Pilot Study of BCAA on Sleep
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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). |
Dietary Supplement: 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).
Other Names:
|
| 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). |
Dietary Supplement: 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).
|
| 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). |
Dietary Supplement: 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).
|
Outcome Measures
Primary Outcome Measures
- Recruitment and retention rates [5 weeks]
Number enrolled per month, proportion who complete the protocol
- Rates of adherence and treatment fidelity [5 weeks]
Proportion of subjects consuming full doses
- Assessment process and patient acceptability [5 weeks]
Proportion of questionnaires properly completed, actiwatches properly worn, and patient acceptance of protocol
Secondary Outcome Measures
- Change in Insomnia Severity Index (ISI) [Baseline; after 3 weeks of intervention]
Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Veteran
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English Speaking
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Accessible via phone
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Sleep problems
Exclusion Criteria:
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Decisional impairment
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Nickel allergy
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Maple syrup urine disease or family history of disease
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Allergy to sucralose
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Currently taking BCAAs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Portland Health Care System | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Portland VA Medical Center
Investigators
- Principal Investigator: Miranda M Lim, MD, PhD, Portland VA Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MIRB 4312