Sleep Deprivation's Regulation of Immune System Function and Behavior

Sleep Clinical Trial

— SS  

Official title:

The Role of Sleep Deprivation in the Regulation of Immune System, Neuroendocrine Responses, and Behavioral Measures.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01730742
• Other study ID #: 192837465
• Status: Active, not recruiting
• Phase: N/A
• First received: October 11, 2012
• Last updated: November 15, 2012
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: November 2012
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sleep
• Sleep Deprivation

Intervention

Behavioral:
• Neuroeconomics task
After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).
• Portion Size Task
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

Procedure:
• Blood sample
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

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention)	No
Secondary	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.	Change in selected portion size from baseline to 1 hr after consuming a caloric preload	No
Secondary	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.	Change in purchasing behaviour 1 hr after consuming a caloric preload	No
Secondary	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	Change in circulating hormone levels from baseline (ie. 1930 - before sleep intervention) to 12hr later (0730 after the nighttime intervention)	No