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

This study has been completed.
Sponsor:
Collaborators:
Inflammation Research Foundation, Marblehead, MA.
NeuroScience, Inc., Osceola, WI.
Information provided by:
St. Vincent's Medical Center
ClinicalTrials.gov Identifier:
NCT00123214
First received: July 19, 2005
Last updated: June 26, 2006
Last verified: July 2005
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00123214     History of Changes
Other Study ID Numbers: IRB 77-04
Study First Received: July 19, 2005
Last Updated: June 26, 2006
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

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014