Obesity, Overweight (BMI > 25), Weight Loss
Conditions
Keywords
Protein supplementation, Resistance training, Body composition, Metabolic rate, Nitrogen balance, Incretin-based medications, Wegovy, Mounjaro, Older adults, Obesity treatment
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.
Interventions
DIETARY_SUPPLEMENTWhey 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
BEHAVIORALResistance 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.
Sponsors
Tel-Aviv Sourasky Medical Center
Ariel University
Assuta Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 - Score |
| Change in Resting Metabolic Rate | Baseline, 3 months, 6 months. | Changes in resting metabolic rate measured using indirect calorimetry (Q-NRG) |
| Change 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 |
| Change 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: Score |
| 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 repetitions |
| Change 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) |
Contacts
Primary ContactShiri Sherf-Dagan, PhD
Outcome results
None listed