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Nutritional Therapy Interventions in Heart Failure

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ClinicalTrials.gov Identifier: NCT03424265
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 23, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Heart Failure NYHA Class II 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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of 12 Weeks of Nutritional Therapy Interventions in Heart Failure
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Pure Protein, 100% Whey Protein Powder, Bayport, NY

Primary Outcome Measures :
  1. Functional test [ Time Frame: Change from baseline to 12 weeks ]
    Measuring 6 minutes walking before and after the intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424265

Contact: Gohar Azhar, M.D 501-526-5935 azhargohar@uams.edu
Contact: Sanghee Park, Ph.D. 501-526-5709 spark@uams.edu

United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Gohar Azhar, M.D.    501-526-5935    AzharGohar@uams.edu   
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Gohar Azhar, M.D University of Arkansas

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03424265     History of Changes
Other Study ID Numbers: 206313
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases