Pilot Study of BCAA on Sleep

NCT03990909 | Recruiting

• 1 other identifier: MIRB 4312
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Recruitment and retention rates

  Number enrolled per month, proportion who complete the protocol

  5 weeks

• Rates of adherence and treatment fidelity

  Proportion of subjects consuming full doses

  5 weeks

• Assessment process and patient acceptability

  Proportion of questionnaires properly completed, actiwatches properly worn, and patient acceptance of protocol

  5 weeks

Secondary Outcomes (1)

• Change in Insomnia Severity Index (ISI)

  Baseline; after 3 weeks of intervention

Study Arms (3)

BCAAs

EXPERIMENTAL

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).

Dietary Supplement: Branched Chain Amino Acids

Rice Protein

PLACEBO COMPARATOR

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).

Dietary Supplement: Rice Protein

Microcrystalline Cellulose

PLACEBO COMPARATOR

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).

Dietary Supplement: Microcrystalline Cellulose

Interventions

Branched Chain Amino Acids DIETARY_SUPPLEMENT

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).

Also known as: BCAAs

BCAAs

Rice Protein DIETARY_SUPPLEMENT

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).

Rice Protein

Microcrystalline Cellulose DIETARY_SUPPLEMENT

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).

Microcrystalline Cellulose

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Portland VA Medical Center: lead

Study Sites (1)

VA Portland Health Care System

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (1)

• Elliott JE, Keil AT, Mithani S, Gill JM, O'Neil ME, Cohen AS, Lim MM. Dietary Supplementation With Branched Chain Amino Acids to Improve Sleep in Veterans With Traumatic Brain Injury: A Randomized Double-Blind Placebo-Controlled Pilot and Feasibility Trial. Front Syst Neurosci. 2022 May 4;16:854874. doi: 10.3389/fnsys.2022.854874. eCollection 2022.

  PMID: 35602971 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Brain Injuries, Traumatic

Interventions

Amino Acids; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Miranda M Lim, MD, PhD

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miranda M Lim, MD, PhD

CONTACT

503-220-8262; lmir@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: March 1, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Information will be sent as soon as is practical and will be available as long as the PI is available.
• Access Criteria: Legitimate research agenda, including but not limited to request to double-check presented or published results and novel analyses.

Locations

US (1)