Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07495904

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry 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.

Treatments and study arms

High Protein Dietary Intervention

Behavioral

Individualized dietary guidelines focusing on increased protein consumption to preserve muscle mass during weight loss.

Control (Standard Mediterranean Diet Counseling)

Behavioral

Standard nutritional counseling based on the Mediterranean diet pattern as part of usual clinical practice.

Primary outcomes

Change from Baseline in Muscle MassBaseline and End of Intervention (up to 24 weeks)

Evaluation of the change in Muscle Mass using a multi-compartment body composition model (4C/5C). This gold-standard approach integrates data from Underwater Weighing (Body Density), Dual-Energy X-ray Absorptiometry (DEXA, for Bone Mineral Content), and Bioelectrical Impedance Spectroscopy (BIS, for Total Body Water) to provide a precise estimation of muscle mass. Results will be reported in kilograms (kg)

Study locations

2 locations were listed when this page was built. The first 40 are shown.

1st Department of Internal Medicine, University General Hospital of Heraklion🇬🇷 Heraklion, Greece

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Theodosios FilippatosContact

Call +302813402360

Theodosios FilippatosPrincipal Investigator

Human Dietetics & Body Composition Laboratory, Department of Nutrition and Dietetics Sciences, Hellenic Mediterranean University🇬🇷 Heraklion, Greece

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Ioanna CharalampidouContact

Email · Call +302810379242

Christopher PapandreouPrincipal Investigator

Ioanna CharalampidouSub Investigator