Multi-species synbiotic supplementation increased fecal short chain fatty acids and anti-inflammatory cytokine interleukin-10 in adult men with dyslipidemia; A randomized, double-blind, clinical trial.

BACKGROUND: Mounting evidence revealed that an imbalance of Gut Microbiota (GM) leads to metabolic disorders. Synbiotics through regulation of GM composition can be an effective intervention in the management of metabolic diseases. This study aimed to investigate the effects of multi-species synbiotic supplementation on serum interleukin10 (IL-10) and fecal Short Chain Fatty Acids (SCFAs) in patients with dyslipidemia. METHODS: In this double-blind, randomized, placebo-controlled clinical trial, fifty-six adult men with dyslipidemia were randomly allocated to intervention and control groups and received either synbiotic or placebo powder twice a day for 12 weeks. Each synbiotic sachet contained 6 species of probiotic microorganisms with a total dose of 3 × 1010 Colony Forming Unit (CFU) and 5 gr inulin and Fructooligosaccharide (FOS) as prebiotics. Blood and stool samples were collected at the baseline and end of the study. Dietary intake, physical activity, anthropometric measurements, serum IL-10, and fecal SCFAs were assessed before and after the intervention. RESULT: There were no significant differences between the baseline characteristics of patients in the two groups. Serum IL-10 was increased in the synbiotic group (p < 0.0001). Moreover, synbiotic supplementation increased fecal concentration of acetate (p < 0.0001), butyrate (p = 0.043), propionate (p < 0.0001), and valerate (p < 0.026). A significant positive correlation was observed between the changes in fecal butyrate level and serum IL-10 concentration in the control group (r = 0.48, p = 0.01). CONCLUSIONS: A Twelve-week synbiotic supplementation increased fecal SCFAs and improved inflammation in adult men with dyslipidemia.

Effects of Multi-species Synbiotic Supplementation on Circulating miR-27a, miR-33a Levels, and Lipid Parameters in Adult Men with Dyslipidemia; A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

MicroRNAs (miRNAs) have emerged as important regulators of lipid metabolism. Recent studies have suggested synbiotics may modulate miRNA expression and lipid metabolism. This study aimed to investigate the effects of synbiotic supplementation on circulating miR-27a, miR-33a, and lipid parameters in patients with dyslipidemia. Fifty-six eligible participants were randomly allocated to receive either synbiotic or placebo sachets twice a day for 12 weeks. Each synbiotic sachet contained 3×1010 CFU six species of probiotic microorganisms and 5 grams of inulin and fructooligosaccharide (FOS) as prebiotics. Serum miR-27a and miR-33a expression levels, serum lipids, and apolipoproteins, the fecal concentration of short-chain fatty acids (SCFAs), and Firmicutes and Bacteroidetes phyla were assessed before and after the study. Real-time PCR was used to determine the relative expression levels of miRNAs. The results showed synbiotic supplementation significantly downregulated the expression levels of miR-27a and miR-33a compared to the placebo group (p = 0.008 and p = 0.001, respectively). Furthermore, the intervention group exhibited significant improvements in serum high-density lipoprotein (HDL-C), small dense low-density lipoprotein (sdLDL-C), apoA-I, and apoB-100 (p = 0.008, p = 0.006, p = 0.003, p = 0.001, respectively). The results showed a significant negative correlation between miR-33a expression levels with HDL-C, butyrate, propionate, and a significant positive correlation with total cholesterol (TC), low-density lipoprotein (LDL-C), and sdLDL-C in the intervention group. Fecal bacteria and SCFAs were significantly increased in the intervention group. This study provides evidence that synbiotic supplementation can modulate miR-27a and miR-33a expression and improve lipid metabolism in patients with dyslipidemia.

Randomized clinical trial evaluating the efficacy of synbiotic supplementation on serum endotoxin and trimethylamine N-oxide levels in patients with dyslipidaemia.

