End Stage Renal Disease
Conditions
Keywords
Fatigue, End-stage kidney disease, Hemodialysis
Brief summary
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.
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.
Interventions
Sponsors
National Center for Advancing Translational Sciences (NCATS)
IIMS-UT Health San Antonio
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
The intervention will be administered to the subjects by appropriately trained delegates.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Fatigue Inventory (BFI) score | Baseline to 17 weeks | Changes in global fatigue score measured with the 9-item Brief Fatigue Inventory (BFI). The first 3 questions assess fatigue severity, and the remaining 6 questions measure the impact of fatigue on activity, mood, walking, work, relationships, and enjoyment of life. Respondents rate each item on a 0-10 numeric scale, with 0 meaning no fatigue and 10 meaning fatigue as bad as you can imagine. Scores of all 9 items yield global fatigue burden. A lower average global fatigue score indicates milder fatigue and a higher score severe fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength test | Baseline to 17 weeks | Change in handgrip strength measured by a dynamometer in lbs |
| Trail Making Test (TMT) | Baseline to 17 weeks | Change in minutes to complete Trail Making Test (TMT) A and B |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dialysate level of amino acids | Baseline to 17 weeks | How is this measured, are there different values for different aa's (if so each one should be reported separately)? |
| Blood valine beta-amino-isobutyric acid (BAIBA) | Baseline to 17 weeks | Change in beta-amino-isobutyric acid (BAIBA) |
| Plasma level of amino acids | Baseline to 17 weeks | How is this measured, are there different values for different aa's (if so each one should be reported separately)? |
| Blood valine metabolite 3-hydroxyisobutyrate (3-HIB) | Baseline to 17 weeks | Change in 3-hydroxyisobutyrate (3-HIB) levels |
Countries
United States
Contacts
Primary ContactSubrata Debnath, PhD
Outcome results
None listed