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.
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.
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.
Parallel
Whey Protein Supplement
Dietary supplementParticipants will take a daily supplement of whey protein powder (Easy Whey) providing 25 grams of protein each day for the duration of 6 months
Resistance Training Program
BehavioralParticipants 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.
Change in Fat Mass (kg)
Change in fat mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis
Change in Fat Mass Percentage (%)
Change in fat mass percentage (%) as measured by InBody 770 bioelectrical impedance analysis
Change in Lean Body Mass (kg)
Change in lean body mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.
Change in Skeletal Muscle Mass (kg)
Change in skeletal muscle mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.
Change in Resting Metabolic Rate
Changes in resting metabolic rate measured using indirect calorimetry (Q-NRG)
Change in Nitrogen Balance
Nitrogen balance measured by 24-hour urine collection to evaluate protein usage in the body.
Change in Short Physical Performance Battery (SPPB) score
Change in physical function assessed using the SPPB, which includes balance, gait speed, and chair stand tests. Unit of Measure: Score from 0 to 12; higher scores indicate better physical function.
Change in Sit-to-Stand Test Performance
Change in the number of repetitions completed in the 30-second sit-to-stand test. Unit of Measure: Number of repetitions
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Assuta Medical Center
Lead sponsor
Tel-Aviv Sourasky Medical Center
Collaborator
Ariel University
Collaborator
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