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.

Beneficial Effects of a Novel Fenugreek Seed Extract (Trigonella foenum-graecum, Furocyst®) in Women with Polycystic Ovary Syndrome (PCOS): A Follow-up Compliance Clinical Investigation.

INTRODUCTION: Polycystic Ovary Syndrome (PCOS) is an endocrine disorder which accounts for infertility around the world. The disease is characterized by elevated secretion of androgens in the women which results in enlargement of ovaries with accumulation of fluid filled cysts, irregular menstrual cycles, and hirsutism. This study reports the efficacy of a patented, standardized Trigonella foenum-graecum extract (Furocyst®) as an effective phytotherapeutic for effective management of PCOS. OBJECTIVE: This randomized one-arm study assessed the efficacy of Furocyst® in 107 female volunteers over a period of 12 consecutive weeks. METHOD: Following approvals of the Institutional Ethical Committee and clinicaltrials.gov, 107 female volunteers (age: 18-45 years) were recruited. Subjects consumed Furocyst® capsules (1,000 mg/day p.o.) over a period of 12 consecutive weeks. Physical (Sonographic scan, Hirsutism Score, Menstrual cycle, Body Weight, BMI, Height, Waist Circumference and Blood Pressure) and biochemical parameters (LH/FSH ratio, TSH, Prolactin, Fasting insulin, Fasting Glucose, triglyceride, cholesterol, HOMA Index, free and total testosterone, 2-hour GTT, DHEAS) were assessed at the beginning of the study as well as at intervals of 4 weeks till 12 weeks to determine the efficacy of Furocyst® on PCOS induced damage on reproductive and endocrine system. RESULTS: Furocyst® treatment induced >40% reduction of mean cyst sizes in both ovaries with corresponding reduction of in ovarian volumes. LH:FSH ratio was also significantly improved with corresponding reduction in total testosterone and prolactin levels. As a result of improvement in endocrine function, menstrual cycle became regular in the subjects. Furocyst® also reduced the severity of other associated ailments such as insulin resistance, dyslipidemia, and improved liver function significantly. CONCLUSIONS: This study reinstated the efficacy of Furocyst® as a safe phytotherapeutic to reverse the effects of PCOS inflicted damage on the female reproductive system without any adverse events.