Health TrialsbyHealthPanel

Pilot Study of BCAA on Sleep

ConditionsSleep DisorderTraumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorPortland VA Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veteran

English Speaking

Accessible via phone

Sleep problems

Disqualifiers

Decisional impairment

Nickel allergy

Maple syrup urine disease or family history of disease

Allergy to sucralose

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: BCAAsExperimental treatment 1 intervention
Group B: Rice ProteinPlacebo comparator 1 intervention
Group C: Microcrystalline CellulosePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment and retention rates

Number enrolled per month, proportion who complete the protocol

Time frame
5 weeks
2

Rates of adherence and treatment fidelity

Proportion of subjects consuming full doses

Time frame
5 weeks
3

Assessment process and patient acceptability

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

Time frame
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)

Time frame
Baseline; after 3 weeks of intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Portland VA Medical Center

Lead sponsor

Source ClinicalTrials.gov
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