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

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123214
• Other study ID #: IRB 77-04
• Status: Completed
• Phase: N/A
• First received: July 19, 2005
• Last updated: June 26, 2006
• Start date: September 2004
• Est. completion date: April 2005

Study information

• Verified date: July 2005
• Source: St. Vincent's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Drug:
• Controlled Dietary Intervention

Locations

Country	Name	City	State
United States	Saint Vincent's Hospital	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
St. Vincent's Medical Center	Inflammation Research Foundation, Marblehead, MA., NeuroScience, Inc., Osceola, WI.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting Metabolic Rate
Secondary	Weight
Secondary	Percent Body Fat
Secondary	Waist Circumference
Secondary	Lipid Profile
Secondary	C-reactive Protein Levels
Secondary	Fasting serum glucose
Secondary	Fasting serum insulin
Secondary	Urinary neurotransmitter levels
Secondary	Salivary a.m. cortisol levels
Secondary	Cognitive scores on: Stroop Test, Hopkins Verbal Learning Test, Trail Making Test, Digit Span, Block Design, Dynamic Visual Acuity, Short Form 36