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NCT07731048
High-Protein Diet and HMB Supplementation in Patients With Heart Failure
Conditions: Heart Failure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 84
Sponsor: Hospital de Clinicas de Porto Alegre
Location: Hospital de Clínicas de Porto Alegre (Clinical Research Center) Porto Alegre Rio Grande do Sul
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
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07731048). StuddyBuddy aggregates publicly available trial information.