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

NCT07731048 | Not Yet Recruiting

• 1 other identifier: 2026-0072
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

High-Protein Diet; β-Hydroxy-β-Methylbutyrate; Muscle Mass; Muscle Strength; Physical Function; Dietary Intervention

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Muscle Mass

  Muscle mass will be assessed using complementary anthropometric measurements, bioelectrical impedance analysis (BIA), and muscle ultrasound. Anthropometric assessment will include mid-upper arm circumference, mid-arm muscle circumference, calf circumference, and adductor pollicis muscle thickness. BIA will be used to estimate skeletal muscle mass and skeletal muscle index (SMI). Muscle ultrasound will assess quadriceps muscle thickness, cross-sectional area, echogenicity, pennation angle, and fascicle length. All measurements will be performed by trained assessors using standardized procedures, and established sex-specific cutoffs will be used to classify reduced muscle mass when applicable.

  Baseline, Week 4, and Week 8

Secondary Outcomes (7)

• Change from Baseline in Muscle strength

  Baseline, Week 4, and Week 8

• Change from Baseline in Physical function

  Baseline, Week 4, and Week 8

• Change from Baseline in Renal function

  Baseline and Week 8

• Change from Baseline in High-Sensitivity C-Reactive Protein

  Baseline and Week 8

• Change from Baseline in New York Heart Association (NYHA) Functional Class

  Baseline and Week 8

Study Arms (3)

Normocaloric Normal-Protein Diet (NCNP)

ACTIVE COMPARATOR

Participants will receive an individualized normocaloric normoprotein diet providing 1.0 g protein/kg/day, 55% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal/kg/day) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily placebo sachet.

Dietary Supplement: Placebo; Behavioral: Individualized Dietary Counseling

Normocaloric High-Protein Diet (NCHP)

EXPERIMENTAL

Participants will receive an individualized normocaloric high-protein diet providing 1.5 g protein/kg/day, 50% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal/kg/day) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily placebo sachet.

Dietary Supplement: Placebo; Behavioral: Individualized Dietary Counseling

Normocaloric High-Protein Diet + HMB (NCHP+HMB)

EXPERIMENTAL

Participants will receive an individualized normocaloric high-protein diet providing 1.5 g protein/kg/day, 50% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal/kg/day) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily HMB-enriched nutritional supplement providing 3 g/day of β-hydroxy-β-methylbutyrate (HMB).

Dietary Supplement: β-Hydroxy-β-Methylbutyrate (HMB); Behavioral: Individualized Dietary Counseling

Interventions

β-Hydroxy-β-Methylbutyrate (HMB) DIETARY_SUPPLEMENT

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.

Normocaloric High-Protein Diet + HMB (NCHP+HMB)

Placebo DIETARY_SUPPLEMENT

Participants will receive one daily placebo sachet identical in appearance, flavor, and packaging to the HMB supplement for 8 weeks

Normocaloric High-Protein Diet (NCHP); Normocaloric Normal-Protein Diet (NCNP)

Individualized Dietary Counseling BEHAVIORAL

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.

Normocaloric High-Protein Diet (NCHP); Normocaloric High-Protein Diet + HMB (NCHP+HMB); Normocaloric Normal-Protein Diet (NCNP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre (Clinical Research Center)

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gabriela C Souza, RD, PhD

  Hospital de Clínicas de Porto Alegre (HCPA)

  PRINCIPAL INVESTIGATOR

• Flávia M Silva, RD, PhD

  Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)

  STUDY CHAIR

Central Study Contacts

Ingrid S Knobloch, PhD Candidate

CONTACT

+55 51 3359 6275; iknobloch@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be explicitly informed of the prescribed dietary protein target and will remain blinded to the HMB versus placebo supplementation. Investigators responsible for prescribing the diet cannot be blinded to the dietary intervention but will remain blinded to the supplementation allocation. Outcome assessors and data analysts will also remain blinded to supplementation allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

BR (1)