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NCT Number: NCT03990909

Pilot Study of BCAA on Sleep

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Miranda M Lim, MD, PhD

CONTACT

[email protected]

503-220-8262 ext. 57404

About this study

The goal of this proposal is to explore the feasibility of, and potential for, dietary supplementation with branched chain amino acids (BCAAs) to effect sleep quality and cognitive function in Veterans. The BCAAs (Leucine, Isoleucine, and Valine) cannot be synthesized endogenously (i.e., they must be obtained through the diet) and are the precursors to >50% of de novo glutamate and GABA synthesis in the brain, which are the primary excitatory and inhibitory neurotransmitters, respectively. Preclinical evidence strongly suggests that dietary BCAA supplementation restores normal sleep-wake patterns and cognitive function following TBI through a restoration in the global cortical excitation:inhibition ratio. BCAA supplementation has been studied extensively in healthy humans and in a variety of disease states, including following TBI, but not yet in Veterans in the chronic phase of recovery from TBI. BCAAs are a commercially available dietary supplement and very well tolerated with minimal side-effects.

Subjects will be randomized in a double-blind fashion through the VA Research Pharmacy to one of three groups: 1) BCAA; 60 g/day in two 30 g doses, 2) rice protein; 60 g/day in two 30 g doses, and 3) placebo; 60 g microcrystalline cellulose in two 30 g doses. BCAA and placebo will be prepared by the VA Research Pharmacy and dispensed in a blinded fashion to Veterans after demonstrating informed consent. Following a ~4-week period of baseline, Veterans will be instructed to consume study product after waking and ~6 hours later, on an empty stomach for a period of up to 21-days. Self-report questionnaires assessing sleep quality, cognitive function, trauma-related symptom severity, and other measures of mental and physical well-being will be administered before and after the experimental period. Wrist actigraphy will be continuously collected over the baseline and the experimental period. Cognitive function will be assessed before and after the experimental period using an established battery of neuropsychological tests (i.e., selected tests from WAIS, D-KEFS, HVLT, COWAT, among others. Pressure pain testing will be conducted before and after the experimental period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: 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).

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).

Primary outcomes

  1. Recruitment and retention rates

    Time frame: 5 weeks

    Number enrolled per month, proportion who complete the protocol

  2. Rates of adherence and treatment fidelity

    Time frame: 5 weeks

    Proportion of subjects consuming full doses

  3. Assessment process and patient acceptability

    Time frame: 5 weeks

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

Secondary outcomes

  1. Change in Insomnia Severity Index (ISI)

    Time frame: Baseline; after 3 weeks of intervention

    Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)

Study contacts

Contact information is provided by the study sponsor or research team.

Miranda M Lim, MD, PhD

CONTACT

[email protected]

503-220-8262 ext. Ext. 57404

Sponsors and collaborators

Lead sponsor

Portland VA Medical Center

Fed

Registry information

Official study title

A Pilot Study of Dietary Supplementation With Branched Chain Amino Acids on Sleep

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2019
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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