A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation
This study has been completed.
Sponsor:
St. Vincent's Medical Center
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Resource links provided by NLM:
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 |
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
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 May 16, 2013