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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whey Protein Supplement, Resistance Training Program.
- Who it may be relevant to
- Registry conditions: Obesity, Overweight (BMI > 25), Weight Loss. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Dietary supplement Whey Protein Supplement
Participants will take a daily supplement of whey protein powder (Easy Whey) providing 25 grams of protein each day for the duration of 6 months - Behavioral Resistance Training Program
Participants will engage in resistance training consisting of one guided online session each week and two additional independent resistance training sessions weekly, totaling three sessions per week, for a duration of 6 months.
Primary outcome measures
- Change in Fat Mass (kg) [Time frame: Baseline, 3 months, 6 months.]
- Change in Fat Mass Percentage (%) [Time frame: Baseline, 3 months, 6 months.]
- Change in Lean Body Mass (kg) [Time frame: Baseline, 3 months, 6 months.]
- Change in Skeletal Muscle Mass (kg) [Time frame: Baseline, 3 months, 6 months.]
- Change in Body Mass Index (BMI) [Time frame: Baseline, 3 months, 6 months.]
Secondary outcome measures (9)
- Change in Resting Metabolic Rate [Time frame: Baseline, 3 months, 6 months.]
- Change in Nitrogen Balance [Time frame: Baseline, 3 months, 6 months.]
- Change in Short Physical Performance Battery (SPPB) score [Time frame: Baseline, 3 months, 6 months.]
- Change in Sit-to-Stand Test Performance [Time frame: Baseline, 3 months, 6 months.]
- Change in Handgrip Strength [Time frame: Baseline, 3 months, 6 months.]
- Change in Nutrient Intake Based on 3-Day Food Diaries [Time frame: Baseline, 3 months, 6 months.]
- Change in Mediterranean Diet Adherence [Time frame: Baseline, 3 months, 6 months.]
- Change in Eating Behavior - Control of Eating Questionnaire (CoEQ) [Time frame: Baseline, 3 months, 6 months.]
- Change in Food Reward Sensitivity - Power of Food Scale (PFS) [Time frame: Baseline, 3 months, 6 months.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06950684 · ASMC 0035-25 and TLV-0168-25 · 1001829006