Sleep DeprivationNCT00123214
A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation
A study of Sleep Deprivation, run by St. Vincent's Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Apr 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Febrile illness
- Smoker
- Food allergies of any kind
- Taking any prescription medication
- History of diabetes or thyroid dysfunction
- Body mass index (BMI)>30
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: A Dietary Intervention May Decrease the Negative Metabolic and Cognitive Consequences of Chronic Sleep Deprivation
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.
Read the 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.
- Conditions
- Sleep Deprivation
- Being tested
- Controlled Dietary Intervention
- Keywords
- Diet, Chronic sleep deprivation, Weight, Cognitive impairment, Lipids, Inflammation, Resting metabolic rate, Weight Gain, Percent Body Fat, Hyperlipidemia
- Medical subject headings
- Sleep Deprivation, Body Weight, Cognitive Dysfunction, Inflammation, Weight Gain, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Dietary InterventionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Metabolic Rate
Secondary outcomes (10)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startSep 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- St. Vincent's Medical Center
- Collaborators
- Inflammation Research Foundation, Marblehead, MA., NeuroScience, Inc., Osceola, WI.
- Investigators
- Valerie A Jones, MD, Principal investigator, Saint Vincent's Hospital, ManhattanSteven M Lascher, DVM, Study director, Saint Vincent's Hospital, Manhattan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123214
- Sponsor's protocol ID
- IRB 77-04
- Status last verified
- Jul 2005
- First submitted
- 19 Jul 2005
- Last updated
- 27 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: A Dietary Intervention May Decrease the Negative Metabolic and Cognitive Consequences of Chronic Sleep Deprivation
- ClinicalTrials.gov ID
- NCT00123214
- Acronym / sponsor ID
- IRB 77-04
- Conditions
- Sleep Deprivation
- Keywords
- Diet, Chronic sleep deprivation, Weight, Cognitive impairment, Lipids, Inflammation, Resting metabolic rate, Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- St. Vincent's Medical Center
- Collaborators
- Inflammation Research Foundation, Marblehead, MA., NeuroScience, Inc., Osceola, WI.
- Study start
- Sep 2004
- Study completion
- Apr 2005
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Febrile illness
- Smoker
- Food allergies of any kind
- Taking any prescription medication
- History of diabetes or thyroid dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled Dietary Intervention | Drug | – |
Primary outcome
Resting Metabolic Rate
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2006.
- Saint Vincent's HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie A Jones, MD principal investigator
Saint Vincent's Hospital, Manhattan
Steven M Lascher, DVM study director
Saint Vincent's Hospital, Manhattan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Sleep Deprivation, run by St. Vincent's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Metabolic Rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2006; AzTrials last refreshed its copy on 28 Oct 2026.