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Protein Supplementation Intervention on Body Weight
Sponsor: Chinese Academy of Sciences
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.
Official title: An Intervention Study Investigating Effect of Dietary Protein Supplementation on Body Weight and Metabolic Homeostasis
Key Details
Gender
All
Age Range
20 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-06-10
Completion Date
2026-12-31
Last Updated
2026-03-17
Healthy Volunteers
Yes
Interventions
General lifestyle and nutritional education
Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.
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.
semaglutide
Participants will receive semaglutide as medically prescribed
Dietary protein supplementation
participants will receive 30 g/day of dietary protein supplementation
Locations (1)
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China