Nutritional Therapy Interventions in Heart Failure

Study Overview
=================
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.

Official Title
-----------------
Effects of 12 Weeks of Nutritional Therapy Interventions in Heart Failure

Conditions
-----------------
Heart Failure NYHA Class II

Intervention / Treatment
-----------------
* Dietary Supplement: EAA mixture
* Dietary Supplement: Placebo (whey protein)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 9g of EAA mixture supplement<br>Twice a day for 12 consecutive weeks. | Dietary Supplement: EAA mixture<br>* Dietary supplement intervention for 12-weeks<br>* Other names: Essential Blends, Fairbanks, Alaska;|
| Experimental: 9g of placebo (whey protein)<br>Twice a day for 12 consecutive weeks. | Dietary Supplement: Placebo (whey protein)<br>* Dietary supplement intervention for 12-weeks<br>* Other names: Pure Protein, 100% Whey Protein Powder, Bayport, NY;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to 12 weeks |