MedTrace Logo

Protein Supplementation Intervention on Body Weight

NCT06989203 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-03-17

No results posted yet for this study

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

Interventions

BEHAVIORAL

General lifestyle and nutritional education

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

BEHAVIORAL

Calorie-restricted balanced diet

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.

DRUG

semaglutide

Participants will receive semaglutide as medically prescribed

DIETARY_SUPPLEMENT

Dietary protein supplementation

participants will receive 30 g/day of dietary protein supplementation

Sponsors & Collaborators

  • Chinese Academy of Sciences

    lead OTHER_GOV

Principal Investigators

  • Xu Lin, PhD · Institute for Nutritional Sciecnes, CAS; Hangzhou Institute for Advanced Study, UCAS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06989203 on ClinicalTrials.gov