Sleep Deprivation and Energy Balance (Sleep)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Energy balance, Weight management, Food intake, Energy expenditure
Eligibility Criteria
Inclusion Criteria:
- Body mass index 22-25 kg/m2
- Right-handed
- Sleep 7-9 hours/night
- Normal score on Pittsburgh Quality of Sleep questionnaire, Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness
Exclusion Criteria:
- Smoker
- Neurological, medical, or psychiatric disorder
- Diabetics
- History of eating disorders
- Sleep disorders
- Travel across time zones within 4 weeks of the study
- History of drug and alcohol abuse
- Shift worker
- Caffeine intake > 300 mg/d
- Excessive daytime sleepiness
- Regular napping
- History of drowsy driving
- Pregnancy or within 1 y post-partum
- Heavy equipment operator or commercial long-distance driver
- Contra-indications for MRI scanning
Sites / Locations
- Clinilabs
- St. Luke's/Roosevelt Hospital
- Columbia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Short Sleep
Regular Sleep
Arm Description
Subjects are permitted to spend 4 hours in bed per night for 5 consecutive nights. Subjects are inpatients for a period of 6 days.
Subjects are permitted to spend 9 hours in bed per night for 5 nights. Subjects are inpatients for a period of 6 days.
Outcomes
Primary Outcome Measures
Resting metabolic rate
Food intake
Hormone Measurements
Regional brain activity
Energy expenditure
Secondary Outcome Measures
Full Information
NCT ID
NCT00935402
First Posted
July 8, 2009
Last Updated
February 22, 2011
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
National Institutes of Health (NIH), Clinilabs, Inc., Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT00935402
Brief Title
Sleep Deprivation and Energy Balance
Acronym
Sleep
Official Title
Sleep Deprivation and Energy Balance
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
National Institutes of Health (NIH), Clinilabs, Inc., Columbia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Observational and epidemiological studies have found a link between obesity and short sleep duration with the prevalence of both increasing in the past decades. At this time, it is unknown whether short sleep is a cause of obesity and how short sleep would lead to obesity. Some studies associate short sleep with increased levels of hormone that stimulate appetite. This study will examine how food intake and energy expenditure can be modified by sleep duration as a means of understanding a potential causal pathway.
Detailed Description
Recent epidemiological studies show that short sleep duration (≤5-7 h/night) correlates with overweight and obesity, such that individuals with short sleep periods tend to have a higher body mass index (BMI) than those who sleep 8-9 h/night. The mechanism for this relationship is currently unknown. However, energy balance must be disrupted to produce weight gain. Therefore, the purpose of this study is to examine the impact of short sleep duration, 4 h/night, relative to habitual sleep duration of 8-9 h/night, on energy balance. The major aims of this study are to compare energy expenditure and energy intake during the periods of habitual and short sleep duration and to examine the neural and hormonal pathways involved in eating behavior under periods of habitual and short sleep. Men and women, 30-45 y and BMI 22-25 kg/m2, will be recruited to participate in this randomized, crossover study of short and habitual sleep periods. During each period of 5 nights, subjects will be required to sleep at the laboratory under supervision. During this time, subjects will be total inpatients to ensure compliance with the protocol. Each sleep duration period will be separated by a 2-4-wk washout period. On the first day of each phase, subjects will be given a dose of doubly-labeled water to measure free-living energy expenditure over the 6-d period. During the first 4 days, energy intake will be controlled and meals served at fixed times. The last 2 days will be ad libitum feeding of self-selected meals. Hormones, including leptin, insulin, ghrelin, PYY, adiponectin, and GLP-1 will be assessed daily in the fasted state and, on day 4, over a 24-hour period, while subjects are consuming a controlled diet with fixed meal times. Functional magnetic resonance imaging measurements of brain activity in response to food stimuli will be done on day 5 to examine brain regions associated with motivation to eat. On day 5, subjects will undergo measurements of basal metabolic rate using indirect calorimetry. Ad libitum energy intakes will be assessed on days 5 and 6. Polysomnographic monitoring will be performed nightly to assess sleep duration. Mediation analyses will allow us to determine whether hormone levels are related to and predictive of energy expenditure and energy intake data. The measurements performed in this study will allow us to determine how reduced sleep periods can impact energy balance and potentially lead to changes in body weight. As such, it will provide comprehensive information of the neural, physiological, hormonal, and behavioral networks related to energy balance and which are affected by sleep duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Energy balance, Weight management, Food intake, Energy expenditure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short Sleep
Arm Type
Experimental
Arm Description
Subjects are permitted to spend 4 hours in bed per night for 5 consecutive nights. Subjects are inpatients for a period of 6 days.
