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

June 26, 2006 updated by: St. Vincent's Medical Center

Pilot Study: A Dietary Intervention May Decrease the Negative Metabolic and Cognitive Consequences of Chronic Sleep Deprivation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Resting Metabolic Rate

Secondary Outcome Measures

Outcome Measure
Lipid Profile
Weight
Fasting serum glucose
Fasting serum insulin
Waist Circumference
Percent Body Fat
C-reactive Protein Levels
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Vincent's Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

July 19, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

June 27, 2006

Last Update Submitted That Met QC Criteria

June 26, 2006

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 77-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Deprivation

Clinical Trials on Controlled Dietary Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe