NCT03424265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 19, 2020

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

January 31, 2018

Results QC Date

July 8, 2020

Last Update Submit

July 8, 2021

Conditions

Heart Failure NYHA Class II

Outcome Measures

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.

    Change from baseline to 12 weeks

Study Arms (2)

9g of EAA mixture supplement

EXPERIMENTAL

Twice a day for 12 consecutive weeks.

Dietary Supplement: EAA mixture

9g of placebo (whey protein)

EXPERIMENTAL

Twice a day for 12 consecutive weeks.

Dietary Supplement: Placebo (whey protein)

Interventions

EAA mixtureDIETARY_SUPPLEMENT

Dietary supplement intervention for 12-weeks

Also known as: Essential Blends, Fairbanks, Alaska
9g of EAA mixture supplement
Placebo (whey protein)DIETARY_SUPPLEMENT

Dietary supplement intervention for 12-weeks

Also known as: Pure Protein, 100% Whey Protein Powder, Bayport, NY
9g of placebo (whey protein)

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (2)

  • Azhar G, Verma A, Zhang X, Pangle A, Patyal P, Zhang W, Che Y, Coker K, Wolfe RR, Wei JY. Differential plasma protein expression after ingestion of essential amino acid-based dietary supplement verses whey protein in low physical functioning older adults. Geroscience. 2023 Jun;45(3):1729-1743. doi: 10.1007/s11357-023-00725-5. Epub 2023 Feb 1.

    PMID: 36720768DERIVED

  • 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.

    PMID: 33475727DERIVED

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Scott Schutzler, R.N.
Organization
University of Arkansas for Medical Sciences
seschutzler@uams.edu
501-526-5734

Study Officials

  • Gohar Azhar, M.D

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 6, 2018

Study Start

February 15, 2018

Primary Completion

June 27, 2019

Study Completion

June 27, 2019

Last Updated

July 12, 2021

Results First Posted

August 19, 2020

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)