Protein Supplementation Intervention on Body Weight

Sponsor
Chinese Academy of Sciences
Study ID
NCT06989203
Status
Recruiting
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Conditions

  • Obesity
  • Protein Supplementation
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
20 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • General lifestyle and nutritional education — BEHAVIORAL
    Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.
  • 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.
  • semaglutide — DRUG
    Participants will receive semaglutide as medically prescribed
  • Dietary protein supplementation — DIETARY_SUPPLEMENT
    participants will receive 30 g/day of dietary protein supplementation

Study Details

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.

Key Dates

Start date
Jun 10, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: CRD
    They will receive calorie restricted balanced diet and placebo
  • Active Comparator: CRD+GLP-1RA
    They will receive calorie restricted balanced diet and semaglutide
  • Experimental: CRD+GLP-1RA+HP
    They will receive calorie restricted balanced diet, semaglutide, and 30g/day of dietary protein supplementation
  • Other: Healthy Comparators
    They will receive general lifestyle and nutritional education.

Primary Outcome Measure

Change in Body Weight (kg) from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

Central Contacts

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