Effect of Fucoxanthin on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion.

The aim of this study was to evaluate the effect of fucoxanthin on metabolic syndrome (MetS), insulin sensitivity, and insulin secretion. A randomized, double-blind, placebo-controlled clinical trial was conducted in 28 patients diagnosed with MetS. Patients were randomly assigned to receive 12 mg of fucoxanthin or placebo once a day for 12 weeks. Before and after the intervention, the components of MetS, insulin sensitivity (Matsuda index), first phase of insulin secretion (Stumvoll index), and total insulin secretion were evaluated during a 2-h oral glucose tolerance test. After fucoxanthin administration, significant differences were observed in body weight (BW) (80.6 ± 11.2 vs. 79.16 ± 12.3 kg, P < .01), body mass index (BMI) (31.1 ± 3.6 vs. 30.3 ± 3.7 kg/m2, P < .01), waist circumference (WC) (101.2 ± 9.1 vs. 98.9 ± 9.3 cm, P < .01), systolic blood pressure (SBP) (126.1 ± 10.3 vs. 120.8 ± 9.7 mmHg, P < .01), diastolic blood pressure (DBP) (81.5 ± 6.5 vs. 78.6 ± 6.3 mmHg, P < .01), triglycerides (TG) (2.2 ± 0.7 vs. 2.1 ± 0.7 mmol/L, P < .01), Stumvoll index (2403 ± 621 vs. 2907 ± 732, P < .05), and total insulin secretion (0.84 ± 0.31 vs. 1.02 ± 0.32, P < .05). In conclusion, fucoxanthin administration leads to a decrease in BW, BMI, WC, SBP, DBP, TG, as well as increase in the first phase of insulin secretion and total insulin secretion in patients with MetS. Clinical Trial Registration number: NCT03613740.

Role of Fenugreek, Cinnamon, Curcuma longa, Berberine and Momordica charantia in Type 2 Diabetes Mellitus Treatment: A Review.

Type 2 diabetes mellitus (T2DM) is a complex disease that has become a major global health concern. Given the efficacy of antidiabetic drugs, pharmacological therapy is considered the first-line treatment of T2DM; however, due to their potential side effects and high costs, new and cost-effective treatments with minimal side effects are needed. Medicinal plants have been used for centuries as part of traditional medicine to treat T2DM. Among these, fenugreek, cinnamon, Curcuma longa, berberine, and Momordica charantia have demonstrated different degrees of hypoglycemic activity in clinical studies and animal models. Therefore, the aim of this review is to synthesize the mechanisms of action of five medicinal plants, as well as the experimental and clinical evidence of their hypoglycemic activity from the published literature.

Anti-hyperglycemic effects of propolis or metformin in type 2 diabetes mellitus.

Background: The aim of this study was to evaluate the effect of propolis or metformin versus placebo on glycemic control in pharmacological treatment-naïve patients with type 2 diabetes mellitus (T2DM). Methods: A double-blind, randomized, placebo-controlled in parallel groups clinical trial was performed in 36 pharmacological treatment-naïve patients with T2DM. They received propolis (300 mg), metformin (850 mg), or placebo twice daily before breakfast and dinner for 12 weeks. At the beginning and end of the study, fasting plasma glucose (FPG), 2-h postload glucose (2-h PG) during a 75-g oral glucose tolerance test, glycated hemoglobin A1c (A1C) and a metabolic profile were measured. Areas under the curve (AUC) of glucose and insulin, total insulin secretion (insulinogenic index), the first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index) were calculated. Statistical analyses: Kruskal-Wallis, Mann-Whitney U and Wilcoxon tests. Results: The propolis and metformin groups exhibited significant reductions in FPG (p=0.009 and p=0.001, respectively), 2-h PG (p=0.034 and p=0.001, respectively) levels, AUC of insulin, Stumvoll index, and an increment in the Matsuda index. The comparison of the changes from baseline to the end showed significant differences between placebo and propolis in FPG (p=0.004) and A1C (p=0.049) levels, while between placebo and metformin were in FPG (p=0.002), 2-h PG (p=0.004) and A1C (p=0.007) levels. Conclusions: The administration of propolis and metformin compared to placebo reduced FPG and A1C levels; in addition, metformin decreased 2-h PG, AUC of glucose and insulin, high-density lipoprotein cholesterol, and increased the insulin sensitivity.

Therapeutic Effect of Fucoidan on Metabolic Diseases: Experimental Data and Clinical Evidence.

