Effect of GLP-1 Receptor Agonists on Body Composition in Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance
NCT07495904 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2026-04-02
Summary
This study investigates how weight-loss medications, specifically GLP-1 receptor agonists, affect body composition, with a special focus on preserving muscle mass in adults with obesity. While these medications are highly effective for weight loss, they can sometimes lead to an unwanted loss of valuable muscle mass (a condition that can lead to sarcopenia).
To explore how to prevent this, researchers are conducting a 3- to 6-month randomized controlled trial involving adults aged 30 to 65 years with a BMI greater than 30 kg/m². Participants who are receiving GLP-1 medications will be randomly assigned to one of two groups: one group will receive the standard medication treatment alone, while the other group will receive the medication along with specific dietary guidance focused on increasing daily protein intake.
Conditions
Interventions
- BEHAVIORAL
-
High Protein Dietary Intervention
Individualized dietary guidelines focusing on increased protein consumption to preserve muscle mass during weight loss.
- BEHAVIORAL
-
Control (Standard Mediterranean Diet Counseling)
Standard nutritional counseling based on the Mediterranean diet pattern as part of usual clinical practice.
Sponsors & Collaborators
-
University General Hospital of Heraklion
collaborator OTHER -
Hellenic Mediterranean University
lead OTHER
Principal Investigators
-
Christopher Papandreou · Hellenic Mediterranean University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-30
- Primary Completion
- 2028-03-30
- Completion
- 2029-01-30
Countries
- Greece
Study Locations
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