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

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

Conditions

• Heart Failure

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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Principal Investigators

• Gabriela C Souza, RD, PhD · Hospital de Clínicas de Porto Alegre (HCPA)

• Flávia M Silva, RD, PhD · Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-08-31

Completion

2027-11-30

Countries

• Brazil

Study Locations