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

NCT ID: NCT03142399

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2019-06-30

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.

Conditions

Heart Failure; Sarcopenia; Muscle Loss; Quality of Life

Keywords

heart failure; cardiac reabilitation; nutritional status; quality of life; milk protein

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

whey protein

The whey protein group will receive whey protein supplementation 30g/day of whey protein during three months (12 weeks)

Group Type: EXPERIMENTAL

whey protein

Intervention Type: DIETARY_SUPPLEMENT

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.

placebo group

The placebo group (maltodextrin) will receive 30g/day of maltodextrin during three months (12 weeks)

Group Type: PLACEBO_COMPARATOR

whey protein

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

supplementation with milk protein

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Elisa Maia dos Santos

Master on Cardiovascular Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Lorenzo, PhD

Role: STUDY_DIRECTOR

National Institute of Cardiology, Laranjeiras, Brazil

Annie SB Moreira, PhD

Role: STUDY_DIRECTOR

National Institute of Cardiology, Laranjeiras, Brazil

Locations

Elisa Maia dos Santos

Rio de Janeiro, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 30089525 (View on PubMed)

Other Identifiers

Whey Protein NICBrazil

Identifier Type: -

Identifier Source: org_study_id