Introduction: Elevated serum endotoxin and trimethylamine N-oxide (TMAO) are associated with metabolic disorders including dyslipidaemia and insulin resistance. This study aimed to evaluate the impact of a 12-week treatment with a synbiotic supplement on serum endotoxin and TMAO levels in patients diagnosed with dyslipidaemia. Material and methods: A total of 56 patients who met the study inclusion criteria were recruited in this randomized, double-blind clinical trial. Participants were randomly assigned into intervention and control groups and received either synbiotic or placebo sachets twice a day for 12 weeks. The sociodemographic data, food intake, physical activity, and anthropometric indices of participants were assessed before and after intervention. Serum endotoxin, TMAO, and fasting blood glucose (FBG) levels were measured at the baseline and end of the study. Results: No significant difference in the baseline characteristics of participants in the 2 groups was observed. After the 12 weeks of intervention, the mean of serum endotoxin (p < 0.0001), TMAO (p < 0.0001), and FBG (p < 0.0001) was decreased in patients who received synbiotic supplements while no significant change was observed in the control group. Moreover, a significant positive correlation between changes in endotoxin (r = 0.41, p = 0.041) and TMAO (r = 0.40, p = 0.047) with FBG changes was observed. Conclusions: A significant reduction in serum endotoxin and TMAO levels, as well as improvements in FBG, following 12 weeks of supplementation with synbiotics, may offer a potential approach for improving metabolic status in patients with dyslipidaemia.

The effects of vitamin C supplementation on glycemic control in patients with type 2 diabetes: A systematic review and meta-analysis.

BACKGROUND AND AIM: It has been suggested that taking vitamin C supplements may improve glycemic control in patients with type 2 diabetes mellitus (T2DM). However, there has not been a thorough evaluation of the actual impact or certainty of the findings. This systematic review and meta-analysis was conducted to determine the effect of vitamin C supplementation on glycemic profile in T2DM patients. METHODS: A systematic search was performed across online databases including Scopus, Web of Science, and PubMed/Medline to identify relevant randomized controlled trials (RCTs) published until July 2022. A random-effects model was applied for the meta-analysis. RESULTS: The present meta-analysis included a total of 22 RCTs with 1447 patients diagnosed with T2DM.A pooled analysis revealed a significant decrease in levels of serum hemoglobin A1c (HbA1c), fasting insulin, and fasting blood glucose (FBG) in vitamin C-treated T2DM patients compared with their untreated counterparts. The dose-response evaluation displayed a substantial linear association between the intervention duration and changes in serum HbA1c levels. However, the analysis did not demonstrate any significant effect of vitamin C on serum values of homeostasis model assessment of insulin resistance(HOMA-IR) in diabetic patients. Subgroup analyses indicated that high-dose vitamin C administration (≥1000 mg/d) considerably decreased serum HOMA-IR levels. CONCLUSION: These findings suggest that long-term (≥12 weeks) and high-dose vitamin C supplementation (≥1000 mg/d) may ameliorate glycemic profile in T2DM patients. However, additional high-quality RCTs are necessary to validate these results.

Association Between Protein Intake From Different Animal and Plant Origins and the Risk of Non-Alcoholic Fatty Liver Disease: A Case-Control Study.

Previous studies have frequently reviewed how different macronutrients affect liver health. Still, no study centered around protein intake and the non-alcoholic fatty liver disease (NAFLD) risk relationship. This study aimed to examine the association between the consumption of total and different sources of protein and NAFLD risk. We allocated 243 eligible subjects to the case and control groups, including 121 incidence cases of NAFLD, and 122 healthy controls. Two groups were matched in age, body mass index, and sex. We evaluated the usual food intake of participants using FFQ. Binary logistic regression was conducted to estimate the risk of NAFLD in relation to different sources of protein intake. The age of participants was 42.7 years on average, and 53.1% were male. We found Higher intake of protein in total (odds ratio [OR], 0.24; 95% confidence interval [CI], 0.11-0.52) was significantly associated with a lower risk of NAFLD, despite adjusting for multiple confounders. in detail, higher tendency to the vegetables (OR, 0.28; 95% CI, 0.13-0.59), grains (OR, 0.24; 95% CI, 0.11-0.52), and nuts (OR, 0.25; 95% CI, 0.12-0.52) as the main sources of protein, were remarkably correlated with lower NAFLD risk. In contrary, increased intake of meat protein (OR, 3.15; 95% CI, 1.46-6.81) was positively associated with a higher risk. Totally, more calorie intake from proteins was inversely associated with lower NAFLD risk. This was more likely when the protein sources were selected less from meats and more from plants. Accordingly, increasing the consumption of proteins, particularly from plants, may be a good recommendation to manage and prevent NAFLD.

The effect of nigella sativa supplementation on cardiometabolic outcomes in patients with non-alcoholic fatty liver: A randomized double-blind, placebo-controlled trial.

