ObesityLEAN-PRO GLP-1NCT07495904
Effect of GLP-1 Receptor Agonists on Body Composition in Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance
A study testing High Protein Dietary Intervention in people with Obesity, run by Hellenic Mediterranean University at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- High Protein Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesGreece
- Study dates
- 30 Mar 2026to 30 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 30-65 years old
- BMI: ≥30 kg/m²
- Signed Informed Consent
Who cannot join
- 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
Show all 25Show fewer
- 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.
- 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
- Other:
- Any condition that, in the opinion of the Investigator, may interfere with participation, adherence, or the interpretation of study results.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christopher Papandreou contact
Greece2 sites, 2 recruiting
- Recruiting
1st Department of Internal Medicine, University General Hospital of Heraklion
Heraklion
Theodosios Filippatos, +302813402360
Theodosios Filippatos
- Recruiting
Human Dietetics & Body Composition Laboratory, Department of Nutrition and Dietetics Sciences, Hellenic Mediterranean University
Heraklion
Ioanna Charalampidou, +302810379242, lab.bodycomp@hmu.gr
Christopher Papandreou
About this study
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
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.
Read the 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 populations.
Muscle tissue is metabolically active; its loss can also reduce resting energy expenditure, potentially leading to weight regain post-treatment. Current guidelines emphasize the synergy between pharmacological treatment and lifestyle interventions. High dietary protein intake is hypothesized to mitigate MM loss by stimulating muscle protein synthesis and enhancing satiety. However, existing research often fails to distinguish between Fat-Free Mass (FFM) and Skeletal Muscle Mass (SMM), leaving a gap in our understanding of true muscle preservation during intensive weight loss.
The primary aim of this research is to address a critical gap in literature by evaluating the combined effect of GLP-1RAs and dietary protein on MM preservation. By synthesizing current research findings, we seek to provide a better understanding of how these agents influence fat and lean tissue distribution, thereby informing clinical practices and guiding future research directions in obesity and diabetes management using GLP-1 RAs.
Specifically, the research aims to:
- Assess the impact of GLP-1 RAs on body composition: It is expected that the treatment will lead to weight loss and a reduction in Fat Mass (FM), but its effect on MM will vary.
- Evaluate the role of protein in attenuating MM loss compared to pharmacological treatment alone: The hypothesis is that combining high-protein intake with GLP-1 RAs will better preserve or even increase MM during weight loss, compared to GLP-1 treatment alone.
- Investigate long-term maintenance: Determine if COM-B-Model-led nutritional changes lead to superior weight maintenance 12 months post-intervention.
This study could lead to more tailored and effective treatments for adults with obesity seeking to lose weight without sacrificing MM and also to explore better practices regarding the currently challenging phase after weight loss, which is maintenance.
- Conditions
- Obesity
- Being tested
- High Protein Dietary Intervention, Control (Standard Mediterranean Diet Counseling)
- Keywords
- Body composition, pharmacologically induced weight loss, GLP-1 receptor agonists, muscle mass, dietary protein
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein Dietary InterventionBehavioural
Individualized dietary guidelines focusing on increased protein consumption to preserve muscle mass during weight loss.
Control (Standard Mediterranean Diet Counseling)Behavioural
Standard nutritional counseling based on the Mediterranean diet pattern as part of usual clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 + Standard Diet | Active comparator | Participants will receive GLP-1 treatment alongside standard nutritional counseling based on the Mediterranean diet pattern, provided within the framework of usual clinical practice. Receives: Behavioral: Control (Standard Mediterranean Diet Counseling) |
| GLP-1 + High Protein Diet | Experimental | Participants will receive GLP-1 treatment along with a specialized dietary intervention featuring individualized guidelines aimed at increasing daily protein intake. Receives: Behavioral: High Protein Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and End of Intervention (up to 24 weeks)
Secondary outcomes (5)
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 (%).
Measured: 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).
Measured: 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.
Measured: 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:
- SARC-F score ≥4 (on a scale of 0-10)
- 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:
- SARC-F score ≥ 4, or
- 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".
Measured: 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).
Measured: Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Mediterranean University
- Sponsor type
- University, hospital or other
- Collaborators
- University General Hospital of Heraklion
- Responsible party
- Principal investigator, Christopher Papandreou, Hellenic Mediterranean University
- Investigators
- Christopher Papandreou, Principal investigator, Hellenic Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495904
- Sponsor's protocol ID
- 159302
- Other IDs
- Protocol No. 44248
- Acronym
- LEAN-PRO GLP-1
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07495904
- Acronym / sponsor ID
- LEAN-PRO GLP-1 / 159302
- Conditions
- Obesity
- Keywords
- Body composition, pharmacologically induced weight loss, GLP-1 receptor agonists, muscle mass, dietary protein
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hellenic Mediterranean UniversityUniversity, hospital or other
- Collaborators
- University General Hospital of Heraklion
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 populations.
Muscle tissue is metabolically active; its loss can also reduce resting energy expenditure, potentially leading to weight regain post-treatment. Current guidelines emphasize the synergy between pharmacological treatment and lifestyle interventions. High dietary protein intake is hypothesized to mitigate MM loss by stimulating muscle protein synthesis and enhancing satiety. However, existing research often fails to distinguish between Fat-Free Mass (FFM) and Skeletal Muscle Mass (SMM), leaving a gap in our understanding of true muscle preservation during intensive weight loss.
The primary aim of this research is to address a critical gap in literature by evaluating the combined effect of GLP-1RAs and dietary protein on MM preservation. By synthesizing current research findings, we seek to provide a better understanding of how these agents influence fat and lean tissue distribution, thereby informing clinical practices and guiding future research directions in obesity and diabetes management using GLP-1 RAs.
Specifically, the research aims to:
- Assess the impact of GLP-1 RAs on body composition: It is expected that the treatment will lead to weight loss and a reduction in Fat Mass (FM), but its effect on MM will vary.
- Evaluate the role of protein in attenuating MM loss compared to pharmacological treatment alone: The hypothesis is that combining high-protein intake with GLP-1 RAs will better preserve or even increase MM during weight loss, compared to GLP-1 treatment alone.
- Investigate long-term maintenance: Determine if COM-B-Model-led nutritional changes lead to superior weight maintenance 12 months post-intervention.
This study could lead to more tailored and effective treatments for adults with obesity seeking to lose weight without sacrificing MM and also to explore better practices regarding the currently challenging phase after weight loss, which is maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 + Standard Diet | Active comparator | Behavioral: Control (Standard Mediterranean Diet Counseling)Participants will receive GLP-1 treatment alongside standard nutritional counseling based on the Mediterranean diet pattern, provided within the framework of usual clinical practice. |
| GLP-1 + High Protein Diet | Experimental | Behavioral: High Protein Dietary InterventionParticipants will receive GLP-1 treatment along with a specialized dietary intervention featuring individualized guidelines aimed at increasing daily protein intake. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 30-65 years old
- BMI: ≥30 kg/m²
- Signed Informed Consent
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Protein Dietary InterventionIndividualized dietary guidelines focusing on increased protein consumption to preserve muscle mass during weight loss. | Behavioural | GLP-1 + High Protein Diet |
| Control (Standard Mediterranean Diet Counseling)Standard nutritional counseling based on the Mediterranean diet pattern as part of usual clinical practice. | Behavioural | GLP-1 + Standard Diet |
Primary outcome
Change from Baseline in Muscle Mass
Time frame: Baseline 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)
5 secondary outcomes
Change from Baseline in Body Composition Parameters
Time frame: Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention
Change from Baseline in Biochemical and Urinary Markers
Time frame: Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention
Long-term Weight Maintenance Efficiency
Time frame: From End of Intervention (up to 24 weeks) to 6 months post-intervention
Change from Baseline in Sarcopenia Risk
Time frame: Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention
Change from Baseline in Energy and Macronutrient Intake
Time frame: Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Papandreou contact
Christopher Papandreou principal investigator
Hellenic Mediterranean University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Dietary Intervention in people with Obesity, run by Hellenic Mediterranean University at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ioanna Charalampidou (+302810379242, icharalampidou@hmu.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Muscle Mass (time frame: Baseline and End of Intervention (up to 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.