High-Protein Diet and HMB Supplementation in Patients With Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: β-Hydroxy-β-Methylbutyrate (HMB), Placebo, Individualized Dietary Counseling.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Dietary supplement β-Hydroxy-β-Methylbutyrate (HMB)
Participants will receive one daily sachet of a powdered nutritional supplement enriched with 3 g of β-hydroxy-β-methylbutyrate (HMB) for 8 weeks. The supplement will be dissolved in water and consumed once daily. - Dietary supplement Placebo
Participants will receive one daily placebo sachet identical in appearance, flavor, and packaging to the HMB supplement for 8 weeks - Behavioral Individualized Dietary Counseling
Participants will receive individualized dietary counseling from a registered dietitian. Energy intake will be prescribed at 20-30 kcal/kg/day to maintain body weight. According to randomization, participants will receive either a normoprotein diet (1.0 g protein/kg/day) or a high-protein diet (1.5 g protein/kg/day), based on the DASH dietary pattern and the Brazilian Dietary Guidelines.
Primary outcome measures
- Change from Baseline in Muscle Mass [Time frame: Baseline, Week 4, and Week 8]
Secondary outcome measures (7)
- Change from Baseline in Muscle strength [Time frame: Baseline, Week 4, and Week 8]
- Change from Baseline in Physical function [Time frame: Baseline, Week 4, and Week 8]
- Change from Baseline in Renal function [Time frame: Baseline and Week 8]
- Change from Baseline in High-Sensitivity C-Reactive Protein [Time frame: Baseline and Week 8]
- Change from Baseline in New York Heart Association (NYHA) Functional Class [Time frame: Baseline and Week 8]
- Change from Baseline in B-Type Natriuretic Peptide (BNP) [Time frame: Baseline and Week 8]
- Change from Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score [Time frame: Baseline and Week 8]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Hospital de Clínicas de Porto Alegre (Clinical Research Center) — Porto Alegre
Identifiers
NCT: NCT07731048 · 2026-0072