The Effects of Acute Total Sleep Deprivation Versus Normal Sleep on Metabolism

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Inhibitory task

Blood samples

Tissue samples

Oral glucose tolerance test

Portion Size Task

About this trial

This is an interventional basic science trial for Sleep Deprivation

Eligibility Criteria

18 Years - 28 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male
Age 18-28y
Healthy (self-reported) and not on medication
Non-smoking
Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries)

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
Current or history of endocrine, neurological or psychiatric disorders
Shift work in the preceding three months or for a long duration
Time travel over a significant number of time zones in the preceding two months
Too much weight gain or weight loss in the preceding three months

Sites / Locations

Department of Neuroscience, Uppsala University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Total sleep deprivation

Sleep

Arm Description

Participants will be required to stay up for the entire night before 'Blood Samples' and 'Tissue samples' will be taken and the 'Portion Size Task' and 'Inhibitory task' will be performed. This will then be followed by the 'Oral glucose tolerance test' with additional 'Blood Samples' to be taken as described for that test.

Participants will have an 8-h sleep opportunity before 'Blood Samples' and 'Tissue samples' will be taken and 'Portion Size Task' and 'Inhibitory task' will be performed. This will be followed by the 'Oral glucose tolerance test' with additional 'Blood Samples' to be taken as described for that test.

Outcomes

Primary Outcome Measures

Gene expression and DNA methylation

This study has been designed to measure the changes in gene expression and DNA methylation in circulating blood, i.e. mainly of white blood cells with active transcription and DNA regulation, and how this relates to possible changes in peripheral tissues involved in metabolism.

Secondary Outcome Measures

Circulating hormone and neuromolecular levels

Participants will have their circulating hormone levels and neuromolecular levels taken and analyzed, including ghrelin, to determine if sleep deprivation alters hormone and neuromolecular levels related primarily to obesity, cognition or weight gain

Appetitive evaluation

Participants will be evaluated on their appetitive ratings in the morning following either nighttime intervention (acute total sleep deprivation or normal 8-hour sleep).

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 partial sleep deprivation and normal sleep, and changes before and after glucose ingestion will be compared between these conditions

Inhibitory task

Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event.

Full Information

NCT ID

NCT01800253

First Posted

February 21, 2013

Last Updated

December 6, 2013

Sponsor

Uppsala University

1. Study Identification

Unique Protocol Identification Number

NCT01800253

Brief Title

The Effects of Acute Total Sleep Deprivation Versus Normal Sleep on Metabolism

Official Title

The Role of Acute Total Sleep Deprivation in the Regulation of Metabolism, Neuroendocrine Responses, and Behavioral Measures

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

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 acute total deprivation affects metabolism as measured through blood and peripheral tissues. Its aim is also to investigate how acute total sleep deprivation affects neurodegenerative markers, as well as hormones, memory performance and aspects of appetite regulation.

Detailed Description

It is predicted that acute total sleep deprivation will affect gene expression and DNA methylation. It is also predicted that sleep deprivation will up-regulate ghrelin, and affect other neuroendocrine markers and hormones in a negative manner. It is further predicted that sleep deprivation will decrease participants' memory performance.

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

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Total sleep deprivation

Arm Type

Experimental

Arm Description

Participants will be required to stay up for the entire night before 'Blood Samples' and 'Tissue samples' will be taken and the 'Portion Size Task' and 'Inhibitory task' will be performed. This will then be followed by the 'Oral glucose tolerance test' with additional 'Blood Samples' to be taken as described for that test.

Arm Title

Sleep

Arm Type

Experimental

Arm Description

Participants will have an 8-h sleep opportunity before 'Blood Samples' and 'Tissue samples' will be taken and 'Portion Size Task' and 'Inhibitory task' will be performed. This will be followed by the 'Oral glucose tolerance test' with additional 'Blood Samples' to be taken as described for that test.

