Placebo controlled, double-blind study for efficacy of two herbal supplements (Trigonella foenum-graecum Seed Extract and Coccinia Grandis Extract) for Normalizing Elevated (pre-diabetic) blood Glucose and improving Insulin Sensitivity - a 3 arm study.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: Arm 1: Trigonella foenum‐graecum Seed Extract, 250mg twice per day (500mg/day) for 12 weeks. capsule taken orally. Arm 2: Coccinia Grandis Extract, 500mg twice per day (1000mg.day) for 12 weeks, capsule taken orally. Arm 3: Placebo (maltodextrin), 2 capsules per day, for 12 weeks, CONDITION: diabetes pre‐diabetes PRIMARY OUTCOME: Fasting and 2 hr blood glucose in oral glucose tolerance test, OGTT. ; Fasting and 2hr insulin in oral glucose tolerance test, OGTT. SECONDARY OUTCOME: Body weight Electrolyte / Liver Function blood test (composite blood test) ; Glycosylated haemoglobin (HbA1c) Lipid Studies on blood test Reported adverse reactions ‐ e.g irritation to nasal passages on application, or any gastrointestinal reactions. Safety outcomes : ; Full Blood Count (RBC) ; ; INCLUSION CRITERIA: Male and females at least 18 years of age at time of entry on study; Impaired Fasting blood glucose levels and/or insulin resistance; BMI is greater than 25; Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment; Agree to undergo venipuncture on multiple occasions; Agree to adhere to the study protocol, including not changing diet or major exercise patterns over the 12 week study period.
Epistemonikos ID: a3ac6b0d12e6d244d8eec9f1f3d7d7598643cb32
First added on: Aug 25, 2024