Health Trials

About this trial

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 criteria

Qualifiers

Aged 20 to 50 years.

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

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

Disqualifiers

Waist circumference ≥ 90 cm for men or ≥ 85 cm for women.

Fasting glucose ≥ 6.1 mmol/L or 2-hour postprandial glucose ≥ 7.8 mmol/L, or a confirmed diagnosis of diabetes.

Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or currently under antihypertensive treatment.

Fasting triglycerides (TG) ≥ 1.7 mmol/L; high-density lipoprotein cholesterol (HDL-C) < 0.9 mmol/L in men or < 1.0 mmol/L in women.

Trial design

Treatments tested in this trial

  • General lifestyle and nutritional education
  • Energy-restricted nutritional and lifestyle intervention
  • Placebo
  • Probiotic
  • semaglutide

Treatment groups

140 Participants
are divided into 4 treatment groups

Locations

1
Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences310024, HangzhouZhejiang, China

Sponsors and collaborators

Chinese Academy of Sciences

Lead sponsor

Source ClinicalTrials.gov