The rising prevalence of metabolic diseases represents a major challenge to public health worldwide. Therefore, there is a strong need to conduct research on the effectiveness of complementary and alternative therapies for metabolic disorders. Fucoidan is a fucose-enriched and sulfated polysaccharide extracted from ubiquitous brown seaweed. The antihypertensive, antidiabetic, antiobesity, and hypolipidemic effects of fucoidan have been reported in preclinical research and clinical trials. This study aims to review the mechanisms of action and the experimental and clinical use of different types of fucoidan for the treatment of metabolic diseases.

The Role of Garlic in Metabolic Diseases: A Review.

Garlic (Allium sativum L.) is a popular spice that has been widely used for thousands of years in traditional medicine. Several organosulfur compounds in garlic have been linked to its beneficial effects on health. Evidence from preclinical studies and clinical trials supports garlic's antihypertensive, antidiabetic, antiobesity, and hypolipidemic effects. This study aims to summarize clinical trial evidence regarding the effects of garlic on metabolic diseases and its mechanisms of action.

Effect of Momordica charantia Administration on Anthropometric Measures and Metabolic Profile in Patients with Obesity: A Pilot Clinical Trial.

The aim of this study was to evaluate the effect of Momordica charantia (MC) administration on anthropometric measures in patients with obesity. A randomized, double-blind, placebo-controlled pilot clinical trial was carried out in 24 patients with obesity. Twelve patients randomly received MC (2000 mg/day) for 12 weeks, and 12 patients received placebo. Body weight (BW), body mass index (BMI), waist circumference (WC), body fat percentage, as well as clinical and laboratory determinations, were evaluated before and after the intervention. Results showed that while reductions in BW, BMI, WC, and body fat percentage were observed in the MC group, these differences did not reach statistical significance. Significant decreases in triglycerides (TG) (1.9 ± 0.6 mM vs. 1.7 ± 0.7 mM, P ≤ .05) and very low-density lipoprotein (VLDL) (0.4 ± 0.1 mM vs. 0.3 ± 0.1 mM, P ≤ .05) levels were found after the intervention with MC. In contrast, significant increases in BW (83.0 ± 10.7 kg vs. 84.6 ± 9.1 kg, P ≤ .05) and BMI (31.9 ± 1.5 kg/m2 vs. 33.0 ± 1.3 kg/m2, P ≤ .05) were observed in the placebo group. In conclusion, no significant reductions in BW, BMI, WC, and body fat percentage were observed after MC administration; however, MC significantly decreased TG and VLDL levels. The protocol was registered at ClinicalTrials.gov with the identifier NCT04916379.

Effect of Banaba (Lagerstroemia speciosa) on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion.

To evaluate the effect of Banaba (Lagerstroemia speciosa) on metabolic syndrome (MetS), insulin sensitivity, and insulin secretion. A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with diagnosis of MetS according to the International Diabetes Federation criteria. Body weight, waist circumference, and blood pressure were evaluated. Fasting plasma glucose (FPG) and insulin concentrations were measured every 30 min during 2 h after a 75-g dextrose load. Lipid profile was determined before and after the pharmacological intervention. Twelve patients received Banaba (500 mg) twice a day, before breakfast and dinner for 12 weeks. The remaining 12 patients received placebo at the same dosage. Body mass index, area under the curve (AUC) of glucose and insulin, insulin sensitivity, total insulin secretion, and the first phase of insulin secretion were calculated. After Banaba administration, there were significant decreases in systolic blood pressure (SBP) (121.5 ± 12.9 vs. 116.3 ± 9.8 mmHg, P = .050), FPG (5.9 ± 0.4 vs. 5.7 ± 0.4 mmol/L, P = .034), triglycerides (TG) (2.3 ± 0.4 vs. 1.7 ± 0.5 mmol/L, P = .021), very low-density lipoprotein (VLDL) (0.5 ± 0.1 vs. 0.3 ± 0.1 mmol/L, P = .021), AUC of insulin (50,675 ± 14,309 vs. 37,983 ± 19,298 mmol/L, P = .017), and insulinogenic index (0.4 ± 0.2 vs. 0.3 ± 0.2, P = .047). Eight patients (67%) of the Banaba group showed remission of MetS. In the placebo group, there was a downward trend toward statistical significance in the Stumvoll index (910.3 ± 514.1 vs. 651.0 ± 405.2, P = .062). Banaba administration leads to remission of MetS and a significant decrease in SBP, FPG, TG, VLDL, AUC of insulin, and total insulin secretion. Clinical Trial Registration number: NCT02767869.

