An interventional study of Sleep in Obesity, sponsored by St. Luke's-Roosevelt Hospital Center. Completed at 3 sites in United States. Open to participants aged 30 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-23.
Sponsored by St. Luke's-Roosevelt Hospital Center · Not applicable, Interventional, and Prevention
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.
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.
300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 248 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →St. Luke's-Roosevelt Hospital Center is the lead sponsor of 68 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects are permitted to spend 4 hours in bed per night for 5 consecutive nights. Subjects are inpatients for a period of 6 days.
Behavioral: Sleep
Subjects are permitted to spend 9 hours in bed per night for 5 nights. Subjects are inpatients for a period of 6 days.
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.
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
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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St. Luke's-Roosevelt Hospital Center