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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
180
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
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.
Change in Fat Mass (kg)
Change in fat mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis
Time frame: Baseline, 3 months, 6 months.
Change in Fat Mass Percentage (%)
Change in fat mass percentage (%) as measured by InBody 770 bioelectrical impedance analysis
Time frame: Baseline, 3 months, 6 months.
Change in Lean Body Mass (kg)
Change in lean body mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.
Time frame: Baseline, 3 months, 6 months.
Change in Skeletal Muscle Mass (kg)
Change in skeletal muscle mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.
Time frame: Baseline, 3 months, 6 months.
Change in Body Mass Index (BMI)
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.
Time frame: Baseline, 3 months, 6 months.
Change in Resting Metabolic Rate
Changes in resting metabolic rate measured using indirect calorimetry (Q-NRG)
Time frame: Baseline, 3 months, 6 months.
Change in Nitrogen Balance
Nitrogen balance measured by 24-hour urine collection to evaluate protein usage in the body.
Time frame: Baseline, 3 months, 6 months.
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.
Time frame: Baseline, 3 months, 6 months.
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
Time frame: Baseline, 3 months, 6 months.
Change in Handgrip Strength
Change in maximal isometric handgrip strength measured using a dynamometer (e.g., JAMAR). Unit of Measure: Kilograms (kg)
Time frame: Baseline, 3 months, 6 months.
Change in Nutrient Intake Based on 3-Day Food Diaries
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)
Time frame: Baseline, 3 months, 6 months.
Change in Mediterranean Diet Adherence
Assessed by the Israeli Mediterranean Diet Adherence Screener (higher scores indicate better adherence on a scale). Unit of Measure - Score
Time frame: Baseline, 3 months, 6 months.
Change in Eating Behavior - Control of Eating Questionnaire (CoEQ)
Change in eating behavior assessed by CoEQ; higher scores indicate greater control over eating behavior. Unit of Measure: Score
Time frame: Baseline, 3 months, 6 months.
Change in Food Reward Sensitivity - Power of Food Scale (PFS)
Assessed using the Power of Food Scale (higher scores reflect greater sensitivity to food cues). Unit of Measure: Score
Time frame: Baseline, 3 months, 6 months.
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