A multicentre, double-blind, placebo-controlled, randomized, parallel comparison, phase 3 trial to evaluate the efficacy and safety of pioglitazone add-on therapy in type 2 diabetic patients treated with metformin and dapagliflozin.

AIM: To investigate the efficacy and safety of pioglitazone compared to placebo when added to metformin plus dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, for patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: In a multicentre study, with a randomized, double-blind, placebo-controlled design, 249 Korean patients with T2DM suboptimally managed on metformin and dapagliflozin were assigned to receive either pioglitazone (15 mg daily) or placebo for 24 weeks, followed by a 24-week pioglitazone extension. Primary outcomes included changes in glycated haemoglobin (HbA1c), with secondary outcomes assessing insulin resistance, adiponectin levels, lipid profiles, liver enzymes, body weight and waist circumference. RESULTS: Pioglitazone administration resulted in a significant reduction in HbA1c levels (from 7.80% ± 0.72% to 7.27% ± 0.82%) compared with placebo (from 7.79% ± 0.76% to 7.69% ± 0.86%, corrected mean difference: -0.42% ± 0.08%; p < 0.01) at 24 weeks. Additional benefits from pioglitazone treatment included enhanced insulin sensitivity, increased adiponectin levels, raised high-density lipoprotein cholesterol levels and reduced liver enzyme levels, resulting in improvement in nonalcoholic fatty liver disease liver fat score. Despite no serious adverse events in either group, pioglitazone therapy was modestly but significantly associated with weight gain and increased waist circumference. CONCLUSIONS: Adjunctive pioglitazone treatment in T2DM inadequately controlled with metformin and dapagliflozin demonstrates considerable glycaemic improvement, metabolic benefits, and a low risk of hypoglycaemia. These advantages must be weighed against the potential for weight gain and increased waist circumference.

Clinical Evaluation of a Novel, Patented Green Coffee Bean Extract (GCB70®), Enriched in 70% Chlorogenic Acid, in Overweight Individuals.

OBJECTIVE: Obesity and overweight are challenging health problems of the millennium that lead to diabetes, hypertension, dyslipidemia, nonalcoholic fatty liver disease (NAFLD), and atherosclerosis. Green coffee bean exhibited significant promise in healthy weight management, potentiating glucose-insulin sensitization and supporting liver health. The safety and efficacy of a novel, patented water-soluble green coffee bean extract (GCB70® enriched in 70% total chlorogenic acid and <1% caffeine) was investigated in 105 participants for 12 consecutive weeks. An institutional review board and Drugs Controller General (India) (DCGI) approvals were obtained, and the study was registered at ClinicalTrials.gov. METHOD: Body weight, body mass index (BMI), waist circumference, lipid profile, plasma leptin, glycosylated hemoglobin (HbA1c), and total blood chemistry were assessed over a period of 12 weeks of treatment. Safety was affirmed. RESULTS: GCB70 (500 mg BID) supplementation significantly reduced body weight (approximately 6%; p = 0.000**) in approximately 97% of the study population. About a 5.65% statistically significant reduction (p = 0.000**) in BMI was observed in 96% of the study volunteers. Waist circumference was significantly reduced by 6.77% and 6.62% in 98% of the male and female participants, respectively. Plasma leptin levels decreased by 13.6% in 99% of the study population as compared to the baseline value. Upon completion of 12 weeks' treatment, fasting glucose levels decreased by 13.05% (p = 0.000**) in 79% of the study population. There was a statistically significant decrease in HbA1c levels in both male and female participants (p = 0.000**), while 86.7% of the study participants showed a statistically significant decrease in thyroid-stimulating hormone (TSH) levels (p = 0.000**). The mean decrease in TSH levels on completion of the treatment was 14.07% in the study population as compared to baseline levels. Total blood chemistry analysis exhibited broad-spectrum safety. CONCLUSIONS: This investigation demonstrated that GCB70 is safe and efficacious in healthy weight management.

