DelfaGLP-1 Atlas

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PRIME

Not yet recruitingPhase NA

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

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

Assets

Semaglutide / Tirzepatide

Listed sites

0

Recruiting sites

—

Enrollment

180

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Total fat mass•Lean mass•BMI, change

Identifiers

Registered as

NCT IDNCT06950684
Org study IDASMC 0035-25 and TLV-0168-25
Secondary ID1001829006Israel Ministry of Innovation, Science & Technology

Timeline

Milestones

Study first posted2025-04-30actual
Last update posted2025-04-30actual
Study start2025-07-01estimated
Primary completion2028-07-01estimated
Study completion2028-07-01estimated

Assets

Investigational agents

SemaglutideTirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age45 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
6
Other clinical outcomes
4
Patient-reported / QoL
2
Other (unclassified)
2

Weight & body composition

6 endpoints
Primary/protocol endpoint

Change in Fat Mass (kg)

Time frame:Baseline, 3 months, 6 months.

Total fat mass

change from baseline, improvement

Primary/protocol endpoint

Change in Fat Mass Percentage (%)

Time frame:Baseline, 3 months, 6 months.

Total fat mass

change from baseline, improvement

Primary/protocol endpoint

Change in Lean Body Mass (kg)

Time frame:Baseline, 3 months, 6 months.

Lean mass

change from baseline, improvement

Primary/protocol endpoint

Change in Skeletal Muscle Mass (kg)

Time frame:Baseline, 3 months, 6 months.

Lean mass

change from baseline, improvement

Primary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Baseline, 3 months, 6 months.

BMI, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Handgrip Strength

Time frame:Baseline, 3 months, 6 months.

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

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

Time frame:Baseline, 3 months, 6 months.

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, 3 months, 6 months.

change from baseline, improvement

Other clinical outcomes

4 endpoints
Secondary/protocol endpoint

Change in Short Physical Performance Battery (SPPB) score

Time frame:Baseline, 3 months, 6 months.

change from baseline, improvement

Secondary/protocol endpoint

Change in Sit-to-Stand Test Performance

Time frame:Baseline, 3 months, 6 months.

change from baseline, improvement

Secondary/protocol endpoint

Change in Nutrient Intake Based on 3-Day Food Diaries

Time frame:Baseline, 3 months, 6 months.

change from baseline, descriptive

Secondary/protocol endpoint

Change in Mediterranean Diet Adherence

Time frame:Baseline, 3 months, 6 months.

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change in Resting Metabolic Rate

Time frame:Baseline, 3 months, 6 months.

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Nitrogen Balance

Time frame:Baseline, 3 months, 6 months.

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.