Sleep Deprivation and Energy Balance

This study has been completed.
Sponsor:
Collaborators:
Clinilabs
Columbia University
Information provided by:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00935402
First received: July 8, 2009
Last updated: February 22, 2011
Last verified: May 2010
  Purpose

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 Intervention
Obesity
Behavioral: Sleep

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sleep Deprivation and Energy Balance

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Resting metabolic rate [ Time Frame: Day 5 of each arm ] [ Designated as safety issue: No ]
  • Food intake [ Time Frame: Days 5-6 of each arm ] [ Designated as safety issue: No ]
  • Hormone Measurements [ Time Frame: Daily fasting, and every 2 hours on day 4 of each arm ] [ Designated as safety issue: No ]
  • Regional brain activity [ Time Frame: Day 6 of each arm ] [ Designated as safety issue: No ]
  • Energy expenditure [ Time Frame: Each 6 day arm ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935402

Locations
United States, New York
St. Luke's/Roosevelt Hospital
New York, New York, United States, 10025
Clinilabs
New York, New York, United States, 10019
Columbia University
New York, New York, United States, 10036
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Clinilabs
Columbia University
Investigators
Principal Investigator: Marie-Pierre St-Onge, Ph.D St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided by St. Luke's-Roosevelt Hospital Center

Additional 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, R01HL091352-01A1
Study First Received: July 8, 2009
Last Updated: February 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Energy balance
Weight management
Food intake
Energy expenditure

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014