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NCT Number: NCT07731048

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre (Clinical Research Center)

Porto Alegre, Rio Grande do Sul, Brazil

Location contact

Ingrid S Knobloch, PhD Canditate

CONTACT

[email protected]

+55 51 3359 6275

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change from Baseline in Muscle Mass

    Time frame: Baseline, Week 4, and Week 8

    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.

Secondary outcomes

  1. Change from Baseline in Muscle strength

    Time frame: Baseline, Week 4, and Week 8

    Muscle strength will be assessed using handgrip strength for upper-limb strength and the Five Times Sit-to-Stand Test (5STS) for lower-limb strength. Handgrip strength will be measured bilaterally using a Jamar® hydraulic dynamometer. Three measurements will be obtained for each hand, and the highest value will be used for analysis. Established sex-specific cutoffs will be used to classify low muscle strength. Lower-limb strength will be evaluated using the Five Times Sit-to-Stand Test, with test completion time recorded and validated cutoffs used to identify reduced lower-limb muscle strength.

  2. Change from Baseline in Physical function

    Time frame: Baseline, Week 4, and Week 8

    Physical function will be assessed using the Timed Up and Go Test. Participants will be instructed to stand up from a standard chair, walk 3 meters, turn around, return to the chair, and sit down. Reduced physical function will be defined as a completion time ≥ 20 s.

  3. Change from Baseline in Renal function

    Time frame: Baseline and Week 8

    Renal function will be assessed by measuring serum creatinine using a standardized laboratory assay and estimating glomerular filtration rate (eGFR) using the CKD-EPI 2021 creatinine equation. Changes in serum creatinine and eGFR will be used to evaluate the effect of the intervention on renal function.

  4. Change from Baseline in High-Sensitivity C-Reactive Protein

    Time frame: Baseline and Week 8

    Systemic inflammation will be assessed by measuring high-sensitivity C-reactive protein (hs-CRP) using an immunoturbidimetric assay. Changes in hs-CRP concentrations will be used to evaluate the effect of the intervention on systemic inflammation.

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

    Time frame: Baseline and Week 8

    Functional status will be assessed using the New York Heart Association (NYHA) functional classification. Changes in NYHA functional class will be used to evaluate the effect of the intervention on heart failure severity and functional status.

  6. Change from Baseline in B-Type Natriuretic Peptide (BNP)

    Time frame: Baseline and Week 8

    Heart failure severity will be assessed by measuring B-type natriuretic peptide (BNP) using a standardized immunoassay. Changes in BNP concentrations will be used to evaluate the effect of the intervention on heart failure severity.

  7. Change from Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score

    Time frame: Baseline and Week 8

    Health-related quality of life will be assessed using the validated Minnesota Living with Heart Failure Questionnaire (MLHFQ), a 21-item disease-specific questionnaire that evaluates the impact of heart failure on physical, emotional, social, and mental aspects of daily life. Total and domain scores will be calculated, with higher scores indicating poorer health-related quality of life. Changes in MLHFQ scores will be used to evaluate the effect of the intervention on health-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Ingrid S Knobloch, PhD Candidate

CONTACT

[email protected]

+55 51 3359 6275

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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