BCAA Supplementation for Concussion

NCT ID: NCT01860404

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2023-01-31

Brief Summary

This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAA's) in the treatment of concussion. The aim of the study is to determine whether, compared to placebo treatment, administration of BCAA's, at one or more doses, after a concussion improves neurocognitive recovery at one or more time-periods post concussion.

Detailed Description

Annually, between 100,000 to 140,000 children present to the emergency department for concussion in the United States.1 The Centers for Disease Control now estimates that 1.6 - 3.8 million sports related concussions occur each year in the United States. A large proportion of these patients have enduring cognitive and neurobehavioral problems. Concussion is a heterogeneous insult to the brain that precipitates a complex pathophysiological process that can result in a cascade of deleterious side effects. At present, there are no proven therapies to mitigate or prevent the neurocognitive and neurobehavioral consequences of concussions. The limbic hippocampus, a brain structure crucial for learning and memory, is often damaged in concussion. In preclinical studies in our laboratory, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated that only the concentrations of the three BCAA's (valine, isoleucine, and leucine) were significantly altered (reduced) after injury. When these brain-injured animals received dietary supplementation with BCAA's, the concentrations of these amino acids were restored in the injured hippocampus and the injured animals demonstrated significant cognitive improvement to levels comparable to those obtained in non-injured control animals. In light of these results and the increasing awareness and morbidity associated with concussion, we are proposing a pilot therapeutic exploratory clinical trial to determine the effects of BCAA's in reducing the neurocognitive side effects of concussion injury.

Conditions

Brain Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo will be administered orally twice daily for 21 days

Group Type: PLACEBO_COMPARATOR

Placebo solution

Intervention Type: DRUG

The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.

Branched Chain Amino Acids (27g BID)

27 grams of BCAA's will be administered twice-daily for 21 days

Group Type: EXPERIMENTAL

Branched Chain Amino Acids

Intervention Type: DRUG

The three BCAA's will be combined together and dissolved in a flavored solution.

Branched Chain Amino Acids (22.5g BID)

22.5 grams of BCAA's will be administered twice-daily for 21 days

Group Type: EXPERIMENTAL

Branched Chain Amino Acids

Intervention Type: DRUG

The three BCAA's will be combined together and dissolved in a flavored solution.

Branched Chain Amino Acids (15g BID)

15 grams of BCAA's will be administered twice-daily for 21 days

Group Type: EXPERIMENTAL

Branched Chain Amino Acids

Intervention Type: DRUG

The three BCAA's will be combined together and dissolved in a flavored solution.

Branched Chain Amino Acids (7.5g BID)

7.5 grams of BCAA's will be administered twice-daily for 21 days

Group Type: EXPERIMENTAL

Branched Chain Amino Acids

Intervention Type: DRUG

The three BCAA's will be combined together and dissolved in a flavored solution.

Interventions

Branched Chain Amino Acids

The three BCAA's will be combined together and dissolved in a flavored solution.

Intervention Type: DRUG

Placebo solution

The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males and females, ages 11 - 34 years, of any race.

2. Subjects who had a concussion, as diagnosed by a qualified physician, within 72 hours prior to enrollment.

3. Ability to have daily email and internet access.

4. Females must have a negative urine pregnancy test and must use an acceptable method of contraception.

5. Subjects must, in the opinion of the referring physician, have the capacity to provide informed consent.

6. Informed consent by the subject, or for subjects <18 years old both informed consent by a parent/guardian and child assent.

Exclusion Criteria

1. Witnessed seizure at the time of injury or penetrating head injury.

2. Prior concussion or TBI within 90 days.

3. Concussion or TBI severe enough to require admission to an intensive care unit for observation or intervention.

4. Previous history of TBI or concussion requiring admission to the hospital, disabling stroke, epilepsy, brain tumor, neurodegenerative condition, or psychiatric disease.

5. Subjects taking neurological or psychoactive medications as a regular daily prescription medication.

6. Known history of maple syrup urine disease or known family history of maple syrup urine disease.

7. Any investigational drug use within 30 days prior to enrollment.

8. Allergy to Food, Drug, and Cosmetic (FD&C) Red #40 (red dye 40) or Sucralose.

9. Lactating females.

10. Parents/guardians or subjects who, in the opinion of the investigators, may be non-compliant with study schedules or procedures.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Dana Foundation

OTHER

Sponsor Role: collaborator

Main Line Health

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Pennsylvania Department of Health

OTHER_GOV

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Sage R Myers

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sage Myers, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

Cole JT, Mitala CM, Kundu S, Verma A, Elkind JA, Nissim I, Cohen AS. Dietary branched chain amino acids ameliorate injury-induced cognitive impairment. Proc Natl Acad Sci U S A. 2010 Jan 5;107(1):366-71. doi: 10.1073/pnas.0910280107. Epub 2009 Dec 7.

Reference Type: BACKGROUND

PMID: 19995960 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

13-010227

Identifier Type: -

Identifier Source: org_study_id