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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00123214 |
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Date of registration:
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19/07/2005 |
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Primary sponsor: |
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Public title:
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A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation
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Scientific title:
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Pilot Study: A Dietary Intervention May Decrease the Negative Metabolic and Cognitive Consequences of Chronic Sleep Deprivation |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00123214 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Steven M Lascher, DVM |
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Address:
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Telephone:
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Email:
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Affiliation:
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Saint Vincent's Hospital, Manhattan |
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Name:
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Valerie A Jones, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Saint Vincent's Hospital, Manhattan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Medical resident in good standing at Cabrini Medical Center or Saint Vincent's
Hospital, NY.
- Must be scheduled for two consecutive weeks of night shift work.
Exclusion Criteria:
- Febrile illness
- Smoker
- Food allergies of any kind
- Taking any prescription medication
- History of diabetes or thyroid dysfunction
- Body mass index (BMI)>30
- Pregnancy
Age minimum:
25 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sleep Deprivation
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Intervention(s)
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Drug: Controlled Dietary Intervention
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Primary Outcome(s)
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Resting Metabolic Rate
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Secondary Outcome(s)
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C-reactive Protein Levels
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Cognitive scores on: Stroop Test, Hopkins Verbal Learning Test, Trail Making Test, Digit Span, Block Design, Dynamic Visual Acuity, Short Form 36
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Fasting serum glucose
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Fasting serum insulin
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Lipid Profile
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Percent Body Fat
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Salivary a.m. cortisol levels
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Urinary neurotransmitter levels
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Waist Circumference
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Weight
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Secondary ID(s)
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IRB 77-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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