Protein Supplementation Intervention on Body Weight

NCT06989203 | Recruiting

• 1 other identifier: HIAS-PSITBW-202504
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Obesity; Weight Loss; Protein Supplementation

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight (kg) from Baseline to Week 12

  The change between the baseline and after 12-week intervention. Weight will be assessed using a Seca-255 scale (ScalesGalore).

  Baseline and Week 12

Secondary Outcomes (37)

• Change in Energy Expenditure Rate (kcal/minute) from Baseline to Week 12

  Baseline and Week 12

• Change in Respiratory Quotient from Baseline to Week 12

  Baseline and Week 12

• Change in Fat Oxidation Rate (g/minute) from Baseline to Week 12

  Baseline and Week 12

• Change in Carbohydrate Oxidation Rate (g/minute) from Baseline to Week 12

  Baseline and Week 12

• Change in Waist Circumference (cm) from Baseline to Week 12

  Baseline and Week 12

Study Arms (4)

CRD

PLACEBO COMPARATOR

They will receive calorie restricted balanced diet and placebo

Behavioral: Calorie-restricted balanced diet

CRD+GLP-1RA

ACTIVE COMPARATOR

They will receive calorie restricted balanced diet and semaglutide

Behavioral: Calorie-restricted balanced diet; Drug: semaglutide

CRD+GLP-1RA+HP

EXPERIMENTAL

They will receive calorie restricted balanced diet, semaglutide, and 30g/day of dietary protein supplementation

Behavioral: Calorie-restricted balanced diet; Drug: semaglutide; Dietary Supplement: Dietary protein supplementation

Healthy Comparators

OTHER

They will receive general lifestyle and nutritional education.

Behavioral: General lifestyle and nutritional education

Interventions

General lifestyle and nutritional education BEHAVIORAL

Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.

Healthy Comparators

Calorie-restricted balanced diet BEHAVIORAL

Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education by dietitian and physicians. APP-connected wearable devices will be utilized to monitor their dietary intakes and APP-connected scale will be used to monitor their weight changes during interventions.

CRD; CRD+GLP-1RA; CRD+GLP-1RA+HP

semaglutide DRUG

Participants will receive semaglutide as medically prescribed

CRD+GLP-1RA; CRD+GLP-1RA+HP

Dietary protein supplementation DIETARY_SUPPLEMENT

participants will receive 30 g/day of dietary protein supplementation

CRD+GLP-1RA+HP

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• Chinese Academy of Sciences: lead

Study Sites (1)

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, 310024, China

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Xu Lin, PhD

  Institute for Nutritional Sciecnes, CAS; Hangzhou Institute for Advanced Study, UCAS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanhui Kang, PhD

CONTACT

+86 86081210; kangwanhui@ucas.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 25, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CN (1)