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

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorHellenic Mediterranean University

About this trial

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.

Eligibility criteria

Qualifiers

Adults 30-65 years old

BMI: ≥30 kg/m²

Signed Informed Consent

Disqualifiers

Uncontrolled type 2 diabetes (HbA1c > 9.0%)

Known cardiovascular disease (e.g., coronary artery disease, heart failure NYHA 3-4)

Chronic kidney disease stage 4-5 (GFR <60 ml/min)

Liver disease (known hepatitis, ALT ≥ 3 or total bilirubin ≥ 2 times ULN)

Trial design

Treatments tested in this trial

  • High Protein Dietary Intervention
  • Control (Standard Mediterranean Diet Counseling)

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hellenic Mediterranean University

Lead sponsor

University General Hospital of Heraklion

Collaborator