Evaluation of the effects of nutritional supplementation combined with tirzepatide on body composition, metabolism, and muscle strength in adults with overweight and obesity

INTERVENTION: This is a 90‐day randomized, controlled clinical trial evaluating whether daily supplementation of 30g of whey protein minimizes lean mass loss in adults with overweight or obesity treated with tirzepatide (2.5 mg/week), involving a total of 100 subjects divided into an intervention group of 50 participants (tirzepatide plus whey protein) and a control group of 50 participants (tirzepatide only), both undergoing supervised physical exercise. Participant randomization is performed using a computer‐generated random sequence, and blinding is maintained through single‐blind allocation concealment where outcome assessors remain masked. The intervention consists of subcutaneous administration of tirzepatide once weekly combined with daily oral supplementation of 30g of whey protein for the intervention group, while the control group receives subcutaneous tirzepatide alone, alongside supervised physical exercise sessions performed three times per week with a duration of 60 minutes per session over the 90‐day intervention period. CONDITION: Body Composition; Muscle ; Nutritional and Metabolic Diseases PRIMARY OUTCOME: Evaluate the variation in body lean mass (kg) between baseline (T0) and 90 days (T90), utilizing bioimpedance or DXA, observing changes measured in absolute values in kilograms to determine the reduction of lean mass loss induced by the interventions SECONDARY OUTCOME: Evaluate muscle strength and functional performance, analyze metabolic and inflammatory parameters, and monitor safety parameters, utilizing physical tests, laboratory blood assays, and clinical adverse event tracking, observing numerical variations in scores, biomarker levels, and incidence rates to evaluate additional effects of the interventions INCLUSION CRITERIA: Age between 18 and 55 years; Body Mass Inde X(BMI) from 27 to 40 kg/m²; Signature of the Free and Informed Consent Form (TCLE); Formal commitment to participate in standardized structured physical activity performed 3 times per week, lasting 45 minutes, combining aerobic and resistance exercises.