Protein Supplementation Intervention on Body Weight

NCT06989203 · Recruiting

Last updated 2026-05-28

This clinical trial tests whether adding protein supplements affects body weight in adults who are overweight or obese over a 12-week period.

Status Recruiting Currently enrolling participants.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) prevention study

Participants 140 people Planned (estimated).

Who can join Ages 20–50 · all sexes Healthy volunteers accepted.

Timeline Started 2025-06 · est. completion 2026-12

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06989203 ↗

Description as written by the study sponsor.

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.

Treatments tested

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

Main thing measured	Change in Body Weight (kg) from Baseline to Week 12
Sponsor	Chinese Academy of Sciences
Conditions studied	Obesity, Weight Loss, Protein Supplementation
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06989203 ↗