A comprehensive overview on the effects of green tea on anthropometric measures, blood pressure, glycemic and lipidemic status: An umbrella review and meta meta-analysis study.

AIM: The aim of this meta-review was to establish the effects of green tea (GT) intake on some cardiometabolic risk factors including anthropometric measures, blood pressure as well as blood glucose and lipids using evidence from previous systematic reviews and meta-analyses. DATA SYNTHESIS: Articles were identified via searches in PubMed, Embase, and the Cochrane Library, Web of Knowledge database from the index date of each database through January 31, 2021. A total of 13 meta-analyses were finally included in the synthesis. Meta-meta-analysis revealed significant effects of GT on weight and waist circumference with weighted mean difference (WMD) of -0.89 (95% CI -1.43 to -0.34, p < 0.001) and -1.01 (95% CI -1.63 to -0.39, p < 0.001), systolic and diastolic blood pressure, with WMDs of -1.17 (95% CI -2.18 to -0.16) and -1.24 (95% CI -2.07 to -0.4), respectively. There was similar effect on fasting blood glucose (WMD, -1.3, 95% CI -2.09 to -0.51, p < 0.001) but not on other glycemic indicators. The findings also revealed a significant effect size of total cholesterol and LDL-C (WMD -4.93; 95% CI -6.41 to -3.46, p < 0.001, WMD -4.31; 95% CI -6.55 to -2.07, p < 0.001, respectively). CONCLUSION: Regular consumption of GT and probably its bioactive constituents as supplements have beneficial effects on different health aspects including weight, blood pressure, blood glucose and lipids. However, these effects might be influenced by several factors such as the amount and frequency of consumption, health/disease condition and life style including dietary habits and physical activity.

Melatonin Supplementation and Anthropometric Indices: A Randomized Double-Blind Controlled Clinical Trial.

Obesity, as the most common metabolic disorder in the world, is characterized by excess body fat. This study is aimed at determining the effects of melatonin supplementation on body weight, nody mass index (BMI), waist circumference (WC), and body fat mass percentage (BFMP) in people with overweight or obesity. Thirty eight overweight or class-I obese adult individuals were recruited in the study (8 men and 30 women). Participants prescribed a weight-loss diet and then randomly were allocated to melatonin or placebo groups. Participants received either a 3-milligram melatonin or placebo tablet per day for 12 weeks. In order to assess differences at the significance level of 0.05, repeated measure ANOVA and paired t-test were used. According to the results, a significant reduction was found in participants' body weight, WC, and BMI in both groups (p = 0.001). However, for the last six weeks, significant reductions of these parameters were observed only in the melatonin group (p = 0.01). The BFMP of participants in the melatonin group showed a significant reduction at the end of the study compared to the initial measurements (p = 0.008). Nevertheless, the results of the present study alone are not sufficient to conclude on the effects of melatonin consumption on anthropometric indices, and it seems that further studies are required in this regard.

The effect of an orally-dosed Caralluma Fimbriata extract on appetite control and body composition in overweight adults.

To examine the effect of a Caralluma Fimbriata extract (CFE) on biomarkers of satiety and body composition in overweight adults. A double-blind, randomised, placebo controlled trial to examine the effect of a Caralluma Fimbriata extract (CFE) on biomarkers of satiety and body composition in overweight adults. Eighty-three men and women aged between 20 and 50 years of age completed 16 weeks of daily supplementation with either CFE or placebo. Plasma cardiometabolic (lipid profile, glucose, insulin) and satiety (ghrelin, leptin, neuropeptideY) biomarkers, body composition, diet history and gastrointenstinal function were assessed at baseline, weeks 4, 8, 12 and 16. Subjects in the CFE and placebo groups were well matched and predominatly female 93% and 87.5%, with a mean age of 40.9 ± 6.7 and 39.5 ± 7.5 years and body mass index (BMI) of 30.0 ± 3.1 and 30.2 ± 2.9 kg/m2 respectively. There was a significant difference in plasma leptin concentration change between groups at week 16 (p = 0.04), with the placebo group increasing concentration (2.27 ± 4.80 ng/mL) while the CFE group (0.05 ± 4.69 ng/mL) remained the same. At week 16, the CFE group had significantly reduced their calorie intake from baseline compared to the placebo group (245 cal vs 15.8 cal respectively p < 0.01). The CFE group also had a significant reduction in waist circumference of 2.7 cm compared to an increase of 0.3 cm in the placebo group (p = 0.02). A weight increase from baseline was seen in the placebo group that was not observed in the CFE group (1.33 kg weight gain vs 0.37 kg weight loss respectively; p = 0.03). The placebo group also had a significant increase in fat mass, android fat mass, BMI and leptin compared to the CFE group (p = 0.04, 0.02, < 0.01 respectively). CFE was effective at maintaining bodyweight during a non-calorie controlled diet compared to a placebo. The mechanism responsible for this action is requiring further research and could be due to an increase in satiety receptor sensitivity.

Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial.

Importance: The effect of continuing vs withdrawing treatment with semaglutide, a glucagon-like peptide 1 receptor agonist, on weight loss maintenance in people with overweight or obesity is unknown. Objective: To compare continued once-weekly treatment with subcutaneous semaglutide, 2.4 mg, with switch to placebo for weight maintenance (both with lifestyle intervention) in adults with overweight or obesity after a 20-week run-in with subcutaneous semaglutide titrated to 2.4 mg weekly. Design, Setting, and Participants: Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or ≥27 with ≥1 weight-related comorbidity) and without diabetes. Interventions: A total of 902 participants received once-weekly subcutaneous semaglutide during run-in. After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups. Main Outcomes and Measures: The primary end point was percent change in body weight from week 20 to week 68; confirmatory secondary end points were changes in waist circumference, systolic blood pressure, and physical functioning (assessed using the Short Form 36 Version 2 Health Survey, Acute Version [SF-36]). Results: Among 803 study participants who completed the 20-week run-in period (with a mean weight loss of 10.6%) and were randomized (mean age, 46 [SD, 12] years; 634 [79%] women; mean body weight, 107.2 kg [SD, 22.7 kg]), 787 participants (98.0%) completed the trial and 741 (92.3%) completed treatment. With continued semaglutide, mean body weight change from week 20 to week 68 was -7.9% vs +6.9% with the switch to placebo (difference, -14.8 [95% CI, -16.0 to -13.5] percentage points; P < .001). Waist circumference (-9.7 cm [95% CI, -10.9 to -8.5 cm]), systolic blood pressure (-3.9 mm Hg [95% CI, -5.8 to -2.0 mm Hg]), and SF-36 physical functioning score (2.5 [95% CI, 1.6-3.3]) also improved with continued subcutaneous semaglutide vs placebo (all P < .001). Gastrointestinal events were reported in 49.1% of participants who continued subcutaneous semaglutide vs 26.1% with placebo; similar proportions discontinued treatment because of adverse events with continued semaglutide (2.4%) and placebo (2.2%). Conclusions and Relevance: Among adults with overweight or obesity who completed a 20-week run-in period with subcutaneous semaglutide, 2.4 mg once weekly, maintaining treatment with semaglutide compared with switching to placebo resulted in continued weight loss over the following 48 weeks. Trial Registration: ClinicalTrials.gov Identifier: NCT03548987.

The Effect of Curcumin Supplementation on Anthropometric Measures among Overweight or Obese Adults.

Over the past decades, the worldwide prevalence of obesity has dramatically increased, thus posing a serious public health threat. Obesity is associated with the development of comorbid conditions and psychological disorders. Several lifestyle interventions have been proposed to tackle obesity; however, long-term maintenance of these interventions often proves challenging. In addition, among the different types of diets there is still a debate about the optimal macronutrient composition that will achieve the best results in weight loss. Recently, several commonly used spices such as pepper, ginger, and curcumin have been shown to play a beneficial role in obesity management. Therefore, exploring the effects of certain herbs or dietary spices on obesity may be promising. Among these spices, curcumin, which is the primary component of the spice turmeric, has gained great interest for its multiple health benefits. Several randomized controlled trials have investigated the potential favorable effects of curcumin supplementation on anthropometric measures. The aim of this review is to evaluate the effect of curcumin supplementation on the anthropometric indices among overweight or obese adults.

