Obesity Clinical Trials

Find Obesity Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Dietary supplement, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 50
Healthy Volunteers: t
View:

• Aged 20 to 50 years.

• Normal-weight participants: 18.5 kg/m² ≤ Body Mass Index (BMI) \< 24 kg/m².

• Overweight or obese participants:

⁃ BMI ≥ 28 kg/m², or 24 kg/m² ≤ BMI \< 28 kg/m² and a clinical diagnosis meeting semaglutide treatment indications (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, cardiovascular disease, etc.).

• Willingness to participate in this study and provide signed informed consent.

Locations
Other Locations
China
Tongde Hospital of Zhejiang Province
RECRUITING
Hangzhou
Contact Information
Primary
Wanhui Kang, PhD
kangwanhui@ucas.ac.cn
+86 86081210
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 140
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Chinese Academy of Sciences

This content was sourced from clinicaltrials.gov