Skip to main content
Clinical Trials/NCT01580761
NCT01580761CompletedNot Applicable

Sleep Restriction and Obesity

Mayo Clinic2 sites in 1 country13 target enrollmentStarted: July 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
13
Locations
2
Primary Endpoint
Change in energy expenditure

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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..

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.

Change in metabolic hormones

Time Frame: baseline to 21 days

Change in metabolic hormones measured during acclimation, experimental and recovery timepoints.

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.

Secondary Outcomes

  • Change in arterial stiffness(baseline to 21 days)
  • Change in markers of inflammation and endothelial function(baseline to 21 days)
  • Change in neurocognitive deficits(baseline to 21 days)
  • Change in electrocardiographic characteristics(baseline to 21 days)
  • Change in cardiovascular reactivity(baseline to 21 days)
  • Change in blood pressure and autonomic function(baseline to 21 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Virend Somers, MD, PhD

MD, PhD

Mayo Clinic

Study Sites (2)

Loading locations...

Similar Trials