Pilot Study of BCAA on Sleep

Part of paid clinical trials in Portland, Oregon.

Sponsor
Portland VA Medical Center
Study ID
NCT03990909
Status
Recruiting
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Conditions

  • Sleep Disorder
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

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).
  • 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).

Study Details

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.

Key Dates

Start date
Mar 1, 2019
Status verified
Nov 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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).
  • 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).

Primary Outcome Measure

Recruitment and retention rates [ Time Frame: 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Portland Health Care SystemPortlandOregon97239
Miranda M Lim, MD, PhD
[email protected]
503-220-8262

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By research site
VA Portland Health Care System· Portland, OR

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