Clinical Trial

Effects of Synbiotics on Obesity

Not Yet Recruiting Phase 2
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Record status
This record was last updated October 9, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.
Summary
Synbiotics are a combination of probiotics and prebiotics that can promote the survival of probiotics in the gut. Probiotics utilize prebiotics to produce various metabolites beneficial to human health, such as short-chain fatty acids. The purpose of this trial is to evaluate the impact of a synbiotics product developed by Leewenhoek Laboratories Co., Ltd., on human obesity and its related biomarkers. Participants will be randomly assigned to either the experimental group or the control group in a double-blind trial. The intervention involves the experimental group taking the synbiotics product twice daily, two capsules per dose, after meals for six weeks. The control group will take an equal amount of placebo daily. During the trial, participants' body weight will be recorded weekly, and their body weight, waist circumference, hip circumference, body fat composition, and skeletal muscle mass will be measured before and after the intervention. Additionally, fasting blood samples and blood samples collected at 30, 60, 90, and 120 minutes after consuming the nutritional supplements will be analyzed. The study will compare body fat percentage, body weight, BMI, waist circumference, hip circumference, skeletal muscle mass, and obesity-related biomarkers in blood between the experimental and control groups. The trial results will be used to assess the efficacy of the synbiotics product in improving obesity and its related biomarkers.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-27.
Trial Details
NCT Number NCT06578143
Lead Sponsor Leeuwenhoek Laboratories Co. Ltd.
Conditions Obesity
Enrollment 80 participants
Start Date 2024-10-15
Primary Completion 2024-12-01 (estimated)
Study Completion 2025-03-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-09