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CompletedNCT03424265Updated Jul 12, 2021Results posted

Nutritional Therapy Interventions in Heart Failure

An interventional study of EAA mixture and Placebo (whey protein) in Heart Failure NYHA Class II, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 60 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-07-12.

Sponsored by University of Arkansas · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
60 Years to 89 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure NYHA Class II

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03

Who can participate

Ages eligible
60 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    9g of EAA mixture supplement

    Twice a day for 12 consecutive weeks.

    Dietary Supplement: EAA mixture

  • Experimental
    9g of placebo (whey protein)

    Twice a day for 12 consecutive weeks.

    Dietary Supplement: Placebo (whey protein)

Interventions

  • Dietary supplementEAA mixture

    Dietary supplement intervention for 12-weeks

    Also known as: Essential Blends, Fairbanks, Alaska

  • Dietary supplementPlacebo (whey protein)

    Dietary supplement intervention for 12-weeks

    Also known as: Pure Protein, 100% Whey Protein Powder, Bayport, NY

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline to 12 weeks

06

Results

Posted Aug 19, 2020

Participant flow

Participant flow — Overall Study
Milestone9g of EAA Mixture Supplement9g of Placebo (Whey Protein)
Started2934
Completed2832
Not completed12
Withdrew: Screening failure10
Withdrew: Withdrawal by subject02

Outcome measures

PrimaryFunctional 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.

Time frame:
Change from baseline to 12 weeks
Reported as:
Mean · feet
Functional Test
feet9g of EAA Mixture Supplement9g of Placebo (Whey Protein)
Functional Test115.91 ± 94.72757.25 ± 150.527

Adverse events

Collected over Subjects were followed for adverse events for the duration of their participation (approx. 4 months).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
9g of EAA Mixture Supplement0/29 (0%)0/29 (0%)0/29 (0%)
9g of Placebo (Whey Protein)3/34 (8.8%)0/34 (0%)3/34 (8.8%)
Most frequent other events
Most frequent other events
Event9g of EAA Mixture Supplement9g of Placebo (Whey Protein)
Prostate pain during urinationReproductive system and breast disorders0/291/34
Respiratory issueRespiratory, thoracic and mediastinal disorders0/291/34
hypertensionVascular disorders0/291/34

Baseline characteristics

Age, Customized
Age, Customized(Participants)9g of EAA Mixture Supplement9g of Placebo (Whey Protein)Total
Age >=60 years.293463
Sex: Female, Male
Sex: Female, Male(Participants)9g of EAA Mixture Supplement9g of Placebo (Whey Protein)Total
Female202343
Male91120
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)9g of EAA Mixture Supplement9g of Placebo (Whey Protein)Total
White, non-Hispanic252853
Asian101
African-American369
07

Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
08

References and documents

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. PubMed 33475727 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03424265
Lead sponsor
University of Arkansas
Responsible party
Sponsor
First posted
Feb 6, 2018
Start date
Feb 15, 2018
Primary completion
Jun 27, 2019
Completion
Jun 27, 2019
Results posted
Aug 19, 2020
Last update
Jul 12, 2021

Study contacts

Gohar Azhar, M.D
principal investigator · University of Arkansas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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