An interventional study of EAA mixture and Placebo (whey protein) in Heart Failure NYHA Class II, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 60 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by University of Arkansas · Not applicable, Interventional, and Basic science
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.
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.
Exclusion Criteria:
Twice a day for 12 consecutive weeks.
Dietary Supplement: EAA mixture
Twice a day for 12 consecutive weeks.
Dietary Supplement: Placebo (whey protein)
Dietary supplement intervention for 12-weeks
Also known as: Essential Blends, Fairbanks, Alaska
Dietary supplement intervention for 12-weeks
Also known as: Pure Protein, 100% Whey Protein Powder, Bayport, NY
Functional Test
Measuring 6 minutes walking before and after the intervention. \*\*\*The results below are the actual increases of walking distance (mean and SD) changes from baseline to end of 12-week intervention.
Time frame: Change from baseline to 12 weeks
| Milestone | 9g of EAA Mixture Supplement | 9g of Placebo (Whey Protein) |
|---|---|---|
| Started | 29 | 34 |
| Completed | 28 | 32 |
| Not completed | 1 | 2 |
| Withdrew: Screening failure | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
Measuring 6 minutes walking before and after the intervention. \*\*\*The results below are the actual increases of walking distance (mean and SD) changes from baseline to end of 12-week intervention.
| feet | 9g of EAA Mixture Supplement | 9g of Placebo (Whey Protein) |
|---|---|---|
| Functional Test | 115.91 ± 94.727 | 57.25 ± 150.527 |
Collected over Subjects were followed for adverse events for the duration of their participation (approx. 4 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 9g of EAA Mixture Supplement | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| 9g of Placebo (Whey Protein) | 3/34 (8.8%) | 0/34 (0%) | 3/34 (8.8%) |
| Event | 9g of EAA Mixture Supplement | 9g of Placebo (Whey Protein) |
|---|---|---|
| Prostate pain during urinationReproductive system and breast disorders | 0/29 | 1/34 |
| Respiratory issueRespiratory, thoracic and mediastinal disorders | 0/29 | 1/34 |
| hypertensionVascular disorders | 0/29 | 1/34 |
| Age, Customized(Participants) | 9g of EAA Mixture Supplement | 9g of Placebo (Whey Protein) | Total |
|---|---|---|---|
| Age >=60 years. | 29 | 34 | 63 |
| Sex: Female, Male(Participants) | 9g of EAA Mixture Supplement | 9g of Placebo (Whey Protein) | Total |
|---|---|---|---|
| Female | 20 | 23 | 43 |
| Male | 9 | 11 | 20 |
| Race/Ethnicity, Customized(Participants) | 9g of EAA Mixture Supplement | 9g of Placebo (Whey Protein) | Total |
|---|---|---|---|
| White, non-Hispanic | 25 | 28 | 53 |
| Asian | 1 | 0 | 1 |
| African-American | 3 | 6 | 9 |
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University of Arkansas