Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2022-02-25
2022-09-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Dietary supplement
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement
1 week of each intervention at bedtime with a 2-week washout period in between interventions
Placebo
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement
1 week of each intervention at bedtime with a 2-week washout period in between interventions
Interventions
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Dietary supplement
1 week of each intervention at bedtime with a 2-week washout period in between interventions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Usual bedtime between 9pm and midnight
* Insomnia for \>6months by ICSD-2 criteria
* Insomnia Severity Index score \>10 and Sleep-onset latency or Waking after sleep onset \>30 minutes
Exclusion Criteria
* Taking chronic medication not on a stable dose for \>1month
* Taking sedating or hypnotic medications
* Have a sleep disorder other than insomnia (like sleep apnea) Adults unable to consent Prisoners Pregnant women Individuals not yet adults
50 Years
ALL
Yes
Sponsors
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Louisiana State University Health Sciences Center in New Orleans
OTHER
Pennington Biomedical Research Center
OTHER
Responsible Party
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Frank Greenway
Professor, Chief Medical Officer
Principal Investigators
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Paula R Brantley, PhD
Role: STUDY_CHAIR
Pennington Biomedical Research Center Institutional Review Board
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Chubon Quality of Life Rating,
Validation of the Insomnia Severity Index
Epworth Sleepiness scale
Pittsburgh Sleep Quality Index
Other Identifiers
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PBRC 2020-039
Identifier Type: -
Identifier Source: org_study_id