Diastolic Blood Pressure (mm Hg) | 75.8 ± 9.9 | 81.1 ± 9.2 | 0.066 |
| Physical Activity Levels | |||
| Vigorous (min/week) | 11.1 ± 3.0 | 14.4 ± 3.2 | 0.683 |
| Moderate (min/week) | 59.4 ± 5.7 | 62.1 ± 8.9 | 0.117 |
| Light (min/week) | 190.2 ± 13.1 | 193.5 ± 3.2 | 0.939 |
| Sedentary Activity (h/day) | 9.20 ± 0.4 | 10.5 ± 0.35 | 0.155 |
| Nutritional Intake | |||
| Energy (kcal) | 2142 ± 551.8 | 2036.9 ± 601.5 | 0.534 |
| Carbohydrate (g) | 256 ± 57.7 | 239.4 ± 84.3 | 0.446 |
| Fat (g) | 82.2 ± 34.1 | 80.5 ± 30.7 | 0.852 |
| Protein (g) | 81.7 ± 28.9 | 86.9 ± 38.4 | 0.609 |
| Dietary fiber (g) | 15.0 ± 9.8 | 17.1 ± 15.2 | 0.648 |
| Biochemical Parameters | |||
| HbA1c (%) | 6.1 ± 0.9 | 6.0 ± 1.7 | 0.763 |
| Glucose (mg/dL) | 101.5 ± 14.0 | 105.6 ± 36.0 | 0.635 |
| Triglycerides (mg/dL) | 94.7 ± 41.6 | 100.9 ± 53.9 | 0.661 |
| Total Cholesterol (mg/dL) | 150.7 ± 34.3 | 157.9 ± 28.2 | 0.413 |
| LDLC (mg/dL) | 2.5 ± 0.9 | 2.50 ± 0.7 | 0.926 |
| HDLC (mg/dL) | 46.3 ± 12.1 | 45.1 ± 12.1 | 0.747 |
After 12 weeks of GA treatment, the experimental group showed significant decreases in both systolic (p = 0.008) and diastolic blood pressure (0.009), as well as fat free mass (p = 0.03), with no intragroup difference in the control group. No significant inter- or intragroup differences were observed in BMI, waist circumference, or body fat between baseline and week 12 (Table 3).
Table 3
Changes in physical characteristics for study population after 12 weeks.
| Control | Intervention | Intergroup Difference (Week 12) | |||||
|---|---|---|---|---|---|---|---|
| Variable | Baseline (Mean ± SD) | Week 12 (Mean ± SD) | p-Value | Baseline (Mean ± SD) | Week 12 (Mean ± SD) | p-Value | p-Value |
| Weight (kg) | 91.74 ± 20.8 | 93.0 ± 22.3 | 0.37 | 92.09 ± 17.4 | 91.43 ± 17.0 | 0.116 | 0.778 |
| BMI (kg/m2) | 31.92 ± 4.7 | 32.6 ± 5.6 | 0.288 | 34.07 ± 5.9 | 33.90 ± 6.0 | 0.465 | 0.43 |
| Waist circ. (cm) | 100.50 ± 16.1 | 100.6 ± 18.9 | 0.937 | 101.20 ± 12.7 | 99.07 ± 13.0 | 0.155 | 0.728 |
| Body Fat (%) | 39.72 ± 8.4 | 40.90 ± 8.90 | 0.206 | 43.70 ± 7.6 | 44.10 ± 7.8 | 0.094 | 0.198 |
| Fat Free Mass (kg) | 53.79 ± 14.5 | 58.80 ± 9.70 | 0.185 | 50.85 ± 9.4 | 55.38 ± 8.9 | 0.030 * | 0.206 |
| Systolic (mm Hg) | 114.80 ± 16.4 | 117.0 ± 15.0 | 0.242 | 118.30 ± 17.0 | 111.30 ± 19.8 * | 0.008 * | 0.273 |
| Diastolic (mm Hg) | 75.8 ± 9.90 | 79.50 ± 9.7 | 0.102 | 81.1 ± 9.2 | 76.70 ± 13.2 * | 0.009 * | 0.419 |
* p = < 0.05.
3.1. Diet and Physical-Activity Assessment
After 12 weeks of GA treatment, the intervention group showed a decrease in carbohydrate (p = 0.008) and calorie (p = 0.014) intake and an increase in dietary fiber consumption (p ≤ 0.001), with no intergroup change in the controls (Table 4). There were also intergroup differences in carbohydrate (p = 0.004) and dietary-fiber (p ≤ 0.001) consumption at 12 weeks. The intervention group also showed a trend toward lower energy intake compared to controls after 12 weeks; however, this did not reach significance (p = 0.069). There were no inter- or intra-group changes to physical activity parameters either in fat or protein consumption (Table 4).
Table 4
Dietary and physical-activity characteristics of the study population.
| Control | Intervention | Intergroup Difference (Week 12) | |||||
|---|---|---|---|---|---|---|---|
| Variable | Baseline (Mean ± SE 1) | Week 12 (Mean ± SE 1) | p-Value | Baseline (Mean ± SE 1) | Week 12 (Mean ± SE 1) | p-Value | p-Value |
| Vigorous (min/week) | 11.1 ± 3.0 | 10.7 ± 2.8 | 0.101 | 14.4 ± 3.2 | 18.4 ± 6.0 | 0.91 | 0.55 |
| Moderate (min/week) | 59.4 ± 5.7 | 71.5 ± 16.6 | 0.525 | 62.1 ± 8.9 | 59.0 ± 10.2 | 0.665 | 0.709 |
| Light (min/week) | 190.2 ± 13.1 | 206.5 ± 14.2 | 0.408 | 193.5 ± 3.2 | 198.4 ± 20.6 | 0.923 | 0.863 |
| Sedentary Activity (h/day) | 9.20 ± 0.4 | 10.9 ± 0.4 | 0.089 | 10.5 ± 0.35 | 10.7 ± 0.43 | 0.677 | 0.847 |
| Energy (kcal) | 2142 ± 62.4 | 2092 ± 55.0 | 0.644 | 2036.9 ± 68.0 | 1810 ± 62.5 * | 0.014 | 0.069 |
| Carbohydrate (g) | 256 ± 6.5 | 256 ± 6.7 | 0.976 | 239.4 ± 9.5 | 194.1 ± 8.8 * | 0.008 | 0.004 |
| Fat (g) | 82.2 ± 3.9 | 73.2 ± 3.11 | 0.259 | 80.5 ± 3.5 | 71.3 ± 3.2 | 0.139 | 0.815 |
| Protein (g) | 81.7 ± 3.3 | 87.0 ± 3.6 | 0.453 | 86.9 ± 4.3 | 84.9 ± 5.2 | 0.836 | 0.854 |
| Dietary fiber (g) | 15.0 ± 1.1 | 16.1 ± 1.2 | 0.829 | 17.1 ± 1.7 | 31.9 ± 1.64 * | 0.001 | <0.001 |
1 Standard Error, * p = <0.05.
3.2. Biochemical Assessment
After 12 weeks of GA treatment, the intervention group had significantly decreased in fasting plasma glucose (p = 0.046), with the control group showing no change; however, there was no difference between the groups at the endpoint (p = 0.101). There were no changes to HbA1c or blood lipid profile in either group (Table 5).
Table 5
Biochemical measurements of study population.
| Control | Intervention | Intergroup Difference (Week 12) | |||||
|---|---|---|---|---|---|---|---|
| Variable | Baseline (Mean ± SD) | Week 12 (Mean ± SD) | p-Value | Baseline (Mean ± SD) | Week 12 (Mean ± SD) | p-Value | p-Value |
| HbA1c (%) | 6.10 ± 0.90 | 6.0 ± 0.4 | 0.662 | 6.0 ± 1.7 | 6.00 ± 0.8 | 0.938 | 0.145 |
| Glucose (mg/dL) | 101.50 ± 14.00 | 99.5 ± 14.2 | 0.489 | 105.6 ± 36.0 | 92.90 ± 13.20 * | 0.046 | 0.55 |
| Triglycerides (mg/dL) | 94.70 ± 41.60 | 94.9 ± 41.0 | 0.955 | 100.9 ± 53.9 | 93.90 ± 44.0 | 0.936 | 0.832 |
| Total Cholesterol (mg/dL) | 150.7 ± 34.30 | 151.2 ± 37.8 | 0.941 | 157.9 ± 28.20 | 152.60 ± 30.6 | 0.892 | 0.709 |
| LDLC (mg/dL) | 2.50 ± 0.90 | 2.3 ± 0.8 | 0.433 | 2.50 ± 0.70 | 2.4 ± 0.7 | 0.625 | 0.925 |
| HDLC (mg/dL) | 46.3 ± 12.1 | 46.2 ± 13.2 | 0.951 | 45.1 ± 12.1 | 44.8 ± 13.9 | 0.736 | <0.001 |
* p = <0.05.
3.3. Bowel Movement
The intervention group reported significant reductions (p = 0.005) in bloating and improvement in bowel movement (0.047) compared to the control group. Although there were no statistically significant differences in abdominal pain, better digestion, or reduction in nausea, the intervention rate responses were almost double those of the control group (Table 6).
Table 6
The effect of GA on the bowel movement at week 12 in the Control and Intervention Groups.
| Response Rate for | Week 12 | ||
|---|---|---|---|
| Control (Yes, %) | Intervention (Yes, %) | p-Value | |
| Improved bowel movements | 33.3 | 54.8 | 0.047 * |
| Reduction in bloating feelings | 20.0 | 51.6 | 0.005 * |
| Reduction in abdominal pain | 10.0 | 22.6 | 0.094 |
| Feeling of better digestion | 23.3 | 41.9 | 0.062 |
| Reduction in nausea | 10.0 | 25.8 | 0.056 |
| Satiety Scores | Baseline (Mean ±SD) | 60 min (Mean ±SE) | |
| Control | 44.9 ± 24.7 | 51.6 ± 24.2 | 0.174 |
| Gum Arabic | 48.7 ± 22.3 | 62.5 ± 27.5 | 0.011 |
* p = <0.05.
3.4. Feeling of Satiety
One hour after taking the GA treatment, the participants in the intervention group showed a significant increase in appetite score (reflective of a decreased appetite) compared to controls receiving the placebo treatment (p = 0.01) (Table 6).
4. Discussion
To the best of our knowledge, the current study is the first to examine the effect of Gum Arabic on individuals with, or at risk of developing, metabolic syndrome. The daily treatment with GA caused improvement in a number of parameters important to modifying outcomes and risk of metabolic syndrome, including fasting plasma glucose, blood pressure, and energy intake. However, contrary to some other studies, our trial found no significant reduction in body weight or BMI. In one study, 30 g of GA per day for 6 weeks caused significant reductions in BMI, body-fat percentage, and weight in adult females compared to placebo-treated controls [3]. Another study on daily GA administration (30 g) for three months also found that BMI, visceral-adiposity index, and body-adiposity index were significantly lowered in the intervention group [26]. The difference in findings may reflect the relative size of the studies, as, while in our study these parameters did not reach significance, there was some evidence of a trend. With a larger group, the results may have become significant. The differences may also be due to differences in patient demographic. In the first study, the participants were younger and generally healthier, and while in the second study they were significantly older, they had a much lower BMI.
The demonstrated decreases in energy and carbohydrate consumption are significant in the context of metabolic syndrome, characterized in large part by impaired glucose metabolism and obesity. Reducing the intake of these through nonpharmacological supplementation could provide a means of management or prevention of the syndrome. While the exact mechanism underlying the behavior change is unclear, it may be due to the increased feelings of satiety following GA administration. These findings are echoed in another study, which showed that supplementation with two blends of GA (EmulGold1 (EG) and PreVitae1 (PV)) decreased the caloric intake significantly three hours after consumption and increased subjective ratings of satiety [19]. An increase in fat free mass (FFM) was also identified in this study. While interesting and potentially of benefit to the population studied, these results should be interpreted with caution. The bioimpedance device used in this study reports two-compartment FFM which measures bone, muscle, connective tissue, and water as one. While this is a reliable measure of body fat, it is unable to discriminate between beneficial changes in muscle or bone mass f
Garis panduan Item Pelaporan Pilihan untuk Kajian Sistematik dan Meta-Analisis diikuti, dan penilaian risiko berat sebelah telah dilakukan mengikut Buku Panduan Cochrane untuk Ulasan Sistematik Intervensi. Kami mengenal pasti 5683 kajian dalam pangkalan data. Selepas mengalih keluar pendua, 3418 kajian kekal. Daripada jumlah ini, 147 kajian memenuhi kriteria kelayakan, dan akhirnya, hanya 20 telah dimasukkan dalam analisis kualitatif.
