High-protein diet with or without HMB supplement for muscle health in heart failure
Tests a high-protein diet, with or without HMB, in adults with heart failure.
Plain-language title generated from the registry record
Registry title: High-Protein Diet and HMB Supplementation in Patients With Heart Failure
Key facts
- Where
- Porto Alegre, BrazilSee the site
Where in Brazil
- Hospital de Clínicas de Porto Alegre (Clinical Research Center)Porto Alegre, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital de Clinicas de Porto Alegre
- Trial code
- NCT07731048
- Record updated
- 28 July 2026
- Original description
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:Read full original descriptionShow less
Effect of a High-Protein Diet and β-Hydroxy-β-Methylbutyrate Supplementation in Comparison to a Normo-protein Diet on Muscle Mass, Strength, and Physical Function in Patients With Heart Failure: Protocol of a Three-Arm, Parallel-Group, Superiority Randomized Clinical Trial
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
Inclusion: 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: 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; Chronic kidney disease stage 3b or higher; Listed for heart transplantation; 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.