NCT07495904 Effect of GLP-1 Receptor Agonists on Body Composition in Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance
| NCT ID | NCT07495904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hellenic Mediterranean University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2026-03-30 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Christopher Papandreou
PRINCIPAL INVESTIGATOR
Hellenic Mediterranean University
Frequently Asked Questions
Who can join the NCT07495904 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07495904 currently recruiting?
Yes, NCT07495904 is actively recruiting participants. Contact the research team at icharalampidou@hmu.gr for enrollment information.
Where is the NCT07495904 trial being conducted?
This trial is being conducted at Heraklion, Greece, Heraklion, Greece.
Who is sponsoring the NCT07495904 clinical trial?
NCT07495904 is sponsored by Hellenic Mediterranean University. The principal investigator is Christopher Papandreou at Hellenic Mediterranean University. The trial plans to enroll 130 participants.
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