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Purpose

The study will test and compare the efficacy of a single essential amino acid valine with a combination of essential amino acids (EAA) supplement on fatigue, frailty, and cognitive function in end-stage kidney disease (ESKD) patients undergoing hemodialysis (HD) treatment.

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or Female 2. Age 18-64 years 3. Receiving 3 x weekly in clinic hemodialysis for at least 6 months

Exclusion Criteria

  1. Hypersensitivity to amino acid(s) and/or any excipient 2. Clinical documentation of COVID-19 3. Concomitant intake of amino acids supplements 4. Current use or abuse of alcohol, marijuana, narcotic, or other substances 5. Heart failure receiving active management 6. Malignant cancer receiving anticancer therapy 7. Diagnosis of major depressive disorder receiving antidepressants 8. Diagnosis of chronic liver disease 9. Cerebrovascular disease with sequelae 10. Upper limb amputation, osteoarthritis, or degenerative diseases of fingers, carpel tunnel syndrome in the non-fistula or graft hand preventing completion of hand grip strength test.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
The study design will consist of a crossover schema, with one arm starting on amino acid Valine and the other on EAA for a period of 8 weeks, followed by a washout period of 1 week, and then assignment to the nutritional supplement that they have not already taken for the remaining 8 week period that they are participating in this study.
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
The intervention will be administered to the subjects by appropriately trained delegates.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment group Valine then EEA 		Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
  • Drug: Valine
    A medical food intended for use under medical supervision
    Other names:
    • Valine Amino Acid Supplement
  • Drug: EEA
    A medical food intended for use under medical supervision
    Other names:
    • Essential Amino Acid Supplement
Experimental
Treatment group EEA then Valine 		EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine
  • Drug: Valine
    A medical food intended for use under medical supervision
    Other names:
    • Valine Amino Acid Supplement
  • Drug: EEA
    A medical food intended for use under medical supervision
    Other names:
    • Essential Amino Acid Supplement

Recruiting Locations

The University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Subrata Debnath, PhD
210-567-4700
nath@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Subrata Debnath, PhD
210-567-4700
nath@uthscsa.edu

Detailed Description

This single center outpatient study will test and compare the efficacy of a single essential amino acid, valine with a combination of essential amino acids (EAA) supplementation on fatigue, fragility and cognitive function in end-stage kidney disease (ESKD) patients aged 18-64 years undergoing hemodialysis (HD) treatment at least three times a week.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.