Heart Failure
Conditions
Keywords
High-Protein Diet, β-Hydroxy-β-Methylbutyrate, Muscle Mass, Muscle Strength, Physical Function, Dietary Intervention
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: 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
Interventions
DIETARY_SUPPLEMENTβ-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_SUPPLEMENTPlacebo
Participants will receive one daily placebo sachet identical in appearance, flavor, and packaging to the HMB supplement for 8 weeks
BEHAVIORALIndividualized 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
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Muscle Mass | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Muscle strength | 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. |
| Change from Baseline in Physical function | 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. |
| Change from Baseline in Renal function | 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. |
| Change from Baseline in High-Sensitivity C-Reactive Protein | 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. |
| Change from Baseline in New York Heart Association (NYHA) Functional Class | 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. |
| Change from Baseline in B-Type Natriuretic Peptide (BNP) | 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. |
| Change from Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score | 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. |
Countries
Brazil
Contacts
CONTACTIngrid S Knobloch, PhD Candidate
PRINCIPAL_INVESTIGATORGabriela C Souza, RD, PhD
Hospital de Clínicas de Porto Alegre (HCPA)
STUDY_CHAIRFlávia M Silva, RD, PhD
Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
Outcome results
None listed