Clinical Trial

High-Protein Diet and HMB Supplementation in Patients With Heart Failure

Not Yet Recruiting
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Summary
The goal of this clinical trial is to evaluate the effects of a high-protein diet with or without HMB supplementation compared with a normoprotein diet on clinical, nutritional, and functional outcomes in patients with heart failure. The main questions it aims to answer are: 1. Does a normocaloric high-protein diet improve muscle mass, muscle strength, and physical function compared with a normocaloric normoprotein diet after 8 weeks? 2. Does adding 3 g/day of β-hydroxy-β-methylbutyrate (HMB) to a normocaloric high-protein diet provide additional benefits for muscle mass, muscle strength, and physical function compared with a normocaloric high-protein diet alone? 3. Do these nutritional interventions improve renal function, inflammatory and clinical biomarkers, functional status, and quality of life after 8 weeks? Researchers will compare three groups (normocaloric normoprotein diet, normocaloric high-protein diet, and normocaloric high-protein diet plus HMB supplementation) to determine the effects of these interventions on clinical, nutritional, and functional outcomes. Participants will: * Be randomly assigned to one of the three study groups * Receive individualized dietary counseling according to their assigned intervention * Receive one study sachet daily containing either an HMB-enriched nutritional supplement (providing 3 g/day of HMB) or a matched placebo, according to the assigned study group * Undergo assessments of muscle mass, muscle strength, physical function, renal function, inflammatory and clinical biomarkers, and quality of life at baseline, 4 weeks, and 8 weeks
Trial Details
NCT Number NCT07731048
Lead Sponsor Hospital de Clinicas de Porto Alegre
Conditions Heart Failure
Enrollment 84 participants
Start Date 2026-09-01
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-28