Sleep Clinical Trial
Official title:
Influence of Diet on Sleep and Cardiovascular Risk
NCT number | NCT04990973 |
Other study ID # | AAAT7042 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2, 2021 |
Est. completion date | October 28, 2022 |
Verified date | April 2023 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to test the impact of diet on sleep and cardiovascular disease risk factors.
Status | Terminated |
Enrollment | 4 |
Est. completion date | October 28, 2022 |
Est. primary completion date | October 28, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Sleep >6 hours/night - Sleep complaints Exclusion Criteria: - Smoking - Allergies to foods - Inability to comply with study procedures - Gastrointestinal disorders |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score on the Pittsburgh Sleep Quality Index (PSQI) | The 19 questions which compose this survey assess sleep quality, latency, duration, habitual sleep efficiency, sleep disturbances, medication use and daytime dysfunction. Scores range 0 (minimum) to 21 (maximum) with >5 indicating poor sleep quality so a lower score is a better outcome. | Baseline and 4 weeks | |
Primary | Arousal index | Arousal index will be actigraphy-derived. | Change from baseline to 4 weeks | |
Primary | Sleep fragmentation index | Sleep fragmentation index will be actigraphy-derived. | Change from baseline to 4 weeks | |
Primary | Sleep duration | Sleep duration will be actigraphy-derived. | Change from baseline to 4 weeks | |
Secondary | Change in Urinary 6-sulfatoxymelatonin level | Urinary 6-sulfatoxymelatonin will be measured by competitive ELISA and urine creatinine by clinical chemistry analyzer. | Change from baseline to 4 weeks | |
Secondary | Change in tryptophan | Tryptophan metabolism | Change from baseline to 4 weeks | |
Secondary | Change in kynurenine | Tryptophan metabolism | Change from baseline to 4 weeks | |
Secondary | Change in serotonin | Neurotransmitter | Change from baseline to 4 weeks |
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