Heart Failure NYHA Class II
Conditions
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTEAA mixture
Dietary supplement intervention for 12-weeks
DIETARY_SUPPLEMENTPlacebo (whey protein)
Dietary supplement intervention for 12-weeks
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* BMI between 18 and 40 kg/m2 * Any ethnicity * Presence of mild-to-moderate heart failure (NYHA II or III symptomatology) as evidenced by prescribed diuretics or reported shortness of breath upon exertion
Exclusion criteria
* Allergic to milk or soy products * Hemoglobin \<10 g/dL * Estimated Glomerular Filtration Rate (eGFR) \< 30 * Inability to perform strength and/or functional assessments * Myocardial infarction in the past 6 months * Unstable angina * Moderate-severe heart valve disease * Atrial fibrillation or other significant (as determined by PI) arrhythmias * Infiltrative, restrictive or hypertrophic cardiomyopathy * Dementia -determined by a SLUMS score of \<20 * Currently having inflammatory bowel disease * Received chemotherapy or radiation therapy within the past 12 months * Currently undergoing tube feeding * Currently receiving palliative care for end-of-life circumstance * Unwilling to refrain from using non-study protein/amino acid supplements during their participation in this study * If deemed medically unstable by the study physician for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Test | Change from baseline to 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 9g of EAA Mixture Supplement Twice a day for 12 consecutive weeks.
EAA mixture: Dietary supplement intervention for 12-weeks | 29 |
| 9g of Placebo (Whey Protein) Twice a day for 12 consecutive weeks.
Placebo (whey protein): Dietary supplement intervention for 12-weeks | 34 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | screening failure | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | 9g of EAA Mixture Supplement | 9g of Placebo (Whey Protein) | Total |
|---|---|---|---|
| Age, Customized Age >=60 years. | 29 Participants | 34 Participants | 63 Participants |
| Race/Ethnicity, Customized African-American | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 25 Participants | 28 Participants | 53 Participants |
| Sex: Female, Male Female | 20 Participants | 23 Participants | 43 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 3 / 34 |
| other Total, other adverse events | 0 / 29 | 3 / 34 |
| serious Total, serious adverse events | 0 / 29 | 0 / 34 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 9g of EAA Mixture Supplement | Functional Test | 115.91 feet | Standard Deviation 94.727 |
| 9g of Placebo (Whey Protein) | Functional Test | 57.25 feet | Standard Deviation 150.527 |