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SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI
Sponsor: VA Office of Research and Development
Summary
The most persistent and disabling postconcussive symptoms following mild traumatic brain injury (mTBI) are sleep disturbances and cognitive dysfunction, with few tractable interventions currently available. Here, a novel therapy will be tested consisting of dietary supplementation with branched chain amino acids (BCAA), based on the study team's previous preclinical work showing restoration of glutamate neurotransmitter balance in sleep and memory circuits. Supplementation with Amino acid Rehabilitative Therapy in TBI (SmART-TBI) is a randomized, placebo-controlled, double-blinded, exploratory clinical trial of BCAA intended to establish the feasibility, acceptability, and limited efficacy of long-term BCAA to improve sleep and cognition in Veterans with mTBI. These results will inform the optimal study design of a future, full-scale randomized controlled trial, including the identification of the proper dose and duration of BCAA to improve sleep and the potential subpopulations of Veterans with mTBI that may benefit the most.
Official title: Supplementation With Amino Acid Rehabilitative Therapy in TBI (SmART-TBI): A Randomized Placebo-Controlled Trial to Improve Sleep
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
159
Start Date
2021-06-01
Completion Date
2025-09-30
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
Branched Chain Amino Acids
Isoleucine, Leucine, and Valine, 10g BID x 12 weeks
Branched Chain Amino Acids
Isoleucine, Leucine, and Valine, 20g BID x 12 weeks
Branched Chain Amino Acids
Isoleucine, Leucine, and Valine, 30g BID x 12 weeks
Protein Control
Protein placebo control - all amino acids except for BCAA, 10g BID x 12 weeks
Locations (1)
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States