Kajian yang disertakan mencadangkan bahawa delima adalah bermanfaat untuk mengurangkan berat badan, tekanan darah, glikemia, trigliserida, jumlah kolesterol, dan kolesterol lipoprotein berketumpatan rendah.
Selain itu, ia boleh menambah paras kolesterol lipoprotein berketumpatan tinggi dan meningkatkan ketahanan insulin.
Walaupun kesan yang berkaitan telah diperhatikan, ujian klinikal tambahan yang direka bentuk dengan baik diperlukan untuk menentukan formulasi dan dos yang betul untuk digunakan untuk mencegah atau merawat komponen MetS.
Berdasarkan keputusan seperti yang dibentangkan dalam kajian sistematik ini, kita boleh menyimpulkan bahawa penggunaan delima boleh memberi manfaat dalam mengurangkan faktor risiko MetS, seperti berat badan, tekanan darah, glikemia, trigliserida, LDL-c, dan jumlah kolesterol. Selain itu, ia boleh menambah tahap HDL-c. Walaupun kesan ini telah diperhatikan, lebih banyak kajian klinikal diperlukan untuk menentukan formulasi dan dos yang betul yang harus digunakan untuk mencegah atau merawat komponen MetS.
Artikel penuh: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9032502/
Pomegranate (Punica granatum L.) and Metabolic Syndrome Risk Factors and Outcomes: A Systematic Review of Clinical Studies
Abstract
Pomegranate (Punica granatum L.) can be considered a multipurpose medicinal and dietary plant due to its anti-inflammatory and antioxidant actions. Pomegranate can be used to prevent or treat metabolic syndrome (MetS) risk factors. Although previously published reviews addressed the effects of pomegranate on different diseases, there is no systematic review that exclusively focuses on clinical trials related to all MetS-related risk factors. In view of this limitation, the objective of this up-to-date, comprehensive, and systematic review is to critically evaluate the potential of pomegranate (P. granatum) on various MetS risk factors on the basis of clinical studies. PubMed, EMBASE, MEDLINE, Google Scholar, COCHRANE, and Clinical Trials.gov databases were searched on 15 October 2021. The Preferred Reporting Items for a Systematic Review and Meta-Analysis guidelines were followed, and the bias risk evaluation was performed according to the Cochrane Handbook for Systematic Reviews of Interventions. We identified 5683 studies in the databases. After removing the duplicates, 3418 studies remained. Of these, 147 studies met the eligibility criteria, and finally, only 20 were included in the qualitative analysis. The included studies suggest that pomegranate can be beneficial to reduce body weight, blood pressure, glycemia, triglycerides, total cholesterol, and low-density lipoprotein cholesterol. Moreover, it can augment high-density lipoprotein cholesterol levels and improve insulin resistance. Although relevant effects were observed, additional well-designed clinical trials are needed to determine the correct formulations and doses to be used to prevent or treat MetS components.
1. Introduction
Since ancient times, people have appreciated natural agents, and plant-derived substances have been used as a source for food and medicine due to their numerous health properties [1,2]. Pomegranate (Punica granatum L.) can be considered a multipurpose medicinal and dietary plant [3,4]. This species is part of the Punicaceae family and corresponds to being one edible fruit that has been known since antiquity. Native to the center of the Asian continent (specifically to Iran), the pomegranate represents a deciduous shrub or small tree that finds extensive use as a medicinal agent [3,4,5]. This plant has been introduced to other continents, such as America and Africa, thus being cultivated in these areas. The anti-inflammatory and antibacterial properties of pomegranate are well known, and these effects are implicated in the prevention and treatment of various human diseases using this superfruit [6,7].
The most known part of the P. granatum plant is the fruit, which is most used for baking, cooking, and producing beverages [8,9]. This fruit has been used across generations due to its anti-inflammatory, antioxidant, and antitumor effects, alongside its neuroprotection and cardiovascular protection properties [10,11]. P. granatum consumption is also associated with antidiabetic effects and it influences other aspects of the diagnostic components of metabolic syndrome (MetS) [12,13].
The globalized world is beneficial to many aspects of humans’ lives, bringing comfort and facilities to the day-after-day routine. Besides that, the consequent lifestyle changes are considered in many aspects to cause disorders. MetS is a complex metabolic disorder, driving health and socioeconomic challenges worldwide, and is considered an epidemic [14,15]. Affecting both sexes, MetS is associated with many cardiometabolic risk factors, and its prevalence in several countries reaches 30% of the total population. The importance of this metabolic condition remains that this disease is significantly related to an increase in cardiovascular risk, leading to cardiovascular diseases, which are considered the chronic degenerative disorders associated with high morbidity and mortality [15,16,17].
MetS is represented by a cluster of different metabolic abnormalities that include hypertension, abdominal or central obesity, insulin resistance (IR), hyperglycemia, and an atherogenic profile of dyslipidemia (low levels of high-density lipoprotein cholesterol (HDL-c) and high levels of serum triglycerides) [14,15]. This metabolic disorder is a global concern, principally due to its high prevalence among the adult population [16]. Although the pathophysiology of this syndrome involves acquired and genetic factors, other risk factors include a positive family history, low socioeconomic status, physical inactivity, history of diabetes, fatty liver disease, unhealthy alimentary habits, use of specific drugs, the aging process, alcoholism, and smoking [17,18]. IR and obesity are the key points of MetS pathophysiology that primarily include inflammation, neurohumoral activation, and IR [19,20]. In addition to the pro-inflammatory adipokines, stimulation of the renin–angiotensin–aldosterone system and the pro-oxidative state can contribute to chronic inflammation [21,22,23,24]. Figure 1 summarizes the main pathophysiological aspects of MetS and the effects of pomegranate on these dysfunctional risk factors.
Metabolic syndrome and pomegranate: a blocking relationship. ↑, increase; ↓, decrease; Φ, impairment; β, beta; ACE, angiotensin converting enzyme; COX-2, cyclooxygenase; ERK, extracellular signal-regulated kinase; MAPK, mitogen-activated protein kinase; NF-κB, nuclear factor-κB; NO, nitric oxide; PMACI, phorbol 12-myristate 13-acetate and calcium ionophore; PGE2, prostaglandin E2; PTGES, prostaglandin E synthase.
P. granatum contains carbohydrates, fiber, proteins, minerals, and vitamins, alongside other nutrients, that are important for preventing MetS [13]. The fruit and other components of the plant contain numerous bioactive compounds, such as phenolic acids, hydrolysable tannins, condensed tannins, and flavonoids, as well as other types of bioactive constituents [25,26,27,28] that can exert antimicrobial [29], anticancer [30], antioxidant [26,31], and anti-inflammatory activities [28]. The plant can also affect glucose and lipid metabolisms [32,33,34], as well as other metabolic conditions, such as obesity [27,34] and IR [35]. Effects of pomegranate on cardiovascular health have also been reported, together with antiosteoporosis properties [35,36]. Table 1 shows the bioactive components of pomegranate and their effects related to MetS on the basis of preclinical and clinical studies.
Table 1
Bioactive compounds of P. granatum and its actions on the risk factors related to MetS.
| Bioactive Compounds | Plant Parts | Molecular Structures | Effects | References |
|---|---|---|---|---|
| Gallic acid | Peel, juice, flower, seeds, and fruit |  |
Antidiabetic, anti-inflammatory, and antioxidant | [36,37,38,39,40,41,42,43,44] |
| Ellagic acid | Peel, juice, fruit, flower, and seeds |  |
Antidiabetic, anti-obesity, anti-inflammatory, and antioxidant | [32,34,36,37,38,39,40,45,46,47,48] |
| Quercetin | Peel and seeds |  |
Antidiabetic and anti-inflammatory | [8,36,37,38,39,40] |
| Punicalin | Peel, juice, and fruit |  |
Antidiabetic and antioxidant | [36,37,38,39,40,48,49] |
| Epicatechin | Peel |  |
Anti-inflammatory | [36,37,39,48] |
| Tannic acid | Peel |  |
Anti-obesity and antioxidant | [34,50,51,52] |
| Punicalagin | Peel, flower, seeds, juice, and fruit |  |
Antidiabetic, antioxidant, and anti-inflammatory | [8,32,36,37,38,39,46,49] |
| Urolithin A | Polyphenol ellagitannin–gut microbial-derived metabolite |  |
Anti-obesity and anti-inflammatory | [53,54,55,56,57] |
| Urolithin B | Polyphenol ellagitannin–gut microbial-derived metabolite |  |
Anti-obesity and antioxidant | [53,55,56] |
| Anthocyanins | Fruit |  |
Antioxidant | [38,49,58,59] |
Several research groups previously reviewed the effects of pomegranate in various metabolic diseases. Medjakovic and Jungbauer [60] summarized the effects of pomegranate fruit on MetS on the basis of in vitro and in vivo findings. Hou et al. [32] reviewed the preclinical effects of pomegranate on lipid profiles. Jandari et al. [61] provided an overview of pomegranate effects on diabetic patients. Eghbali et al. [25] performed a simple review of clinical trials that evaluated the effects of pomegranate on oral cavity disorders, stomatitis, diabetes, cardiovascular and neoplastic diseases. The study of Akaberi et al. [62] summarized the therapeutic effects of pomegranate and its active constituents in metabolic disorders on the basis of in vitro and in vivo studies. Although these studies are interesting, they are not systematic reviews. Asgary et al. [7] published a systematic review and meta-analysis focused on pomegranate’s actions on vascular adhesion factors. Although previously published reviews addressed the effects of pomegranate on different diseases, there is no systematic review that exclusively focuses on clinical trials related to all MetS-related risk factors. In view of this limitation, the objective of this up-to-date, comprehensive, and systematic review is to critically evaluate the potential of pomegranate (P. granatum) on various MetS risk factors on the basis of clinical studies.
2. Literature Search Strategy and Study Selection
The search for this review was performed on 15 October 2021 and was carried out by two authors (L.F.L. and S.M.B.). For this work, only clinical studies published in English were selected using PubMed, EMBASE, MEDLINE, Google Scholar, COCHRANE, and Clinical Trials.gov databases. The descriptors used were P. granatum or pomegranate and metabolic syndrome or syndrome X, hypertension or blood pressure, lipid profile or lipids or triglycerides or high-density lipoprotein cholesterol, obesity or body weight or waist circumference, insulin resistance or diabetes or glycemia, and clinical trials or trials. All these descriptors helped the authors to identify published clinical trials that associated the consumption of any part or extract of P. granatum or pomegranate with ameliorations of the components of MetS. The guidelines of the 2020 Preferred Reporting Items for a Systematic Review and Meta-Analysis (PRISMA) were followed to perform this systematic review [63]. The inclusion criteria considered randomized controlled trials (RCTs) that included double-blind and single-blind studies, placebo-controlled trials, prospective and crossover studies, triple-blind trials, parallel-group studies, and open-label trials that were published in English. The exclusion criteria comprised of in vitro studies, in vivo studies (such as animal experiments), editorials, review studies, posters presentations, conference abstracts, and case reports. The risk of bias evaluation of the RCTs involved with this systematic review was evaluated according to the Cochrane Handbook for Systematic Reviews of Interventions [64].
