NCT01730742

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

1.1 years

First QC Date

October 11, 2012

Last Update Submit

November 15, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • Portion Size Task

    Change in selected portion size from baseline to 1 hr after consuming a caloric preload

  • Neuro-economics task

    Change in purchasing behaviour 1 hr after consuming a caloric preload

  • Circulating hormone levels

    Change in circulating hormone levels from baseline (ie. 1930 - before sleep intervention) to 12hr later (0730 after the nighttime intervention)

Study Arms (2)

Sleep deprivation

EXPERIMENTAL

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

Behavioral: Neuroeconomics taskBehavioral: Portion Size TaskProcedure: Blood sample

Sleep

EXPERIMENTAL

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

Behavioral: Neuroeconomics taskBehavioral: Portion Size TaskProcedure: Blood sample

Interventions

After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).

SleepSleep deprivation

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

SleepSleep deprivation
Blood samplePROCEDURE

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

SleepSleep deprivation

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, Uppsala County, 75105, Sweden

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christian Benedict, PhD

    dept. of Neuroscience, Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2012

First Posted

November 21, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations