Sleep Deprivation and Energy Balance
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sleep deprivation
Normal sleep
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Deprivation focused on measuring sleep deprivation, sleep restriction
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
sleep deprivation
Normal sleep
Arm Description
These are subjects who are randomized to undergo sleep deprivation.
These are subjects who are randomized to sleep normally.
Outcomes
Primary Outcome Measures
Sleep Deprivation results in positive energy balance
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01334788
First Posted
October 26, 2010
Last Updated
May 11, 2023
Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01334788
Brief Title
Sleep Deprivation and Energy Balance
Official Title
Sleep Deprivation and Energy Balance
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
sleep deprivation, sleep restriction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sleep deprivation
Arm Type
Experimental
Arm Description
These are subjects who are randomized to undergo sleep deprivation.
Arm Title
Normal sleep
Arm Type
Other
Arm Description
These are subjects who are randomized to sleep normally.
Intervention Type
Other
Intervention Name(s)
sleep deprivation
Other Intervention Name(s)
sleep restriction
Intervention Description
Sleep restriction
Intervention Type
Other
Intervention Name(s)
Normal sleep
Other Intervention Name(s)
control
Intervention Description
These are subjects who are randomized to sleep normally.
Primary Outcome Measure Information:
Title
Sleep Deprivation results in positive energy balance
Description
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.
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik K St Louis, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25424573
Citation
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.
Results Reference
derived
PubMed Identifier
23392199
Citation
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.
Results Reference
derived
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Sleep Deprivation and Energy Balance
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