Clinical Trial

Effect of GLP-1 Receptor Agonists on Body Composition in Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance

Study acronym: LEAN-PRO GLP-1
Recruiting
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-03
Trial Details
NCT Number NCT07495904
Lead Sponsor Hellenic Mediterranean University
Collaborators: University General Hospital of Heraklion
Conditions Obesity
Enrollment 130 participants
Start Date 2026-03-30
Primary Completion 2028-03-30 (estimated)
Study Completion 2029-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-02