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Amino Acid Supplement

BCAA Supplements for Traumatic Brain Injury

N/A

Recruiting

Led By Miranda M Lim, MD, PhD

Research Sponsored by Portland VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Maple syrup urine disease or family history of disease

Currently taking BCAAs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Summary

This trial is testing whether BCAA supplements can help improve symptoms for people with TBI.

Who is the study for?

This trial is for English-speaking veterans who have sleep issues after a traumatic brain injury. They must be reachable by phone. People with allergies to sucralose or nickel, decisional impairments, maple syrup urine disease (or family history of it), or those currently taking BCAAs cannot participate.

What is being tested?

The study tests the effects of Branched Chain Amino Acids (BCAA) on sleep in individuals with traumatic brain injury. Participants will be randomly assigned to take either BCAA or a placebo made from microcrystalline cellulose or rice protein twice daily for three weeks.

What are the potential side effects?

Potential side effects are not specified for this trial but could include reactions related to the ingredients used in the supplements such as digestive discomfort if one has sensitivities to these compounds.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have maple syrup urine disease or it runs in my family.

Select...

I am currently taking branched-chain amino acids (BCAAs).

Select...

I have difficulty making decisions due to a mental condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment process and patient acceptability

Rates of adherence and treatment fidelity

Recruitment and retention rates

Secondary study objectives

Change in Insomnia Severity Index (ISI)

Side effects data

From 2023 Phase 2 trial • 42 Patients • NCT01860404

38%

Mild (not interfering with daily life) or Moderate (limitation to daily activity)

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Branched Chain Amino Acids (7.5g BID)

Branched Chain Amino Acids (15g BID)

Branched Chain Amino Acids (22.5g BID)

Branched Chain Amino Acids (27g BID)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: BCAAsExperimental Treatment1 Intervention

60 grams of BCAA (2:1:1 ratio of Leucine:Isoleucine:Valine) consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21 days (42 total drinks).

Group II: Rice ProteinPlacebo Group1 Intervention

Rice protein control group: 60 grams of rice protein consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21 days (42 total drinks).

Group III: Microcrystalline CellulosePlacebo Group1 Intervention

Placebo control group: 60 grams of microcrystalline cellulose, consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21 days (42 total drinks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Branched Chain Amino Acids

2019

Completed Phase 2

~60

0 / 3Eligibility criteria met