Study S002319

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

ClinicalTrials.gov record

Registration

Registration: NCT06950684
Acronym: PRIME
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Masking: NONE
Status: NOT_YET_RECRUITING
Enrollment: 180
Start: 2025-07-01
Primary completion: 2028-07-01
Lead sponsor: Assuta Medical Center
Conditions: Obesity; Overweight (BMI > 25); Weight Loss
Interventions: DIETARY_SUPPLEMENT:Whey Protein Supplement; BEHAVIORAL:Resistance Training Program
Results posted: FALSE
Individual participant data sharing: UNDECIDED
Secondary identifiers: OTHER_GRANT:1001829006

Registered primary outcomes

Change in Fat Mass (kg) [Baseline, 3 months, 6 months.]
Change in Fat Mass Percentage (%) [Baseline, 3 months, 6 months.]
Change in Lean Body Mass (kg) [Baseline, 3 months, 6 months.]
Change in Skeletal Muscle Mass (kg) [Baseline, 3 months, 6 months.]
Change in Body Mass Index (BMI) [Baseline, 3 months, 6 months.]

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