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Probiotic Intervention on Body Weight

NCT06989177 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Chinese Academy of Sciences

    lead OTHER_GOV

Principal Investigators

  • Xu Lin, PhD · Institute for Nutritional Sciecnes, CAS; Hangzhou Institute for Advanced Study, UCAS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2026-12-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT06989177 on ClinicalTrials.gov