RecruitingNot ApplicableNCT06989203

Protein Supplementation Intervention on Body Weight

An Intervention Study Investigating Effect of Dietary Protein Supplementation on Body Weight and Metabolic Homeostasis


Sponsor

Chinese Academy of Sciences

Enrollment

140 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Calorie-restricted balanced diet, Dietary protein supplementation, and others for people with obesity, protein supplementation, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 20 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALGeneral lifestyle and nutritional education

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

BEHAVIORALCalorie-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.

DRUGsemaglutide

Participants will receive semaglutide as medically prescribed

DIETARY_SUPPLEMENTDietary protein supplementation

participants will receive 30 g/day of dietary protein supplementation


Locations(1)

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

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NCT06989203


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