This study tests whether high-dose branched chain amino acids (BCAAs), which are natural building blocks found in protein, can help people recover faster from concussions. Participants will receive either BCAAs or a placebo (inactive treatment) and be monitored to see if the BCAAs improve recovery symptoms and speed up healing.
Key Objective:The trial is testing whether BCAAs can accelerate concussion recovery and reduce symptoms compared to placebo.
Who to Consider:People who have recently suffered a concussion and want to explore an experimental treatment that might speed their recovery should consider this trial.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAAs) in the treatment of concussion. The aim of the study is to determine whether administration of high-dose BCAAs compared to placebo promotes concussion recovery.
Eligibility Criteria
Inclusion Criteria: 1. Males and females,11 - 23 years of age. 2. Weigh at least 40kg. 3. Meeting concussion criteria for the American Congress of Rehabilitative Medicine. 4. Present within 4 days of injury. 5. Post-menarchal females must have a negative urine pregnancy test and must use an acceptable method of contraception. 6. Informed consent by the participant, or for participants \<18 years old both informed consent by a parent/guardian and child assent. Exclusion Criteria: 1. Evidence of moderate or severe Traumatic Brain Injury (TBI), including Glasgow Coma Scale (GCS) \<13, TBI requiring hospital admission, or TBI requiring neurosurgical intervention. 2. Prior concussion or TBI within 90 days. 3. Known history of maple syrup urine disease or known family history of maple syrup urine disease. 4. Any investigational drug use within 30 days prior to enrollment. 5. Hypersensitivity to any ingredient in the active or placebo products. 6. Participants who are pregnant, planning on be