NCT07731048Not yet recruiting
High-Protein Diet and HMB Supplementation in Patients With Heart Failure
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
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 23 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Diseases
- Heart failure
- NCT number
- NCT07731048
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 1 Sept 2026 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Chronic kidney disease stage 3b or higher;
- Listed for heart transplantation;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Clínicas de Porto Alegre (Clinical Research Center) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.