Sleep Restriction and Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01580761
First received: April 17, 2012
Last updated: March 13, 2014
Last verified: March 2014

April 17, 2012
March 13, 2014
July 2012
June 2016   (final data collection date for primary outcome measure)
  • Change in caloric intake [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
  • Change in activity energy expenditure [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    Change in activity energy expenditure, measured during acclimation, experimental, and recovery.
  • Change in total energy expenditure [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    Change in total energy expenditure, a combination of activity energy expenditure, thermic effect of food (TEF), and basal metabolic rate (BMR).
  • Change in leptin levels, fat tissue characteristics, and body composition [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    Changes in energy expenditure will be associated with alterations in fat tissue characteristics from serial fat biopsies, and altered body composition measured by DEXA and computed tomography imaging
Same as current
Complete list of historical versions of study NCT01580761 on ClinicalTrials.gov Archive Site
  • Change in neurocognitive deficits [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    Change in neurocognitive function measured by battery.
  • Change in blood pressure and autonomic function [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    Change in mean arterial blood pressure and autonomic function over 24 hour periods.
  • Change in markers of inflammation and endothelial function [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Sleep Restriction and Obesity
Sleep Restriction and Obesity

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Obesity
Behavioral: Sleep restriction
14 days of sleep restriction, 4 hours of sleep per day.
  • Experimental: Sleep restriction
    Sleep restriction
    Intervention: Behavioral: Sleep restriction
  • No Intervention: Normal sleep
    Normal sleep
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2018
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-40 years
  • BMI of 18.5-24.9 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
Both
18 Years to 40 Years
Yes
Contact: Diane E Davison, MA, RN CPL@mayo.edu
United States
 
NCT01580761
11-007272
No
Virend Somers, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Virend Somers, MD, PhD Mayo Clinic
Mayo Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP