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

National Institute of Cardiology, Laranjeiras, Brazil

Status: Unknown

Conditions: Quality of Life; Heart Failure; Muscle Loss; Sarcopenia

Treatments: Dietary Supplement: whey protein

Study type: Interventional

Funder types: Other

Identifiers

NCT03142399

Whey Protein NICBrazil

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

4 participants in 2 patient groups, including a placebo group

whey protein

Experimental group

Description:

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

Treatment:

Dietary Supplement: whey protein

placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: whey protein