Nutritional Therapy Interventions in Heart Failure
Condition: Heart Failure NYHA Class II
MeSH terms: Heart Failure
Study type: Interventional

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.
    

Intervention name(s): EAA mixture; Placebo (whey protein)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplement intervention for 12-weeks; Dietary supplement intervention for 12-weeks
Other intervention name(s): Essential Blends, Fairbanks, Alaska; Pure Protein, 100% Whey Protein Powder, Bayport, NY
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science