NCT06950684Not yet recruiting
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
The Effect of Protein Supplementation and Resistance Training on Body Composition, Functional Parameters, Metabolic Adaptation, and Nitrogen Balance in Adults (Aged ≥45 Years) With Overweight/Obesity Receiving Incretin-Based Weight Loss Medication for 6 Months: A Multicenter RCT
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Assuta Medical Center
- Diseases
- Obesity
- NCT number
- NCT06950684
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 1 Jul 2025 to the primary completion date, 1 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medical contraindications for incretin-based weight-loss medications.
- Current treatment with insulin or sulfonylurea medications.
- Previous bariatric surgery or bariatric endoscopic procedures.
- Use of other weight management medications within the past month.
Other illness
- Inflammatory bowel disease.
- Active or unstable psychiatric disorders or cognitive impairment.
- Implanted cardiac pacemaker or other electronic implants.
- Allergy or intolerance to dairy proteins or vegan lifestyle.
Other
- Active bulimia nervosa.
- Weight loss of ≥5% within the past three months.
- Regular resistance training within the past three months.
- Regular use of protein supplements.
Who the study is looking for
- 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.
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.