Can vitamin E supplementation affect obesity indices? A systematic review and meta-analysis of twenty-four randomized controlled trials.

BACKGROUND: Several mechanisms have been proposed for the effect of vitamin E on weight loss. Yet various interventional studies with wide ranges of doses and durations have reported contradictory results. METHODS: Cochrane Library, PubMed, Scopus, and Embase databases were searched up to December 2020. Meta-analysis was performed using random-effect method. Effect size was presented as weighted mean difference (WMD) and 95% confidence interval (CI). Heterogeneity was evaluated using the I2 index. In order to identification of potential sources of heterogeneity, predefined subgroup and meta regression analyses was conducted. RESULTS: A total of 24 studies with 33 data sets were included. There was no significant effect of vitamin E on weight (WMD: 0.15, 95% CI: -1.35 to 1.65, P = 0.847), body mass index (BMI) (WMD = 0.04, 95% CI: -0.29 to 0.37, P = 0.815), and waist circumference (WC) (WMD = -0.19 kg, 95% CI: -2.06 to 1.68, P = 0.842), respectively. However, subgroup analysis revealed that vitamin E supplementation in studies conducted on participants with normal BMI (18.5-24.9) had increasing impact on BMI (P = 0.047). CONCLUSION: There was no significant effect of vitamin E supplementation on weight, BMI and WC. However, vitamin E supplementation might be associated with increasing BMI in people with normal BMI (18.5-24.9).

Daily supplementation with the Lab4P probiotic consortium induces significant weight loss in overweight adults.

This 9-month randomised, parallel, double-blind, single-centre, placebo-controlled study (PROBE, ISRCTN18030882) assessed the impact of probiotic supplementation on bodyweight. Seventy overweight Bulgarian participants aged 45-65 years with BMI 25-29.9 kg/m2 received a daily dose of the Lab4P probiotic comprising lactobacilli and bifidobacteria (50 billion cfu/day). Participants maintained their normal diet and lifestyle over the duration of the study. The primary outcome was change from baseline in body weight and secondary outcomes included changes in waist circumference, hip circumference and blood pressure. A significant between group decrease in body weight (3.16 kg, 95% CI 3.94, 2.38, p < 0.0001) was detected favouring the probiotic group. Supplementation also resulted in significant between group decreases in waist circumference (2.58 cm, 95% CI 3.23, 1.94, p < 0.0001) and hip circumference (2.66 cm, 95% CI 3.28, 2.05, p < 0.0001) but no changes in blood pressure were observed. These findings support the outcomes of a previous shorter-term Lab4P intervention study in overweight and obese participants (PROMAGEN, ISRCTN12562026). We conclude that Lab4P has consistent weight modulation capability in free-living overweight adults.

The effect and safety of Berberine on polycystic ovary syndrome: a systematic review.

The aim of this systematic review is to assess the effect of Berberine (BBR) on women's health to provide greater insights about its effect on women with polycystic syndrome for both patients and health care providers. Electronic databases such as PubMed, Web of Science, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL) were systematically searched from the base to July 1th, 2019 to identify clinical trials and randomised controlled trials that had explored the effect of BBR on the polycystic syndrome. With regard to the weight and composition body, BBR did not have any significant effect on reducing body weight and conflicting findings had been reported about waist circumference (WC) and body mass index (BMI). However, BBR led to a significant decrease in waist to hip ratio (WHR), profile hormonal insulin resistance (IR), and insulin resistance (HOMA-IR). Further, androstenedione dropped significantly following treatment with BBB. However, BBB did not have a significant effect on follicle stimulating hormone (FSH) and luteinizing hormone (LH).

Favorable effect of sodium-glucose cotransporter 2 inhibitor, dapagliflozin, on non-alcoholic fatty liver disease compared with pioglitazone.

