Study of a 12-Week Nutritional Supplement on Body Composition and Metabolic Health in Women Aged 38 to 55

What this Trial Is About

Researchers are evaluating whether a 12-week nutritional supplement can cause significant changes in body composition, metabolism, and physical performance in females aged 38 to 55 years. The study focuses on menopause-related symptoms and changes, such as body mass index, body fat composition, metabolite levels in plasma and urine, and grip strength. The trial compares a supplement containing myo-inositol, berberine, cinnamon, and chromium against a placebo to understand its potential effects during the menopausal transition. Participants are randomly assigned to take either the nutritional supplement or a placebo. For the first 10 days, participants take one capsule three times daily at the start of meals. From day 11 to day 84, they increase to three capsules three times daily. The study uses a quadruple-blind design to ensure unbiased results. Participants attend two visits at a clinical research facility for assessments and sample collection. During the study, participants will provide fasting blood and urine samples at baseline and after 12 weeks. Researchers measure waist and hip circumference, body composition, grip and leg strength, and collect data via health and menopause-related questionnaires. Participants also keep a daily diary to track supplement intake. The main outcome is the change in body mass index, with additional measures including body fat, metabolomic and transcriptomic profiles, menopause symptoms, and physical strength. The total study duration is 12 weeks with two clinic visits.

Nutritional Supplementation on Physiological and Metabolic Markers in Females