NCT07495904

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

The Effect of GLP-1 Receptor Agonist-based Treatment on Body Composition and Muscle Mass in Adults With Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Hellenic Mediterranean University · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Obesity is a global public health challenge. While weight loss is essential, preserving Muscle Mass (MM) is crucial for maintaining metabolic health, functional capacity, and long-term treatment outcomes. Although Glucagon Like Peptide- 1 Receptor Agonists (GLP-1 RAs) are highly effective for weight reduction, significant loss of lean mass raises concerns regarding sarcopenic obesity, especially in vulnerable populations. Muscle tissue is metabolically active; its loss can also reduce resting energy expenditure, potentially leading to weight regain post-treatment. Current guidelines emphasize the synergy between pharmacological treatment and lifestyle interventions. High dietary protein intake is hypothesized to mitigate MM loss by stimulating muscle protein synthesis and enhancing satiety. However, existing research often fails to distinguish between Fat-Free Mass (FFM) and Skeletal Muscle Mass (SMM), leaving a gap in our understanding of true muscle preservation during intensive weight loss. The primary aim of this research is to address a critical gap in literature by evaluating the combined effect of GLP-1RAs and dietary protein on MM preservation. By synthesizing current research findings, we seek to provide a better understanding of how these agents influence fat and lean tissue distribution, thereby informing clinical practices and guiding future research directions in obesity and diabetes management using GLP-1 RAs. Specifically, the research aims to: 1. Assess the impact of GLP-1 RAs on body composition: It is expected that the treatment will lead to weight loss and a reduction in Fat Mass (FM), but its effect on MM will vary. 2. Evaluate the role of protein in attenuating MM loss compared to pharmacological treatment alone: The hypothesis is that combining high-protein intake with GLP-1 RAs will better preserve or even increase MM during weight loss, compared to GLP-1 treatment alone. 3. Investigate long-term maintenance: Determine if COM-B-Model-led nutritional changes lead to superior weight maintenance 12 months post-intervention. This study could lead to more tailored and effective treatments for adults with obesity seeking to lose weight without sacrificing MM and also to explore better practices regarding the currently challenging phase after weight loss, which is maintenance.

Conditions

• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-30
• Primary completion: 2028-03-30
• Completion: 2029-01-30
• First posted: 2026-03-27
• Last updated: 2026-04-02

Locations

2 sites across 1 country: Greece