AIMS/INTRODUCTION: Sodium-glucose cotransporter 2 inhibitors, as well as thiazolidines, suppress nonalcoholic fatty liver disease (NAFLD); however, few comparative studies have been reported. Dapagliflozin has shown non-inferiority compared with pioglitazone for glycemic control, and superiority regarding weight reduction in patients with type 2 diabetes. We carried out a secondary analysis for the favorable effects of sodium-glucose cotransporter inhibitors for NAFLD. MATERIALS AND METHODS: In this multicenter, open-label, prospective, randomized, parallel-group comparison trial, patients taking pioglitazone for ≥12 weeks were randomly switched to dapagliflozin or continued pioglitazone for a further 24 weeks. The fatty liver index (FLI), consisting of body mass index, triglycerides, waist circumference and γ-glutamyl transpeptidase, was used for the evaluation of NAFLD. RESULTS: A total of 53 participants with NAFLD (27 dapagliflozin; 26 pioglitazone) were included in this analysis. FLI decreased significantly in the dapagliflozin group (48.7 ± 23.4 to 42.1 ± 23.9) compared with the pioglitazone group (49.0 ± 26.1 to 51.1 ± 25.8; P < 0.01). Multiple linear regression analysis showed that the changes in FLI had a significantly positive correlation with changes in glycated hemoglobin (P = 0.03) and insulin level (P < 0.01) in the dapagliflozin group. CONCLUSION: Dapagliflozin might be more beneficial than pioglitazone in patients with NAFLD. Improvements in FLI would be closely related to glycemic control.

The effects of supplementation with Cynara scolymus L. on anthropometric indices: А systematic review and dose-response meta-analysis of clinical trials.

BACKGROUND: Studies on the efficacy of artichoke administration on anthropometric indices gave different outcomes. Hence, a systematic review and dose-response meta-analysis were accomplished to understand the effects of artichoke administration on anthropometric indices. METHODS: Related clinical trials were found by searching in PubMed, Embase, the Cochrane Library and Scopus databases up to 29 February 2020. Weighted Mean Differences (WMD) were analyzed using a random-effects model. Heterogeneity, publication bias and sensitivity analysis were assessed for anthropometric indices. RESULTS: Pooled analysis of 10 randomized controlled trials (RCTs) suggested that the artichoke administration has effect on waist circumference (WMD: -1.11 cm, 95 % CI: -2.08 to - 0.14), as opposed to the other anthropometric indices including weight (WMD: -0.62 kg, 95 % CI: -1.86 to 0.61) or BMI (WMD: -0.12, 95 % CI: -0.43 to 0.20). However, the analysis of the subgroups according to the health status showed that artichoke supplementation in hypertensive patients significantly reduced weight (WMD: -2.34 kg, 95 % CI: -3.11 to -1.57) but not the other indicators (WMD: -0.06 kg, 95 % CI: 0.78 to 0.67). CONCLUSIONS: The artichoke supplementation has effect on the waist circumference, but not on the other anthropometric indices. For establishment of more accurate conclusion more studies with longer administration duration are need to be done.

The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects with Newly Detected Impaired Fasting Glycemia: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.

Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynarascolymus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycemic control, insulin sensitivity and other metabolic parameters (total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) Triglycerides, Apolipo protein B (ApoB), Apolipo protein A (ApoA), waist circumference, visceral adipose tissue (VAT) by dual-energy X-ray absorptiometry (DXA) in overweight subjects with newly diagnosed IFG. Fifty-four subjects (females/males 26/28, mean ± SD age 51.5 ± 6.2) were randomly assigned to the supplemented group (n = 27) and placebo (n = 27). After multiple testing correction, statistically significant interactions between time and group were observed for the primary endpoint glycemia (ß = 0.36, p < 0.0001) and for the secondary endpoints HDL (ß = -0.10, p < 0.0001), total cholesterol/HDL (ß = 0.27, p < 0.0001), LDL (ß = 0.15, p = 0.005), LDL/HDL (ß = 0.23, p = 0.001), insulin (ß = 1.28, p = 0.04), glycated hemoglobin (ß = 0.21, p = 0.0002), A1c-derived average glucose (ß = 0.34, p = 0.0002), ApoB (ß = 6.00, p = 0.01), ApoA (ß = -4.50, p = 0.04), ApoB/ApoA (ß = 0.08, p = 0.003), waist circumference (ß = 1.89, p = 0.05), VATß = 222.37, p = 0.005). In conclusion, these results confirm that Cs supplementation has a significant effect on metabolic parameters in IFG patients.

