Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT06950684

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Overweight (BMI > 25), Weight Loss

Full registry criteria

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.

Treatments and study arms

Whey Protein Supplement

Dietary 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

Resistance Training Program

Behavioral

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.

Primary outcomes

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.

Study locations

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No public site location was included in this record. Check the original registry for updates.