3. Result Findings
Figure 2 represents a scheme to depict a literature search and study selection process. We identified 5683 studies in the databases that were searched. After removing the duplicates, 2458 studies remained. Of these, 147 studies met the eligibility criteria and, after applying the inclusion and exclusion criteria, only 20 were included in the qualitative analysis. From the 20 studies selected and included in this systematic review, seven were from Iran [10,12,65,66,67,68,69], four were from the United States [70,71,72,73], three were from the United Kingdom [74,75,76], one was from Mexico [77], one was from Spain [78], one was from Greece [79], one was from Serbia [80], one was from Israel [81], and one was from South Korea [82]. In the included studies, the respective authors used different formulations derived from pomegranate to treat the participants: pomegranate juice [10,12,65,68,69,71,72,73,75,76,77,78,79,80,81], pomegranate extract [68,70,73,74], pomegranate juice enriched with probiotic microorganisms [67], diluted pomegranate juice [66,78], and pomegranate vinegar [82]. The studies did not report serious adverse effects and high drop-outs rates. However, two studies had more than 20% drop-outs [78,81].
From the 20 included RCTs, 828 participants were evaluated in this systematic review. From the total participants, 21 were diagnosed with hypertension, 136 were women diagnosed with polycystic ovary syndrome (PCOS), 175 were healthy subjects, 19 had severe carotid artery stenosis and were symptomatic, 146 were obese or overweight, 112 were diagnosed with type 2 diabetes mellitus (T2DM), 45 had ischemic coronary heart disease and myocardial ischemia, 199 had end-stage renal disease (ESRD) or needed hemodialysis treatment, and 23 were diagnosed with MetS.
The included studies have shown that the treatment with pomegranate, pomegranate extracts, or pomegranate-derived substance was able to improve cardiometabolic risk factors, such as fasting blood glucose and glycemic levels, systolic and diastolic blood pressures, lipid profiles, and body weight, which are the main diagnostic aspects of MetS (Table 2). Total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), HDL-c, serum triglycerides (TG), body mass index (BMI), homeostasis model of assessment insulin resistance (HOMA-IR), systolic blood pressure (SBP), and diastolic blood pressure (DBP), fasting blood glucose levels, and serum insulin levels were assessed from the studies in which these risk factors were disponible. Additionally, in many clinical trials, the inflammatory and oxidative information of the participants were available. These were mainly interleukin-6 (IL-6) levels, C-reactive protein (CRP), high-sensitivity CRP (hs-CRP) levels, malondialdehyde (MDA) levels, and total antioxidant capacity (TAC) levels.
Table 2
The effects of P. granatum on various components of MetS.
| Type of the Study | Country of the Study | Interventions | Lipid Profile | Body Weightor Obesity | Diabetes or IR |
Blood Pressure | Adverse Effects | Reference |
|---|---|---|---|---|---|---|---|---|
| Randomized clinical trial with 42 women participants (18–40 years) diagnosed with PCOS. | Iran | Participants were randomized into two groups: intervention (n = 21, 45 mL/day of concentrated pomegranate juice added to 180 mL of water for 8 weeks) and control (n = 21). | Reduction of TG (p < 0.03) and increase of HDL-c (p < 0.01). No significant changes in the control group. | Intervention BMI: 29.65 ± 0.70 to 29.30 ± 0.72 (p = 0.02) Control BMI: 31.86 ± 1.15 to 31.89 ± 1.17 |
Not significant | Reduction of SBP and DBP (p < 0.001) in the intervention group. Control: no significant changes. | There were no adverse effects. | Abedini et al., 2020 [66] |
| Randomized, triple-blind, placebo-controlled trial with 92 women participants (15–48 years) diagnosed with PCOS. | Iran | Participants received symbiotic pomegranate juice (300 mL/day with symbiotic organisms/8 week) or pomegranate juice (300 mL/day)/8 weeks) or symbiotic beverage (water with symbiotic organisms/8 weeks) or placebo. | SPJ: reduction of LDL-c and increase of HDL-c (p < 0.01); PJ: increase of HDL-c (p < 0.01); SB: decrease of TC and LDL-c (p < 0.01). |
Not reported | Not reported | Reduction of SBP and DBP (p < 0.001) in the intervention group. Control: no significant changes. | Any adverse effects were encountered. | Esmaeilinezhad et al., 2020 [67] |
| Randomized crossover trial with 41 hemodialysis participants (47.8 ± 13.3 years, 25♂, 16♀). | Iran | Participants received pomegranate juice (100 mL right after hemodialysis sections 3 x/week) or placebo. This study had a washout design (4-week period), and the study’s intervention took 20 weeks. | Reduction of TG (p < 0.001) and increase of HDL-c (p < 0.001). No significant changes in the control group. | Not significant | Not reported | Reduction of SBP and DBP (p < 0.001) in the intervention group. Control: no significant changes. | Stomach discomfort was reported by 1 dropped-out participant of the pomegranate juice. | Barati Boldaji et al., 2020 [10] |
| Randomized, single-blind, placebo-controlled clinical trial with 60 participants (40–65 years; 30♀, 30♂) diagnosed with T2DM. | Iran | Subjects were randomly separated into control (n = 30) and treatment (n = 30, 200 mL of pomegranate juice daily/6 weeks). | Not significant. | Not significant | Not reported | Reduction of SBP and DBP (p < 0.001) in the intervention group. Control: no significant changes. | Not reported. | Sohrab et al., 2019 [12] |
| Randomized study with 23 women (aged 40–60 years) diagnosed with MetS. | Serbia | Participants received 300 mL of polyphenolic-rich pomegranate juice daily/6 weeks) or placebo. | Not significant. | Not significant | Not significant | Not significant. | Not reported. | Kojadinovic et al., 2017 [80] |
| Randomized, double-blind, placebo-controlled clinical trial with 53 participants (18–65 years, 40♀, 13♂). | United Kingdom | Participants received pomegranate extract capsule (210 mg of punicalagins, 328 mg of polyphenols, and 0.37 mg of anthocyanins)/day/8 weeks) or placebo. | Not reported. | Not significant | Not reported | Reduction of DBP (p < 0.05) in the intervention group. Control: no significant changes. | Not reported. | Stockton et al., 2017 [74] |
| Randomized and controlled clinical trial with 10 healthy participants (5♂ and 5♀). | Greece | Participants received 500 mL of pomegranate juice daily for 14 days or placebo. | Not significant. | Not significant | Not significant | Not significant. | Not reported. | Manthou et al., 2017 [79] |
| Randomized, double-blind, placebo-controlled trial with 42 (30–60 years) overweight and obese participants. | Iran | Participants received 1000 mg of pomegranate extract containing 40% of ellagic acid daily for 30 days) or placebo. | Intervention: reduction of TC (p < 0.003) and LDL-c (p < 0.009); increase of HDL-c (p < 0.001). |
Not significant | Intervention and control: reduction of GLU (p < 0.001) and IR (p < 0.001) |
Not reported. | One individual in the placebo group presented stomach cramps. | Hosseini et al., 2016 [68] |
| Randomized, double-blind, parallel-group, multicenter, controlled trial with 31 male athletes. | Spain | Participants received placebo or pomegranate juice (200 mL/day) or diluted pomegranate juice (200 mL/day dilute in the same amount of water)/21 day. | PJ and diluted PJ: increase of HDL-c: (p < 0.05). |
Not significant | Not significant | Not reported. | Not reported. | Fuster-Muñoz et al., 2016 [78] |
| Prospective, randomized, crossover clinical trial with 24 participants (13♀, 11♂, 61 ± 14 years) diagnosed with ESRN receiving hemodialysis thrice weekly. | USA | Participants received pomegranate juice (100 mL/day/4 weeks) or pomegranate extract (1050 mg/day/4 weeks). After 4 weeks, there was a washout period of 4 weeks and after the intervention was inverted, the groups received the alternative intervention for more 4 weeks. | Not significant. | Not reported | Not reported | Not significant. | No direct study-related adverse effects were reported. | Rivara et al., 2015 [73] |
| Randomized, placebo-controlled, double-blind with 27 participants that need to pass through hemodialysis. | USA | Participants were randomly assigned into two groups: pomegranate (n = 13, 1000 mg capsule of pomegranate’s purified polyphenol extract 7 days/week for 6 months) and placebo (n = 14). | Not significant. | Not significant | Not reported | Reduction of SBP and DBP (p < 0.05) in the intervention group. Control: no significant changes. | NR here, but the authors suggested no GI adverse effects. | Wu et al., 2015 [70] |
| Randomized, double-blind, placebo-controlled clinical trial with 101 hemodialysis participants (66.5 ± 11.8 years, 54.5%♂ and 45.5♀). | Israel | Participants received 0.7 mmol of polyphenols in form of 100 cc of pomegranate juice, 3 × weeks/1 year or placebo. The interventions were all made during the first hour of dialysis sections. | Reduction of TG (p < 0.05) and increase of HDL-c (p < 0.05). No significant changes in the control group. |
Not reported | Not reported | Reduction of SBP, DBP, and PP (p < 0.05)Control: no significant changes. | NR here, but the authors suggested no GI adverse effects. | Shema-Didi et al., 2014 [81] |
| Randomized and single-blind clinical trial with 21 participants (30–67 years, 15♀, 6♂) diagnosed with hypertension. | Iran | Participants were randomly separated into intervention group (150 mL daily of pomegranate juice for 2 weeks) and control. | Not significant. | Not reported | Not significant | Reduction of SBP and DBP (p < 0.05) in the intervention group. Control: no significant changes. | Not reported. | Asgary et al., 2014 [65] |
| Randomized, double-blind, placebo-controlled clinical trial with 44 participants (40–60 years, 23♂, 21♀) diagnosed with T2DM. | Iran | Participants were assigned into two groups: intervention (250 mL daily of pomegranate juice containing 1946 mg/L of polyphenols for 12 weeks) and control. | Not significant. | Not significant | Not significant | Not reported. | There were no adverse effects. | Sohrab et al., 2014 [69] |
| Randomized, double-blind, placebo-controlled clinical trial with 77 overweight women (20–65 years, BMI of 25–35 kg/m2). | South Korea | Participants received 200 mL/day of pomegranate vinegar containing 1.5 g of acetic acid added to 700 μg of ellagic acid for 8 weeks) or placebo. | Not significant | Not significant | Not significant | Not reported. | Not reported. | Park et al., 2014 [82] |
| Randomized, placebo-controlled, crossover clinical trial with 28 participants (16♀, 12♂). | United Kingdom | Participants received 500 mL of pomegranate juice with 1685 mg/L of polyphenols or placebo/4 weeks. After a 1-week washout period, groups were changed to the alternative experiment (placebo group was transformed in intervention and vice-versa)/4 weeks. | Not significant. | Not significant | InterventionHOMA-IR: 2.216 ± 1.43 to 1.825 ± 1.12 (p = 0.028) ControlHOMA-IR: 2.245 ± 0.23 to 2.226 ± 0.12 (not significant) | Reduction of SBP and DBP (p < 0.031) in the intervention group. Control: no significant changes. | NR here. | Tsang et al., 2012 [76] |
| Randomized, placebo-controlled, parallel-group, open-label clinical trial with 48 healthy participants (30–50 years, 32♀, ♂16 male). | United Kingdom | The groups were intervention (n = 24, 330 mL/day of pomegranate juice for 4 weeks) and control (n = 24). | Not reported | Not significant | Not reported | Reduction of SBP and DBP (p < 0.001) in the intervention group. Control: no significant changes. | n = 2 problems in consumption of the juice. | Lynn et al., 2012 [75] |
| Randomized, double-blind, placebo-controlled clinical trial with 20 obese participants (25–55 years). | Mexico | The obese patients were randomly assigned into two groups: intervention (120 mL of pomegranate juice daily for 1 month, n = 10) and placebo (n = 10). | Not significant | InterventionFM (%): 41.3 ± 6.2 to 39.9 ± 6.5 (p = 0.010) Control FM (%): 36.3 ± 7.7 to 37.4 ± 7.8 |
Not significant | Not reported. | There were no adverse effects. | González-Ortiz et al., 2011 [77] |
| Randomized, double-blind, placebo-controlled study with 45 participants (5♀, 40♂) diagnosed with ischemic coronary heart disease and myocardial ischemia. | USA | Participants were randomly assigned into 2 groups: intervention (240 mL/day of pomegranate juice for 3 months) and control. | Not significant | Not significant | Not significant | Not significant. | Not reported. | Sumner et al., 2005 [71] |
| Randomized clinical trial with 19 participants (65–75 years, 5♀, 14♀) diagnosed with asymptomatic severe carotid artery stenosis. | USA | Participants received pomegranate juice (50 mL/day of pomegranate with 1.5 mmoles of polyphenols for 1 year) or placebo. After this period, 5 participants of the pomegranate intervention agreed to continue the study for up to 3 years. | Not significant | Not significant | Not significant | Reduction of SBP and DBP (p < 0.05) in the intervention group (1 y). Control: no significant changes. | Not reported. | Aviram et al., 2004 [72] |
BMI, body mass index (kg/m2); cc, cubic centimeters (c3); DBP, diastolic blood pressure; ESRN, end-stage renal disease; FM: fat mass; GI, gastrointestinal; GLU, glucose; HDL-c, high-density lipoprotein cholesterol; HOMA, homeostasis model of assessment; IR, insulin resistance; LDL-c, low-density lipoprotein cholesterol; MetS, metabolic syndrome; NR: not reported; PCOS, polycystic ovary syndrome; PJ, pomegranate juice; PP, pulse pressure; SB, symbiotic beverage; SBP, systolic blood pressure; SPJ, symbiotic pomegranate juice; TC, total cholesterol; TG; triglycerides; T2DM, type 2 diabetes mellitus.