L-Carnitine's Effect on the Biomarkers of Metabolic Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

A systematic review and meta-analysis of randomized controlled trials (RCTs) was carried out to assess L-carnitine supplements' influence on the biomarkers of metabolic syndrome (MetSyn). PubMed, EMBASE, Cochrane library, and CINAHL were used to collect RCT studies published prior to February 2020. RCT studies were included if they had at least one of the following biomarker outcome measurements: waist circumference (WC), blood pressure (BP), fasting blood sugar (FBS), triglyceride (TG), or high density lipoprotein-cholesterol (HDLc). Nine of twenty studies with adequate methodological quality were included in this meta-analysis. The dose of L-carnitine supplementation administered varied between 0.75 and 3 g/day for durations of 8-24 weeks. L-carnitine supplementation significantly reduced WC and systolic BP (SBP), with no significant effects on FBS, TG, and HDLc. We found that L-carnitine supplementation at a dose of more than 1 g/d significantly reduced FBS and TG and increased HDLc. In conclusion, L-carnitine supplementation is correlated with a significant reduction of WC and BP. A dose of 1-3 g/d could improve the biomarkers of MetSyn by reducing FBS and TG and increasing HDLc.

Comparison of the effect of rapeseed oil or amaranth seed oil supplementation on weight loss, body composition, and changes in the metabolic profile of obese patients following 3-week body mass reduction program: a randomized clinical trial.

BACKGROUND: Amaranth seed oil (ASO) and rapeseed oil (RSO) are functional foods that display antioxidant and hepatoprotective properties. These oils are also known to lower glucose and cholesterol levels. The current study compared the effects exerted by RSO and ASO on weight loss and metabolic parameters during a 3-week body mass reduction program. METHODS: Eighty-one obese subjects (BMI > 30 kg/m2), aged 25-70 years, were enrolled in a 3-week body mass reduction program based on a calorie-restricted diet and physical activity. Participants were randomly categorized into an AO group (administered 20 mL/d of ASO), a RO group (administered 20 mL/d of RSO), and a C group (control; untreated). Anthropometric and metabolic parameters were measured at baseline and endpoint. RESULTS: Significant decreases in weight, body mass index (BMI), waist circumference (WC), hip circumference (HC), fat mass (FM), lean body mass (LBM), visceral fat mass (VFM), and total body water (TBW%) were observed in all groups (P <  0.05). No significant improvements were observed in the clinical parameters of group C. Fasting insulin (Δ - 5.9, and Δ - 5.7) and homeostatic model assessment of insulin resistance (HOMA-IR) (Δ - 1.1 and Δ - 0.5) were decreased in both RO and AO groups, respectively. Fasting glucose (Δ -8.5; P = 0.034), total cholesterol (Δ -14.6; P = 0.032), non-HDL cholesterol (Δ 15.9; P = 0.010), TG/HDL ratio (Δ -0.6; P = 0.032), LDL cholesterol (Δ -12.3; P = 0.042), and triglycerides (Δ -6.5; P = 0.000) were significantly improved in the AO group, compared to the RO group. CONCLUSIONS: The 3-week body mass reduction intervention caused a significant reduction in the weight, BMI, WC, HC, FM, and VFM of all groups. Except for HOMA-IR, there were no statistical differences between the clinical parameters of all groups. However, a trend toward improved insulin levels and HDL% was noticeable in AO and RO. Therapies involving edible oils with high nutritional value, such as RSO and ASO, show potential for improving metabolic measurements during body mass reduction programs. Thus, obese patients undertaking weight reduction programs may benefit from RSO and ASO supplementation. TRIAL REGISTRATION: retrospectively registered, DRKS00017708.

