Effect of Whey Protein' Supplementation and Exercise in Patients With Heart Failure (PROT-HF)

Effect of Supplementation With Whey Protein in Preservation of Muscle Mass and Strength, Quality of Life of Patients With Heart Failure in Cardiac Rehabilitation

The aim of this study is evaluate the effect of whey protein supplementation on muscle mass preservation, improvement of strength and quality of life, and inflammatory parameters in patients with heart failure NYHA I or II followed by a cardiac rehabilitation program.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Quality of Life; Sarcopenia; Muscle Loss
• Intervention / Treatment: Dietary supplement: whey protein

Detailed Description

Heart failure is the final route of most heart diseases and is a worldwide problem due to its high prevalence, morbidity and mortality. In Brazil, it is an important cause of hospitalization and one of the most important health challenges, since its prevalence tends to increase with the aging of the population and the increase in the survival of patients who have suffered acute coronary events. This is an ongoing epidemic problem, resulting in a high socioeconomic cost, represented by the expense of medications, repeated hospitalizations, loss of productivity, early retirements, possible surgeries and, ultimately, heart transplantation. In this sense, it is of great importance to carry out studies that evaluate the possible benefits of new clinical and nutritional interventions for HF patients, favoring the development of treatment strategies for these individuals and also for public health.

Our hypothesis is based on the fact that whey protein supplementation associated with physical exercise in patients with heart failure could promote preservation of muscle mass, increase in muscle strength, and improve quality of life, Body composition and physical capacity. The volunteers will receive 30 grams per day of whey protein or maltodextrin in a double-blind, controlled clinical trial lasting 12 weeks. During this period they will perform supervised physical exercise 3 times a week in a cardiac rehabilitation program. They will also receive nutritional counseling.

• Study Type: Interventional
• Enrollment (Anticipated): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22240-006
    • Elisa Maia dos Santos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of heart failure NYHA I or II after medical evaluation;
• Indication to participate in a cardiac rehabilitation program;
• Fully medicated for heart disease;
• Age greater than or equal to 50 years;
• Ejection fraction less than 50%.

Exclusion Criteria:

• Neoplasia at any site;
• Impaired renal function (<50ml / min / 1.73m2);
• Impaired hepatic function (TGP> 150U / l) or decompensated hepatic cirrhosis classified with Child-Pugh B or C;
• Presence of ressincronizer or other device;
• Atrial fibrilation;
• Allergy of milk protein.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: whey protein; The whey protein group will receive whey protein supplementation 30g/day of whey protein during three months (12 weeks)	Dietary supplement: whey protein; Supplementation with whey protein isolate or maltodextrin (30 grams per day) for 12 weeks associated with supervised exercise and nutritional counseling in patients with heart failure.; Other Names: supplementation with milk protein
PLACEBO_COMPARATOR: placebo group; The placebo group (maltodextrin) will receive 30g/day of maltodextrin during three months (12 weeks)	Dietary supplement: whey protein; Supplementation with whey protein isolate or maltodextrin (30 grams per day) for 12 weeks associated with supervised exercise and nutritional counseling in patients with heart failure.; Other Names: supplementation with milk protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preservation of skeletal muscle mass	Assessment of body composition through bioelectrical impedance and anthropometry	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Evaluation of health-related quality of life through the application of the Minnesota Living With Heart Failure Questionnaire validated for brazilian population	12 weeks
Muscle strength	Evaluation of manual gripping force through dynamometry	12 weeks
Change in peak oxygen uptake (VO2 peak)	Cardiopulmonary exercise test will be performed to measure VO2 peak and other parameters representative of cardiovascular reserve.	12 weeks
Microvascular reactivity	A laser speckle contrast imaging system with a laser wavelength of 785 nm (PeriCam PSI system, Perimed, Järfälla, Sweden) coupled to iontophoresis of acetylcholine and sodium nitroprusside will measure non-invasively real time cutaneous microvascular flow changes in the forearm. For the post occlusive reactive hyperemia (PORH) test, arterial occlusion will be performed with suprasystolic pressure (50 mmHg above the systolic arterial pressure) using a sphygmomanometer applied to the arm of the subject over three minutes. Peak skin flow will be measured after pressure release.	12 weeks

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil
• Investigators: Study Director: Andrea Lorenzo, PhD, National Institute of Cardiology, Laranjeiras, Brazil; Study Director: Annie SB Moreira, PhD, National Institute of Cardiology, Laranjeiras, Brazil

Publications and helpful links

General Publications

• Dos Santos EM, de Moraes R, Tibirica EV, Huguenin GVB, Moreira ASB, De Lorenzo AR. Whey protein supplementation for the preservation of mass and muscular strength of patients with heart failure: study protocol for a randomized controlled trial. Trials. 2018 Aug 8;19(1):431. doi: 10.1186/s13063-018-2811-4.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 2, 2018
• Primary Completion (ANTICIPATED): December 30, 2018
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (ACTUAL): May 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 10, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: quality of life; nutritional status; heart failure; cardiac reabilitation; milk protein
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Heart Failure; Sarcopenia
• Other Study ID Numbers: Whey Protein NICBrazil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All volunteer information obtained during the collection, intervention and data analysis will not be available other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No