Not Yet RecruitingNot Applicable

Impact of Protein Supplementation and Resistance Training on Body Composition, Functional Parameters, Metabolic Adaptation, and Nitrogen Balance in Adults Aged 45 Years and Older With Overweight or Obesity Receiving Incretin-based Medications

180 participantsStarted 2025-07-01

Plain-language summary

This study aim to evaluate the effects of protein supplements and resistance training on body composition, functional parameters, metabolic adaptation, and nitrogen balance in adults (aged ≥45 years) with overweight/obesity receiving weekly Incretin-Based obesity management medication treatment for 6 months. A parallel design, open-label, multicenter randomized controlled trial will be conducted among 240 patients (aged ≥45 years) initiating Incretin-Based obesity management medication. Participants will be recruited through obesity clinics at the Tel-Aviv Sourasky Medical Center and the Tel-Aviv Assuta Medical Center, obesity clinics of HMOs, and social media groups. They will be randomly assigned to one of two groups in a 1:1 ratio: protein supplements ('Easy Whey' 25 gr protein/day) plus weekly resistance training and no intervention. Data will be collected at baseline, 3, and 6 months, including demographics, medical status, body composition, functional parameters, resting metabolic rate, nitrogen balance, and physical activity performance. All participants will be advised to follow an exercise regime, a reduced-calorie diet based on the principle of the Mediterranean eating pattern and be encouraged to follow a regular meeting schedule with a registered dietitian.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged ≥45 years. * Overweight or obese (BMI ≥30, or BMI ≥27 with at least one obesity-related comorbidity). * Eligible to receive incretin-based weight loss medications (e.g. Wegovy or Mounjaro). * Able to read and speak Hebrew fluently. Exclusion Criteria: * Medical contraindications for incretin-based weight-loss medications. * Current treatment with insulin or sulfonylurea medications. * Inflammatory bowel disease. * Active or unstable psychiatric disorders or cognitive impairment. * Active bulimia nervosa. * Previous bariatric surgery or bariatric endoscopic procedures. * Use of other weight management medications within the past month. * Weight loss of ≥5% within the past three months. * Implanted cardiac pacemaker or other electronic implants. * Regular resistance training within the past three months. * Regular use of protein supplements. * Allergy or intolerance to dairy proteins or vegan lifestyle.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Fat Mass (kg)

Timeframe: Baseline, 3 months, 6 months.

Change in Fat Mass Percentage (%)

Timeframe: Baseline, 3 months, 6 months.

Change in Lean Body Mass (kg)

Timeframe: Baseline, 3 months, 6 months.

Change in Skeletal Muscle Mass (kg)

Timeframe: Baseline, 3 months, 6 months.

Change in Body Mass Index (BMI)

Timeframe: Baseline, 3 months, 6 months.

Trial details

NCT IDNCT06950684

SponsorAssuta Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-01

Contact for this trial

Shiri Sherf-Dagan, PhD

972525122203 shiris@ariel.ac.il

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Fat Mass (kg)

Timeframe: Baseline, 3 months, 6 months.

Change in Fat Mass Percentage (%)

Timeframe: Baseline, 3 months, 6 months.

Change in Lean Body Mass (kg)

Timeframe: Baseline, 3 months, 6 months.

Change in Skeletal Muscle Mass (kg)

Timeframe: Baseline, 3 months, 6 months.

Change in Body Mass Index (BMI)

Timeframe: Baseline, 3 months, 6 months.