Table 3 shows the description of the bias observed in the included studies according to the Cochrane Handbook for Systematic Reviews of Interventions [64]. Undertaking this methodological research tool, we were able to examine if certain sources of bias could show a substantial impact on the quality of the included clinical trials, diminishing the risk of bad systematic review quality.
Table 3
Possible biases of the included randomized clinical trials (RCTs).
| Study | Question Focus | Appropriate Randomization | Allocation Blinding | Double-Blind | Losses (<20%) | Prognostic and Demographic Characteristics | Outcomes | Intention to Treat Analysis | Sample Calculation | Adequate Follow-Up |
|---|---|---|---|---|---|---|---|---|---|---|
| Abedini et al., 2020 [66] | Yes | No | No | No | Yes | Yes | Yes | No | Yes | Yes |
| Esmaeilinezhad et al., 2020 [67] | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes |
| Barati Boldaji et al., 2020 [10] | Yes | Nr | No | No | Yes | Yes | Yes | Yes | Yes | Yes |
| Sohrab et al., 2019 [12] | Yes | Yes | No | No | Yes | Yes | Yes | No | Nr | Yes |
| Kojadinovic et al., 2017 [80] | Yes | Nr | No | No | Yes | Yes | Yes | Yes | Nr | Yes |
| Stockton et al., 2017 [74] | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes |
| Manthou et al., 2017 [79] | Yes | Nr | No | No | Yes | Yes | Yes | Yes | Yes | No |
| Hosseini et al., 2016 [68] | Yes | No | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes |
| Fuster-Muñoz et al., 2016 [78] | Yes | Nr | Yes | Yes | No | Yes | Yes | No | No | No |
| Rivara et al., 2015 [73] | Yes | Nr | No | No | Yes | Yes | Yes | Yes | Nr | Yes |
| Wu et al., 2015 [70] | Yes | Nr | Yes | No | Yes | Yes | Yes | No | Nr | Yes |
| Shema-Didi et al., 2014 [81] | Yes | Nr | Yes | Yes | No | Yes | Yes | No | Nr | Yes |
| Asgary et al., 2014 [65] | Yes | Nr | No | No | Yes | Yes | Yes | Yes | Nr | No |
| Sohrab et al., 2014 [69] | Yes | No | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes |
| Park et al., 2014 [82] | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes |
| Tsang et al., 2012 [76] | Yes | Nr | No | No | Yes | Yes | Yes | Yes | Nr | Yes |
| Lynn et al., 2012 [75] | Yes | No | No | No | Yes | Yes | Yes | No | Yes | Yes |
| González-Ortiz et al., 2011 [77] | Yes | Nr | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| Sumner et al., 2005 [71] | Yes | No | Yes | Yes | Yes | Yes | Yes | No | Nr | Yes |
| Aviram et al., 2004 [72] | Yes | Nr | No | No | Yes * | No | Yes | Yes * | Nr | Yes |
Nr, not reported. * This study had initially 19 participants. After the first year of treatment, only 5 participants continued the study intervention for three years. The ‘’yes’’ is for the 1-year original intervention.
4. Discussion
Several clinical trials investigated the effects of P. granatum in metabolic conditions in humans. These studies are shown in Table 2. The potential bias is described in Table 3. In the following sections, we briefly discuss various RCTs.
Abedini et al. [66] showed that the use of concentrated pomegranate juice can produce beneficial actions on blood pressure, TG, and HDL-c levels. One limitation of this study is the non-double-blinded assessments. Additionally, this study presented a small sample size, which can interfere with the results.
Esmaeilinezhad et al. [67] evaluated the effects of pomegranate juice added to symbiotics on reducing cardiovascular risk factors of women diagnosed with PCOS. The results showed that the pomegranate intervention improved metabolic, oxidative, hemodynamic, and inflammatory characteristics of the treated women. This study was triple-blind, and the sample size was calculated.
The trial of Barati Boldaji et al. [10] assessed the actions of pomegranate juice intake on cardiometabolic risk factors of hemodialysis patients. The study was not double-blind, and there is a lack of a constant control group due to ethical approvements. These ethical consensuses obligated the authors of this study to change the participants between control and intervention groups after a washout period of 4 weeks. This study also presents a small sample size and is not double-blind.
Sohrab et al. [12] conducted a trial to evaluate the actions of pomegranate juice on blood pressure and lipid profiles of individuals affected by T2DM. The main limitation of this study was the short duration of the intervention. The intervention brought benefits on blood pressure rates, although there were no benefits to the individual lipid profiles. Information about possible alterations of fasting blood sugar was not mentioned in the study. Six intervention group participants reported the use of antihypertensive drugs, in turn of seven in the control group. Twenty-seven subjects of the intervention group reported using at least one oral hypoglycemic drug, in turn of 25 in the control group. Seven intervention group participants reported the use of lipid-lowering drugs, in turn of five in the control group. These findings can be potentially biased to the results of the study. Another limitation is that this study was not double-blind, and the duration of the trial was short.
Kojadinovica1 et al. [80] conducted a randomized study to investigate the effects of pomegranate juice on lipid metabolism of women diagnosed with MetS. The sample size was 23, which can be considered a limitation of this study due to its small size. Another limitation lies in the fact that only women were evaluated. Additionally, this clinical trial was not double-blind, and the placebo group received water instead of something that was more similar to pomegranate juice.
Stockton et al. [74] investigated the effects of pomegranate extract capsule intake on blood pressure and anthropometry parameters. The results showed positive effects on DBP and non-significant effects on body-weight parameters and SBP of the participants who received pomegranate intervention.
Manthou et al. [79] investigated the effects of pomegranate juice consumption on biochemical and blood parameters. The sample size was small but was calculated. The results showed positive effects on erythropoiesis and a non-significant impact on lipid profiles and glucose levels. One limitation is that this study is not a double-blind trial. Furthermore, there is a lack of demographic information of the participants of each group (intervention and control).
The trial of Hosseini et al. [68] evaluated the effects of pomegranate extract intake on inflammatory parameters of obese and overweight individuals. One relevant limitation of this trial is the small duration.
Fuster-Muñoz et al. [78] conducted a trial to evaluate the actions of pomegranate juice consumption on circulating cytokines and OS parameters of athletes. This study was conducted only with men and had a high drop-out rate. Although the intervention occurred in a short time (21 days), changes in malondialdehyde and carbonyls were observed. Besides this, the control group did not consume a placebo, but rather a small piece of the proper pomegranate fruit.
Rivara et al. [73] performed a study to evaluate the actions of pomegranate supplementations in patients submitted to hemodialysis (patients diagnosed with end-stage renal disease). The results of this trial showed that the interventions were well tolerated. However, none of them demonstrated significant benefits to lipid profiles or inflammatory and OS parameters. One limitation of this trial is the small size of the studied sample, which can limit the study results. Another limitation is that this study is not double-blind.
Wu et al. [70] discussed the effects of supplementation of a pomegranate extract on physical function and cardiovascular risk factors of hemodialysis patients. It was found that the treatment with pomegranate extract reduced SBP and DBP and increased antioxidant capacities. In the pomegranate extract supplementation group, paraoxonase-1 activity was increased by more than 26. Information about fasting blood glucose rates was not found in this study. At baseline, the characteristics of blood pressures between intervention and control groups were very different. Another limitation of this trial is that it used a small sample, which can limit the study conclusions. Moreover, the study was not double-blind.
Shema-Didi et al. [81] conducted a trial with hemodialysis participants. After the intervention time, HDL-c, TG SBP, DBP, and pulse pressure rates were improved. One strong point of this trial is the long-term interventional period, although the intervention with polyphenolic-rich pomegranate juice was performed only three times weekly. The high dropout rate observed in this study and the resulted small sample size are all limitations that can limit the study results.
The trial performed by Asgary et al. [65] evaluated the actions of pomegranate juice in blood pressure, endothelial function, inflammation, and lipid profiles of hypertensive subjects. The results showed hypotensive effects, in addition to effects ameliorating endothelial function. The small sample size, the percentage of women participants in both groups (more than 70% in each group), and the non-double-blinded assessments are all characteristics that may interfere with the results of the study. Moreover, the intervention period was small (2 weeks).
Sohrab et al. [69] evaluated the effects of pomegranate juice intake on participants diagnosed with T2DM. The sample size of this RCT was calculated, but there were six drop-outs. This study demonstrated that pomegranate juice can exert anti-inflammatory effects on participants diagnosed with T2DM due to measurements of inflammatory biomarkers. This intervention presented a complete table of dietary factors involved at baseline and in the participants’ final intervention. OS parameters could have been measured, and this is a limitation of the study.
The trial performed by Park et al. [82] evaluated the actions of pomegranate vinegar on visceral fat accumulation. The intervention led to a reduction in the visceral accumulation of fat in the treated participants and enhanced AMPK (AMP-activated protein kinase) phosphorylation, which only improved adiposity levels. One limitation of this trial is that only women were included, which can limit its conclusions.
Tsang et al. [76] performed a trial to evaluate the actions of pomegranate juice on the urinary glucocorticoid homeostasis model assessment of insulin resistance (HOMA-IR) and blood pressure of volunteers. This trial was not double-blind, and the sample was small. Furthermore, some data are missing, such as for weight and BMI of the control group.
Lynn et al. [75] evaluated the effects of pomegranate juice on pulse wave velocity and blood pressure parameters. There was a sample size calculation, but the design was open label. The adverse effects were not reported. Possible modifications of lipid profiles and glucose parameters from baseline to the end of the intervention were not demonstrated.
González-Ortiz et al. [77] conducted a trial to evaluate the effects of pomegranate juice consumption on insulin parameters of obese participants. This study had a calculated sample size and was double blind. There was a lack of demographic information about the participants between the groups. No adverse effects were reported.
Sumner et al. [71] investigated the effects of pomegranate juice consumption on myocardial perfusion of individuals diagnosed with ischemic coronary heart disease and myocardial ischemia. Participants of both groups presented use of lipid-lowering, antihypertensive, and antidiabetic drugs, in addition to the use of nitrates by some participants. After the interventional period, the stress-induced extent of ischemia was diminished in the treated group and increased in the control. In addition, hypertensive and hyperlipidemic subjects were more prevalent in the pomegranate juice group than the control. Moreover, hypertensive and hyperlipidemic subjects were more prevalent in the pomegranate juice group than the control.
Aviram et al. [72] conducted a trial to evaluate the effects of pomegranate juice on participants diagnosed with carotid artery stenosis. This study was initially designed for one year, but some participants agreed to continue the intervention along for up to 3 years. This 3-year consumption reduced standard carotid intima-media thickness, LDL oxidation, and blood pressure. The improvements in blood pressure were accentuated in the first 1 year of intervention. This study was not double-blind, and there is a lack of confident prognostic and demographic information about the participants, which can be limitations of the study. Moreover, adverse effects were not well reported.
Various bioactive actions of P. granatum can be useful in the prevention or the reduction of several health disorders, including reduction of MetS risk factors, since they can reduce inflammation and OS, thus preventing damage to cell components, reducing insulin resistance and improving dyslipidemia and fat accumulation [38,39,49,58,59,83].
