Nutritional Therapy Interventions in Heart Failure

Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:60 - 89
Start Date:February 15, 2018
End Date:February 15, 2021
Contact:Gohar Azhar, M.D

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Effects of 12 Weeks of Nutritional Therapy Interventions in Heart Failure

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

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.
We found this trial at
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Phone: 501-526-5935
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
Little Rock, AR
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