Nutritional Therapy Interventions in Heart Failure

Not Applicable

Completed

Conditions: Heart Failure NYHA Class II

Interventions: Dietary Supplement: EAA mixture
Dietary Supplement: Placebo (whey protein)

Registration Number: NCT03424265

Lead Sponsor: University of Arkansas

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
9g of EAA mixture supplement	EAA mixture	Twice a day for 12 consecutive weeks.
9g of placebo (whey protein)	Placebo (whey protein)	Twice a day for 12 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures