Sleep DeprivationSSNCT01730742
Sleep Deprivation's Regulation of Immune System Function and Behavior
A study testing Neuroeconomics task, Portion Size Task and Blood sample in people with Sleep Deprivation and Sleep, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep
- What is being tested?
- Neuroeconomics task, Portion Size Task and Blood sample
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Mar 2013
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sleep Deprivation, Sleep
- Being tested
- Neuroeconomics task, Portion Size Task, Blood sample
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroeconomics taskBehavioural
After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).
Portion Size TaskBehavioural
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
Blood sampleProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Neuroeconomics task; Behavioral: Portion Size Task; Procedure: 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 Receives: Behavioral: Neuroeconomics task; Behavioral: Portion Size Task; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention)
Secondary outcomes (3)
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.
Measured: Change in selected portion size from baseline to 1 hr after consuming a caloric preload
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.
Measured: Change in purchasing behaviour 1 hr after consuming a caloric preload
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
Measured: Change in circulating hormone levels from baseline (ie. 1930 - before sleep intervention) to 12hr later (0730 after the nighttime intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Benedict, PhD, Principal investigator, dept. of Neuroscience, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730742
- Sponsor's protocol ID
- 192837465
- Acronym
- SS
- Status last verified
- Nov 2012
- First submitted
- 11 Oct 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25710379Hogenkamp 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.
PubMed 23428257
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sleep Deprivation in the Regulation of Immune System, Neuroendocrine Responses, and Behavioral Measures.
- ClinicalTrials.gov ID
- NCT01730742
- Acronym / sponsor ID
- SS / 192837465
- Conditions
- Sleep Deprivation, Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 21 Nov 2012 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | Experimental | Behavioral: Neuroeconomics task, Behavioral: Portion Size Task, Procedure: Blood sampleTotal 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 | Experimental | Behavioral: Neuroeconomics task, Behavioral: Portion Size Task, Procedure: Blood sampleSleep: participants had an 8-h sleep opportunity before a 'Blood Sample' was taken and the 'Neuroeconomics task' and 'Portion size task' were performed |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Neuroeconomics taskAfter a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario). | Behavioural | Sleep, Sleep deprivation |
| Portion Size TaskParticipants 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 | Behavioural | Sleep, Sleep deprivation |
| Blood sampleAfter 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 | Procedure or surgery | Sleep, Sleep deprivation |
Primary outcome
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)
3 secondary outcomes
Portion Size Task
Time frame: Change in selected portion size from baseline to 1 hr after consuming a caloric preload
Neuro-economics task
Time frame: Change in purchasing behaviour 1 hr after consuming a caloric preload
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Derived from this study: PubMed 25710379Nilsson 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.
- Derived from this study: PubMed 23428257Hogenkamp 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.
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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.
Christian Benedict, PhD principal investigator
dept. of Neuroscience, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroeconomics task, Portion Size Task and Blood sample in people with Sleep Deprivation and Sleep, run by Uppsala University at 1 site in Sweden.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Nov 2012. 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 Sweden. 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?
Results are not available in the source record.
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?
Neutrophil phagocytotic function production (time frame: Change in 4 neutrophil phagocytotic function from baseline to 36hours later (after the nighttime intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01730742, which also lists 2 linked publications.
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 21 Nov 2012.