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ObesityPRIMENCT06950684

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

A study testing Whey Protein Supplement and Resistance Training Program in people with Obesity and Overweight (BMI > 25), run by Assuta Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Obesity, Overweight (BMI > 25), Weight Loss
What is being tested?
Whey Protein Supplement and Resistance Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
No sites listed yet
Study dates
1 Jul 2025to 1 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Shiri Sherf-Dagan, PhD contact

972525122203

shiris@ariel.ac.il

About this study

Official 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

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.

Being tested
Whey Protein Supplement, Resistance Training Program
Keywords
Protein supplementation, Resistance training, Body composition, Metabolic rate, Nitrogen balance, Incretin-based medications, Wegovy, Mounjaro, Older adults, Obesity treatment
Medical subject headings
Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whey Protein SupplementDietary 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 ProgramBehavioural

    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.

Study groups in NCT06950684
Study groupRoleWhat they receive
Protein Supplementation and Resistance TrainingExperimentalParticipants 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.
Receives: Dietary Supplement: Whey Protein Supplement; Behavioral: Resistance Training Program
Control GroupNo interventionParticipants 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Fat Mass (kg)

    Change in fat mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis

    Measured: Baseline, 3 months, 6 months.

  2. Change in Fat Mass Percentage (%)

    Change in fat mass percentage (%) as measured by InBody 770 bioelectrical impedance analysis

    Measured: Baseline, 3 months, 6 months.

  3. Change in Lean Body Mass (kg)

    Change in lean body mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.

    Measured: Baseline, 3 months, 6 months.

  4. Change in Skeletal Muscle Mass (kg)

    Change in skeletal muscle mass (in kilograms) as measured by InBody 770 bioelectrical impedance analysis.

    Measured: Baseline, 3 months, 6 months.

  5. 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.

    Measured: Baseline, 3 months, 6 months.

Secondary outcomes (9)

  1. Change in Resting Metabolic Rate

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

    Measured: Baseline, 3 months, 6 months.

  2. Change in Nitrogen Balance

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

    Measured: Baseline, 3 months, 6 months.

  3. 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.

    Measured: Baseline, 3 months, 6 months.

  4. 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

    Measured: Baseline, 3 months, 6 months.

  5. Change in Handgrip Strength

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

    Unit of Measure: Kilograms (kg)

    Measured: Baseline, 3 months, 6 months.

  6. 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)

    Measured: Baseline, 3 months, 6 months.

  7. 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

    Measured: Baseline, 3 months, 6 months.

  8. 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

    Measured: Baseline, 3 months, 6 months.

  9. 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

    Measured: Baseline, 3 months, 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06950684
Sponsor's protocol ID
ASMC 0035-25 and TLV-0168-25
Other IDs
1001829006
Acronym
PRIME
Status last verified
Apr 2025
First submitted
8 Apr 2025
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Whey Protein Supplement and Resistance Training Program in people with Obesity and Overweight (BMI > 25), run by Assuta Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shiri Sherf-Dagan, PhD (972525122203, shiris@ariel.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fat Mass (kg) (time frame: Baseline, 3 months, 6 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06950684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.

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