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出境医 / 临床实验 / Pilot Study of BCAA on Sleep

Pilot Study of BCAA on Sleep

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
Sleep Disorder Traumatic Brain Injury Dietary Supplement: Branched Chain Amino Acids Dietary Supplement: Rice Protein Dietary Supplement: Microcrystalline Cellulose Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Dietary Supplementation With Branched Chain Amino Acids on Sleep
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2025
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 Name: BCAAs
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 :
  1. Recruitment and retention rates [ Time Frame: 5 weeks ]
    Number enrolled per month, proportion who complete the protocol

  2. Rates of adherence and treatment fidelity [ Time Frame: 5 weeks ]
    Proportion of subjects consuming full doses

  3. Assessment process and patient acceptability [ Time Frame: 5 weeks ]
    Proportion of questionnaires properly completed, actiwatches properly worn, and patient acceptance of protocol


Secondary Outcome Measures :
  1. Change in Insomnia Severity Index (ISI) [ Time Frame: Baseline; after 3 weeks of intervention ]
    Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veteran
  • English Speaking
  • Accessible via phone
  • Sleep problems

Exclusion Criteria:

  • Decisional impairment
  • Nickel allergy
  • Maple syrup urine disease or family history of disease
  • Allergy to sucralose
  • Currently taking BCAAs
Contacts and Locations

Contacts
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Contact: Miranda M Lim, MD, PhD 503-220-8262 ext Ext. 57404 lmir@ohsu.edu

Locations
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United States, Oregon
VA Portland Health Care System Recruiting
Portland, Oregon, United States, 97239
Contact: Miranda M Lim, MD, PhD    503-220-8262 ext 57404    lmir@ohsu.edu   
Sponsors and Collaborators
Portland VA Medical Center
Investigators
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Principal Investigator: Miranda M Lim, MD, PhD Portland VA Medical Center
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019) 		Change in Insomnia Severity Index (ISI) [ Time Frame: Baseline; after 3 weeks of intervention ]
Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of BCAA on Sleep
Official Title  ICMJE A Pilot Study of Dietary Supplementation With Branched Chain Amino Acids on Sleep
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Disorder
  • Traumatic Brain Injury
Intervention  ICMJE
  • 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 Name: BCAAs
  • 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).
  • 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).
Study Arms  ICMJE
  • 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).
    Intervention: Dietary Supplement: Branched Chain Amino Acids
  • 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).
    Intervention: Dietary Supplement: Rice Protein
  • 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).
    Intervention: Dietary Supplement: Microcrystalline Cellulose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2025
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Veteran
  • English Speaking
  • Accessible via phone
  • Sleep problems

Exclusion Criteria:

  • Decisional impairment
  • Nickel allergy
  • Maple syrup urine disease or family history of disease
  • Allergy to sucralose
  • Currently taking BCAAs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Miranda M Lim, MD, PhD 503-220-8262 ext Ext. 57404 lmir@ohsu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990909
Other Study ID Numbers  ICMJE MIRB 4312
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All non-identifiable data will be made available to qualified researchers on request to the study PI.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Information will be sent as soon as is practical and will be available as long as the PI is available.
Access Criteria: Legitimate research agenda, including but not limited to request to double-check presented or published results and novel analyses.
Responsible Party Miranda M Lim, Portland VA Medical Center
Study Sponsor  ICMJE Portland VA Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Miranda M Lim, MD, PhD Portland VA Medical Center
PRS Account Portland VA Medical Center
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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