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

Heart Failure Clinical Trial

— PROT-HF  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03142399
• Other study ID #: Whey Protein NICBrazil
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 3, 2017
• Last updated: December 10, 2017
• Start date: January 2, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2017
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4
• Est. completion date: June 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Muscle Loss
• Quality of Life
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Elisa Maia dos Santos	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preservation of skeletal muscle mass	Assessment of body composition through bioelectrical impedance and anthropometry	12 weeks
Secondary	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
Secondary	Muscle strength	Evaluation of manual gripping force through dynamometry	12 weeks
Secondary	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
Secondary	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