BACKGROUND AND PURPOSE: Non-alcoholic fatty liver disease (NAFLD) is one of the metabolic disturbances associated with liver cell inflammation. Nigella sativa (N.sativa) is a widely used medicinal plant known for its anti-inflammatory, antimicrobial, antioxidant, and hepato-protective properties. This study aimed to assess the effect of supplementation of N. sativa oil on plasma levels of adiponectin, leptin, and blood pressure (BP) in patients diagnosed with NAFLD. MATERIALS AND METHODS: This randomized, double-blind, placebo-controlled clinical trial was conducted on 44 NAFLD patients. Participants were randomly assigned to two groups (n = 22/group); the experimental group received 1000 mg of N. sativa oil per day, while the control group received a placebo for eight weeks. The primary outcome measures were serum levels of adiponectin, leptin, and systolic and diastolic blood pressure measured at the baseline and the end of the intervention. RESULTS: After eight weeks of supplementation with N. sativa oil, no statistically significant differences were found in serum levels of adiponectin (p = 0.40), leptin (p = 0.89), systolic BP (p = 0.13), and diastolic BP (p = 0.09) between the two groups. Furthermore, after supplementation with N. sativa, no significant changes were observed in leptin (p = 0.07), adiponectin (p = 0.13), systolic BP (p = 0.82), and diastolic BP (p = 0.38) within the two groups. CONCLUSION: These results indicate that administration of N. sativa oil 1000 mg/day for 8 weeks has no favorable effect on cardiometabolic measures in NAFLD patients. Further studies with higher dosage over a longer period are needed to investigate whether this effect is dose- and time-dependent.

The association between Dietary Diversity Score and odds of nonalcoholic fatty liver disease: a case-control study.

OBJECTIVE: There is no previous study that investigated the association between Dietary Diversity Score (DSS) and odds of nonalcoholic fatty liver disease (NAFLD). The present study aimed to examine the association between DDS and its components and NAFLD among Iranian adults. METHODS: In the case-control study, we enrolled 121 newly diagnosed cases of NAFLD and 122 with age, BMI and sex-matched controls. All NAFLD patients were diagnosed through ultrasonography methods by gastroenterologists. Anthropometric parameters of participants including weight, height, hip circumference and waist circumference were measured. A validated 147-item semi-quantitative food frequency questionnaire was applied to assess the usual dietary intakes of participants. Binary logistic regression was conducted to estimate the risk of NAFLD in relation to DDS and its components, including refined grains, vegetables, fruits, dairy and meats. RESULTS: The mean age of study participants was 42.7 years of them 53.1% were male. Higher adherence to DDS [odds ratio (OR) = 0.48; 95% confidence interval (CI), 0.25-0.95] and vegetable group (OR = 0.34; 95% CI, 0.16-0.71) were remarkably associated with lower risk of NAFLD, after adjusting for several confounders including age, BMI, physical activity, energy intake, job, education, and antihypertensive drugs usage. Contrastingly, greater adherence to the refined grain (OR = 3.36; 95% CI, 1.44-7.87) and meat group (OR = 3.27; 95% CI, 1.25-6.90) was significantly associated with increased risk of NAFLD. CONCLUSION: High DDS is inversely correlated with the risk of NAFLD. Hence, increasing the diversity score of diet by emphasizing the higher diversity scores for vegetables and less for meat and refined grains may be profitable for the management of NAFLD.

Effect of flaxseed supplementation on lipid profile: An updated systematic review and dose-response meta-analysis of sixty-two randomized controlled trials.

Raised plasma lipids are one the most important risk factors for cardiovascular disease. Flaxseed contains considerable amounts of α-linolenic acid, phenolic compounds, and lignans, which each have the capacity to reduce circulating lipid concentrations. This study aimed to systematically review current evidence to identify the potential effects of flaxseed supplementation on blood lipid profiles using a meta-analysis of randomized controlled trials (RCTs). PubMed, Scopus, Web of Science, and Google Scholar databases were searched for publications between January 1900 and May 2019. Weighted mean differences (WMDs) were analyzed using a random-effects model. The Cochrane Collaboration tool was also used to assess the risk of bias of the studies included. Sixty-two RCTs with a total of 3772 participants met the eligibility criteria. Our analysis showed that flaxseed supplementation significantly reduced total cholesterol (TC) (WMD = -5.389 mg/dL; 95% CI: -9.483, -1.295, p = 0.010), triglyceride (TG) (WMD = -9.422 mg/dL; 95% CI: -15.514, -3.330, p = 0.002), and low-density lipoprotein cholesterol (LDL-C) (WMD = -4.206 mg/dl; 95% CI: -7.260, -1.151, p = 0.007) concentrations. However, it had no effects on high-density lipoprotein cholesterol (WMD = 0.047 mg/dl; 95% CI: -0.777, 0.872, p = 0.910). This meta-analysis suggested that flaxseed supplementation improves serum TC, TG, and LDL-C, which could delay the progression of heart disease. Further studies with large-scale and better design are now needed to confirm these results.

