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Sleep Deprivation's Regulation of Immune System Function and Behavior (SS)

Primary Purpose

Sleep Deprivation, Sleep

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Neuroeconomics task
Portion Size Task
Blood sample
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Deprivation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Uppsala University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sleep deprivation

Sleep

Arm Description

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

Sleep: participants had an 8-h sleep opportunity before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed

Outcomes

Primary Outcome Measures

Neutrophil phagocytotic function production
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)

Secondary Outcome Measures

Portion Size Task
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.
Neuro-economics task
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.
Circulating hormone levels
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

Full Information

First Posted
October 11, 2012
Last Updated
November 15, 2012
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT01730742
Brief Title
Sleep Deprivation's Regulation of Immune System Function and Behavior
Acronym
SS
Official Title
The Role of Sleep Deprivation in the Regulation of Immune System, Neuroendocrine Responses, and Behavioral Measures.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Sleep

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep deprivation
Arm Type
Experimental
Arm Description
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
Arm Title
Sleep
Arm Type
Experimental
Arm Description
Sleep: participants had an 8-h sleep opportunity before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed
Intervention Type
Behavioral
Intervention Name(s)
Neuroeconomics task
Intervention Description
After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).
Intervention Type
Behavioral
Intervention Name(s)
Portion Size Task
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Description
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
Primary Outcome Measure Information:
Title
Neutrophil phagocytotic function production
Description
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)
Time Frame
Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention)
Secondary Outcome Measure Information:
Title
Portion Size Task
Description
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.
Time Frame
Change in selected portion size from baseline to 1 hr after consuming a caloric preload
Title
Neuro-economics task
Description
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.
Time Frame
Change in purchasing behaviour 1 hr after consuming a caloric preload
Title
Circulating hormone levels
Description
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
Time Frame
Change in circulating hormone levels from baseline (ie. 1930 - before sleep intervention) to 12hr later (0730 after the nighttime intervention)

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Benedict, PhD
Organizational Affiliation
dept. of Neuroscience, Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University
City
Uppsala
ZIP/Postal Code
75105
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25710379
Citation
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.
Results Reference
derived
PubMed Identifier
23428257
Citation
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.
Results Reference
derived

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Sleep Deprivation's Regulation of Immune System Function and Behavior

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