Recruiting

BCAA

Sponsor:

Portland VA Medical Center

Code:

NCT03990909

Conditions

Sleep Disorder

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Branched Chain Amino Acids

Rice Protein

Microcrystalline Cellulose

Study Details

Brief summary:

Individuals will be recruited from the VA Portland Health Care System and the community affiliated with Oregon Health \& Science University. Traumatic brain injury status will be assessed as a contributing factor. Subjects will be randomized to one of 3 groups (BCAA or one of 2 placebo conditions) and instructed to consume study product twice daily for 21 days. Self-report questionnaires, wrist actigraphy, pressure pain testing, and cognitive function will be assessed pre and post the experimental period.

Conditions

Sleep Disorder

Traumatic Brain Injury

Study ID

NCT03990909

Start date

Mar 1, 2019

Status verified date

Nov, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veteran
  • English Speaking
  • Accessible via phone
  • Sleep problems

Exclusion Criteria:

  • Decisional impairment
  • Nickel allergy
  • Maple syrup urine disease or family history of disease
  • Allergy to sucralose
  • Currently taking BCAAs

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BCAAs

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).

placebo comparator: Rice Protein

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).

placebo comparator: Microcrystalline Cellulose

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).

Interventions

Branched Chain Amino Acids

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 to21days (42 total drinks).

Rice Protein

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

Microcrystalline Cellulose

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

Primary outcome measure

  • Recruitment and retention rates [ Time Frame: 5 weeks ]
  • Rates of adherence and treatment fidelity [ Time Frame: 5 weeks ]
  • Assessment process and patient acceptability [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Miranda M Lim, MD, PhD

503-220-8262lmir@ohsu.edu

Locations

VA Portland Health Care System

Recruiting

Portland, Oregon, United States, 97239

Contacts

Miranda M Lim, MD, PhD

503-220-8262lmir@ohsu.edu

More Information

Sponsor

Portland VA Medical Center

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Portland VA Medical Center on 2025-11-14.