A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation

NCT ID: NCT00123214

Last Updated: 2006-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Sleep Deprivation

Keywords

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Diet Chronic sleep deprivation Weight Cognitive impairment Lipids Inflammation Resting metabolic rate Weight Gain Percent Body Fat Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Controlled Dietary Intervention

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inflammation Research Foundation, Marblehead, MA.

UNKNOWN

Sponsor Role collaborator

NeuroScience, Inc., Osceola, WI.

INDUSTRY

Sponsor Role collaborator

St. Vincent's Medical Center

UNKNOWN

Sponsor Role lead

Principal Investigators

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Valerie A Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Vincent's Hospital, Manhattan

Steven M Lascher, DVM

Role: STUDY_DIRECTOR

Saint Vincent's Hospital, Manhattan

Locations

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Saint Vincent's Hospital

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.svcmc.org

Saint Vincent's Hospital

Other Identifiers

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IRB 77-04

Identifier Type: -

Identifier Source: org_study_id