Whey protein supplementation for the preservation of mass and muscular strength of patients with heart failure: study protocol for a randomized controlled trial.

BACKGROUND: Heart failure (HF) is an important public health problem, considered a new epidemic with high morbidity and mortality. The progression of HF often determines weight reduction, muscle mass loss, and reduced physical ability. Whey protein supplementation may increase the effects of exercise on strength and muscle mass, in addition to promoting improved endothelial function, body composition and quality of life. However, studies are needed to evaluate its benefits in patients with HF.

METHODS/DESIGN: This is a double-blind, randomized, placebo-controlled clinical trial in which patients with HF will be randomly allocated to two groups to receive supplementation with whey protein or placebo, associated with supervised exercise, for 12 weeks. The frequency of exercise will be three times a week. The study variables will be evaluated at baseline and 12 weeks. The main outcome will be maintenance of muscle mass and strength. Microvascular reactivity, quality of life, and inflammatory parameters will be evaluated as secondary outcomes.

DISCUSSION: HF is associated with severe loss of muscle mass and strength, directly contributing to exercise intolerance and inability to maintain daily life activities, becoming a strong predictor of reduced quality of life and mortality. The results of this study will add to the evidence base for providing new dietary recommendations.

TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03142399 . Registered on 29 May 2016. Effect of Whey Protein' Supplementation and Exercise in Patients with Heart Failure (PROT-HF).