Actively Recruiting
Probiotic Intervention on Body Weight
Led by Chinese Academy of Sciences · Updated on 2026-03-17
140
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Probiotic Intervention on Body Weight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 20 to 50 years.
- Normal-weight participants with BMI between 18.5 and less than 24 kg/m².
- Overweight or obese participants with BMI 28 kg/m² or higher, or BMI between 24 and less than 28 kg/m² with clinical diagnoses like hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or cardiovascular disease.
- Willingness to participate and provide signed informed consent.
You will not qualify if you...
- Abnormal metabolic indicators including waist circumference above 90 cm for men or 85 cm for women, high fasting or postprandial glucose, diabetes diagnosis, high blood pressure or antihypertensive treatment, abnormal blood lipids.
- For overweight or obese participants, exclusion if fasting glucose above 11.1 mmol/L, HbA1c above 9%, diabetes diagnosis, insulin or antidiabetic medication use, severe hypertension, recent lipid-lowering drug use, or very high triglycerides or LDL levels.
- Pregnancy or breastfeeding.
- Weight change over 5 kg within 90 days before screening.
- Use of antibiotics, antimicrobials, anti-inflammatory drugs, estrogen therapy, GLP-1 receptor agonists, or probiotics within specified recent periods.
- Heavy alcohol use exceeding defined daily limits.
- Severe liver or kidney dysfunction.
- Gastrointestinal diseases affecting digestion or absorption.
- Surgery within the past year (except appendectomy or hernia repair).
- Severe cardiovascular or cerebrovascular diseases.
- Presence of metallic implants like cardiac stents or pacemakers.
- Cancer or recent radiation or chemotherapy.
- Personal or family history of certain thyroid cancers or thyroid disease.
- Pancreatitis.
- Infectious diseases such as hepatitis B, tuberculosis, or HIV.
- Participation in other clinical studies recently.
- Claustrophobia.
- Psychiatric disorders or use of related medications.
- Inability to read, write, use a smartphone, or perform daily activities independently.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China, 310024
Actively Recruiting
Research Team
W
Wanhui Kang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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