The influence of vitamin D supplementation on IGF-1 levels in humans: A systematic review and meta-analysis.

BACKGROUND: Inconsistencies exist with regard to influence of vitamin D supplementation on IGF-1 levels. The inconsistencies could be attributed to several factors, such as dosage and duration of intervention, among others. To address these inconsistencies, this study was conducted to determine the impact of vitamin D supplementation on IGF-1 levels through a systematic review and meta-analysis of randomized controlled trials (RCTs). METHODS: A comprehensive systematic search was carried out in PubMed/MEDLINE, Web of Science, SCOPUS and Embase for RCTs that investigated the impact of vitamin D intake on circulating IGF-1 levels from inception until June 2019. Weighted mean difference (WMD) with the 95 % CI were applied for estimating combined effect size. Subgroup analysis was performed to specify the source of heterogeneity among studies. RESULTS: Pooled results from eight studies demonstrated an overall non-significant increase in IGF-1 following vitamin D supplementation (WMD: 4 ng/ml, 95 % CI: -4 to 11). However, a significant degree of heterogeneity among studies was observed (I2 = 66 %). The subgroup analyses showed that vitamin D dosage of ≤1000 IU/day (WMD: 10 ng/ml) significantly increased IGF-1 compared to the vitamin D dosage of <1000 IU/day (WMD: -1 ng/ml). Moreover, intervention duration ≤12 weeks (WMD: 11 ng/ml) significantly increased IGF-1 compared to intervention duration <12 weeks (WMD: -3 ng/ml). In the epidemiological cohort study, participants under 60 years of age with a higher dietary vitamin D intake had significantly higher IGF-1 levels when compared to those with lower dietary vitamin D intake in second categories. CONCLUSION: The main results indicate a non-significant increase in IGF-1 following vitamin D supplementation. Additionally, vitamin D dosages of <1000 IU/day and intervention durations of <12 weeks significantly raised IGF-1 levels.

The effect of green-coffee extract supplementation on obesity: A systematic review and dose-response meta-analysis of randomized controlled trials.

BACKGROUND: Given that the most recent systematic review investigating Green-Coffee Extract (GCE) as a weight loss facilitator was nearly a decade ago and that the authors reported there no consensus on the effect of GCE/CGA (Chlorogenic acids) on body composition indices, a comprehensive systematic review and dose-response meta-analysis of all available randomized controlled trial (RCTs) was undertaken to examine the effect of GCE and CGA intervention on body weight (BW), body mass index (BMI) and waist circumference (WC) in adults. METHODS: We conducted a systematic search of all available randomized controlled trials (RCTs) performed up to June 2019 in the following electronic databases: PubMed, Scopus and Google Scholar. RCTs that investigated the effect GCE/CGA Supplementation on BW, BMI and WC in adults were included for final analysis. The pooled weight mean difference (WMD) of included studies was estimated using a random-effects model. RESULTS: A total of 13 articles with 16 RCTs were included in the meta-analysis. Results revealed significant reduction in BMI (WMD: -0.403 kg/m2, 95% CI: -0.800, -0.005, p = 0.047) and no significant change in BW (WMD: -0.585 kg, 95% CI: -1.498, 0.329, p = 0.210) and WC (WMD: -0.847 cm, 95% CI: -1.764, 0.071, p = 0.070). In the subgroup analysis, studies that were conducted on baseline BMI ≥25 kg/m2 revealed a significant greater reduction in body weight and BMI than those performed on baseline BMI <25 kg/m2. Moreover, short supplementation periods of less than 4 weeks had no effect. CONCLUSION: The results of current meta-analysis study support the use of GCE supplementation for the improvement of obesity indices, with sub-group analysis highlighting greater improvements in individuals with a starting BMI ≥25 kg/m2.