Sleep Deprivation and Energy Balance (Sleep)
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| ClinicalTrials.gov Identifier: NCT00935402 |
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Recruitment Status :
Completed
First Posted : July 9, 2009
Last Update Posted : February 23, 2011
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Sponsor:
St. Luke's-Roosevelt Hospital Center
Collaborators:
National Institutes of Health (NIH)
Clinilabs, Inc.
Columbia University
Information provided by:
St. Luke's-Roosevelt Hospital Center
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity | Behavioral: Sleep | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Sleep Deprivation and Energy Balance |
| Study Start Date : | November 2008 |
| Actual Primary Completion Date : | July 2010 |
| Actual Study Completion Date : | July 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Short Sleep
Subjects are permitted to spend 4 hours in bed per night for 5 consecutive nights. Subjects are inpatients for a period of 6 days.
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Behavioral: Sleep
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. |
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Active Comparator: Regular Sleep
Subjects are permitted to spend 9 hours in bed per night for 5 nights. Subjects are inpatients for a period of 6 days.
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Behavioral: Sleep
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 Measures :
- Resting metabolic rate [ Time Frame: Day 5 of each arm ]
- Food intake [ Time Frame: Days 5-6 of each arm ]
- Hormone Measurements [ Time Frame: Daily fasting, and every 2 hours on day 4 of each arm ]
- Regional brain activity [ Time Frame: Day 6 of each arm ]
- Energy expenditure [ Time Frame: Each 6 day arm ]
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| Ages Eligible for Study: | 30 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935402
Locations
| United States, New York | |
| Clinilabs | |
| New York, New York, United States, 10019 | |
| St. Luke's/Roosevelt Hospital | |
| New York, New York, United States, 10025 | |
| Columbia University | |
| New York, New York, United States, 10036 | |
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
National Institutes of Health (NIH)
Clinilabs, Inc.
Columbia University
Investigators
| Principal Investigator: | Marie-Pierre St-Onge, Ph.D | St. Luke's-Roosevelt Hospital Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Marie-Pierre St-Onge/Research Associate, St. Luke's/Roosevelt Hospital |
| ClinicalTrials.gov Identifier: | NCT00935402 History of Changes |
| Other Study ID Numbers: |
R01HL091352-01A1 ( U.S. NIH Grant/Contract ) R01HL091352-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 9, 2009 Key Record Dates |
| Last Update Posted: | February 23, 2011 |
| Last Verified: | May 2010 |
Keywords provided by St. Luke's-Roosevelt Hospital Center:
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Energy balance Weight management Food intake Energy expenditure |
Additional relevant MeSH terms:
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Sleep Deprivation Dyssomnias Sleep Wake Disorders Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Mental Disorders |