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Sleep Restriction and Obesity

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ClinicalTrials.gov Identifier: NCT01580761
Recruitment Status : Recruiting
First Posted : April 19, 2012
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic

Brief Summary:
Insufficient sleep may be one of the most common, and most preventable, obesity risk factors. The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. The investigators hypothesize that sleep restriction will result in increased energy balance.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Sleep restriction Not Applicable

Detailed Description:
Numerous studies have reported that self-reported short sleep duration is associated with obesity and weight gain. Insufficient sleep may be one of the most common, and most preventable, obesity risk factors. Given that sleep restriction is largely voluntary and potentially correctable, understanding the mechanisms that link insufficient sleep to positive energy balance and the development of obesity, particularly visceral obesity, is crucial to clinical applications, public health policy, and informing future studies. The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. The investigators will combine energy balance, biomarker, and imaging data with state-of-the art sleep monitoring to provide unambiguous data on the effects of sleep restriction on obesity. Together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of obesity, and suggest strategies to reduce this risk.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sleep Restriction and Obesity
Study Start Date : July 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Sleep restriction
Sleep restriction
Behavioral: Sleep restriction
14 days of sleep restriction, 4 hours of sleep per day.

No Intervention: Normal sleep
Normal sleep



Primary Outcome Measures :
  1. Change in caloric intake and hunger [ Time Frame: baseline to 21 days ]
    Change in caloric intake and hunger, measured during acclimation, experimental and recovery timepoints.

  2. Change in energy expenditure [ Time Frame: baseline to 21 days ]
    Change in energy expenditure, including activity energy expenditure, thermic effect of food (TEF), and basal metabolic rate (BMR), measured during acclimation, experimental and recovery timepoints..

  3. Change in fat tissue characteristics and body composition [ Time Frame: baseline to 21 days ]
    Changes in fat tissue characteristics from serial fat biopsies, and in body composition from DEXA and CT imaging, measured during acclimation, experimental and recovery timepoints.

  4. Change in metabolic hormones [ Time Frame: baseline to 21 days ]
    Change in metabolic hormones measured during acclimation, experimental and recovery timepoints.


Secondary Outcome Measures :
  1. Change in neurocognitive deficits [ Time Frame: baseline to 21 days ]
    Change in neurocognitive function measured by battery, measured during acclimation, experimental and recovery timepoints..

  2. Change in blood pressure and autonomic function [ Time Frame: baseline to 21 days ]
    Change in mean arterial blood pressure and autonomic function, measured during acclimation, experimental and recovery timepoints.

  3. Change in markers of inflammation and endothelial function [ Time Frame: baseline to 21 days ]
    Change in markers of inflammation and endothelial function, measured during acclimation, experimental and recovery timepoints.

  4. Change in electrocardiographic characteristics [ Time Frame: baseline to 21 days ]
    Change in electrocardiographic characteristics, measured during acclimation, experimental and recovery timepoints.

  5. Change in arterial stiffness [ Time Frame: baseline to 21 days ]
    Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.

  6. Change in cardiovascular reactivity [ Time Frame: baseline to 21 days ]
    Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-40 years
  • BMI of 18.5-30 kg/m2
  • Not a current smoker or tobacco user
  • No chronic medical or psychiatric disorders
  • On no prescription medications other than second generation antihistamines (cetirizine, fexofenadine, desloratadine, loratadine, etc), oral contraceptive pills, or intrauterine devices
  • History of normal sleep patterns, defined as nocturnal sleep duration of 6.5-8 hours per night without regular daytime naps

Exclusion Criteria:

  • The investigators will exclude subjects who have any medical or psychiatric disorders
  • History of anxiety or depression
  • Those taking any medications other than non-sedating antihistamines or oral contraceptives will be excluded
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580761


Contacts
Contact: Lisa Block cplsleep@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Virend Somers, MD, PhD Mayo Clinic

Responsible Party: Virend Somers, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01580761     History of Changes
Other Study ID Numbers: 11-007272
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms