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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assuta Medical Center
- Enrollment
- 180
- Primary Endpoint
- Change in Fat Mass (kg)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Protein Supplementation and Resistance Training
Participants in this arm will consume a daily dietary supplement of 25 grams of whey protein powder (Easy Whey) and participate in a structured resistance training program consisting of one guided online session per week, plus two additional independent sessions weekly, for a total duration of 6 months.
Intervention: Whey Protein Supplement (Dietary Supplement)
Protein Supplementation and Resistance Training
Participants in this arm will consume a daily dietary supplement of 25 grams of whey protein powder (Easy Whey) and participate in a structured resistance training program consisting of one guided online session per week, plus two additional independent sessions weekly, for a total duration of 6 months.
Intervention: Resistance Training Program (Behavioral)
Control Group
Participants in this arm will not receive protein supplementation or structured resistance training. They will be provided with general dietary recommendations at the beginning of the study and will continue their usual care for 6 months
Outcomes
Primary Outcomes
Change in Fat Mass (kg)
Time Frame: Baseline, 3 months, 6 months.
Change in fat mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis
Change in Fat Mass Percentage (%)
Time Frame: Baseline, 3 months, 6 months.
Change in fat mass percentage (%) as measured by InBody 770 bioelectrical impedance analysis
Change in Lean Body Mass (kg)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Change in Resting Metabolic Rate(Baseline, 3 months, 6 months.)
- Change in Nitrogen Balance(Baseline, 3 months, 6 months.)
- Change in Short Physical Performance Battery (SPPB) score(Baseline, 3 months, 6 months.)
- Change in Sit-to-Stand Test Performance(Baseline, 3 months, 6 months.)
- Change in Handgrip Strength(Baseline, 3 months, 6 months.)
- Change in Nutrient Intake Based on 3-Day Food Diaries(Baseline, 3 months, 6 months.)
- Change in Mediterranean Diet Adherence(Baseline, 3 months, 6 months.)
- Change in Eating Behavior - Control of Eating Questionnaire (CoEQ)(Baseline, 3 months, 6 months.)
- Change in Food Reward Sensitivity - Power of Food Scale (PFS)(Baseline, 3 months, 6 months.)
Investigators
Shiri Sherf Dagan
Dietitian and Epidemiologist
Assuta Medical Center