Arm Title
Regular Sleep
Arm Type
Active Comparator
Arm Description
Subjects are permitted to spend 9 hours in bed per night for 5 nights. Subjects are inpatients for a period of 6 days.
Intervention Type
Behavioral
Intervention Name(s)
Sleep
Intervention Description
Subjects are randomly assigned to one of 2 arms sequence: short followed by regular or regular followed by short. Each arm is 6 days in length and separated by a 2-4 week washout period.
Primary Outcome Measure Information:
Title
Resting metabolic rate
Time Frame
Day 5 of each arm
Title
Food intake
Time Frame
Days 5-6 of each arm
Title
Hormone Measurements
Time Frame
Daily fasting, and every 2 hours on day 4 of each arm
Title
Regional brain activity
Time Frame
Day 6 of each arm
Title
Energy expenditure
Time Frame
Each 6 day arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index 22-25 kg/m2
Right-handed
Sleep 7-9 hours/night
Normal score on Pittsburgh Quality of Sleep questionnaire, Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness
Exclusion Criteria:
Smoker
Neurological, medical, or psychiatric disorder
Diabetics
History of eating disorders
Sleep disorders
Travel across time zones within 4 weeks of the study
History of drug and alcohol abuse
Shift worker
Caffeine intake > 300 mg/d
Excessive daytime sleepiness
Regular napping
History of drowsy driving
Pregnancy or within 1 y post-partum
Heavy equipment operator or commercial long-distance driver
Contra-indications for MRI scanning
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre St-Onge, Ph.D
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinilabs
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
St. Luke's/Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31416797
Citation
Smith I, Salazar I, RoyChoudhury A, St-Onge MP. Sleep restriction and testosterone concentrations in young healthy males: randomized controlled studies of acute and chronic short sleep. Sleep Health. 2019 Dec;5(6):580-586. doi: 10.1016/j.sleh.2019.07.003. Epub 2019 Aug 12.
Results Reference
derived
PubMed Identifier
28401667
Citation
McNeil J, St-Onge MP. Increased energy intake following sleep restriction in men and women: A one-size-fits-all conclusion? Obesity (Silver Spring). 2017 Jun;25(6):989-992. doi: 10.1002/oby.21831. Epub 2017 Apr 12.
Results Reference
derived
PubMed Identifier
26156950
Citation
St-Onge MP, Roberts A, Shechter A, Choudhury AR. Fiber and Saturated Fat Are Associated with Sleep Arousals and Slow Wave Sleep. J Clin Sleep Med. 2016 Jan;12(1):19-24. doi: 10.5664/jcsm.5384.
Results Reference
derived
PubMed Identifier
25311835
Citation
Shechter A, St-Onge MP. Delayed sleep timing is associated with low levels of free-living physical activity in normal sleeping adults. Sleep Med. 2014 Dec;15(12):1586-9. doi: 10.1016/j.sleep.2014.07.010. Epub 2014 Sep 2.
Results Reference
derived
PubMed Identifier
23779051
Citation
St-Onge MP, Wolfe S, Sy M, Shechter A, Hirsch J. Sleep restriction increases the neuronal response to unhealthy food in normal-weight individuals. Int J Obes (Lond). 2014 Mar;38(3):411-6. doi: 10.1038/ijo.2013.114. Epub 2013 Jun 19.
Results Reference
derived
PubMed Identifier
23115399
Citation
St-Onge MP, O'Keeffe M, Roberts AL, RoyChoudhury A, Laferrere B. Short sleep duration, glucose dysregulation and hormonal regulation of appetite in men and women. Sleep. 2012 Nov 1;35(11):1503-10. doi: 10.5665/sleep.2198.
Results Reference
derived
PubMed Identifier
22357722
Citation
St-Onge MP, McReynolds A, Trivedi ZB, Roberts AL, Sy M, Hirsch J. Sleep restriction leads to increased activation of brain regions sensitive to food stimuli. Am J Clin Nutr. 2012 Apr;95(4):818-24. doi: 10.3945/ajcn.111.027383. Epub 2012 Feb 22.
Results Reference
derived
PubMed Identifier
21715510
Citation
St-Onge MP, Roberts AL, Chen J, Kelleman M, O'Keeffe M, RoyChoudhury A, Jones PJ. Short sleep duration increases energy intakes but does not change energy expenditure in normal-weight individuals. Am J Clin Nutr. 2011 Aug;94(2):410-6. doi: 10.3945/ajcn.111.013904. Epub 2011 Jun 29.
Results Reference
derived
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Sleep Deprivation and Energy Balance
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