Actively Recruiting
Effect of GLP-1 Receptor Agonists on Body Composition in Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance
Led by Hellenic Mediterranean University · Updated on 2026-04-02
130
Participants Needed
2
Research Sites
148 weeks
Total Duration
On this page
Sponsors
H
Hellenic Mediterranean University
Lead Sponsor
U
University General Hospital of Heraklion
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Effect of GLP-1 Receptor Agonists on Body Composition in Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 30 to 65 years old
- Body Mass Index (BMI) of 30 kg/m² or higher
- Signed informed consent to participate in the study
You will not qualify if you...
- Uncontrolled type 2 diabetes with HbA1c greater than 9.0%
- Known cardiovascular disease such as coronary artery disease or heart failure NYHA class 3-4
- Chronic kidney disease stage 4 or 5 with GFR less than 60 ml/min
- Liver disease including known hepatitis or elevated liver enzymes (ALT 2 3 times ULN or total bilirubin 2 2 times ULN)
- Inflammatory bowel disease
- Celiac disease
- History of pancreatitis
- Any condition causing malabsorption
- Active cancer or history of malignancy within past 3 years
- Psychiatric disorders affecting study adherence or assessment
- Chronic use of medications affecting metabolism or body composition such as corticosteroids or anti-obesity drugs
- Use of anti-inflammatory or antioxidant medications
- Use of probiotics, prebiotics, or laxatives in the last month
- Unstable medication regimen with changes in the past 3 months
- Use of protein or creatine supplements
- Alcohol or substance abuse
- Participation in intense regular physical activity
- Pregnancy or breastfeeding
- Pregnancy within past 12 months
- Plans to become pregnant during the study
- Any other condition that might interfere with participation or study results as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
1st Department of Internal Medicine, University General Hospital of Heraklion
Heraklion, Greece
Actively Recruiting
2
Human Dietetics & Body Composition Laboratory, Department of Nutrition and Dietetics Sciences, Hellenic Mediterranean University
Heraklion, Greece
Actively Recruiting
Research Team
I
Ioanna Charalampidou
CONTACT
C
Christopher Papandreou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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