Probiotic Intervention on Body Weight

Sponsor
Chinese Academy of Sciences
Study ID
NCT06989177
Status
Recruiting
Apply to this trial

Conditions

  • Homeostasis
  • Obesity
  • Probiotic Intervention
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
20 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • General lifestyle and nutritional education — BEHAVIORAL
    Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.
  • Energy-restricted nutritional and lifestyle intervention — BEHAVIORAL
    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.
  • Placebo — DIETARY_SUPPLEMENT
    Participants will receive one bag (2 g; 1 × 10¹² CFU) daily of LC-19.
  • Probiotic — DIETARY_SUPPLEMENT
    participants will receive daily one bag of LC-19 (10\^12 cfu/bag).
  • semaglutide — DRUG
    Participants will receive prescibed semaglutide therapy

Study Details

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.

Key Dates

Start date
Jun 10, 2025
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Control Group
    They will receive energy-restricted nutritional and lifestyle intervention and placebo
  • Active Comparator: GLP-1RA Group
    They will receive an energy-restricted nutritional and lifestyle intervention , in conjunction with prescribed semaglutide therapy.
  • Experimental: Probiotic Group
    They will receive an energy-restricted nutritional and lifestyle intervention and LC-19
  • Other: Healthy Comparators
    They will receive general lifestyle and nutritional education.

Primary Outcome Measure

Change in Body Weight (kg) from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

Central Contacts

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