← Back to Search

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
Accessible via phone
English Speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can be reached by phone.
Select...
I speak English.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment process and patient acceptability
Rates of adherence and treatment fidelity
Recruitment and retention rates
Secondary outcome measures
Change in Insomnia Severity Index (ISI)

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

Find a Location

Who is running the clinical trial?

Portland VA Medical CenterLead Sponsor
41 Previous Clinical Trials
7,065 Total Patients Enrolled
Miranda M Lim, MD, PhDPrincipal Investigator - Portland VA Medical Center
Portland VA Medical Center
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Branched Chain Amino Acids (Amino Acid Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03990909 — N/A
Sleep Disorders Research Study Groups: BCAAs, Rice Protein, Microcrystalline Cellulose
Sleep Disorders Clinical Trial 2023: Branched Chain Amino Acids Highlights & Side Effects. Trial Name: NCT03990909 — N/A
Branched Chain Amino Acids (Amino Acid Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03990909 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings in this experiment that participants can apply for?

"Clinicaltrials.gov documents this medical trial as actively seeking participants; it was first uploaded on March 1, 2019 and recently updated April 4th 2022."

Answered by AI

For what demographics is this trial most suitable?

"300 individuals aged 18 to 89 are being recruited for this study, with the primary focus on sleep disorders and disruptions. To be qualified, veterans must have access to a phone and fluency in English as well as present evidence of sleeping issues."

Answered by AI

Does this clinical investigation include individuals aged 45 or older?

"The age parameters of this clinical trial are those aged 18 or over, and below the age of 89."

Answered by AI

What is the participant quota for this investigation?

"Yes, recent updates on clinicaltrials.gov demonstrate this trial's current recruitment of participants. Initially posted on March 1st 2019 and most recently edited on April 4th 2022, the research is currently in search of 300 individuals from a single site."

Answered by AI
~14 spots leftby Aug 2024