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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
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- 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.
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.
- Conditions
- Obesity, Overweight (BMI > 25), Weight Loss
- 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 group | Role | What they receive |
|---|---|---|
| Protein Supplementation and Resistance Training | Experimental | 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. Receives: Dietary Supplement: Whey Protein Supplement; Behavioral: Resistance Training Program |
| Control Group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Change in Fat Mass Percentage (%)
Change in fat mass percentage (%) as measured by InBody 770 bioelectrical impedance analysis
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months.
Secondary outcomes (9)
Change in Resting Metabolic Rate
Changes in resting metabolic rate measured using indirect calorimetry (Q-NRG)
Measured: Baseline, 3 months, 6 months.
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.
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.
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.
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.
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.
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.
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.
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.
- First posted30 Apr 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center, Ariel University
- Responsible party
- Principal investigator, Shiri Sherf Dagan, Assuta Medical Center
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