Sleep Restriction and Obesity

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01580761
Collaborator
(none)
13
1
2
70
0.2

Study Details

Study Description

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
  • Behavioral: Sleep restriction
N/A

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
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Sleep Restriction and Obesity
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in caloric intake and hunger [baseline to 21 days]

    Change in caloric intake and hunger, measured during acclimation, experimental and recovery timepoints.

  2. Change in energy expenditure [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 [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 [baseline to 21 days]

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

Secondary Outcome Measures

  1. Change in neurocognitive deficits [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 [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 [baseline to 21 days]

    Change in markers of inflammation and endothelial function, measured during acclimation, experimental and recovery timepoints.

  4. Change in electrocardiographic characteristics [baseline to 21 days]

    Change in electrocardiographic characteristics, measured during acclimation, experimental and recovery timepoints.

  5. Change in arterial stiffness [baseline to 21 days]

    Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.

  6. Change in cardiovascular reactivity [baseline to 21 days]

    Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Virend Somers, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Virend Somers, MD, PhD, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01580761
Other Study ID Numbers:
  • 11-007272
First Posted:
Apr 19, 2012
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 21, 2022