Probiotic Intervention on Body Weight
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 peptid
| Condition(s) | Obesity, Homeostasis, Weight Loss, Probiotic Intervention |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 optimi |
| Who can participate | Inclusion Criteria: * 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. Exclusion Criteria: * Abnormal metabolic indicators (meeting any one of the following criteria is grounds for exclusion): 1\. Normal weight (18.5 kg/m² ≤ BMI \< 24 kg/m²): 1. Waist circumference ≥ 90 cm for men or ≥ 85 cm for women. 2. Fasting glucose ≥ 6.1 mmol/L or 2-hour postprandial glucose ≥ 7.8 mmol/L, or a confirmed diagno |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Chinese Academy of Sciences |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2025-06-10 |
| NCT ID | NCT06989177 |
| Official listing | https://clinicaltrials.gov/study/NCT06989177 |