Sleep Deprivation and Energy Balance

Obesity Clinical Trial

— Sleep  

Official title:

Sleep Deprivation and Energy Balance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935402
• Other study ID #: R01HL091352-01A1
• Secondary ID: R01HL091352-01A1
• Status: Completed
• Phase: N/A
• First received: July 8, 2009
• Last updated: February 22, 2011
• Start date: November 2008
• Est. completion date: July 2010

Study information

• Verified date: May 2010
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Sleep Deprivation

Intervention

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.

Locations

Country	Name	City	State
United States	Clinilabs	New York	New York
United States	Columbia University	New York	New York
United States	St. Luke's/Roosevelt Hospital	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	Clinilabs, Columbia University, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting metabolic rate		Day 5 of each arm	No
Primary	Food intake		Days 5-6 of each arm	No
Primary	Hormone Measurements		Daily fasting, and every 2 hours on day 4 of each arm	No
Primary	Regional brain activity		Day 6 of each arm	No
Primary	Energy expenditure		Each 6 day arm	No