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

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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

Key Dates

First listed

Jul 28, 2026

Start date

Sep 1, 2026

Status verified

Jul 2026

Primary completion

Aug 31, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

84 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Normocaloric Normal-Protein Diet (NCNP)
  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.
• Experimental: Normocaloric High-Protein Diet (NCHP)
  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.
• Experimental: Normocaloric High-Protein Diet + HMB (NCHP+HMB)
  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).

Primary Outcome Measure

Change from Baseline in Muscle Mass [ Time Frame: Baseline, Week 4, and Week 8 ]

Central Contacts

• Ingrid S Knobloch, PhD Candidate
  +55 51 3359 6275
  [email protected]

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