Sleep Deprivation and Energy Balance

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01334788
First received: October 26, 2010
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

Chronic sleep deprivation may constitute an important and potentially correctable behavioral factor in the alarming increase in obesity. There are no definitive experimental studies in humans showing whether sleep deprivation indeed contributes to increased energy intake and/or reduced energy expenditure. The investigators propose a series of novel studies to investigate abnormalities in energy homeostasis imparted by sleep deprivation. The investigators will measure food intake, energy expenditure (basal metabolic rate, thermal effect of food, and non-exercise activity thermogenesis), and neurohormone levels in 24 healthy subjects with normal BMI (20-25 kg/m2). Twelve subjects (6 men and 6 women) will be randomized to sleep deprivation. Measurements will be compared to those obtained in 12 subjects who are randomized to a control group, and are not sleep deprived. The investigators will test the following hypotheses: 1. That sleep deprivation results in positive energy balance (increased caloric intake and decreased energy expenditure, as reflected by decreased non-exercise activity thermogenesis). 2. That dysregulation of appetite and energy expenditure is associated with changes in molecules controlling appetite and metabolism. 3. That changes associated with 8 days of modest sleep deprivation resolve, at least in part, over a 4 day recovery period.


Condition Intervention
Sleep Deprivation
Other: sleep deprivation
Other: Normal sleep

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Sleep Deprivation and Energy Balance

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Sleep Deprivation results in positive energy balance [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    The investigators are testing the hypothesis that sleep deprivation results in increased caloric intake (calories from food consumed) and reduced energy expenditure (calories burned), resulting in a net positive energy balance.


Enrollment: 17
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sleep deprivation
These are subjects who are randomized to undergo sleep deprivation.
Other: sleep deprivation
Sleep restriction
Other Name: sleep restriction
No Intervention: Normal sleep
These are subjects who are randomized to sleep normally.
Other: Normal sleep
These are subjects who are randomized to sleep normally.
Other Name: control

Detailed Description:

The demands of present day living have placed a high premium on time. Voluntary sleep curtailment is endemic and many adults typically sleep an average of six hours per night. Observational data suggest that short sleep duration is associated with a greater likelihood of being obese. Low grade chronic sleep deprivation may constitute an important and potentially correctable behavioral factor in the alarming increase in obesity. There are no definitive experimental studies in humans showing whether sleep deprivation indeed contributes to increased energy intake and/or reduced energy expenditure. The investigators propose a series of novel studies to investigate abnormalities in energy homeostasis imparted by sleep deprivation. These studies combine state-of-the-art techniques for monitoring sleep, food intake, energy expenditure and neuroendocrine energy regulation. The investigators will measure food intake, energy expenditure (basal metabolic rate, thermal effect of food, and non-exercise activity thermogenesis), and neurohormone levels in 24 healthy subjects with normal BMI (20-25 kg/m2). Twelve subjects (6 men and 6 women) will be randomized to sleep deprivation. After a 3 day baseline evaluation, these subjects will undergo 8 days of modest sleep deprivation followed by a 4 day recovery period. Measurements will be compared to those obtained in 12 subjects who are randomized to a control group, and are not sleep deprived. Sleep deprived and control subjects will be comparable for age and gender and will undergo similar monitoring and measurements in the Clinical Research Unit over the same duration. The investigators will test the following hypotheses: 1. That sleep deprivation results in positive energy balance (increased caloric intake and decreased energy expenditure, as reflected by decreased non-exercise activity thermogenesis). 2. That dysregulation of appetite and energy expenditure is associated with changes in molecules controlling appetite and metabolism. 3. That changes associated with 8 days of modest sleep deprivation resolve, at least in part, over a 4 day recovery period. This exploratory application builds on established research programs addressing first, neuroendocrine mechanisms in sleep and obesity, and second, the regulation of energy intake and energy expenditure in humans. These studies will provide novel and important insights into whether sleep deprivation promotes increased food intake and/or reduced activity levels, and into the potential role of molecules that regulate appetite and metabolism. PUBLIC HEALTH RELEVANCE: The investigators propose to examine whether two weeks of modest sleep restriction results in increased food intake and decreased energy expenditure, thus potentially predisposing to obesity. These findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of obesity, and suggest novel strategies for weight control.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All subjects will be sedentary. Sedentary will be defined as those with an occupational calorie expenditure that is not estimated at greater than 50% above basal (desk job or light activity at work: on feet 30-50% of the work day) and whose exercise activity is defined as sedentary according to a self-reported activity questionnaire, and confirmed by actigraphy measurements. Sedentary lifestyle will be defined as fewer than four 20 min episodes of moderate or vigorous intensity activity in the previous four weeks.

Exclusion Criteria:

  • We will exclude subjects who have any medical or psychiatric disorders, including history of anxiety or depression, and those taking any medications.
  • Those found to have depression on a depression screening tool (BDI-II) will be excluded.
  • Current smokers will be excluded.
  • All female subjects will undergoing a screening pregnancy test and excluded if positive.
  • Subjects found to have significant sleep disorders will be excluded. -
  • Subjects found to have occult coronary artery disease by exercise treadmill testing will be excluded.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01334788

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Erik K St Louis, MD Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virend Somers, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01334788     History of Changes
Other Study ID Numbers: 08-006780, R21HL096071-02
Study First Received: October 26, 2010
Last Updated: May 10, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Mayo Clinic:
sleep deprivation
sleep restriction

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 14, 2014