The effect of green coffee extract supplementation on anthropometric measures in adults: A comprehensive systematic review and dose-response meta-analysis of randomized clinical trials.

BACKGROUND AND AIM: Two meta-analyses summarized data on the effects of green coffee extract (GCE) supplementation on anthropometric measures. However, the accuracy of those meta-analyses is uncertain due to several methodological limitations. Therefore, we aimed to conduct a comprehensive systematic review and dose-response meta-analysis to summarize all available evidence on the effects of GCE supplementation on anthropometric measures by considering the main limitations in the previous meta-analyses. METHODS: We searched available online databases for relevant publications up to January 2020, using relevant keywords. All randomized clinical trials (RCTs) investigating the effects of GCE supplementation, compared with a control group, on anthropometric measures [including body weight, body mass index (BMI), body fat percentage, waist circumference (WC) and waist-to-hip ratio (WHR)] were included. RESULTS: After identifying 1871 studies from our initial search, 15 RCTs with a total sample size of 897 participants were included in the systematic review and meta-analysis. We found a significant reducing effect of GCE supplementation on body weight (weighted mean difference (WMD): -1.23, 95 % CI: -1.64, -0.82 kg,P < 0.001), BMI (WMD: -0.48, 95 % CI: -0.78, -0.18 kg/m2, P = 0.001), and WC (WMD: -1.00, 95 % CI: -1.70, -0.29 cm, P = 0.006). No significant effect of GCE supplementation on body fat percentage and WHR was seen. In the dose-response analyses, there was no significant association between chlorogenic acid (CGA) dosage, as the main polyphenol in green coffee, and changes in anthropometric measures. CONCLUSION: We found that GCE supplementation had a beneficial effect on body weight, BMI and WC. It provides a cost-effective and safe alternative for the treatment of obesity. Additional well-designed studies are required to further confirm our findings.

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

The effects of green tea (GT) in obese subjects have been evaluated in different studies, but no consensus has been obtained due to the heterogeneity of the results. The dosage, the type of extract, and the duration of the intervention are the main contributors to the heterogeneity of the results. Therefore, the present systematic review and meta-analysis aimed to evaluate the efficacy and dose-response relationship of GT. Several databases were searched from inception to September 2019 to identify clinical trials that examined the influence of GT supplements on obesity indices in humans. Combined results using the random-effects model indicated that body weight (WMD: -1.78 kg, 95% CI: -2.80, -0.75, p = .001) and body mass index (BMI) (WMD: -0.65 kg/m2 , 95% CI: -1.04, -0.25, p = .001) did change significantly following GT administration. The reduction in waist circumference (WC) after GT consumption was significant in subjects in trials employing GT ≥800 mg/day (WMD: -2.06 cm) and with a treatment duration <12 weeks (WMD: -2.39 cm). Following the dose-response evaluation, GT intake did alter body weight, with a more important reduction when the GT dosage was <500 mg/day and the treatment duration was of 12 weeks. The results of present meta-analysis study support the use of GT for the improvement of obesity indices. Thus, we suggest that the use of GT can be combined with a balanced and healthy diet and regular physical exercise in the management of obese patients.