Moreover, P. granatum possesses flavonoids, tannins, ascorbic acid, α-tocopherol, and β-carotene that also can be related to the improvement of the oxidative damage observed in patients with the above-mentioned MetS risk factors. In the peel and in the juice, it is possible to identify the presence of punicalagin, a potent antioxidant compound. The peel also contains catechins, gallic acid, ellagic acid, punicalagin, ellagitannins, and punicalin. These bioactive compounds can decrease the risk of development of endothelial dysfunction and cardiovascular outcomes [38,39,49,58,59,83].
P. granatum and its BCs are well tolerated and exert health effects both in human and animal organisms. The plant and its derivatives and extracts ameliorate some altered metabolic affections, such as diabetes, hypertension, and dyslipidemia. Added to that, pomegranate can be used to protect against hypertension. However, the results of RCTs that assess these effects are diverse. Nevertheless, the conduction of other RCTs is extremely necessary to the correct establishment of effective doses, treatment periods, and pharmaceutical presentations needed for the use of pomegranate to treat and prevent MetS diagnostic components.
Figure 3 summarizes the most relevant findings of the included RCTs. Pomegranate constituents have been responsible for reducing systolic and diastolic blood pressure, as well as body weight. Additionally, the use of pomegranate has also been linked to reduced dyslipidemia and improved HDL-c levels. Lastly, pomegranate treatments improved glycemia.
Pertinent findings of the included randomized clinical trials. ↑, increase; ↓, decrease; HDL-c, high-density lipoprotein cholesterol; LDL-c, low-density lipoprotein cholesterol; RCTs, randomized clinical trials; TC, total cholesterol; TG, triglycerides.
5. Conclusions
On the basis of the results as presented in this systematic review, we can conclude that the use of pomegranate can be beneficial in exerting reductions of MetS risk factors, such as body weight, blood pressure, glycemia, triglycerides, LDL-c, and total cholesterol. Moreover, it can augment HDL-c levels. Although these effects have been observed, more clinical studies are necessary to determine the correct formulations and doses that should be used to prevent or treat MetS components.
Acknowledgments
The authors attribute to Smart Servier (https://smart.servier.com/ accessed on 31 October 2021) the provision of some images that were included in this article under license of public copyrights (https://creativecommons.org/licenses/by/3.0/ accessed on 31 October 2021) and disclaimer of warranties. The Smart Servier’s images were not modified while preparing certain illustrations.
Author Contributions
Conceptualization, A.B., L.F.L. and S.M.B.; methodology, A.B., L.F.L. and S.M.B.; software, A.B., L.F.L., A.R.M. and S.M.B.; validation, A.I.d.S.G., R.d.A.G., R.J.T., A.B., A.R.M., S.M.B. and L.F.L.; formal analysis, A.B., A.R.M., L.F.L. and S.M.B.; investigation, A.B., A.R.M., L.F.L. and S.M.B.; resources, S.M.B. and A.B.; data curation, S.M.B. and A.B.; writing—original draft preparation, A.B., A.R.M., L.F.L. and S.M.B.; writing—review and editing, A.B., A.R.M., L.F.L. and S.M.B.; visualization, A.B. and S.M.B.; supervision, S.M.B. and A.B.; project administration, A.I.d.S.G., R.d.A.G., R.J.T., A.B., A.R.M., S.M.B. and L.F.L. All authors have read and agreed to the published version of the manuscript.
Kami (Amjad H. Jarrar dan rakan-rakan) berhasrat untuk mengkaji kesan Gum Arabic pada mereka yang mempunyai, atau berisiko, sindrom metabolik untuk mengenal pasti kesan ke atas meningkatkan parameter penyakit penting yang berkaitan dengan hasil kardiovaskular.
Percubaan single-blind, randomized, placebo-controlled trial, telah dijalankan untuk mengenal pasti kesan suplemen Gam Arabic harian ke atas faktor risiko metabolik dan kardiovaskular. Sebanyak 80 peserta secara rawak menerima 20 g Gum Arabic setiap hari (n = 40) atau plasebo (1 g pektin, n = 40) selama 12 minggu. Titik akhir utama termasuk indeks antropometri badan, diet dan penilaian aktiviti fizikal, dan kimia darah (HbA1c, glukosa puasa dan lipid darah). Daripada 80 yang mendaftar, 61 telah menyelesaikan kajian (intervensi: 31, kawalan: 30) dengan 19 tercicir kerana pematuhan rawatan yang lemah.
Selepas 12 minggu, peserta yang menerima Gam Arabic menunjukkan penurunan ketara dalam tekanan darah sistolik dan diastolik, jisim badan tanpa lemak, penggunaan tenaga dan karbohidrat, dan glukosa plasma puasa, serta peningkatan pengambilan serat makanan. Mereka juga melaporkan peningkatan dalam kembung perut yang dirasakan sendiri dan kualiti pergerakan usus, serta penurunan skor selera makan berikutan penggunaan Gam Arabic . Keputusan ini menunjukkan bahawa Gam Arabic boleh menjadi ubat tambahan yang selamat dan bermanfaat kepada rawatan lain bagi mereka yang mempunyai, atau berisiko, sindrom metabolik.
Kajian ini membandingkan kumpulan intervensi yang menerima 20 g Gum Arabic setiap hari selama 12 minggu dengan kumpulan kawalan yang menerima plasebo harian yang mengandungi 1 g pektin untuk tempoh yang sama. sasaran akhir utama kajian adalah glukosa darah, profil lipid, tekanan darah, komposisi badan, gerakan gastrousus, dan rasa kenyang.
Kajian ini dijalankan di jabatan Pemakanan dan Kesihatan, Kolej Makanan dan Pertanian di Universiti Emiriah Arab Bersatu (UAEU) dalam tempoh Januari hingga Mei 2018. Kajian ini dijalankan mengikut prinsip deklarasi Helsinki mengenai etika penyelidikan manusia
dan telah diluluskan oleh jawatankuasa etika penyelidikan saintifik UAEU (rujuk. no. ERH_2016_4372).
Pengambilan harian 20 g Gum Arabic selama 12 minggu telah memperlihatkan peningkatan rasa kenyang dan mengurangkan pengambilan tenaga dan karbohidrat dengan ketara. Ia juga meningkatkan tekanan darah, glukosa darah, dan pergerakan usus, sambil meningkatkan rasa kenyang. Ini meletakkan Gam Arabic sebagai makananan tambahan yang berpotensi kepada mereka yang mempunyai atau berisiko mengalami sindrom metabolik. Gam Arabic ialah bahan yang bak untuk suplemen, kerana ia boleh dimakan, selamat dan sudah tersedia secara meluas dalam tetapan industri.
Ia terbukti mempunyai kesan yang bermanfaat dalam beberapa bidang utama yang relevan untuk meningkatkan kualiti hidup mereka yang mengalami sindrom metabolik, dan boleh menjadi satu cara untuk mengurangkan beban penyakit NCD di seluruh dunia.
Kajian penuh boleh layari: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7826716/
]]>Latar Belakang:
Ekstrak biji anggur (GSE) ialah suplemen semulajadi yang terkenal dengan pelbagai manfaat kesihatannya, termasuk kesan anti-radang. Kajian ini bertujuan untuk menilai kesan suplemen GSE pada keradangan, neuropeptida Y, ukuran antropometrik, dan selera makan dalam individu obes atau berat badan berlebihan.
Kaedah dan bahan:
Percubaan double-blind clinical trial telah dilakukan ke atas 40 subjek obes atau berat badan berlebihan yang secara rawak ditugaskan untuk menerima GSE (300 mg/hari) atau plasebo untuk tempoh 12 minggu. Kedua-dua kumpulan berada di bawah diet kalori terhad (RCD)(~250 kcal lebih rendah daripada anggaran keperluan tenaga). Pengukuran antropometrik, biomarker biokimia dan pengambilan diet ditentukan semasa tempoh kajian.
Keputusan:
Pengurangan berat badan, indeks jisim badan, lilitan pinggang, dan nisbah pinggang ke pinggul adalah lebih tinggi dengan ketara dalam kumpulan GSE berbanding kumpulan plasebo (P = 0.045, 0.033, 0.029, dan 0.021, masing-masing). Tahap neuropeptida Y yang lebih rendah, alfa faktor nekrosis tumor, dan protein C-reaktif sensitiviti tinggi diperhatikan dalam kumpulan GSE berbanding dengan kumpulan plasebo (P = 0.041, 0.001, dan 0.034, masing-masing).
Kesimpulan:
Suplemen GSE dengan RCD mempunyai kesan yang baik dalam mengurangkan ukuran antropometrik dan penanda keradangan dalam individu obes atau berat badan berlebihan, dan mungkin memainkan peranan yang berkesan dalam rawatan obesiti.
Artikel asal: https://pubmed.ncbi.nlm.nih.gov/31713941/#affiliation-1w
]]>Dalam keadaan normal, sel darah merah berbentuk bundar dan lentur dan mudah bergerak dalam pembuluh darah. Anemia Sel Sabit adalah penyakit melibatkan bentuk sel darah yang abnormal iaitu berbentuk sabit atau “C”.
Bagi pesakit Anemia Sel Sabit, sel darah merah menjadi keras dan melekit serta sel cepat mati. Jadi pesakit akan selalu kekurangan darah (Anemia). Keadaan sel yang keras dan melekit boleh menyebabkan sel darah bergumpal dan menyebabkan sumbatan salur darah yang mampu menyebabkan masalah serius yang lain seperti jangkitan atau strok.
Di Malaysia, Secara keseluruhannya, 21.3% dari populasi rakyat Malaysia mengalami anemia yang dianggarkan kira-kira 4.6 juta orang. Mengikut negeri, kadar Anemia di Kelantan adalah tertinggi iaitu 27.2% dari populasi keseluruhan.
Satu kajian oleh Lamis AbdelGadir Kaddam dari Alneelain University, Sudan dan Anas Suliman Kaddam dari Institute of Tropical Medicine, Sudan Academy of Sciences, Sudan ke atas Al manna (gum arabic) bagi melihat Kesan Gum Arabic (al manna) terhadap tahap protein C-reaktif dalam kalangan pesakit anemia sel sabit. Kajian ini diterbitkan pada 18 Mac 2020 di PubMed.
Objektif Kajian
Keradangan adalah proses berterusan di kalangan anemia sel sabit walaupun dalam keadaan stabil. Protein C reaktif (CRP) adalah penanda kardinal yang digunakan secara meluas sebagai penunjuk keradangan. Gum Arabic (al manna) ialah exudates bergetah daripada pokok Acacia senegal. Penapaian oleh bakteria kolon meningkatkan kepekatan serum butyrate, jadi dianggap sebagai agen prebiotik. Gum Arabic (al manna) mempunyai aktiviti anti-radang melalui butyrate.
Terdahulu kami telah membuktikan bahawa pengambilan Gum Arabic (al manna) GA secara tetap meningkatkan hemoglobin janin dan kapasiti anti-oksida yang berkemungkinan besar melalui peningkatan paras butirat, yang akan mengurangkan gejala anemia sel sabit. Sepanjang pengetahuan kami ini adalah kajian pertama yang dijalankan untuk menyiasat pengambilan Gum Arabic (al manna) pada penanda keradangan di kalangan pesakit sabit.
Keputusan Ini adalah kajian retrospektif yang dijalankan ke atas sampel yang disimpan daripada percubaan Gum Arabic dan anemia sel sabit. CRP kuantitatif diukur oleh Mindray BS 200 sebelum dan selepas penggunaan Gum Arabic selama 12 minggu. Pengambilan harian Gum Arabic (al manna) menurunkan tahap protein C reaktif dengan ketara (P.V = 001) (95% CI 0.943–3.098). Tiada korelasi antara CRP dan umur, hemoglobin janin, penanda hemolisis dan sel darah putih.
Penemuan kami mendedahkan kesan baru Gum Arabic (al manna) sebagai agen anti-radang boleh dimakan sebagai makanan tambahan semula jadi untuk memodulasi keterukan penyakit dan mengecilkan proses keradangan.
