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
- Conditions
- ObesityOverweight (BMI > 25)Weight Loss
- Registration Number
- NCT06950684
- Lead Sponsor
- Assuta Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Body Mass Index (BMI) Baseline, 3 months, 6 months. hange in Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²), based on body weight measured by InBody 770.
Change in Fat Mass (kg) Baseline, 3 months, 6 months. Change in fat mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis
Change in Fat Mass Percentage (%) Baseline, 3 months, 6 months. Change in fat mass percentage (%) as measured by InBody 770 bioelectrical impedance analysis
Change in Lean Body Mass (kg) Baseline, 3 months, 6 months. Change in lean body mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.
Change in Skeletal Muscle Mass (kg) Baseline, 3 months, 6 months. Change in skeletal muscle mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.
- Secondary Outcome Measures
Name Time Method Change in Resting Metabolic Rate Baseline, 3 months, 6 months. Changes in resting metabolic rate measured using indirect calorimetry (Q-NRG)
Change in Nitrogen Balance Baseline, 3 months, 6 months. Nitrogen balance measured by 24-hour urine collection to evaluate protein usage in the body.
Change in Short Physical Performance Battery (SPPB) score Baseline, 3 months, 6 months. 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 Baseline, 3 months, 6 months. Change in the number of repetitions completed in the 30-second sit-to-stand test.
Unit of Measure: Number of repetitionsChange in Handgrip Strength Baseline, 3 months, 6 months. Change in maximal isometric handgrip strength measured using a dynamometer (e.g., JAMAR).
Unit of Measure: Kilograms (kg)Change in Nutrient Intake Based on 3-Day Food Diaries Baseline, 3 months, 6 months. Average daily intake of protein, fat, and carbohydrates (in grams per day) derived from 3-day food diaries.
Unit of Measure: Grams per day (g/day)Change in Mediterranean Diet Adherence Baseline, 3 months, 6 months. Assessed by the Israeli Mediterranean Diet Adherence Screener (higher scores indicate better adherence on a scale).
Unit of Measure - ScoreChange in Eating Behavior - Control of Eating Questionnaire (CoEQ) Baseline, 3 months, 6 months. Change in eating behavior assessed by CoEQ; higher scores indicate greater control over eating behavior.
Unit of Measure: ScoreChange in Food Reward Sensitivity - Power of Food Scale (PFS) Baseline, 3 months, 6 months. Assessed using the Power of Food Scale (higher scores reflect greater sensitivity to food cues).
Unit of Measure: Score