Probiotic Intervention on Body Weight

Launched by CHINESE ACADEMY OF SCIENCES · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of two different treatments—Lactobacillus paracasei LC-19, a type of probiotic, and semaglutide, a medication that helps with weight loss—on people who are overweight or obese. The study will involve 120 participants who have a body mass index (BMI) of 24 or higher, along with 20 participants of normal weight. Over 12 weeks, participants will follow a nutrition and lifestyle plan while receiving either a placebo (inactive treatment), the probiotic, or semaglutide. The main goal is to see how well these treatments help reduce weight and improve energy and metabolism, as well as to compare any side effects they may cause.

To be eligible for this study, participants need to be between 20 and 50 years old and meet specific BMI requirements. For instance, those who are overweight or obese must have a BMI of 24 or higher, while normal-weight participants must have a BMI between 18.5 and 24. Participants will need to commit to the study and be willing to follow the guidelines provided. Throughout the trial, they can expect regular check-ins and assessments to track their progress and any potential side effects. Overall, this study aims to gather valuable information to improve weight loss strategies for individuals in the future.

Gender

ALL

Eligibility criteria

• 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 diagnosis of diabetes.
• • 3. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or currently under antihypertensive treatment.
• • 4. 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.
• 2. Overweight or obese (BMI ≥ 24 kg/m²):
• • 1. Fasting plasma glucose \> 11.1 mmol/L or HbA1c \> 9%, or previously diagnosed diabetes, or currently using insulin or any antidiabetic medication.
• • 2. Blood pressure ≥ 160/100 mmHg, or clinically diagnosed stage 2 or stage 3 (moderate or severe) hypertension, or currently under antihypertensive treatment.
• • 3. Use of lipid-lowering drugs (e.g., fibrates, bile acid sequestrants, statins, PCSK9 inhibitors) within the past 3 months, or TG ≥ 5.7 mmol/L, or LDL ≥ 4.9 mmol/L.
• • Pregnancy or lactation.
• • Self-reported weight change of more than 5 kg within the 90 days prior to screening.
• • Use of antibiotics, antimicrobials, or anti-inflammatory/analgesic salicylates (e.g., aspirin) within the 3 months prior to screening for 3 days or more.
• • Use of estrogen therapy or other hormonal medications within the past 6 months.
• • Use of GLP-1 receptor agonists or probiotics within the past 3 months.
• • Heavy alcohol consumption (females \> 40 g/day, approximately 250 mL of huangjiu \[yellow rice wine\], or 1000 mL of beer, or 100 mL of liquor per day; males \> 80 g/day).
• • Severe liver or kidney dysfunction (ALT, AST, or serum creatinine exceeding 3 times the upper limit of normal, UACR ≥ 30 mg/g, or eGFR \< 60 mL/min).
• • Gastrointestinal diseases affecting digestion and absorption (e.g., severe diarrhea, severe constipation, severe inflammatory bowel disease, peptic ulcer, gallstones, cholecystitis).
• • Underwent surgery within the past year (excluding appendectomy or hernia repair).
• • Severe cardiovascular or cerebrovascular diseases (e.g., heart failure, myocardial infarction, stroke, acute myocarditis, severe arrhythmia, or receiving interventional therapy).
• • Presence of metallic implants such as a cardiac stent or pacemaker.
• • Cancer or having received radiation or chemotherapy within the past 5 years.
• • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, or a personal history of hyperthyroidism or hypothyroidism.
• • Chronic or acute pancreatitis.
• • Positive hepatitis B surface antigen (HBsAg), active tuberculosis, HIV, or other infectious diseases.
• • Currently participating in another clinical study or having done so within the past 3 months.
• • Claustrophobia.
• • Any psychiatric disorder such as attention-deficit/hyperactivity disorder (ADHD), bipolar disorder, or epilepsy (including current use of antiepileptic medications), or use of antidepressant medications.
• • Inability to read, write, operate a smartphone, or perform daily activities independently.