Momordica Charantia: A Review of Its Effects on Metabolic Diseases and Mechanisms of Action.

The global rise in the prevalence of metabolic diseases such as diabetes, obesity, and dyslipidemia is a serious public health issue. The search for safe and effective complementary and alternative therapies to treat metabolic disorders is a key field of research. Momordica charantia (MC) is a tropical and subtropical vine of the Cucurbitaceae family used as a medicinal plant since ancient times. Although MC has been widely studied for its hypoglycemic potential, hypolipidemic and antiobesity effects have also been reported in preclinical studies and clinical trials. This study aims to review the metabolic effects of MC reported in clinical trials as well as its mechanisms of action.

Effect of Berberine Plus Bezafibrate Administration on the Lipid Profile of Patients with Mixed Dyslipidemia: A Pilot Clinical Trial.

To evaluate the effect of berberine (BBR) plus bezafibrate administration on the lipid profile of patients with mixed dyslipidemia. A double-blind randomized pilot clinical trial with parallel groups was carried out in 36 patients, aged 30-60 years with mixed dyslipidemia [triglycerides (TG) ≥1.7 mM and total cholesterol (TC) ≥5.2 mM]. Patients were assigned to 3 groups of 12 patients each, receiving oral administration during 90 days of BBR 500 mg t.i.d., bezafibrate 400 mg b.i.d., or BBR 500 mg t.i.d. plus bezafibrate 400 mg b.i.d, respectively. Clinical evaluation, lipid profile, glucose, creatinine, and uric acid levels were measured before and after the pharmacological intervention. Kruskal-Wallis, Wilcoxon, Mann-Whitney U, and χ2 tests were used for statistical analyses; a P ≤ .05 was considered statistically significant. BBR reduced TC levels. Bezafibrate decreased TG, TC, low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein (VLDL) concentrations. BBR plus bezafibrate decreased TG (2.6 ± 0.8 vs. 1.3 ± 0.7 mM, P = .007), TC (6.3 ± 0.7 vs. 4.6 ± 1.2 mM, P = .005), LDL-C (3.4 ± 0.6 vs. 2.2 ± 1.3 mM, P = .037), and VLDL (0.5 ± 0.2 vs. 0.2 ± 0.1 mM, P = .007) levels. Bezafibrate and BBR plus bezafibrate significantly decreased TG, TC, LDL-C, and VLDL concentrations, and thus, remitting the diagnosis of mixed dyslipidemia in 90% of the patients.

Momordica charantia Administration Improves Insulin Secretion in Type 2 Diabetes Mellitus.

An improvement in parameters of glycemic control has been observed with Momordica charantia in patients with type 2 diabetes mellitus (T2DM). It is unknown whether this improvement is through a modification of insulin secretion, insulin sensitivity, or both. We hypothesized that M. charantia administration can improve insulin secretion and/or insulin sensitivity in patients with T2DM, without pharmacological treatment. The objective of the study was to evaluate the effect of M. charantia administration on insulin secretion and sensitivity. A randomized, double-blinded, placebo-controlled, clinical trial was carried out in 24 patients who received M. charantia (2000 mg/day) or placebo for 3 months. A 2-h oral glucose tolerance test (OGTT) was done before and after the intervention to calculate areas under the curve (AUC) of glucose and insulin, total insulin secretion (insulinogenic index), first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index). In the M. charantia group, there were significant decreases in weight, body mass index (BMI), fat percentage, waist circumference (WC), glycated hemoglobin A1c (A1C), 2-h glucose in OGTT, and AUC of glucose. A significant increase in insulin AUC (56,562 ± 36,078 vs. 65,256 ± 42,720 pmol/L/min, P = .043), in total insulin secretion (0.29 ± 0.18 vs. 0.41 ± 0.29, P = .028), and during the first phase of insulin secretion (557.8 ± 645.6 vs. 1135.7 ± 725.0, P = .043) was observed after M. charantia administration. Insulin sensitivity was not modified with any intervention. In conclusion, M. charantia administration reduced A1C, 2-h glucose, glucose AUC, weight, BMI, fat percentage, and WC, with an increment of insulin AUC, first phase and total insulin secretion.

Effect of Irvingia gabonensis on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion.

