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Effects of Synbiotics on Obesity

NCT06578143 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-10-09

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Placebo

Placebo is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.

OTHER

Synbiotics

Synbiotics is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.

Sponsors & Collaborators

  • Leeuwenhoek Laboratories Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2024-12-01
Completion
2025-03-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06578143 on ClinicalTrials.gov