Pengenalan
Anemia sel sabit (SCA) adalah penyakit genetik resesif autosomal yang terhasil daripada mutasi titik tunggal pada kedudukan 6 rantai β-globin, yang membawa kepada penghasilan hemoglobin S (HbS) [1]. Afrika adalah asal utama mutasi sabit (βS) [2, 3]. Pempolimeran hemoglobin sabit terdeoksigen adalah peristiwa utama dalam patogenesis molekul penyakit sel sabit dan bertanggungjawab untuk fenomena vasooklusif yang merupakan ciri penyakit [4].
Penyakit sel sabit (SCD) telah lama diiktiraf sebagai keadaan keradangan dan tekanan oksidatif memainkan peranan penting dalam patofisiologi SCA [5]. Pesakit SCA mempunyai pelbagai penunjuk tindak balas keradangan, termasuk peningkatan jumlah sel putih, tahap protein C-reaktif (CRP), sitokin, serta monosit, neutrofil, platelet, dan sel endothelial yang diaktifkan [4].
Hati menghasilkan CRP sebagai sebahagian daripada tindak balas fasa akut, sebagai tindak balas kepada pelbagai sitokin pro inflamasi [6, 7]. CRP mempunyai penerimaan luas sebagai penunjuk yang boleh dipercayai untuk keradangan sistematik dan kerosakan tisu [7, 8]. Tahap CRP yang tinggi, sebagai penanda umum keradangan, telah dilaporkan sebelum ini dalam pesakit SCD dan tikus sabit [5, 9].
Peningkatan CRP dalam pesakit SCA mungkin sebagai tindak balas kepada kerosakan endothelium akibat penyumbatan endothelium vaskular oleh eritrosit sabit [5]. Selanjutnya, nampaknya CRP dinaikkan walaupun semasa tempuh krisis bebas iaitu antara keadaan mantap [6, 10]. Ketinggian CRP semasa keadaan mantap mungkin dikaitkan dengan episod oklusif vaso klinikal subklinikal, yang menimbulkan tindak balas keradangan terselindung [10]. Tindak balas ini dimediasi oleh sitokin terutamanya IL6 [10].
FDA AS mengiktiraf Gum Arabic (al manna) sebagai salah satu serat pemakanan yang paling selamat [11, 12]. Gum Arabic (al manna) tidak boleh dihadam untuk kedua-dua manusia dan haiwan; penapaiannya oleh bakteria usus kolon membawa kepada pembentukan pelbagai produk degradasi, seperti asid lemak rantai pendek [13].
Pengambilan Gum Arabic meningkatkan kepekatan asid lemak rantai pendek serum, terutamanya butirat dan propionat [11, 14]. Kepekatan butirat serum meningkat selepas pentadbiran GA dalam subjek yang sihat [11, 15]. Butyrate mempunyai kesan anti-radang yang kuat. Ia mengurangkan ekspresi sitokin pro-radang melalui perencatan NFκB [16, 17]. Pengambilan oral Gum Arabic (al manna) telah ditunjukkan untuk memberikan beberapa manfaat kesihatan[18], seperti kesan prebiotik [12]..
Gum Arabic (al manna) mempunyai imun-modulasi [13, 19], anti-radang [20],dan sifat antioksidan [11, 12, 21, 22]. Kami membuat hipotesis degradasi Gum Arabic (al manna) menyampaikan asid lemak rantai pendek, yang seterusnya telah ditunjukkan untuk merangsang ekspresi hemoglobin janin dalam RBC seperti yang dikaji sebelum ini [23].. Juga, berfungsi sebagai agen anti-radang melalui pengeluaran Asid Lemak Rantaian Pendek (SCFA) dan memberikan sedikit perlindungan terhadap kesan merosakkan keradangan dan krisis vaso-oklusif. Kajian ini menguji sama ada Gum Arabic boleh mempengaruhi tahap CRP. Untuk pengetahuan terbaik kami, ini adalah kajian pertama yang dijalankan untuk menyiasat kesan pemberian oral GA pada penanda keradangan dalam pesakit anemia sel sabit.
Method
Ini adalah kajian retrospektif yang dijalankan ke atas sampel darah yang mengandungi Gum Arabic (al manna) dan ujian klinikal sel Sabit.
Kriteria kemasukan, pemantauan klinikal, dan pengukuran makmal telah diterangkan secara terperinci sebelum ini [23]. Pesakit berada dalam keadaan stabil seperti yang ditakrifkan sebagai tempoh bebas krisis selama 3 minggu dan 3 bulan atau lebih selepas pemindahan darah terakhir [10].
Sampel darah dikumpulkan sebelum mentadbir Gum Arabic (al manna) dan selepas 12 minggu, seperti yang dinyatakan dalam protokol percubaan [22].
Dua ml dalam bekas EDTA, Tiga ml dalam bekas biasa. Serum dan plasma dipisahkan dengan sentrifugasi dan disimpan pada suhu - 85 °C. Sampel darah disimpan antara dua belas dan lapan belas bulan sebelum analisis. Kajian mendedahkan bahawa CRP boleh kekal stabil lebih daripada sepuluh tahun apabila disimpan pada / kurang daripada - 80 °C [24, 25].
Pengurusan Gum Arabic – Al Manna
Kaedah meguruskan Gum Arabic (al manna) telah diterangkan secara terperinci dalam laporan sebelumnya [23]. Sifat dan komposisi Gum Arabic (al manna) disenaraikan di tempat lain [21]. CRP kuantitatif diukur oleh Mindray BS 200 menggunakan kaedah turbidimetri dan dinyatakan dalam mg/L. Prinsip ujian: Penentuan kepekatan CRP melalui pengukuran fotometrik imunokompleks antara antibodi CRP dan CRP yang terdapat dalam sampel, peningkatan penyerapan adalah berkadar terus dengan kepekatan CRP [26]. Data dianalisis menggunakan SPSS versi 24. Ujian T sampel berpasangan digunakan untuk membandingkan antara keputusan pra dan pasca intervensi. Korelasi orang digunakan untuk mengkaji korelasi antara pembolehubah yang dipertikaikan. Nilai P sama atau kurang daripada 0.05 dianggap signifikan.
Keputusan
Tiga puluh empat sampel tersedia untuk analisis CRP sebelum dan selepas pentadbiran Gum Arabic (al manna).
Table 1
Demographics and baseline characteristics
| Characteristics | Mean | SD | Median | Minimum | Maximum |
|---|---|---|---|---|---|
| Age | 15.65 | 8.9 | 14 | 5 | 42 |
| Gender | 17(50%) Male | ||||
| Base line weight (Kg) | 35·34 | 1.68 | 35 | 13 | 63 |
| Base line height (Cm) | 147·1 | 23·21 | 154·5 | 107 | 190 |
| Hb (g/dL) | 7.28 | 1.105 | 7 | 11 | 5.5 |
| Hb F (%) | 7.83 | 6.53 | 6.2 | .00 | 29.60 |
| Hb S (%) | 88.89 | 6.22 | 91 | 68.00 | 97.00 |
| CRP (mg/L) | 4.22 | 5.89 | 2.3 | 0.10 | 27.80 |
| WBCs (103/uL) | 14.51 | 4.45 | 13.8 | 7.60 | 26.00 |
| LDH (U/L) | 688.19 | 220.44 | 630 | 352.00 | 1250.00 |
Daily oral intake of GA significantly decreased CRP level (Fig. 1).
Effect of GA intake on CRP (P value = 0.001). *Indicates significant difference from baseline
CRP showed no significant correlation with age, HbF level, TWBCs counts, Platelets count, and LDH level (Table 2).
Ciri-ciri latar belakang pesakit dibentangkan dalam Jadual 1. Kesemuanya adalah orang Sudan; 50% adalah lelaki (umur 5 hingga 42 tahun). Lima pesakit diberi dos stabil hydroxyurea 500 g sehari. Tempoh rawatan adalah selama 12 minggu.
Pengambilan oral harian GA menurunkan tahap CRP dengan ketara (Rajah 1).
CRP tidak menunjukkan korelasi yang signifikan dengan umur, tahap HbF, kiraan TWBC, kiraan Platelet dan tahap LDH (Jadual 2).
Table 2
Correlation of different biomarkers with CRP level among SCA patients
| Bio marker | Person correlation | P value |
|---|---|---|
| Age | − .091 | 0.608 |
| Hb F | − .133 | 0.452 |
| Hemoglobin | .169 | 0.339 |
| WBCs | .155 | 0.383 |
| Platelets | − .124 | 0.486 |
| Reticulocytes | .146 | 0.589 |
| LDH | − .300 | 0.101 |
| Urea | − .180 | 0.333 |
| Creatinine | .070 | 0.710 |
Perbincangan
Penyakit sel sabit adalah kecacatan hemoglobin yang paling biasa di seluruh dunia, dengan kejadian yang tinggi di sub-Sahara Afrika [27].Terdapat bukti kukuh yang menjana hubungan rapat antara proses keradangan kronik dan penyakit sel sabit [28, 29]. Yang ia kelihatan sebagai ciri yang wujud dari sel endothelia sabit [29].
Keradangan mempunyai peranan asas dalam banyak komorbiditi dan kematian yang berkaitan dengan SCD seperti sindrom dada akut contohnya. CRP adalah penanda yang paling biasa dinilai untuk keradangan akut dan kronik [28]
Dalam kajian semasa, kami mendedahkan tiada hubungan yang signifikan antara tahap CRP dan Hb F (Table 2). Keputusan kami adalah setanding dengan kajian terdahulu, yang mentafsir keputusan mereka kepada faktor luaran lain seperti keradangan dan vaso-oklusi akibat SCA [6]. Monosit, neutrofil, dan platelet juga terlibat secara aktif dalam pelbagai interaksi pelekat dan manifestasi klinikal [30]. Hemolisis kronik memainkan peranan utama dalam keradangan, di kalangan pesakit HbSS keadaan mantap yang mungkin melalui kecederaan endothelial vaskular subklinikal dan kejadian vasoocclusive sementara [9]. Sebaliknya, tiada penanda hemolitik (LDH, kiraan Reticulocyte, kepekatan Hb) berkorelasi secara statistik dengan tahap CRP dalam kajian ini (Table 2). Tahap CRP boleh diaktifkan oleh sitokin pro-radang lain seperti Tumor Necrosis Factorα dan IL-1b [9]. yang didapati secara konsisten meningkat di kalangan pesakit SCA [31]. Keputusan ini disahkan kemudian oleh penyiasat lain yang mendapati tiada perbezaan yang signifikan antara TNFα dan tahap sitokin inflamasi lain antara SCA dalam keadaan mantap dan dalam krisis vaso-oklusif [30].
Gum Arabic (al manna) menurunkan tahap CRP dengan ketara (Rajah 1). Kesan baru Gum Arabic (al manna) ini mungkin sangat penting, kerana keradangan adalah komponen kardinal patofisiologi SCD [32]. Kajian terdahulu menunjukkan kesan anti-radang Gum Arabic (al manna) kerana ia mengurangkan beberapa penanda keradangan seperti TNFα, ESR dan CRP [19, 20].
Pengurangan tahap CRP boleh diakreditasikan kepada sifat prebiotik Gum Arabic (al manna) . Oleh kerana beberapa kajian mencadangkan bahawa perubahan dalam mikrobiota usus boleh mengurangkan keradangan [33–35]. SCFA khususnya butyrate mempunyai kesan anti-radang yang kuat[16, 17, 36]. Percubaan klinikal Gum Arabic (al manna) di kalangan pengeluaran HbF yang disebabkan oleh sabit [23] dan ini mungkin mempunyai peranan dalam pengurangan proses keradangan yang berterusan dan menurunkan tahap CRP.
Walau bagaimanapun, kami mendapati tiada korelasi yang signifikan antara CRP dan hemoglobin janin (Table 2) Sebaliknya, terdapat hubungan yang kuat mengenai tekanan oksidatif dan keradangan dan kedua-duanya dikaitkan dengan patogenesis SCD [5, 32, 37–39].. Terdahulu kami mendokumenkan Gum Arabic (al manna) mempamerkan sifat anti-oksidan yang kuat di kalangan pesakit SCA [22]. Oleh itu, pengurangan dalam CRP boleh menjadi sekunder untuk penurunan dalam penanda tegasan oksidatif. Banyak terapi antioksidan menimbulkan tindak balas anti-radang [32].