The aim of this study was to evaluate the effect of Irvingia gabonensis on metabolic syndrome (MetS), insulin sensitivity, and insulin secretion. A randomized, double-blind, placebo-controlled clinical trial was performed in 24 patients with MetS in accordance with the International Diabetes Federation criteria. Twelve patients received I. gabonensis (150 mg) twice a day during 90 days, and 12 patients received placebo. Glucose and insulin concentrations were measured during a 2-h oral glucose tolerance test. Also, lipid profile, creatinine, uric acid, and hepatic enzymes were determined. The area under the curve (AUC) of glucose and insulin, total insulin secretion, first phase of insulin secretion, and insulin sensitivity were calculated. Data were tested using non-parametric tests. The Ethics Committee approved the protocol. After I. gabonensis administration, significant decreases in waist circumference (WC) (94.0 ± 8.0 vs. 91.0 ± 8.2 cm, P < .01), glucose 90' (10.0 ± 2.5 vs. 8.6 ± 2.7 mmol/L, P < .05), glucose 120' (8.8 ± 2.4 vs. 7.6 ± 2.7 mmol/L, P < .05), triglycerides (2.5 ± 1.2 vs. 2.0 ± 1.1 mmol/L, P < .05), very low-density lipoproteins (VLDL) (0.5 ± 0.2 vs. 0.4 ± 0.2 mmol/L, P < .05), and AUC of glucose (694 ± 142 vs. 629 ± 172 mmol/L/min, P < .05) were found. Seven patients (58.3%) of the I. gabonensis group showed remission of MetS and two patients (16.7%) of the placebo group (P = .045). I. gabonensis lead to remission of MetS in 58.3% of the patients and significantly decreased WC, glucose 90', glucose 120', triglycerides, VLDL, and AUC of glucose.

Novel nutraceutic therapies for the treatment of metabolic syndrome.

Nutraceutic therapies such as berberine, bitter melon, Gymnema sylvestre, Irvingia gabonensis, resveratrol and ursolic acid have been shown to help control metabolic syndrome (MetS). The effect of berberine on glucose and lipid metabolism, hypertension, obesity and MetS has been evaluated in animal models and humans. Most clinical trials involving bitter melon have been conducted to evaluate its effect on glucose metabolism; nevertheless, some studies have reported favorable effects on lipids and blood pressure although there is little information about its effect on body weight. Gymnema sylvestre helps to decrease body weight and blood sugar levels; however, there is limited information on dyslipidemia and hypertension. Clinical trials of Irvingia gabonensis have shown important effects decreasing glucose and cholesterol concentrations as well decreasing body weight. Resveratrol acts through different mechanisms to decrease blood pressure, lipids, glucose and weight, showing its effects on the population with MetS. Finally, there is evidence of positive effects with ursolic acid in in vitro and in vivo studies on glucose and lipid metabolism and on body weight and visceral fat. Therefore, a review of the beneficial effects and limitations of the above-mentioned nutraceutic therapies is presented.

Effect of resveratrol administration on metabolic syndrome, insulin sensitivity, and insulin secretion.

AIM: This study evaluated the effect of resveratrol administration on metabolic syndrome, insulin sensitivity, and insulin secretion. METHODS: A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with diagnosis of metabolic syndrome in accordance with the International Diabetes Federation criteria. Glucose and insulin levels were measured after a 75-gram dextrose load. Triglycerides and high-density lipoprotein cholesterol concentrations at baseline were also evaluated. Twelve patients received trans-resveratrol (500 mg) three times per day before meals for 90 days. The remaining 12 patients received placebo at the same dose. The area under the curve (AUC) values of glucose and insulin, total insulin secretion, first-phase of insulin secretion, and insulin sensitivity were calculated. RESULTS: After resveratrol administration, there were significant differences in total weight (94.4±13.2 vs. 90.5±12.3 kg, P=0.007), body mass index (BMI) (35.6±3.2 vs. 34.3±3.0 kg/m(2), P=0.006), fat mass (41.2±7.9 vs. 38.8±6.0 kg, P=0.001), and waist circumference (WC) (109±9 vs. 105±10 cm, P=0.004). There were also significant differences in AUC of insulin (48,418±22,707 vs. 26,473±8,273 pmol/L, P=0.003) and insulinogenic index (0.48±0.22 vs. 0.28±0.08, P=0.004). CONCLUSIONS: Administration of resveratrol significantly decreases weight, BMI, fat mass, WC, AUC of insulin, and total insulin secretion.

Effect of berberine administration on metabolic syndrome, insulin sensitivity, and insulin secretion.

