Do GLP-1 weight-loss medicines plus higher protein protect muscle in adults with obesity?
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
This trial tests whether increasing daily protein helps adults aged 30–65 with obesity who are taking GLP-1 weight-loss medications keep skeletal muscle while they lose weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Hellenic Mediterranean University Academic / other |
| Locations | 2 sites (Heraklion and 1 other locations) |
| Trial ID | NCT07495904 on ClinicalTrials.gov |
What this trial studies
Researchers will run a 3-to-6 month randomized controlled trial in adults with BMI ≥30 kg/m² who are receiving GLP-1 receptor agonists, randomly assigning participants to standard medication alone or medication plus targeted higher-protein dietary guidance. The intervention group will receive specific counseling to increase daily protein intake while the control group receives standard Mediterranean diet counseling. Body composition will be measured to distinguish fat loss from changes in fat-free and skeletal muscle mass to determine whether higher protein preserves muscle during pharmacologic weight loss. The study excludes people with major medical conditions or treatments that could affect body composition or safety.
Who should consider this trial
Good fit: Adults aged 30–65 with BMI ≥30 kg/m² who are receiving or starting GLP-1 receptor agonist therapy and who meet the study safety criteria are ideal candidates.
Not a fit: People with uncontrolled diabetes, advanced kidney or liver disease, recent cancer, malabsorption disorders, or on medications that affect body composition are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could help people using GLP-1 drugs lose fat while preserving muscle, improving metabolic health and physical function.
How similar studies have performed: GLP-1 receptor agonists reliably produce weight loss but direct randomized evidence that adding higher dietary protein prevents muscle loss with these drugs is limited, though nutrition studies generally support protein's role in preserving muscle during weight loss.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 30-65 years old * BMI: ≥30 kg/m² * Signed Informed Consent Exclusion Criteria: A. Metabolic and Medical Conditions: * 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) * Inflammatory bowel disease * Celiac disease * History of pancreatitis * Any disorder potentially causing malabsorption * Active cancer or history of malignancy within the past 3 years * Psychiatric disorders affecting adherence or assessment B. Medication and Supplement Use * Chronic use of medications affecting metabolism or body composition (e.g., corticosteroids, anti-obesity drugs) * Use of anti-inflammatory or antioxidant medications * Use of probiotics, prebiotics, or laxatives within the last month * Unstable medication regimen (changes within the past 3 months) * Use of protein and creatine supplements. C. Dietary and Lifestyle Factors: * Alcohol or substance abuse * Engagement in intense regular physical activity D. Reproductive Status: * Pregnancy or breastfeeding * Pregnancy within the past 12 months * Plans to become pregnant during the study E. Other: \- Any condition that, in the opinion of the Investigator, may interfere with participation, adherence, or the interpretation of study results.
Where this trial is running
Heraklion and 1 other locations
- 1st Department of Internal Medicine, University General Hospital of Heraklion — Heraklion, Greece (Recruiting)
- Human Dietetics & Body Composition Laboratory, Department of Nutrition and Dietetics Sciences, Hellenic Mediterranean University — Heraklion, Greece (Recruiting)
Study contacts
- Principal investigator: Christopher Papandreou — Hellenic Mediterranean University
- Study coordinator: Ioanna Charalampidou
- Email: icharalampidou@hmu.gr
- Phone: +302810379242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.