Status:
NOT_YET_RECRUITING
Probiotic Intervention on Body Weight
Lead Sponsor:
Chinese Academy of Sciences
Conditions:
Obesity
Homeostasis
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief 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 nutritiona...
Detailed Description
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 lon...
Eligibility Criteria
Inclusion
- 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
- 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):
- 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.
- 2\. Overweight or obese (BMI ≥ 24 kg/m²):
- Fasting plasma glucose \> 11.1 mmol/L or HbA1c \> 9%, or previously diagnosed diabetes, or currently using insulin or any antidiabetic medication.
- Blood pressure ≥ 160/100 mmHg, or clinically diagnosed stage 2 or stage 3 (moderate or severe) hypertension, or currently under antihypertensive treatment.
- 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.
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06989177
Start Date
June 10 2025
End Date
December 31 2026
Last Update
May 30 2025
Active Locations (1)
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1
Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China, 310024