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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00123214
Other study ID # IRB 77-04
Secondary ID
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
Est. primary completion date
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


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
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