Clinical trial NCT06950684: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Overweight (BMI &gt; 25)
Weight Loss
Keywords: Protein supplementation
Resistance training
Body composition
Metabolic rate
Nitrogen balance
Incretin-based medications
Wegovy
Mounjaro
Older adults
Obesity treatment
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
Collaborators: name: Tel-Aviv Sourasky Medical Center
name: Ariel University
First posted: 2025-04-30
Enrollment: 180
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Fat Mass (kg)
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Fat Mass Percentage (%)
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Lean Body Mass (kg)
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Skeletal Muscle Mass (kg)
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, 3 months, 6 months.
Secondary outcomes:
measure: Change in Resting Metabolic Rate
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Nitrogen Balance
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Short Physical Performance Battery (SPPB) score
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Sit-to-Stand Test Performance
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Handgrip Strength
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Nutrient Intake Based on 3-Day Food Diaries
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Mediterranean Diet Adherence
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Eating Behavior - Control of Eating Questionnaire (CoEQ)
timeFrame: Baseline, 3 months, 6 months.
measure: Change in Food Reward Sensitivity - Power of Food Scale (PFS)
timeFrame: Baseline, 3 months, 6 months.
Other outcomes:
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Study officials:
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