Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03990909 |
| Other study ID # |
MIRB 4312 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
August 1, 2025 |
Study information
| Verified date |
April 2022 |
| Source |
Portland VA Medical Center |
| Contact |
Miranda M Lim, MD, PhD |
| Phone |
503-220-8262 |
| Email |
lmir[@]ohsu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Individuals will be recruited from the VA Portland Health Care System and the community
affiliated with Oregon Health & Science University. Traumatic brain injury status will be
assessed as a contributing factor. Subjects will be randomized to one of 3 groups (BCAA or
one of 2 placebo conditions) and instructed to consume study product twice daily for 21 days.
Self-report questionnaires, wrist actigraphy, pressure pain testing, and cognitive function
will be assessed pre and post the experimental period.
Description:
The goal of this proposal is to explore the feasibility of, and potential for, dietary
supplementation with branched chain amino acids (BCAAs) to effect sleep quality and cognitive
function in Veterans. The BCAAs (Leucine, Isoleucine, and Valine) cannot be synthesized
endogenously (i.e., they must be obtained through the diet) and are the precursors to >50% of
de novo glutamate and GABA synthesis in the brain, which are the primary excitatory and
inhibitory neurotransmitters, respectively. Preclinical evidence strongly suggests that
dietary BCAA supplementation restores normal sleep-wake patterns and cognitive function
following TBI through a restoration in the global cortical excitation:inhibition ratio. BCAA
supplementation has been studied extensively in healthy humans and in a variety of disease
states, including following TBI, but not yet in Veterans in the chronic phase of recovery
from TBI. BCAAs are a commercially available dietary supplement and very well tolerated with
minimal side-effects.
Subjects will be randomized in a double-blind fashion through the VA Research Pharmacy to one
of three groups: 1) BCAA; 60 g/day in two 30 g doses, 2) rice protein; 60 g/day in two 30 g
doses, and 3) placebo; 60 g microcrystalline cellulose in two 30 g doses. BCAA and placebo
will be prepared by the VA Research Pharmacy and dispensed in a blinded fashion to Veterans
after demonstrating informed consent. Following a ~4-week period of baseline, Veterans will
be instructed to consume study product after waking and ~6 hours later, on an empty stomach
for a period of up to 21-days. Self-report questionnaires assessing sleep quality, cognitive
function, trauma-related symptom severity, and other measures of mental and physical
well-being will be administered before and after the experimental period. Wrist actigraphy
will be continuously collected over the baseline and the experimental period. Cognitive
function will be assessed before and after the experimental period using an established
battery of neuropsychological tests (i.e., selected tests from WAIS, D-KEFS, HVLT, COWAT,
among others. Pressure pain testing will be conducted before and after the experimental
period.
