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

Elisa Maia Dos Santos, Roger de Moraes, Eduardo Vera Tibiriça, Grazielle Vilas Bôas Huguenin, Annie Seixas Belo Moreira, Andrea Rocha De Lorenzo, Elisa Maia Dos Santos, Roger de Moraes, Eduardo Vera Tibiriça, Grazielle Vilas Bôas Huguenin, Annie Seixas Belo Moreira, Andrea Rocha De Lorenzo

Abstract

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).

Keywords: Cardiac rehabilitation; Heart failure; Randomized controlled trial; Study design; Whey proteins.

Conflict of interest statement

Elisa Maia dos Santos, MS is a dietitian in the Instituto Nacional de Cardiologia and a PhD student at Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil; Roger de Moraes, PhD is a professor and researcher at the Universidade Estácio de Sá, Rio de Janeiro, RJ, Brazil; Eduardo Vera Tibiriça, PhD is a professor and researcher at the Instituto Nacional de Cardiologia and Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brazil; Grazielle Vilas Bôas Huguenin, PhD is a professor and researcher at the Universidade Federal Fluminense, Niterói, Brazil and Instituto Nacional de Cardiologia, Rio de Janeiro, RJ, Brazil; Annie Seixas Belo Moreira, PhD is a professor and researcher at the Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil; Andrea Rocha De Lorenzo, PhD is a professor and researcher at the Instituto Nacional de Cardiologia and Universidade Federal do Rio de Janeiro.

Ethical approval was obtained from the Ethics and Research Committee of the National Institute of Cardiology, in Rio de Janeiro, Brazil and the participants will sign the free and informed consent form.

We have gained informed consent for publication of the dataset from patients at the point of recruitment to the trial. All the patient details will be fully anonymous.

The authors declare that they have no competing interests.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flowchart
Fig. 2
Fig. 2
Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT): the schedule of enrollment, interventions, and assessments

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