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

Официальное название

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

Обзор

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

Вмешательства

• Пищевая добавка β-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.
• Пищевая добавка Placebo
  Participants will receive one daily placebo sachet identical in appearance, flavor, and packaging to the HMB supplement for 8 weeks
• Поведенческое Individualized 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.

Первичные конечные точки

• Change from Baseline in Muscle Mass [Срок оценки: Baseline, Week 4, and Week 8]

Вторичные конечные точки (7)

• Change from Baseline in Muscle strength [Срок оценки: Baseline, Week 4, and Week 8]
• Change from Baseline in Physical function [Срок оценки: Baseline, Week 4, and Week 8]
• Change from Baseline in Renal function [Срок оценки: Baseline and Week 8]
• Change from Baseline in High-Sensitivity C-Reactive Protein [Срок оценки: Baseline and Week 8]
• Change from Baseline in New York Heart Association (NYHA) Functional Class [Срок оценки: Baseline and Week 8]
• Change from Baseline in B-Type Natriuretic Peptide (BNP) [Срок оценки: Baseline and Week 8]
• Change from Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score [Срок оценки: Baseline and Week 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Hospital de Clínicas de Porto Alegre (Clinical Research Center) — Porto Alegre

Идентификаторы

NCT: NCT07731048 · 2026-0072

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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