Actively Recruiting
Protein Supplementation 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 clinical trail with a parallel design, involving 120 overweight/obese (body-mass index, BMI ≥ 24 kg/m²) participants and 20 normal-weight participants. Overweight/obese participants will be randomly allocated to one of three groups: 1) calorie restricted balanced diet (CRD)group; 2) CRD + semaglutide group; or 3) CRD + segaglutide with protein supplementation. Through a 3-month weight loss intervention and 6-month follow-up, this study aims to investigate the effects of dietary protein supplementation combined with semaglutide on weight loss, energy and glucose and lipid metabolism, muscle loss, and weight regain. Additionally, the study will explore key factors affecting intervention efficacy, including obesity phenotypes, gut microbiota profiles, genetic backgrounds, and lifestyle factors, to provide evidence for optimizing individualized intervention strategies.
CONDITIONS
Official Title
Protein Supplementation 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 and a clinical diagnosis meeting semaglutide treatment indications such as hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or cardiovascular disease.
- Willingness to participate in the study and provide signed informed consent.
You will not qualify if you...
- For normal-weight participants: waist circumference 90 cm or more for men, or 85 cm or more for women.
- For normal-weight participants: fasting glucose 6.1 mmol/L or higher, 2-hour postprandial glucose 7.8 mmol/L or higher, or a confirmed diagnosis of diabetes.
- For normal-weight participants: systolic blood pressure 130 mmHg or higher, diastolic blood pressure 85 mmHg or higher, or currently receiving antihypertensive treatment.
- For normal-weight participants: fasting triglycerides 1.7 mmol/L or higher; HDL cholesterol less than 0.9 mmol/L in men or less than 1.0 mmol/L in women.
- For overweight or obese participants: fasting plasma glucose above 11.1 mmol/L or HbA1c above 9%, previously diagnosed diabetes, or currently using insulin or antidiabetic medication.
- For overweight or obese participants: blood pressure 160/100 mmHg or higher, clinically diagnosed moderate or severe hypertension, or currently receiving antihypertensive treatment.
- Use of lipid-lowering drugs within the past 3 months, triglycerides 5.7 mmol/L or higher, or LDL cholesterol 4.9 mmol/L or higher.
- Pregnancy or lactation.
- Weight change of more than 5 kg within the 90 days before screening.
- Use of antibiotics, antimicrobials, or anti-inflammatory/analgesic salicylates for 3 days or more within 3 months before screening.
- 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 over 40 g/day, males over 80 g/day).
- 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 radiation/chemotherapy within the past 5 years.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, or personal thyroid disorders.
- Chronic or acute pancreatitis.
- Positive hepatitis B surface antigen, active tuberculosis, HIV, or other infectious diseases.
- Current or recent participation in another clinical study within 3 months.
- 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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongde Hospital of Zhejiang Province
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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