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Effect of GLP-1 Receptor Agonists on Body Composition in Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance (LEAN-PRO GLP-1) 130 Randomized Dietary

Recruiting
Clinical Trial NCT07495904 (LEAN-PRO GLP-1) is an interventional study for Obesity that is recruiting. It started on March 30, 2026 with plans to enroll 130 participants. Led by Hellenic Mediterranean University, it is expected to complete by January 30, 2029. The latest data from ClinicalTrials.gov was last updated on April 2, 2026.
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 ...

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Detailed Description
Obesity is a global public health challenge. While weight loss is essential, preserving Muscle Mass (MM) is crucial for maintaining metabolic health, functional capacity, and long-term treatment outcomes. Although Glucagon Like Peptide- 1 Receptor Agonists (GLP-1 RAs) are highly effective for weight reduction, significant loss of lean mass raises concerns regarding sarcopenic obesity, especially in vulnerable populat...Show More
Official Title

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

Conditions
Obesity
Other Study IDs
  • LEAN-PRO GLP-1
  • 159302
  • Protocol No. 44248 (Other Identifier) (University General Hospital of Heraklion (PAGNI))
NCT ID Number
NCT07495904
Start Date (Actual)
2026-03-30
Last Update Posted
2026-04-02
Completion Date (Estimated)
2029-01-30
Enrollment (Estimated)
130
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Body composition
pharmacologically induced weight loss
GLP-1 receptor agonists
muscle mass
dietary protein
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorGLP-1 + Standard Diet
Participants will receive GLP-1 treatment alongside standard nutritional counseling based on the Mediterranean diet pattern, provided within the framework of usual clinical practice.
Control (Standard Mediterranean Diet Counseling)
Standard nutritional counseling based on the Mediterranean diet pattern as part of usual clinical practice.
ExperimentalGLP-1 + High Protein Diet
Participants will receive GLP-1 treatment along with a specialized dietary intervention featuring individualized guidelines aimed at increasing daily protein intake.
High Protein Dietary Intervention
Individualized dietary guidelines focusing on increased protein consumption to preserve muscle mass during weight loss.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change from Baseline in Muscle Mass
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)
Baseline and End of Intervention (up to 24 weeks)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change from Baseline in Body Composition Parameters
Assessment of changes in Fat Mass (FM), Fat-Free Mass (FFM), Total Body Protein (TBPro), Total Body Water (TBW), Intracellular Water (ICW), Extracellular Water (ECW), and hydration of FFM, utilizing the 4- and 5- Compartment models. Assessment of changes in body composition utilizing the 4- and 5-Compartment models. The parameters evaluated include Fat-Free Mass (FFM) and Total Body Protein (TBPro), which will be reported in kilograms (kg). Fat Mass (FM) will be reported both in kilograms (kg) and as a Body Fat Percentage (%). Total Body Water (TBW), Intracellular Water (ICW), and Extracellular Water (ECW) will be reported in liters (L) and as a percentage (%). The hydration of FFM will be reported as a percentage (%).
Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention
Change from Baseline in Biochemical and Urinary Markers
Assessment of changes in systemic biomarkers. Blood markers include glycemic control (Fasting Glucose, Insulin \[reported in mg/dL or μU/mL\], HbA1c \[%\]), lipid profile (Total, HDL, LDL Cholesterol, Triglycerides \[mg/dL\]), renal/hepatic function (Creatinine, Urea, Bilirubin \[mg/dL\], ALT \[U/L\]), thyroid function (TSH \[mIU/L\]), inflammatory markers (CRP \[mg/L\]), and micronutrient status (B12, Vit D3, Folic Acid, Calcium, Magnesium \[reported in standard clinical units, e.g., pg/mL, ng/mL, mg/dL\]). Urinary biomarkers (Urinary Urea Nitrogen, Albumin, Creatinine) will also be assessed and reported in standard units (e.g., mg/dL, g/24h).
Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention
Long-term Weight Maintenance Efficiency
Evaluation of the sustainability of the intervention results after treatment cessation. This measure primarily tracks the change in Body Weight to assess potential weight regain during the follow-up phase. The preservation of Muscle Mass (MM) and Fat Mass (FM) will also be monitored. Changes in Body Weight, MM, and FM will be reported in kilograms (kg) and as a percentage (%) of the weight/mass lost during the active intervention phase.
From End of Intervention (up to 24 weeks) to 6 months post-intervention
Change from Baseline in Sarcopenia Risk
Participants will be classified as "at risk" for early sarcopenia if they meet at least one of the following criteria: 1. SARC-F score ≥4 (on a scale of 0-10) 2. Handgrip strength below the EWGSOP2 thresholds (men \<27 kg, women \<16 kg) Evaluation of sarcopenia risk using a combination of the Greek validated SARC-F questionnaire and handgrip strength measured via a calibrated dynamometer. The SARC-F score ranges from 0 to 10, where higher scores indicate a greater risk of sarcopenia (worse outcome). Handgrip strength will be reported in kilograms (kg). Participants will be classified as "at risk" for early sarcopenia based on the EWGSOP2 criteria if they meet at least one of the following: 1. SARC-F score ≥ 4, or 2. Handgrip strength below the gender-specific thresholds (men \< 27 kg, women \< 16 kg). The overall outcome will be reported as the change in the continuous parameters (SARC-F score and grip strength in kg) and the proportion (%) of participants classified as "at risk".
Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention
Change from Baseline in Energy and Macronutrient Intake
Assessment of total energy intake and macronutrient distribution to evaluate dietary adherence. Data will be collected via three-day 24-hour dietary recalls (two weekdays and one weekend day). Total energy intake will be reported in kilocalories (kcal). Macronutrient distribution (specifically protein, carbohydrates, and fats) will be reported in absolute amounts (grams, g) and as a relative proportion of the diet (percentage, %, of total energy intake).
Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
30 Years
Eligible Sexes
All
  • Adults 30-65 years old
  • BMI: ≥30 kg/m²
  • Signed Informed Consent

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.

Hellenic Mediterranean University logoHellenic Mediterranean University
University General Hospital of Heraklion logoUniversity General Hospital of Heraklion
Study Responsible Party
Christopher Papandreou, Principal Investigator, Assistant Professor, Department of Nutrition & Dietetics Sciences, Hellenic Mediterranean University
Study Central Contact
Contact: Ioanna Charalampidou, +302810379242, [email protected]
Contact: Christopher Papandreou
2 Study Locations in 1 Countries
1st Department of Internal Medicine, University General Hospital of Heraklion, Heraklion, Greece
Theodosios Filippatos, Contact, +302813402360
Theodosios Filippatos, Principal Investigator
Recruiting
Human Dietetics & Body Composition Laboratory, Department of Nutrition and Dietetics Sciences, Hellenic Mediterranean University, Heraklion, Greece
Ioanna Charalampidou, Contact, +302810379242, [email protected]
Christopher Papandreou, Principal Investigator
Ioanna Charalampidou, Sub-Investigator
Vasileios Zafiropoulos, Sub-Investigator
Recruiting