Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03424265 |
| Other study ID # |
206313 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2018 |
| Est. completion date |
June 27, 2019 |
Study information
| Verified date |
July 2021 |
| Source |
University of Arkansas |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators will examine the effects of 12-weeks of nutritional interventions in older
participants who have a symptom of mild to moderate heart failure.
Description:
Heart failure develops when cardiac muscle becomes weakened and consequently is compromised
in its ability to contract, relax, or both. Impaired heart function leads to reduced exercise
capacity, which in turn leads to progressive muscle weakness and a vicious cycle of sedentary
behavior, weight gain, and subsequent development of metabolic abnormalities and sarcopenia.
Approximately 6-10% of individuals over the age of 65 suffer from heart failure, and the risk
of death is 35% in the first year after diagnosis. In addition, there is a wide range of
potential causes of heart failure, including the natural process of aging. Regardless of the
specific underlying cause, there are common pathophysiological responses such as impaired
exercise capacity, shortness of breath, fatigue and muscle strength, leading to decreased
physical function. Moreover, some long-term consequences of reduced exercise tolerance and
malabsorption in long-standing heart failure are loss of muscle mass and the development of
cardiac cachexia, resulted in progression of sarcopenia. As protein and amino acid
supplements are known to prevent loss of muscle mass or maintain muscle mass in alder
individuals, in a pilot study 18 overweight/obese subjects with heart failure (all exceeded
40% body fat) were studied. Nine subjects received 12 weeks of dietary supplementation with
20 g of whey protein consumed daily, while the other nine were controls. The findings showed
that supplementation with whey protein failed to improve functional performance as well as a
limited stimulation of muscle protein synthesis. The lack of a demonstrable effect of whey
protein is consistent with the diminished responsiveness to the stimulation of muscle protein
synthesis. In contrast, a 2016 University of Arkansas for Medical Sciences (UAMS) pilot study
found that the essential amino acid (EAA) mixture is better at overcoming anabolic resistance
than Ensure Heart Health. In this study we will perform a randomized clinical trial of a
commercially produced nutritional supplement as compared to a placebo in order to determine
effects on physical function and health-related quality of life. Subjects will ingest either
the EAA mixture product or placebo every day for 12 consecutive weeks. Outcomes will be
determined by comparing the results of physical and functional tests from weeks -1 to 6 and
12.