Intervention Type

Behavioral

Intervention Name(s)

Inhibitory task

Intervention Description

Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event

Intervention Type

Procedure

Intervention Name(s)

Blood samples

Intervention Description

Hormone levels, neuromolecular levels and gene expression profiles will be analyzed from repeated blood samples obtained before and after the nighttime intervention

Intervention Type

Procedure

Intervention Name(s)

Tissue samples

Intervention Description

Expression profiles will be analyzed from samples obtained from tissues involved in metabolism

Intervention Type

Procedure

Intervention Name(s)

Oral glucose tolerance test

Intervention Description

75 g of glucose will be dissolved in 300 ml of water and given to participants, followed by blood sampling at 0, 15, 30, 60, 90, 120 and 150 minutes following the ingestion of the glucose solution.

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

Primary Outcome Measure Information:

Title

Gene expression and DNA methylation

Description

This study has been designed to measure the changes in gene expression and DNA methylation in circulating blood, i.e. mainly of white blood cells with active transcription and DNA regulation, and how this relates to possible changes in peripheral tissues involved in metabolism.

Time Frame

Change from baseline (ie. around 1930 in the evening - before sleep intervention) to 12 hours later (around 0730 in the morning after the nighttime intervention), and to 15 hours later (around 1030 in the morning after the nighttime intervention)

Secondary Outcome Measure Information:

Title

Circulating hormone and neuromolecular levels

Description

Participants will have their circulating hormone levels and neuromolecular levels taken and analyzed, including ghrelin, to determine if sleep deprivation alters hormone and neuromolecular levels related primarily to obesity, cognition or weight gain

Time Frame

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

Title

Appetitive evaluation

Description

Participants will be evaluated on their appetitive ratings in the morning following either nighttime intervention (acute total sleep deprivation or normal 8-hour sleep).

Time Frame

Change in appetitive ratings after the sleep intervetion (from around 0700 in the morning after the nighttime intervention), repeated each hour

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 partial sleep deprivation and normal sleep, and changes before and after glucose ingestion will be compared between these conditions

Time Frame

Change in selected portion size in the morning, at around 0830 hours in the morning following each nighttime intervention, and 2h30min later, i.e. 30 min after consuming an Oral glucose tolerance test, i.e. around 1100 hours

Title

Inhibitory task

Description

Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event.

Time Frame

Change in cognitive inhibitory performance at around 0810 hours in the morning following the respective nighttime intervention.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

28 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male Age 18-28y Healthy (self-reported) and not on medication Non-smoking Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries) 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 Current or history of endocrine, neurological or psychiatric disorders Shift work in the preceding three months or for a long duration Time travel over a significant number of time zones in the preceding two months Too much weight gain or weight loss in the preceding three months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Benedict, PhD

Organizational Affiliation

Department of Neuroscience, Uppsala University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Neuroscience, Uppsala University

City

Uppsala

ZIP/Postal Code

75324

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

34476847

Citation

Mateus Brandao LE, Espes D, Westholm JO, Martikainen T, Westerlund N, Lampola L, Popa A, Vogel H, Schurmann A, Dickson SL, Benedict C, Cedernaes J. Acute sleep loss alters circulating fibroblast growth factor 21 levels in humans: A randomised crossover trial. J Sleep Res. 2022 Apr;31(2):e13472. doi: 10.1111/jsr.13472. Epub 2021 Sep 2.

Results Reference

derived

PubMed Identifier

26168277

Citation

Cedernaes J, Osler ME, Voisin S, Broman JE, Vogel H, Dickson SL, Zierath JR, Schioth HB, Benedict C. Acute Sleep Loss Induces Tissue-Specific Epigenetic and Transcriptional Alterations to Circadian Clock Genes in Men. J Clin Endocrinol Metab. 2015 Sep;100(9):E1255-61. doi: 10.1210/JC.2015-2284. Epub 2015 Jul 13.

Results Reference

derived

Sleep Deprivation, Sleep

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial