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NCT Number: NCT06950684

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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Overweight (BMI > 25) Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  1. Change in Resting Metabolic Rate

    Time frame: Baseline, 3 months, 6 months.

    Changes in resting metabolic rate measured using indirect calorimetry (Q-NRG)

  2. Change in Nitrogen Balance

    Time frame: Baseline, 3 months, 6 months.

    Nitrogen balance measured by 24-hour urine collection to evaluate protein usage in the body.

  3. Change in Short Physical Performance Battery (SPPB) score

    Time frame: 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.

  4. Change in Sit-to-Stand Test Performance

    Time frame: 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

  5. Change in Handgrip Strength

    Time frame: Baseline, 3 months, 6 months.

    Change in maximal isometric handgrip strength measured using a dynamometer (e.g., JAMAR).

    Unit of Measure: Kilograms (kg)

  6. Change in Nutrient Intake Based on 3-Day Food Diaries

    Time frame: 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)

  7. Change in Mediterranean Diet Adherence

    Time frame: 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

  8. Change in Eating Behavior - Control of Eating Questionnaire (CoEQ)

    Time frame: Baseline, 3 months, 6 months.

    Change in eating behavior assessed by CoEQ; higher scores indicate greater control over eating behavior.

    Unit of Measure: Score

  9. Change in Food Reward Sensitivity - Power of Food Scale (PFS)

    Time frame: Baseline, 3 months, 6 months.

    Assessed using the Power of Food Scale (higher scores reflect greater sensitivity to food cues).

    Unit of Measure: Score

Study contacts

Contact information is provided by the study sponsor or research team.

Shiri Sherf-Dagan, PhD

CONTACT

[email protected]

972525122203

Sponsors and collaborators

Lead sponsor

Assuta Medical Center

Other

Collaborators

  • Ariel University
  • Tel-Aviv Sourasky Medical Center

Registry information

Official study title

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

Acronym: PRIME

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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