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Nutritional Therapy Interventions in Heart Failure

Primary Purpose

Heart Failure NYHA Class II

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EAA mixture
Placebo (whey protein)
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heart Failure NYHA Class II

Eligibility Criteria

60 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

9g of EAA mixture supplement

9g of placebo (whey protein)

Arm Description

Twice a day for 12 consecutive weeks.

Twice a day for 12 consecutive weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2018
Last Updated
July 8, 2021
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT03424265
Brief Title
Nutritional Therapy Interventions in Heart Failure
Official Title
Effects of 12 Weeks of Nutritional Therapy Interventions in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
June 27, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class II

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
9g of EAA mixture supplement
Arm Type
Experimental
Arm Description
Twice a day for 12 consecutive weeks.
Arm Title
9g of placebo (whey protein)
Arm Type
Experimental
Arm Description
Twice a day for 12 consecutive weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
EAA mixture
Other Intervention Name(s)
Essential Blends, Fairbanks, Alaska
Intervention Description
Dietary supplement intervention for 12-weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (whey protein)
Other Intervention Name(s)
Pure Protein, 100% Whey Protein Powder, Bayport, NY
Intervention Description
Dietary supplement intervention for 12-weeks
Primary Outcome Measure Information:
Title
Functional Test
Description
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.
Time Frame
Change from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gohar Azhar, M.D
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33475727
Citation
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.
Results Reference
derived

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Nutritional Therapy Interventions in Heart Failure

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