- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01334788
Sleep Deprivation and Energy Balance
May 11, 2023 updated by: Virend Somers, MD, PhD, Mayo Clinic
Chronic sleep deprivation may constitute an important and potentially correctable behavioral factor in the alarming increase in obesity.
There are no definitive experimental studies in humans showing whether sleep deprivation indeed contributes to increased energy intake and/or reduced energy expenditure.
The investigators propose a series of novel studies to investigate abnormalities in energy homeostasis imparted by sleep deprivation.
The investigators will measure food intake, energy expenditure (basal metabolic rate, thermal effect of food, and non-exercise activity thermogenesis), and neurohormone levels in 24 healthy subjects with normal BMI (20-25 kg/m2).
Twelve subjects (6 men and 6 women) will be randomized to sleep deprivation.
Measurements will be compared to those obtained in 12 subjects who are randomized to a control group, and are not sleep deprived.
The investigators will test the following hypotheses: 1.
That sleep deprivation results in positive energy balance (increased caloric intake and decreased energy expenditure, as reflected by decreased non-exercise activity thermogenesis).
2. That dysregulation of appetite and energy expenditure is associated with changes in molecules controlling appetite and metabolism.
3.
That changes associated with 8 days of modest sleep deprivation resolve, at least in part, over a 4 day recovery period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The demands of present day living have placed a high premium on time.
Voluntary sleep curtailment is endemic and many adults typically sleep an average of six hours per night.
Observational data suggest that short sleep duration is associated with a greater likelihood of being obese.
Low grade chronic sleep deprivation may constitute an important and potentially correctable behavioral factor in the alarming increase in obesity.
There are no definitive experimental studies in humans showing whether sleep deprivation indeed contributes to increased energy intake and/or reduced energy expenditure.
The investigators propose a series of novel studies to investigate abnormalities in energy homeostasis imparted by sleep deprivation.
These studies combine state-of-the-art techniques for monitoring sleep, food intake, energy expenditure and neuroendocrine energy regulation.
The investigators will measure food intake, energy expenditure (basal metabolic rate, thermal effect of food, and non-exercise activity thermogenesis), and neurohormone levels in 24 healthy subjects with normal BMI (20-25 kg/m2).
Twelve subjects (6 men and 6 women) will be randomized to sleep deprivation.
After a 3 day baseline evaluation, these subjects will undergo 8 days of modest sleep deprivation followed by a 4 day recovery period.
Measurements will be compared to those obtained in 12 subjects who are randomized to a control group, and are not sleep deprived.
Sleep deprived and control subjects will be comparable for age and gender and will undergo similar monitoring and measurements in the Clinical Research Unit over the same duration.
The investigators will test the following hypotheses: 1.
That sleep deprivation results in positive energy balance (increased caloric intake and decreased energy expenditure, as reflected by decreased non-exercise activity thermogenesis).
2. That dysregulation of appetite and energy expenditure is associated with changes in molecules controlling appetite and metabolism.
3.
That changes associated with 8 days of modest sleep deprivation resolve, at least in part, over a 4 day recovery period.
This exploratory application builds on established research programs addressing first, neuroendocrine mechanisms in sleep and obesity, and second, the regulation of energy intake and energy expenditure in humans.
These studies will provide novel and important insights into whether sleep deprivation promotes increased food intake and/or reduced activity levels, and into the potential role of molecules that regulate appetite and metabolism.
PUBLIC HEALTH RELEVANCE: The investigators propose to examine whether two weeks of modest sleep restriction results in increased food intake and decreased energy expenditure, thus potentially predisposing to obesity.
These findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of obesity, and suggest novel strategies for weight control.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- All subjects will be sedentary. Sedentary will be defined as those with an occupational calorie expenditure that is not estimated at greater than 50% above basal (desk job or light activity at work: on feet 30-50% of the work day) and whose exercise activity is defined as sedentary according to a self-reported activity questionnaire, and confirmed by actigraphy measurements. Sedentary lifestyle will be defined as fewer than four 20 min episodes of moderate or vigorous intensity activity in the previous four weeks.
Exclusion Criteria:
- We will exclude subjects who have any medical or psychiatric disorders, including history of anxiety or depression, and those taking any medications.
- Those found to have depression on a depression screening tool (BDI-II) will be excluded.
- Current smokers will be excluded.
- All female subjects will undergoing a screening pregnancy test and excluded if positive.
- Subjects found to have significant sleep disorders will be excluded. -
- Subjects found to have occult coronary artery disease by exercise treadmill testing will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sleep deprivation
These are subjects who are randomized to undergo sleep deprivation.
|
Sleep restriction
Other Names:
|
Other: Normal sleep
These are subjects who are randomized to sleep normally.
|
These are subjects who are randomized to sleep normally.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Deprivation results in positive energy balance
Time Frame: 15 days
|
The investigators are testing the hypothesis that sleep deprivation results in increased caloric intake (calories from food consumed) and reduced energy expenditure (calories burned), resulting in a net positive energy balance.
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Erik K St Louis, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Calvin AD, Covassin N, Kremers WK, Adachi T, Macedo P, Albuquerque FN, Bukartyk J, Davison DE, Levine JA, Singh P, Wang S, Somers VK. Experimental sleep restriction causes endothelial dysfunction in healthy humans. J Am Heart Assoc. 2014 Nov 25;3(6):e001143. doi: 10.1161/JAHA.114.001143.
- Calvin AD, Carter RE, Adachi T, Macedo PG, Albuquerque FN, van der Walt C, Bukartyk J, Davison DE, Levine JA, Somers VK. Effects of experimental sleep restriction on caloric intake and activity energy expenditure. Chest. 2013 Jul;144(1):79-86. doi: 10.1378/chest.12-2829.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
October 26, 2010
First Submitted That Met QC Criteria
April 12, 2011
First Posted (Estimate)
April 13, 2011
Study Record Updates
Last Update Posted (Actual)
May 12, 2023
Last Update Submitted That Met QC Criteria
May 11, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-006780
- R21HL096071-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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