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

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital de Clinicas de Porto Alegre

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

84 Participants
are divided into 3 treatment groups
Group A: Normocaloric Normal-Protein Diet (NCNP)Active comparator 2 interventions
Group B: Normocaloric High-Protein Diet (NCHP)Experimental treatment 2 interventions
Group C: Normocaloric High-Protein Diet + HMB (NCHP+HMB)Experimental treatment 2 interventions

Trial outcomes

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.

Time frame
Baseline, Week 4, and Week 8

Secondary outcomes

1

Change from Baseline in Muscle strength

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.

Time frame
Baseline, Week 4, and Week 8
2

Change from Baseline in Physical function

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.

Time frame
Baseline, Week 4, and Week 8
3

Change from Baseline in Renal function

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.

Time frame
Baseline and Week 8
4

Change from Baseline in High-Sensitivity C-Reactive Protein

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.

Time frame
Baseline and Week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital de Clinicas de Porto Alegre

Lead sponsor

Source ClinicalTrials.gov

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