A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation - Full Text View

Sponsors and Collaborators:	St. Vincent's Medical Center Inflammation Research Foundation, Marblehead, MA. NeuroScience, Inc., Osceola, WI.
Information provided by:	St. Vincent's Medical Center
ClinicalTrials.gov Identifier:	NCT00123214

Purpose

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.

Condition	Intervention
Sleep Deprivation	Drug: Controlled Dietary Intervention

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Pilot Study: A Dietary Intervention May Decrease the Negative Metabolic and Cognitive Consequences of Chronic Sleep Deprivation

Further study details as provided by St. Vincent's Medical Center:

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

Estimated Enrollment:	18
Study Start Date:	September 2004
Estimated Study Completion Date:	April 2005

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.

Eligibility

Ages Eligible for Study:	25 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123214

Locations

United States, New York
Saint Vincent's Hospital
New York, New York, United States, 10011

Sponsors and Collaborators

St. Vincent's Medical Center

Inflammation Research Foundation, Marblehead, MA.

NeuroScience, Inc., Osceola, WI.

Investigators

Principal Investigator:	Valerie A Jones, MD	Saint Vincent's Hospital, Manhattan
Study Director:	Steven M Lascher, DVM	Saint Vincent's Hospital, Manhattan

More Information

Saint Vincent's Hospital This link exits the ClinicalTrials.gov site

Study ID Numbers:	IRB 77-04
Study First Received:	July 19, 2005
Last Updated:	June 26, 2006
ClinicalTrials.gov Identifier:	NCT00123214
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Vincent's Medical Center:

Diet
Chronic sleep deprivation
Weight
Cognitive impairment
Lipids

Inflammation
Resting metabolic rate
Weight Gain
Percent Body Fat
Hyperlipidemia

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Hyperlipidemias
Mental Disorders
Neurologic Manifestations

Sleep Disorders
Dyssomnias
Weight Gain
Sleep Deprivation
Inflammation

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009