Skip to main content
OpenTrials
Completed

NCT Number: NCT00935402

Sleep Deprivation and Energy Balance

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinilabs, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sleep

Behavioral

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 outcomes

  1. Resting metabolic rate

    Time frame: Day 5 of each arm

  2. Food intake

    Time frame: Days 5-6 of each arm

  3. Hormone Measurements

    Time frame: Daily fasting, and every 2 hours on day 4 of each arm

  4. Regional brain activity

    Time frame: Day 6 of each arm

  5. Energy expenditure

    Time frame: Each 6 day arm

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Collaborators

  • Clinilabs, Inc.
  • Columbia University
  • National Institutes of Health (NIH)

Registry information

Acronym: Sleep

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 9, 2009
Registry last updated
Feb 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.