BACKGROUND: The aim of this study was to evaluate the effect of berberine administration on metabolic syndrome, insulin sensitivity, and insulin secretion. METHODS: A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome. Glucose and insulin levels after a dextrose load were measured. Triglycerides and high-density lipoprotein cholesterol concentrations at baseline were also measured. Twelve patients received berberine hydrochloride (500 mg) three times daily before meals for 3 months. The remaining 12 patients received placebo. Area under the curve (AUC) of glucose and insulin, total insulin secretion, first-phase of insulin secretion, and insulin sensitivity were assessed. RESULTS: After berberine administration, patients had a remission of 36% (P=0.037) in the presence of metabolic syndrome and a significant decrease in waist circumference in females (106±4 vs. 103±3 cm, P<0.05), systolic blood pressure (SBP) (123±7 vs. 115±9 mmHg, P<0.01), triglycerides (2.4±0.7 vs. 1.4±0.5 mmol/L, P<0.01), area under the curve (AUC) of glucose (1182.1±253.6 vs. 1069.5±172.4 mmol/l, P<0.05), AUC of insulin (92,056±72,148 vs. 67,407±46,441 pmol/L, P<0.01), and insulinogenic index (0.78±0.69 vs. 0.62±0.46, P<0.05), as well as an increase in the Matsuda index (2.1±1.0 vs. 3.1±1.6, P<0.01). CONCLUSIONS: Administration of berberine leads to remission of metabolic syndrome and decreases in waist circumference, SBP, triglycerides, and total insulin secretion, with an increase in insulin sensitivity.

Effect of vildagliptin on glucose and insulin concentrations during a 24-hour period in type 2 diabetes patients with different ranges of baseline hemoglobin A1c levels.

BACKGROUND: Currently, it is still unknown whether differences in glycemic control have any effect on glucose and insulin kinetics after vildagliptin administration. The aim of this study was to evaluate the effect of vildagliptin on glucose and insulin concentrations during a 24-h period in type 2 diabetes patients with different ranges of baseline hemoglobin A1c (A1C) levels. PATIENTS AND METHODS: A randomized, double-blind, crossover, placebo-controlled clinical trial was carried out in 12 drug-naive adult volunteers with type 2 diabetes and overweight or obesity. Subjects had fasting glucose values between 7.2 and 13.3 mmol/L. Six patients had A1C between 7.0% and 8.4% (Group A), and the remaining subjects had A1C between 8.5% and 10.0% (Group B). Patients received oral administration of vildagliptin (50 mg twice daily) or placebo in a crossover manner for two consecutive days. Until the second day of the interventions, glucose and insulin concentrations were measured every hour during a 24-h period, and areas under the curve (AUCs) were calculated. Statistical analyses were evaluated with Wilcoxon and Mann-Whitney U tests. RESULTS: There were significant decreases in glucose concentrations after vildagliptin administration in both groups when comparing placebo in all measurements throughout the 24-h period and in the AUC. There were no significant changes in insulin concentration in both groups after vildagliptin administration when comparing placebo in all measurements throughout the 24-h period and in the AUC. CONCLUSIONS: Vildagliptin administration improved glucose control during a 24-h period in type 2 diabetes patients, independent of the basal A1C level, without changes in insulin levels.

Effect of pomegranate juice on insulin secretion and sensitivity in patients with obesity.

AIM: To evaluate the effect of pomegranate juice on insulin secretion and sensitivity in patients with obesity. METHODS: A randomized, double-blind, placebo-controlled clinical trial was carried out in 20 obese, adult volunteer subjects. After random allocation of the intervention, 10 patients received 120 ml of pomegranate juice or placebo while in a fasted state for 1 month. Glucose, uric acid, creatinine, lipid profile, and insulin were measured at baseline, and glucose and insulin were also measured at 30, 60, 90, and 120 min. The area under the curve of glucose and insulin, total insulin secretion, and insulin sensitivity was calculated. RESULTS: There was a significant increase in weight, body mass index, and fat mass in the placebo group after the intervention. Insulin secretion and insulin sensitivity were not modified with administration of pomegranate juice. There was a significant difference in changes from baseline in fat mass between groups (1.1 ± 1.1% vs. -1.4 ± 3.0%, p = 0.010; placebo and pomegranate groups, respectively). CONCLUSION: Pomegranate juice administration for 1 month did not modify insulin secretion and sensitivity in patients with obesity; however, the natural evolution to increased weight and adiposity was halted.