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Not Yet Recruiting NCT07731048

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

Conditions: Heart Failure

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 84
Sponsor: Hospital de Clinicas de Porto Alegre

Location: Hospital de Clínicas de Porto Alegre (Clinical Research Center) Porto Alegre Rio Grande do Sul

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

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 years or older; * Male or female; * Diagnosis of chronic heart failure for at least 3 months, established according to the Brazilian Guidelines for Chronic and Acute Heart Failure and confirmed by medical records. Exclusion Criteria: * Chronic kidney disease stage 3b or higher; * Listed for heart transplantation; * Hospitalization for decompensated heart failure within the previous 3 months; * Active cancer treatment or cancer treatment within the previous 5 years; * History of alcohol or illicit drug abuse within the previous 12 months; * Chronic use of anti-inflammatory drugs, anticonvulsants, corticosteroids, or immunosuppressive agents; * Pregnancy or breastfeeding; * Wheelchair use preventing anthropometric assessment; * Current use of protein supplements; * Participation in another randomized clinical trial with interventions that may interfere with the primary outcome.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07731048). StuddyBuddy aggregates publicly available trial information.