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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Dietary supplement, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 50
Healthy Volunteers: t
View:

• Aged 20 to 50 years.

• Normal-weight participants: 18.5 kg/m² ≤ Body Mass Index (BMI) \< 24 kg/m².

• Overweight or obese participants:

⁃ BMI ≥ 28 kg/m², or 24 kg/m² ≤ BMI \< 28 kg/m² and a clinical diagnosis meeting semaglutide treatment indications (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, cardiovascular disease, etc.).

• Willingness to participate in this study and provide signed informed consent.

Locations
Other Locations
China
Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences
RECRUITING
Hangzhou
Contact Information
Primary
Wanhui Kang, PhD
kangwanhui@ucas.ac.cn
+86 86081210
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 140
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Chinese Academy of Sciences

This content was sourced from clinicaltrials.gov