Sleep Restriction and Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01580761
First received: April 17, 2012
Last updated: April 25, 2016
Last verified: April 2016
  Purpose
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 Intervention
Obesity
Behavioral: Sleep restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Sleep Restriction and Obesity

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in caloric intake and hunger [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    Change in caloric intake and hunger, measured during acclimation, experimental and recovery timepoints.

  • Change in energy expenditure [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    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 fat tissue characteristics and body composition [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    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.

  • Change in metabolic hormones [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    Change in metabolic hormones measured during acclimation, experimental and recovery timepoints.


Secondary Outcome Measures:
  • Change in neurocognitive deficits [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    Change in neurocognitive function measured by battery, measured during acclimation, experimental and recovery timepoints..

  • 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, measured during acclimation, experimental and recovery timepoints.

  • Change in markers of inflammation and endothelial function [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    Change in markers of inflammation and endothelial function, measured during acclimation, experimental and recovery timepoints.

  • Change in electrocardiographic characteristics [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
    Change in electrocardiographic characteristics, measured during acclimation, experimental and recovery timepoints.


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580761

Contacts
Contact: CPL Lab CPL@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
  More Information

Responsible Party: Virend Somers, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01580761     History of Changes
Other Study ID Numbers: 11-007272 
Study First Received: April 17, 2012
Last Updated: April 25, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2016