Effect of Supplementation With Whey Protein in Preservation of Muscle Mass and Strength, Quality of Life of Patients With Heart Failure in Cardiac Rehabilitation
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
- 否
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
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
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
Elisa Maia dos Santos
Master on Cardiovascular Sciences
National Institute of Cardiology, Laranjeiras, Brazil
