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COMPLETED
NCT04603443
NA

SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Branched Chain Amino Acids

Isoleucine, Leucine, and Valine, 10g BID x 12 weeks

DIETARY_SUPPLEMENT

Branched Chain Amino Acids

Isoleucine, Leucine, and Valine, 20g BID x 12 weeks

DIETARY_SUPPLEMENT

Branched Chain Amino Acids

Isoleucine, Leucine, and Valine, 30g BID x 12 weeks

DIETARY_SUPPLEMENT

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