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

BACKGROUND: and purpose: Clinical studies investigating the effects of berberine supplementation on anthropometric indices in humans have generated inconsistent results. Thus, the objective of this systematic review and meta-analysis was to clarify the effects of berberine supplementation on obesity indices in human subjects. METHODS: Several online medical databases were systematically searched up to February 2019. All clinical trials exploring the effects of berberine supplementation on indices of obesity were included. The combined weighted mean difference (WMD) of eligible studies was assessed using a random-effects model. We evaluated publication bias by using the Egger's test. RESULTS: Overall, 10 studies were included. The combined outcomes suggested a significant influence of berberine administration on body mass index (BMI) (WMD: -0.29 kg/m2, 95% CI: -0.51 to -0.08, p = 0.006) and waist circumference (WC) (WMD: -2.75 cm, 95% CI: -4.88 to -0.62, p = 0.01). However, berberine supplementation yielded no significant decline in body weight (BW) (WMD: -0.11 kg, 95% CI: -0.99 to 0.76, p = 0.79). Following the dose-response evaluation, berberine intake was found to significantly reduce BMI (r = -0.02) and WC (r = -0.72) based on treatment duration. CONCLUSION: The results of the current study support the use of berberine supplementation for the improvement of obesity indices.

The effect of Saffron supplementation on waist circumference, HA1C, and glucose metabolism: A systematic review and meta-analysis of randomized clinical trials.

OBJECTIVE: Carotenoids (including zeaxanthin and lycopene) and phytosterols reportedly confer beneficial effects on metabolic profile and function, which is of clinical importance. Thus, we sought to review the saffron effects on waist circumstance (WC), fasting plasma glucose (FPG), and HA1C concentrations reported in Randomized Control Trials (RCTs). METHOD: A comprehensive systematic electronic search was performed in PubMed/MEDLINE, Embase, Google Scholar, Cochrane, Web of sciences, and SCOPUS to identify RCTs up to February 2019 without any language restrictions. The pooled weighted mean difference (WMD) calculated with DerSimonian-Laird random. PRISMA guidelines adhered to for this meta-analysis. RESULT: Nine articles with 12 arms containing 595 participants were included in this study. Our study found WC was significantly reduced (WMD: -2.18 cm, 95 % CI: -4.05, -0.32) and FPG (WMD: -6.54 mg/dl, 95 % CI: -10.22, -2.85) following saffron intervention. Subgroup analysis highlighted that FPG levels (WMD: -10.24 mg/dl, 95 % CI: -15.76, -4.72) reduced significantly when intervention duration was longer than twelve weeks. There was no significant effect on HA1C levels (WMD: -0.13 mg/dl, 95 % CI: -0.31, 0.04) following saffron intervention. CONCLUSION: In conclusion, the present study indicates beneficial effects on WC and FPG, following saffron supplementation.

Safety and side effects of apple vinegar intake and its effect on metabolic parameters and body weight: a systematic review.

INTRODUCTION: Apple vinegar (AV) has been proclaimed to have different health benefits, such as a weight loss, the ability to lower blood glucose levels, and reducing the risk of heart diseases. Studies on animals have demonstrated effects of AV consumption, deepening our knowledge of the beneficial effects and side effects. AIM: The aims of this study were to evaluate the evidence of the effect of AV on metabolic parameters and body weight in humans, furthermore, to evaluate the safety and side effects of ingesting AV, and additionally to evaluate the evidence of the effect of AV on metabolic parameters, safety, and side effects of AV from studies performed on animals (mammals). METHODS: A systematic literature search was performed. The databases PubMed (MEDLINE), PsycInfo (Ebsco), CINAHL (Ebsco), and Embase (Ovid) were searched for relevant articles. Primary outcomes were glycated hemoglobin, postprandial glucose, and synonyms for blood glucose. Secondary outcomes were waist circumference, visceral fat, high-density lipoprotein, low-density lipoprotein, triglycerides, and total cholesterol. Studies performed on humans and animals were included. The included studies performed on humans were quality assessed for risk of bias using a version of the Cochrane Collaboration's tool. RESULTS: A total of 487 papers were identified in the literature search. Of these, 13 studies performed on humans and 12 studies performed on animals were included. There may be beneficial health effects from the consumption of AV. The risk of side effects when ingested in recommended quantities and in recommended ways seems inconsiderable. CONCLUSION: Due to inadequate research of high quality, the evidence for the health effects of AV is insufficient. Therefore, more large-scale, long-term clinical studies with a low risk of bias are needed before definitive conclusions can be made.