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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorAssuta Medical Center

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Whey Protein Supplement
  • Resistance Training Program

Treatment groups

180 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Assuta Medical Center

Lead sponsor

Tel-Aviv Sourasky Medical Center

Collaborator

Ariel University

Collaborator