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OpenTrials
Completed

NCT Number: NCT01580761

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Restriction

Behavioral

14 days of sleep restriction, 4 hours of sleep per day.

Primary outcomes

  1. 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.

  2. 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..

  3. 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.

  4. Change in metabolic hormones

    Time frame: baseline to 21 days

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

Secondary outcomes

  1. Change in neurocognitive deficits

    Time frame: 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

    Time frame: 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

    Time frame: baseline to 21 days

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

  4. Change in electrocardiographic characteristics

    Time frame: baseline to 21 days

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

  5. Change in arterial stiffness

    Time frame: baseline to 21 days

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

  6. Change in cardiovascular reactivity

    Time frame: baseline to 21 days

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2012
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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