Sleep DisorderNCT03990909
Pilot Study of BCAA on Sleep
A study testing Branched Chain Amino Acids, Rice Protein and Microcrystalline Cellulose in people with Sleep Disorder and Traumatic Brain Injury, run by Portland VA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Sleep Disorder, Traumatic Brain Injury
- What is being tested?
- Branched Chain Amino Acids, Rice Protein and Microcrystalline Cellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- English Speaking
- Accessible via phone
- Sleep problems
Who cannot join
- Decisional impairment
- Nickel allergy
- Maple syrup urine disease or family history of disease
- Allergy to sucralose
- Currently taking BCAAs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Portland Health Care System
Portland, Oregon, 97239
Miranda M Lim, MD, PhD, 503-220-8262 ext. 57404, lmir@ohsu.edu
About this study
Official title: A Pilot Study of Dietary Supplementation With Branched Chain Amino Acids 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.
Read the detailed description
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.
- Conditions
- Sleep Disorder, Traumatic Brain Injury
- Being tested
- Branched Chain Amino Acids, Rice Protein, Microcrystalline Cellulose
- Medical subject headings
- Sleep Wake Disorders, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched Chain Amino AcidsDietary supplement
Also called 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 to21days (42 total drinks).
Rice ProteinDietary 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 CelluloseDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Dietary Supplement: Microcrystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention rates
Number enrolled per month, proportion who complete the protocol
Measured: 5 weeks
Rates of adherence and treatment fidelity
Proportion of subjects consuming full doses
Measured: 5 weeks
Assessment process and patient acceptability
Proportion of questionnaires properly completed, actiwatches properly worn, and patient acceptance of protocol
Measured: 5 weeks
Secondary outcomes (1)
Change in Insomnia Severity Index (ISI)
Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)
Measured: Baseline; after 3 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Mar 2019
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Miranda M Lim, Portland VA Medical Center
- Investigators
- Miranda M Lim, MD, PhD, Principal investigator, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990909
- Sponsor's protocol ID
- MIRB 4312
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2019
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All non-identifiable data will be made available to qualified researchers on request to the study PI.
Publications
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.
PubMed 35602971
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Dietary Supplementation With Branched Chain Amino Acids on Sleep
- ClinicalTrials.gov ID
- NCT03990909
- Acronym / sponsor ID
- MIRB 4312
- Conditions
- Sleep Disorder, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCAAs | Experimental | Dietary Supplement: Branched Chain Amino Acids60 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). |
| Rice Protein | Placebo comparator | Dietary Supplement: Rice ProteinRice 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). |
| Microcrystalline Cellulose | Placebo comparator | Dietary Supplement: Microcrystalline CellulosePlacebo 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). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran
- English Speaking
- Accessible via phone
- Sleep problems
Key exclusion criteria (5 listed)
- Decisional impairment
- Nickel allergy
- Maple syrup urine disease or family history of disease
- Allergy to sucralose
- Currently taking BCAAs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Branched Chain Amino AcidsAlso: BCAAs60 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). | Dietary supplement | BCAAs |
| Rice Protein60 grams of rice protein consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21days (42 total drinks). | Dietary supplement | Rice Protein |
| Microcrystalline Cellulose60 grams of microcrystalline cellulose, consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21days (42 total drinks). | Dietary supplement | Microcrystalline Cellulose |
Primary outcome
Recruitment and retention rates
Time frame: 5 weeks
Number enrolled per month, proportion who complete the protocol
Rates of adherence and treatment fidelity
Time frame: 5 weeks
Proportion of subjects consuming full doses
Assessment process and patient acceptability
Time frame: 5 weeks
Proportion of questionnaires properly completed, actiwatches properly worn, and patient acceptance of protocol
1 secondary outcome
Change in Insomnia Severity Index (ISI)
Time frame: Baseline; after 3 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 35602971Elliott 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.
- Individual participant dataSharing planned: Yes. All non-identifiable data will be made available to qualified researchers on request to the study PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miranda M Lim, MD, PhD principal investigator
Portland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Branched Chain Amino Acids, Rice Protein and Microcrystalline Cellulose in people with Sleep Disorder and Traumatic Brain Injury, run by Portland VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miranda M Lim, MD, PhD (503-220-8262 ext. Ext. 57404, lmir@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rates (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03990909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.