Nutritional Therapy Interventions in Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure NYHA Class II
• Intervention / Treatment: Dietary supplement: EAA mixture; Dietary supplement: Placebo (whey protein)

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 9g of EAA mixture supplement; Twice a day for 12 consecutive weeks.	Dietary supplement: EAA mixture; Dietary supplement intervention for 12-weeks; Other Names: Essential Blends, Fairbanks, Alaska
EXPERIMENTAL: 9g of placebo (whey protein); Twice a day for 12 consecutive weeks.	Dietary supplement: Placebo (whey protein); Dietary supplement intervention for 12-weeks; 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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Gohar Azhar, M.D, University of Arkansas

Publications and helpful links

General Publications

• Azhar G, Wei JY, Schutzler SE, Coker K, Gibson RV, Kirby MF, Ferrando AA, Wolfe RR. Daily Consumption of a Specially Formulated Essential Amino Acid-Based Dietary Supplement Improves Physical Performance in Older Adults With Low Physical Functioning. J Gerontol A Biol Sci Med Sci. 2021 Jun 14;76(7):1184-1191. doi: 10.1093/gerona/glab019.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2018
• Primary Completion (ACTUAL): June 27, 2019
• Study Completion (ACTUAL): June 27, 2019

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (ACTUAL): February 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 206313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No