- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730742
Sleep Deprivation's Regulation of Immune System Function and Behavior (SS)
November 15, 2012 updated by: Uppsala University
The Role of Sleep Deprivation in the Regulation of Immune System, Neuroendocrine Responses, and Behavioral Measures.
The study proposes to investigate whether sleep deprivation will affect a variety of measures, including hormones, immune system functioning, and behaviors related to food intake and hunger.
It is predicted that sleep deprivation will affect circulating neutrophil activity, and do so via affects on DNA methylation.
It is also predicted that sleep deprivation will up-regulate ghrelin, and down-regulate circulating oxytocin.
Finally, it is predicted that sleep deprivation will increase participants' tendencies to pick larger portions of food, and also increase their tendency to purchase foods that are more caloric in a mock supermarket scenario.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Uppsala, Sweden, 75105
- Uppsala University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Age 18-35y
- Healthy (self-reported) and not on medication
- Non-smoking
- Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported)
Exclusion Criteria:
- Major illness
- Taking any serious medications
- Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
- Any dietary issues with the food items provided
- A history of endocrine or psychiatric disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sleep deprivation
Total sleep deprivation: participants were required to stay up for the entire night before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed
|
Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume
After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).
After a night of wakefulness, a blood sample was taken to assess the level and efficacy of circulating neutrophils, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as oxytocin and ghrelin
|
|
Experimental: Sleep
Sleep: participants had an 8-h sleep opportunity before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed
|
Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume
After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).
After a night of wakefulness, a blood sample was taken to assess the level and efficacy of circulating neutrophils, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as oxytocin and ghrelin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neutrophil phagocytotic function production
Time Frame: Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention)
|
This project is designed to test the inflammatory capacity of circulating neutrophils. It also aims to investigate if any changes in neutrophil efficacy are governed by alterations in DNA methylation. Measured during 36 hours (at 1930 day 1, 0730 and 1930 day 2, 0730 day 3) |
Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Portion Size Task
Time Frame: Change in selected portion size from baseline to 1 hr after consuming a caloric preload
|
Participants will be evaluated on their tendency to choose larger or smaller portions of a variety of meal items on a computer screen.
This will be conducted both following sleep deprivation and sleep, and changes over the hour will be compared between these conditions.
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Change in selected portion size from baseline to 1 hr after consuming a caloric preload
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|
Neuro-economics task
Time Frame: Change in purchasing behaviour 1 hr after consuming a caloric preload
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Participants will be evaluated on their purchasing behavior with regards to high-calorie and low-calorie food items in a mock supermarket scenario following sleep and sleep deprivation.
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Change in purchasing behaviour 1 hr after consuming a caloric preload
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|
Circulating hormone levels
Time Frame: Change in circulating hormone levels from baseline (ie. 1930 - before sleep intervention) to 12hr later (0730 after the nighttime intervention)
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Participants will have their circulating hormone levels taken and analyzed, including ghrelin and oxytocin, to determine if sleep deprivation alters hormone levels related primarily to obesity or weight gain
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Change in circulating hormone levels from baseline (ie. 1930 - before sleep intervention) to 12hr later (0730 after the nighttime intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Benedict, PhD, dept. of Neuroscience, Uppsala University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nilsson EK, Ernst B, Voisin S, Almen MS, Benedict C, Mwinyi J, Fredriksson R, Schultes B, Schioth HB. Roux-en Y gastric bypass surgery induces genome-wide promoter-specific changes in DNA methylation in whole blood of obese patients. PLoS One. 2015 Feb 24;10(2):e0115186. doi: 10.1371/journal.pone.0115186. eCollection 2015.
- Hogenkamp PS, Nilsson E, Nilsson VC, Chapman CD, Vogel H, Lundberg LS, Zarei S, Cedernaes J, Rangtell FH, Broman JE, Dickson SL, Brunstrom JM, Benedict C, Schioth HB. Acute sleep deprivation increases portion size and affects food choice in young men. Psychoneuroendocrinology. 2013 Sep;38(9):1668-74. doi: 10.1016/j.psyneuen.2013.01.012. Epub 2013 Feb 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Anticipated)
March 1, 2013
Study Completion (Anticipated)
March 1, 2013
Study Registration Dates
First Submitted
October 11, 2012
First Submitted That Met QC Criteria
November 15, 2012
First Posted (Estimate)
November 21, 2012
Study Record Updates
Last Update Posted (Estimate)
November 21, 2012
Last Update Submitted That Met QC Criteria
November 15, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 192837465
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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