Kesimpulannya, keputusan kami mendapati bahawa keradangan di kalangan pesakit sel Sabit adalah proses berterusan walaupun dalam tempoh keadaan mantap. Gum Arabic (al manna) menurunkan tahap CRP dengan ketara, penemuan mendedahkan kesan inovatif Gum Arabic (al manna, yang mungkin dimakan sebagai serat pemakanan semula jadi untuk melemahkan keradangan dalam pesakit SCD dan patogenesis lain yang dikaitkan dengan proses keradangan.
Artikel asal: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7079462/
]]>
Selain itu, data terkini menunjukkan bahawa diabetes adalah masalah kesihatan awam yang semakin meningkat di rantau Timur Tengah dan Afrika Utara (MENA); prevalens T2DM di rantau ini kini dianggarkan pada 9.7% [2]. Adalah penting untuk kita menangani isu kesihatan awam ini dengan mengkaji potensi punca penyakit ini yang berbeza dan kelazimannya yang semakin meningkat.
Terdapat dua hormon utama yang terlibat dalam diabetes. Ini dirembeskan dalam pulau pankreas sel β Langerhans: insulin dan Polipeptida Amyloid Islet manusia (hIAPP atau amylin). Insulin telah menjadi yang paling biasa dikaji daripada kedua-dua ini, dan kami mendapati lebih sedikit data mengenai peranan amilin asli, terutamanya bentuk patologinya [3]. hIAPP dilaporkan bertanggungjawab untuk pembentukan amiloid semasa T2DM [[4], [5], [6]].
Terdapat beberapa peptida dan protein lain yang turut menyebabkan pembentukan amiloid akibat daripada oligomerisasi yang menyimpang dan pemendapan ke dalam pelbagai agregat. Proses ini membawa kepada sejumlah besar penyakit patologi, termasuk penyakit Parkinson (PD), penyakit Alzheimer (AD) dan T2DM [[7], [8], [9]].
Kandungan polifenol buah kurma telah diuji dan didapati berkesan sebagai terapi yang berpotensi untuk pencegahan dan rawatan diabetes mellitus jenis 2. Kajian yberkenaan telah dijalankan oleh penyelidik dari Weill Cornell Medicine Qatar dan juga Aligarh Muslim University, India iaitu Ali Chaari 1, Basma Abdellatif 2, Faisal Nabi 3, Rizwan Hasan Khan 3
Latar belakang kajian:
Kematian sel-β adalah ciri utama diabetes mellitus jenis 2 (T2DM). Kajian terbaru mencadangkan bahawa diet berasaskan buah kurma memberikan pelbagai manfaat kesihatan, kerana buah-buahan ini secara semulajadi diperkaya dengan polifenol tumbuhan.
Kaedah:
Dalam kajian ini, kami menggunakan pendekatan biofizikal yang luas, menggunakan teknik biologi sel dan alat bioinformatik, untuk menunjukkan bahawa pelbagai polifenol daripada buah kurma (Phoenix dactylifera L.) menghalang pengagregatan dan sitotoksisiti hIAPP dengan ketara.
Keputusan:
Keputusan kami menunjukkan bahawa semua polifenol menunjukkan kesan perencatan, walaupun berbeza-beza, pada pembentukan amiloid hIAPP toksik. Korelasi antara ujian daya maju sel, permeabilisasi ujian vesikel fosfolipid sintetik, dan ukuran florescence ANS, mendedahkan bahawa kedua-dua kelas polifenol melindungi sel INS-1E daripada ketoksikan agregat amylin.
Keputusan dok menunjukkan bahawa polifenol yang digunakan berinteraksi secara fizikal dengan kedua-dua kawasan amiloidogenik hIAPP (sisa Ser20-Ser29) dan kawasan bukan amiloidogenik melalui interaksi hidrofobik dan hidrogen, sekali gus mengurangkan tahap pengagregatan.
Kesimpulan:
Penemuan ini menyerlahkan faedah pengambilan kurma dan potensi besar polifenolnya sebagai terapi yang berpotensi untuk pencegahan dan rawatan diabetes mellitus jenis 2 T2DM serta untuk banyak penyakit berkaitan amiloid lain.
Sumber: https://www.sciencedirect.com/science/article/pii/S0141813020341702?via%3Dihub#!
]]>Kajian itu menyimpulkan bahawa polifenol dalam daun zaitun berfungsi meningaktkan kepekaan aktiviti insulin sebanyak 15%. Ini sangat berguna untuk mengawal kelestarian proses penguraian gula dalam darah terutamanya kepada mereka yang mengalami obesiti atau berlebihan berat badan.
Latar belakang Kajian
Daun zaitun (Olea europaea L.) telah digunakan selama berabad-abad dalam perubatan rakyat untuk merawat diabetes, tetapi terdapat data yang sangat terhad yang mengkaji kesan polifenol zaitun pada homeostasis glukosa pada manusia.
Objektif
Untuk menilai kesan suplemen dengan polifenol daun zaitun (51.1 mg oleuropein, 9.7 mg hydroxytyrosol sehari) ke atas tindakan insulin dan faktor risiko kardiovaskular pada lelaki yang berlebihan berat badan pertengahan umur.
Reka bentuk
Percubaan silang secara rawak, double blind, plasebo terkawal, di New Zealand. 46 peserta (berumur 46.4±5.5 tahun dan BMI 28.0±2.0 kg/m2) dipilih secara rawak untuk menerima kapsul ekstrak daun zaitun (OLE) atau plasebo selama 12 minggu selama 6 minggu. Hasil utama ialah kepekaan insulin (kaedah Matsuda). Hasil sekunder termasuk profil glukosa dan insulin, sitokin, profil lipid, komposisi badan, tekanan darah ambulatori 24 jam, dan ketebalan intima-media karotid.
Keputusan
Penilaian rawatan adalah berdasarkan prinsip niat untuk merawat. Semua peserta mengambil >96% kapsul yang ditetapkan. Suplemen ekstrak daun zaitun OLE dikaitkan dengan peningkatan 15% dalam sensitiviti insulin (p = 0.024) berbanding plasebo. Terdapat juga peningkatan 28% dalam tindak balas sel β pankreas (p = 0.013). Suplemen ekstrak daun zaitun OLE juga membawa kepada peningkatan kepekatan interleukin-6 puasa (p = 0.014), IGFBP-1 (p = 0.024), dan IGFBP-2 (p = 0.015). Walau bagaimanapun, tiada kesan pada interleukin-8, TNF-α, CRP ultra-sensitif, profil lipid, tekanan darah ambulatori, komposisi badan, ketebalan intima-media karotid, atau fungsi hati.
Kesimpulan
Pengambilan suplemen polifenol daun zaitun selama 12 minggu meningkatkan sensitiviti insulin dan kapasiti rembesan sel β pankreas dengan ketara pada lelaki pertengahan umur yang berlebihan berat badan yang berisiko mengalami sindrom metabolik. Ini sangat baik untuk kawalan gula darah bagi pencegahan penyakit diabetes / kencing manis.
Artikel penuh boleh dibaca di sini: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3596374/
]]>Meninjau penyelidikan baru-baru ini, daun zaitun dipilih sebagai suplemen terapi bersama yang berpotensi untuk rawatan dan peningkatan manifestasi klinikal pada pesakit COVID-19. Daun zaitun kaya dengan sebatian fenolik seperti oleuropein, hidroksi tirosol, verbaskosida, apigenin-7-glukosida dan luteolin-7-glukosida yang telah dilaporkan sebagai metabolit anti-SARS-CoV-2 dalam silico, komputasi dan dalam kajian vitro.
Di samping itu, ekstrak daun zaitun sebelumnya dilaporkan dalam beberapa kajian in vivo untuk aktiviti anti-radang, analgesik, antipiretik, imunomodulator dan anti-trombotiknya yang sangat bermanfaat dalam pengendalian keradangan sitokin yang berkaitan dan penyebaran pembekuan intravaskular dalam COVID -19 pesakit.
Percubaan klinikal secara rawak dan plasebo di Hospital Universiti Fayoum di Mesir akan dijalankan. RT-PCR mengesahkan COVID-19 orang dewasa yang menunjukkan penyakit ringan hingga sederhana akan didaftarkan dalam kajian ini. Pesakit yang mengalami kegagalan multi-organ, sokongan ventilator, dan penyakit kronik (kecuali diabetes mellitus dan hipertensi) dikeluarkan. Pesakit ditugaskan secara rawak dalam nisbah 1: 1 untuk menerima kapsul daun zaitun standard (mengandungi 20-50% oleuropein) atau plasebo hingga 10 hari bersama dengan rawatan standard. Hasil yang diharapkan termasuk pengurangan gejala, pelepasan virus, peningkatan analisis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, kreatinin, ALT dan AST) dan kematian 30 hari pada populasi yang ingin merawat.
Objektif:
Kami akan menilai keberkesanan kapsul daun zaitun standard sebagai terapi tambahan untuk rejimen terapi standard (selama 10 hari) terhadap gejala klinikal, pembersihan virus, peningkatan analisis:
Kiraan darah lengkap (CBC).
Protein C-Reaktif (CRP)
Lactate dehydrogenase (LDH).
Kadar Pemendapan Erythrocyte (ESR).
Serum Ferritin
D-dimer
Creatinine serum.
Alanine Amino Transferase (ALT) dan Aspartate Amino Transferase (AST).
Juga, kematian 30 hari pada pesakit dengan COVID-19 yang disahkan, yang ringan hingga sederhana.
Reka bentuk percubaan:
Ini adalah percubaan klinikal pusat tunggal, rawak, double-blind, plasebo yang dikendalikan dengan reka bentuk kumpulan selari yang dijalankan di Hospital universiti Fayoum, Fayoum, Mesir.
Rancangan dan Metodologi Penyelidikan 1-Riwayat pesakit yang lengkap akan direkodkan (penyakit lain, ubat semasa, usia, seks, dll.) 2-Penyiasatan klinikal pesakit oleh doktor di Jabatan Dada, Hospital Universiti Fayoum termasuk pengukuran seperti Suhu dan ketepuan Oksigen .
3-Pesakit akan diuji untuk dijangkiti oleh PCR dan semua pesakit yang akan didaftarkan dalam kajian harus menunjukkan hasil PCR yang positif.
4-Analisis berikut akan dilakukan untuk semua pesakit yang termasuk dalam kajian; CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT dan AST sebelum rawatan dan untuk tindak lanjut setiap lima hari.
5- Imbasan tomografi berkomputer (CT) dapat dilakukan di dada sebelum dan selepas rawatan.
Peserta:
Semua pesakit luar yang dimasukkan ke Jabatan Penyakit Dada Hospital universiti Fayoum, akan diperiksa untuk kriteria berikut.
Kriteria kemasukan:
- Dewasa.
- Diagnosis SARS-CoV-2 yang disahkan (tindak balas rantai polimerase positif dengan sapuan nasofaring).
- Pesakit COVID-19 Ringan hingga Sederhana.
- Tiada sejarah penggunaan suplemen kapsul daun zaitun semasa.
Kriteria pengecualian:
- Pesakit COVID-19 yang teruk dan kritikal yang memerlukan rawatan di hospital.
- Pesakit memerlukan sokongan ventilasi atau menunjukkan penyakit paru obstruktif kronik (COPD).
- Pesakit menunjukkan sebarang penyakit kronik (kecuali hipertensi dan diabetes mellitus).
- Pesakit yang mengalami kegagalan multiorgan.
- Penggunaan alkohol, ubat penyiasatan lain, dan ubat haram (selama 30 hari terakhir).
Intervention dan pembanding:
Sebanyak 60 pesakit secara rawak menjadi dua kumpulan (30 dalam setiap kumpulan). Pesakit akan dibahagikan kepada 2 kumpulan Kumpulan intervensi: Semua pesakit menerima rejimen rawatan standard untuk COVID-19, menurut protokol Kementerian Kesihatan Mesir, bersama dengan 2-3 kapsul / hari daun zaitun standard yang mengandungi 20-50% oleuropein (500-750 mg oleuropein setiap hari) selama sepuluh hari.
