Sleep Restriction and Obesity

January 18, 2022 updated by: Virend Somers, MD, PhD, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep restriction
14 days of sleep restriction, 4 hours of sleep per day.
No Intervention: Normal sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 21 days
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..
baseline to 21 days
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.
baseline to 21 days
Change in metabolic hormones
Time Frame: baseline to 21 days
Change in metabolic hormones measured during acclimation, experimental and recovery timepoints.
baseline to 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in neurocognitive deficits
Time Frame: baseline to 21 days
Change in neurocognitive function measured by battery, measured during acclimation, experimental and recovery timepoints..
baseline to 21 days
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.
baseline to 21 days
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.
baseline to 21 days
Change in electrocardiographic characteristics
Time Frame: baseline to 21 days
Change in electrocardiographic characteristics, measured during acclimation, experimental and recovery timepoints.
baseline to 21 days
Change in arterial stiffness
Time Frame: baseline to 21 days
Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.
baseline to 21 days
Change in cardiovascular reactivity
Time Frame: baseline to 21 days
Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.
baseline to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 11-007272

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Sleep restriction

Subscribe