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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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
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
7,042 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion is too general to summarize without more context. Can you provide additional information or specify the type of sleep problems being referred to?I have maple syrup urine disease or it runs in my family.I am currently taking branched-chain amino acids (BCAAs).I have difficulty making decisions due to a mental condition.This criterion does not provide enough context for me to summarize it effectively. Can you please provide more information or clarify the context?You are allergic to nickel.I can be reached by phone.I speak English.You are allergic to sucralose.
Research Study Groups:
This trial has the following groups:- Group 1: BCAAs
- Group 2: Rice Protein
- Group 3: Microcrystalline Cellulose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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