Clinical trial NCT00123214: A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation
Official title: Pilot Study: A Dietary Intervention May Decrease the Negative Metabolic and Cognitive Consequences of Chronic Sleep Deprivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Keywords: Diet
Chronic sleep deprivation
Weight
Cognitive impairment
Lipids
Inflammation
Resting metabolic rate
Weight Gain
Percent Body Fat
Hyperlipidemia
Lead sponsor: St Vincent's Hospital
Sponsor class: OTHER
Collaborators: name: Inflammation Research Foundation, Marblehead, MA.
name: NeuroScience, Inc., Osceola, WI.
First posted: 2005-07-22
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Resting Metabolic Rate
Secondary outcomes:
measure: Weight
measure: Percent Body Fat
measure: Waist Circumference
measure: Lipid Profile
measure: C-reactive Protein Levels
measure: Fasting serum glucose
measure: Fasting serum insulin
measure: Urinary neurotransmitter levels
measure: Salivary a.m. cortisol levels
measure: Cognitive scores on: Stroop Test, Hopkins Verbal Learning Test, Trail Making Test, Digit Span, Block Design, Dynamic Visual Acuity, Short Form 36
Other outcomes:
Locations:
city: New York
country: United States
facility: Saint Vincent's Hospital
state: New York
Study officials:
affiliation: Saint Vincent's Hospital, Manhattan
name: Valerie A Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Vincent's Hospital, Manhattan
name: Steven M Lascher, DVM
role: STUDY_DIRECTOR
References: