跳至主要内容
临床试验/NCT03142399
NCT03142399Unknown不适用

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

National Institute of Cardiology, Laranjeiras, Brazil2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
4
试验地点
2
主要终点
Preservation of skeletal muscle mass

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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%.

排除标准

  • 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.

研究组 & 干预措施

whey protein

Experimental

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

干预措施: whey protein (Dietary Supplement)

placebo group

Placebo Comparator

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

干预措施: whey protein (Dietary Supplement)

结局指标

主要结局

Preservation of skeletal muscle mass

时间窗: 12 weeks

Assessment of body composition through bioelectrical impedance and anthropometry

次要结局

  • Microvascular reactivity(12 weeks)
  • Quality of life(12 weeks)
  • Muscle strength(12 weeks)
  • Change in peak oxygen uptake (VO2 peak)(12 weeks)

研究者

发起方
National Institute of Cardiology, Laranjeiras, Brazil
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Elisa Maia dos Santos

Master on Cardiovascular Sciences

National Institute of Cardiology, Laranjeiras, Brazil

研究点 (2)

Loading locations...

相似试验