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RECRUITING
NCT06989177
NA

Probiotic Intervention on Body Weight

Sponsor: Chinese Academy of Sciences

View on ClinicalTrials.gov

Summary

This study is a randomized controlled trial with 120 overweight or obese (body-mass index, BMI, ≥ 24 kg/m²) participants and 20 normal-weight participants. Twelve weeks of energy-restricted nutritional and lifestyle intervention with placebo, Lactobacillus paracasei LC-19 (LC-19), or semaglutide (a glucagon-like peptide-1 receptor agonist, GLP-1RA) will be randomly conducted in the overweight or obese participants. The primary goal is to clarify the roles of LC-19 and semaglutide in weight reduction and in improving energy, glucose, and lipid metabolism, while also comparing side effects, adverse events, and long-term outcomes such as weight regain between these two interventions. In addition, the study will explore key factors affecting intervention response to provide evidence for optimizing individualized intervention strategies.

Official title: An Interventional Study Investigating the Effects of Probiotics on Body Weight and Metabolic Homeostasis

Key Details

Gender

All

Age Range

20 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-06-10

Completion Date

2026-12-31

Last Updated

2026-03-17

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

General lifestyle and nutritional education

Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.

BEHAVIORAL

Energy-restricted nutritional and lifestyle intervention

Participants will receive dietary advice, behavioral guidance and nutritional and lifestyle education by dietitian and physicians. App-connected wearable devices will be utilized to monitor their dietary intakes and App-connected scale will be used to monitor their weight changes during interventions.

DIETARY_SUPPLEMENT

Placebo

Participants will receive one bag (2 g; 1 × 10¹² CFU) daily of LC-19.

DIETARY_SUPPLEMENT

Probiotic

participants will receive daily one bag of LC-19 (10\^12 cfu/bag).

DRUG

semaglutide

Participants will receive prescibed semaglutide therapy

Locations (1)

Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences

Hangzhou, Zhejiang, China