Effect of Whey Protein' Supplementation and Exercise in Patients With Heart Failure

Not Applicable

• Conditions: Heart Failure; Muscle Loss; Sarcopenia; Quality of Life
• Interventions: Dietary Supplement: whey protein

• Registration Number: NCT03142399
• Lead Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-10
• Last Update Posted: 2017-12-12
• Study Start: 2018-01-02
• Primary Completion: 2018-12-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
whey protein	whey protein	The whey protein group will receive whey protein supplementation 30g/day of whey protein during three months (12 weeks)
placebo group	whey protein	The placebo group (maltodextrin) will receive 30g/day of maltodextrin during three months (12 weeks)

Primary Outcome Measures

Name	Time	Method
Preservation of skeletal muscle mass	12 weeks	Assessment of body composition through bioelectrical impedance and anthropometry

Secondary Outcome Measures

Name	Time	Method
Microvascular reactivity	12 weeks	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.
Quality of life	12 weeks	Evaluation of health-related quality of life through the application of the Minnesota Living With Heart Failure Questionnaire validated for brazilian population
Muscle strength	12 weeks	Evaluation of manual gripping force through dynamometry
Change in peak oxygen uptake (VO2 peak)	12 weeks	Cardiopulmonary exercise test will be performed to measure VO2 peak and other parameters representative of cardiovascular reserve.

Trial Locations

Locations (1)

Elisa Maia dos Santos; 🇧🇷 Rio de Janeiro, Brazil