What this study is
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.
What's being tested
- Branched Chain Amino Acids
Intervention · 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).
- Rice Protein
Intervention · 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
Intervention · 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).
Study details
- Official title
- A Pilot Study of Dietary Supplementation With Branched Chain Amino Acids on Sleep
- Sponsor
- Portland VA Medical Center
- Conditions
- Sleep Disorder · Traumatic Brain Injury
- Enrolling
- 300 people
- Starts
- 2019-03-01
- Est. completion
- 2028-12-01
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 89 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Veteran
- English Speaking
- Accessible via phone
- Sleep problems
You can't join if
- Decisional impairment
- Nickel allergy
- Maple syrup urine disease or family history of disease
- Allergy to sucralose
- Currently taking BCAAs
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVA Portland Health Care System
Portland, Oregon, United States
- Miranda M Lim, MD, PhD · Contact503-220-8262 ext. 57404lmir@ohsu.edu
Recruiting
Study team
Sponsor
Portland VA Medical Center
Study ID MIRB 4312
Principal investigator
Miranda M Lim, MD, PhD
Portland VA Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.