Clinical trial NCT03142399: Effect of Whey Protein' Supplementation and Exercise in Patients With Heart Failure
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Sarcopenia
Muscle Loss
Quality of Life
Keywords: heart failure
cardiac reabilitation
nutritional status
quality of life
milk protein
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2017-05-05
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Preservation of skeletal muscle mass
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 12 weeks
measure: Muscle strength
timeFrame: 12 weeks
measure: Change in peak oxygen uptake (VO2 peak)
timeFrame: 12 weeks
measure: Microvascular reactivity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Elisa Maia dos Santos
Study officials:
affiliation: National Institute of Cardiology, Laranjeiras, Brazil
name: Andrea Lorenzo, PhD
role: STUDY_DIRECTOR
affiliation: National Institute of Cardiology, Laranjeiras, Brazil
name: Annie SB Moreira, PhD
role: STUDY_DIRECTOR
References:
citation: 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.