BCAA Supplementation for TBI
(SmART-TBI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a dietary supplement called BCAA to help Veterans with mild traumatic brain injury improve their sleep and cognitive function. BCAA helps balance a brain chemical important for these functions. The study aims to see if BCAA is effective and safe over time. BCAA supplementation has shown promise in improving outcomes for severe TBI, but its benefits for mild TBI are not yet well-established.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are already using a sleep intervention, it must be stable and not change during the study.
Is BCAA supplementation safe for humans?
In a study on amyotrophic lateral sclerosis (ALS) patients, BCAA supplementation was linked to higher mortality, leading to the trial's early termination. However, BCAAs are generally considered safe in other contexts, such as muscle protein balance and certain critical conditions, but their safety in traumatic brain injury (TBI) specifically is not well-documented.12345
How is the BCAA treatment for TBI different from other treatments?
The BCAA treatment for TBI is unique because it focuses on supplementing branched-chain amino acids, which are crucial for energy production and neurotransmitter synthesis in the brain. This approach aims to address the decreased levels of BCAAs observed in TBI patients, potentially improving cognitive recovery and reducing TBI pathology.35678
What evidence supports the effectiveness of BCAA supplementation as a treatment for traumatic brain injury (TBI)?
Research suggests that branched-chain amino acids (BCAAs) may help improve cognitive recovery in patients with severe TBI and could be neuroprotective, potentially reducing the severity of injury if taken before TBI. BCAAs are involved in energy production and neurotransmitter synthesis, which are important for brain function and recovery.357910
Who Is on the Research Team?
Miranda M Lim, MD PhD
Principal Investigator
VA Portland Health Care System, Portland, OR
Are You a Good Fit for This Trial?
This trial is for English-speaking Veterans aged 18-65 with mild traumatic brain injury (mTBI) who experience sleep disturbances or cognitive issues. Participants must not be pregnant, have maple syrup urine disease, work night shifts, start other sleep treatments during the study, or currently use branched chain amino acids.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BCAA or placebo supplementation to assess feasibility, acceptability, and limited efficacy on sleep disturbances
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Branched Chain Amino Acids
Branched Chain Amino Acids is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Children's Hospital of Philadelphia
Collaborator
Oregon Health and Science University
Collaborator