Kumpulan kawalan: Rejimen terapi standard untuk COVID-19 bersama dengan kapsul plasebo setiap hari selama tempoh sepuluh hari.
Hasil utama:
Hasil utama adalah peningkatan gejala klinikal, serta ketepuan oksigen, pelepasan virus, peningkatan analisis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT dan AST) dalam 10 hari pengacakan pada pesakit dengan COVID-19 yang disahkan, yang sakit ringan hingga sederhana.
Randomization:
Pesakit yang dimasukkan akan dialokasikan ke salah satu kumpulan kajian menggunakan pengacakan blok dalam nisbah 1: 1 (setiap blok terdiri daripada 10 pesakit). Kaedah rawak ini memastikan peruntukan seimbang antara kumpulan semasa kajian. Sistem berasaskan web akan menghasilkan nombor rawak untuk urutan peruntukan dan rujukan.
Pertimbangan etika Semua peserta harus menandatangani persetujuan yang dimaklumkan dan menunjukkan kesediaan untuk menerima penempatan kepada mana-mana kumpulan rawatan yang ditetapkan.
Reka Bentuk Kajian
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Assessment of the Clinical Effectiveness of Standardized Olive Leaf Capsules; as a Co-therapy in the Treatment of Non-hospitalized COVID-19 Patients; a Randomized Clinical Trial
Estimated Study Start Date: May 10, 2021
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date: September 30, 2021
Pembanding Aktif: Kapsul daun zaitun
Pesakit COVID-19 yang tidak dimasukkan ke hospital yang mempunyai hasil PCR positif dan menunjukkan manifestasi dan gejala klinikal ringan hingga sederhana (20-30 pesakit) akan menerima kapsul daun zaitun standard 50% 750 mg (700 mg oleuropein / hari; prinsip aktif dalam zaitun daun) dua kali sehari selama sepuluh hari bersama dengan ubat protokol Mesir. Semua peserta pembanding yang aktif mestilah orang dewasa, tanpa penyakit kronik (kecuali darah tinggi dan diabetes), bukan penagih atau alkohol.
Makanan Tambahan: Kapsul daun zaitun standard Nusapure, 750 mg (50% oleuropein)
dua kumpulan kajian; kumpulan ujian akan menerima kapsul daun zaitun standard Nusapure, 750 mg (50% oleuropein) sementara kumpulan plasebo akan menerima kumpulan pati
Pembanding plasebo: Kapsul pati
Pesakit COVID-19 yang tidak dimasukkan ke hospital yang mempunyai hasil PCR positif dan menunjukkan manifestasi dan gejala klinikal ringan hingga sederhana (20-30 pesakit) akan menerima kapsul pati plasebo (750 mg) dua kali sehari selama sepuluh hari bersama dengan orang Mesir ubat protokol. Semua peserta pembanding plasebo mestilah orang dewasa, tanpa penyakit kronik (kecuali darah tinggi dan diabetes), bukan penagih atau alkohol.
Makanan Tambahan: Kapsul daun zaitun standard Nusapure, 750 mg (50% oleuropein)
dua kumpulan kajian; kumpulan ujian akan menerima kapsul daun zaitun standard Nusapure, 750 mg (50% oleuropein) sementara kumpulan plasebo akan menerima kumpulan pati
Langkah-langkah Hasil Utama:
- Memperbaiki gejala klinikal pada pesakit COVID ringan hingga sederhana -19 [Jangka Masa: 5 hari selepas rawatan]
- Diharapkan ubat yang diperiksa dapat meredakan gejala seperti demam, batuk, sakit tekak dan sakit otot
- Pembersihan virus pada pesakit COVID ringan hingga sederhana -19 [Jangka Masa: 10 hari selepas rawatan]
- Diharapkan ubat yang diperiksa akan membuat keputusan tindak balas rantai Polimerase (PCR) untuk kumpulan ujian negatif dalam masa 10 hari rawatan
- peningkatan analisis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT dan AST) [Jangka Masa: 5-10 hari selepas rawatan]
Diharapkan bahawa rawatan akan meningkatkan analisis makmal untuk kumpulan rawatan seperti meningkatkan jumlah limfosit dalam jumlah darah lengkap (CBC), mencegah peningkatan dan / atau menurunkan nilai peningkatan berikut: D-dimer, C-Reactive protein (CRP) , Laktat dehidrogenase (LDH), kadar pemendapan Erythrocyte (ESR), kreatinin, Alanine Amino Transferase (ALT) dan Aspartate Amino Transferase (AST).
Langkah-langkah Hasil Sekunder:
Menilai kadar kematian 30 hari pada pesakit dengan COVID-19 yang disahkan sakit sederhana [Jangka Masa: 30 hari selepas rawatan]
Diharapkan ubat tersebut dapat mengurangkan penukaran pada kes dari kes yang sederhana hingga yang teruk dan seterusnya menurunkan kadar kematian
Kriteria Penyertaan:
- Dewasa.
- Diagnosis SARS-CoV-2 yang disahkan (tindak balas rantai polimerase positif dengan sapuan nasofaring).
- Pesakit COVID-19 Ringan hingga Sederhana.
- Tiada sejarah penggunaan suplemen kapsul daun zaitun semasa.
Kriteria pengecualian:
- Pesakit COVID-19 yang teruk dan kritikal yang memerlukan rawatan di hospital.
- Pesakit memerlukan sokongan ventilasi atau menunjukkan penyakit paru obstruktif kronik (COPD).
- Pesakit menunjukkan sebarang penyakit kronik (kecuali hipertensi dan diabetes mellitus).
- Pesakit yang mengalami kegagalan multiorgan.
- Penggunaan alkohol, ubat penyiasatan lain, dan ubat haram (selama 30 hari terakhir).
| Responsible Party: | Shimaa M. Abdelgawad, Assisting lecturer, Pharmacognosy Department, Faculty of Pharmacy, Fayoum University, Egypt, Fayoum University |
| ClinicalTrials.gov Identifier: | NCT04873349 History of Changes |
| Other Study ID Numbers: | EC 2121 |
| First Posted: | May 5, 2021 Key Record Dates |
| Last Update Posted: | May 7, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Saintis Annalisa Tito, Senior Researcherdari Arterra Bioscience spa Naples, Italy bersama 8 saintis lain telah menjalankan penyelidikan potensi Ekstrak Kulit Buah Delima untuk merawat jangkitan disebabkan oleh SARS-CoV-2 atau Covid 19.
Kegiatan metabolit sekunder tumbuhan terhadap jangkitan dan replikasi SARS-CoV-2 telah dikaji secara meluas dalam masa terakhir ini (da Silva Antonio et al., 2020; Sayed et al., 2020; Weng, 2020) dan banyak kajian, berdasarkan pendekatan silico, mencadangkan beberapa jenis dari tumbuhan ini sebagai calon ubat yang berpotensi untuk rawatan COVID-19 (Majumder and Mandal, 2020; Singh et al., 2020).
Kedua-dua protein struktur virus, seperti Spike, dan protein bukan struktur, seperti 3CLpro, PLpro, dan RdRp, telah diusulkan sebagai sasaran penting untuk strategi terapi anti-SARS-CoV-2. Melalui kajian molecular-docking, Khalifa et al. (2020) mendapati bahawa beberapa tanin yang dapat dihidrolisis, khususnya pedunculagin, tercatain, dan castalin, mungkin berfungsi sebagai perencat berpotensi SARS-CoV-2 kerana mereka dapat secara khusus mengikat pemangkin protease 3CL.
Dalam kajian serupa, Hariprasad et al. (2020) menguji interaksi virtual antara beberapa metabolit sekunder tumbuhan dan empat protein sasaran yang terlibat dalam COVID-19, proteinase host TMPRSS2 dan tiga protein virus, Spike, protease utama, dan RNA polimerase yang bergantung pada RNA, dan diramalkan di antara kelas triterpenoids sebatian paling aktif dalam menyekat pengikat Spike.
Bhatia et al. (2020) juga mengenal pasti punicalagin antara polifenol makanan sebagai perencat berpotensi Spike dan protein lain. Di sisi lain, sasaran manusia juga dipertimbangkan: ACE2 tentunya yang paling banyak dijelajahi kerana ternyata “kunci pintu” utama yang digunakan virus untuk masuk ke dalam sel. Walau bagaimanapun, ACE2 juga mempunyai peranan penting dalam banyak proses fisio-patologi dalam tisu manusia, sehingga mensasarkan enzim ini memerlukan penilaian yang teliti untuk memastikan keseimbangan manfaat-risiko berubah menjadi baik (Lacroix et al., 2015; Mostafa-Hedeab, 2020)
Dalam kajian ini, kami mendapati bahawa polifenol yang terkandung dalam ekstrak etanol yang berasal dari kulit delima menghalang interaksi antara Spike dan ACE2, dan mengurangkan aktiviti protease 3CL virus (in vitro), berpotensi menyarankan penggunaan ekstrak sebagai bahan tambahan dalam rawatan terhadap jangkitan SARS-CoV-2. Data menunjukkan bahawa polifenol yang paling berkesan dalam ekstrak adalah punicalagin dan ellagic acid mungkin melalui interaksi kimia kumpulan hidroksil dan galloyl dalam molekul mereka dengan residu asid amino di tempat aktif sasaran protein SARS-CoV-2 atau sel manusia, seperti yang disokong oleh kajian lain berdasarkan analisis dokumentasi molekul (Surucic et al., 2021).
Kesan kawalan pada pengikatan Spike / ACE2 disahkan oleh eksperimen dengan lentivirus pseudotaip, yang masuk ke dalam sel manusia bergantung pada protein Spike. Selaras dengan pemerhatian in-vitro, data kami menunjukkan bahawa jangkitan lentivirus hampir sepenuhnya dihapuskan oleh Ekastrak Kulit Delima (PPE) yang mengandung polifenol. Perencatan ini juga dikaitkan dengan regulasi ekspresi gen kedua ACE2 dan protease TMPRSS2, yang terlibat dalam priming Spike. Khususnya, dalam kajian ini 0.04 mg / ml Ekastrak Kulit Delima (PPE) digunakan untuk eksperimen in vitro dalam kultur sel HK-2. Kepekatan ini kelihatan lebih tinggi daripada yang digunakan dalam beberapa laporan di mana ia menunjukkan bahawa CC50 Ekastrak Kulit Delima adalah sekitar 55,6 μg / ml (Moradi et al., 2019).
Bagaimanapun, dalam literatur, data sitotoksisiti yang berbeza dilaporkan berkaitan dengan kultur sel yang berbeza yang digunakan (Dana et al., 2015; Mastrogiovanni et al., 2019; Sorrenti et al., 2019; Keta et al., 2020). Lebih-lebih lagi, kami juga memberikan bukti bahawa Ekastrak Kulit Delima (PPE) mampu mengekang aktiviti protease 3CL hingga 80%, menunjukkan bahawa Ekastrak Kulit Delima (PPE) mungkin mempunyai banyak peranan biologi dalam mengurangi peluang virus untuk masuk ke dalam sel.
Kesimpulannya, menghalang pengikatan Spike / ACE2 masih merupakan salah satu strategi yang paling popular untuk mengawal SARS-CoV-2 (Covid 19), dan ekstrak yang kaya dengan polifenol sangat berpotensi untuk mengurangkan jangkitan dan replikasi virus sehingga dicadangkan sebagai bahan bioaktif dalam farmasi, nutraseutikal, dan / atau formulasi kosmetik.
Sesuai dengan hasil penemuan kami, laporan baru-baru ini menunjukkan bahawa jus delima berkesan dalam mengurangkan kapasiti berjangkit virus SARS-CoV-2 (Covid 19) dan influenza dalam sel VeroE6 yang menunjukkan aktiviti antivirus kedua-dua virus (Frank et al., 2020). Kajian di sini menunjukkan jalan untuk penyelidikan yang lebih lanjut dan mendalam mengenai aktiviti polifenol kulit buah delima dalam mencegah jangkitan SARS-CoV-2 in vivo dan juga dapat mempromosikan idea baru mengenai bagaimana menggunakan semula produk sampingan agroindustri untuk aplikasi yang berharga dan sihat .
Artikel penuh: https://www.frontiersin.org/articles/10.3389/fchem.2021.638187/full
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