NCT06989203Recruiting
Protein Supplementation Intervention on Body Weight
An Intervention Study Investigating Effect of Dietary Protein Supplementation on Body Weight and Metabolic Homeostasis
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 6 May 2025
- Start date
- Jun 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Chinese Academy of Sciences
- Diseases
- Obesity
- NCT number
- NCT06989203
What you commit to
- Study type: Interventional
- Planned participants: 140
- From Jun 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
- 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).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongde Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.