A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlled Dietary Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Sleep Deprivation focused on measuring Diet, Chronic sleep deprivation, Weight, Cognitive impairment, Lipids, Inflammation, Resting metabolic rate, Weight Gain, Percent Body Fat, Hyperlipidemia
Eligibility Criteria
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
Sites / Locations
- Saint Vincent's Hospital
Outcomes
Primary Outcome Measures
Resting Metabolic Rate
Secondary Outcome Measures
Weight
Percent Body Fat
Waist Circumference
Lipid Profile
C-reactive Protein Levels
Fasting serum glucose
Fasting serum insulin
Urinary neurotransmitter levels
Salivary a.m. cortisol levels
Cognitive scores on: Stroop Test, Hopkins Verbal Learning Test, Trail Making Test, Digit Span, Block Design, Dynamic Visual Acuity, Short Form 36
Full Information
NCT ID
NCT00123214
First Posted
July 19, 2005
Last Updated
June 26, 2006
Sponsor
St. Vincent's Medical Center
Collaborators
Inflammation Research Foundation, Marblehead, MA., NeuroScience, Inc., Osceola, WI.
1. Study Identification
Unique Protocol Identification Number
NCT00123214
Brief Title
A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation
Official Title
Pilot Study: A Dietary Intervention May Decrease the Negative Metabolic and Cognitive Consequences of Chronic Sleep Deprivation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
St. Vincent's Medical Center
Collaborators
Inflammation Research Foundation, Marblehead, MA., NeuroScience, Inc., Osceola, WI.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether or not a low calorie, low glycemic index diet with omega-3 fatty acid supplements can prevent some of the negative consequences of sleep deprivation.
Detailed Description
This pilot study included 18 medical residents at two academic medical centers in New York City. All residents who participated in the study were assigned to work a night shift schedule for two weeks, and began the study on the morning prior to their first evening shift. The study subjects were randomly assigned to one of two groups:
Intervention diet -- consisting of 40% carbohydrates, 30% protein, and 30% fat with 2.4g of long chain fatty acid supplements (n=9) Total calories for males was 1600/day, and 1200/day for females
Control group -- ad lib diet.
Main outcome measures included:
weight
resting metabolic rate
percent body fat
lipid profile
CRP
fasting glucose and insulin levels
urinary neurotransmitter levels
salivary cortisol
six cognitive tests of memory, attention, and executive function.
Subjects were tested on day 1, 7, and 14 of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
Diet, Chronic sleep deprivation, Weight, Cognitive impairment, Lipids, Inflammation, Resting metabolic rate, Weight Gain, Percent Body Fat, Hyperlipidemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Controlled Dietary Intervention
Primary Outcome Measure Information:
Title
Resting Metabolic Rate
Secondary Outcome Measure Information:
Title
Weight
Title
Percent Body Fat
Title
Waist Circumference
Title
Lipid Profile
Title
C-reactive Protein Levels
Title
Fasting serum glucose
Title
Fasting serum insulin
Title
Urinary neurotransmitter levels
Title
Salivary a.m. cortisol levels
Title
Cognitive scores on: Stroop Test, Hopkins Verbal Learning Test, Trail Making Test, Digit Span, Block Design, Dynamic Visual Acuity, Short Form 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie A Jones, MD
Organizational Affiliation
Saint Vincent's Hospital, Manhattan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven M Lascher, DVM
Organizational Affiliation
Saint Vincent's Hospital, Manhattan
Official's Role
Study Director
Facility Information:
Facility Name
Saint Vincent's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.svcmc.org
Description
Saint Vincent's Hospital
Learn more about this trial
A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation
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