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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Assuta Medical Center · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Overweight (BMI > 25)
• Weight Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-04-30
• Last updated: 2025-04-30