Probiotic Intervention on Body Weight

Exclusion Criteria29

• Abnormal metabolic indicators (meeting any one of the following criteria is grounds for exclusion):
• \. 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.
• \. 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.