NCT07495904Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 23 Mar 2026
- Start date
- 30 Mar 2026
- Primary completion date
- 30 Mar 2028
- Lead sponsor
- Hellenic Mediterranean University
- Diseases
- Obesity
- NCT number
- NCT07495904
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 30 Mar 2026 to the primary completion date, 30 Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic use of medications affecting metabolism or body composition (e.g., corticosteroids, anti-obesity drugs)
- Use of anti-inflammatory or antioxidant medications
- Unstable medication regimen (changes within the past 3 months)
Other illness
- Metabolic and Medical Conditions:
- Known cardiovascular disease (e.g., coronary artery disease, heart failure NYHA 3-4)
- 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
- Other:
- \- Any condition that, in the opinion of the Investigator, may interfere with participation, adherence, or the interpretation of study results.
Lab values
- Uncontrolled type 2 diabetes (HbA1c \> 9.0%)
- Chronic kidney disease stage 4-5 (GFR \<60 ml/min)
- Liver disease (known hepatitis, ALT ≥ 3 or total bilirubin ≥ 2 times ULN)
Other
- Use of probiotics, prebiotics, or laxatives within the last month
- Use of protein and creatine supplements.
- Dietary and Lifestyle Factors:
- Alcohol or substance abuse
- Engagement in intense regular physical activity
- Reproductive Status:
- Pregnancy or breastfeeding
- Pregnancy within the past 12 months
- Plans to become pregnant during the study
Who the study is looking for
- Adults 30-65 years old
- BMI: ≥30 kg/m²
- Signed Informed Consent
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 1st Department of Internal Medicine, University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Recruiting |
| Human Dietetics & Body Composition Laboratory, Department of Nutrition and Dietetics Sciences, Hellenic Mediterranean University Coordinator of this site? Confirm its status | Heraklion | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.