Protein Supplementation Intervention on Body Weight

Korábbi kezelés

• 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.
• 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).
• Cancer or having received radiation or chemotherapy within the past 5 years.

Más betegség

• Gastrointestinal diseases affecting digestion and absorption (e.g., severe diarrhea, severe constipation, severe inflammatory bowel disease, peptic ulcer, gallstones, cholecystitis).
• Presence of metallic implants such as a cardiac stent or pacemaker.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, or a personal history of hyperthyroidism or hypothyroidism.
• Positive hepatitis B surface antigen (HBsAg), active tuberculosis, HIV, or other infectious diseases.
• 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.

Laborértékek

• 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.
• 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).

Egyéb

• Pregnancy or lactation.
• 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).
• Chronic or acute pancreatitis.
• Currently participating in another clinical study or having done so within the past 3 months.
• Claustrophobia.
• Inability to read, write, operate a smartphone, or perform daily activities independently.

• 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.