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Sleep Restriction and Obesity

Sleep Restriction and Obesity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01580761
Enrollment
13
Registered
2012-04-19
Start date
2012-07-31
Completion date
2018-05-01
Last updated
2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

BEHAVIORALSleep restriction

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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in caloric intake and hungerbaseline to 21 daysChange in caloric intake and hunger, measured during acclimation, experimental and recovery timepoints.
Change in energy expenditurebaseline to 21 daysChange 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 compositionbaseline to 21 daysChanges 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 hormonesbaseline to 21 daysChange in metabolic hormones measured during acclimation, experimental and recovery timepoints.

Secondary

MeasureTime frameDescription
Change in arterial stiffnessbaseline to 21 daysChange in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.
Change in neurocognitive deficitsbaseline to 21 daysChange in neurocognitive function measured by battery, measured during acclimation, experimental and recovery timepoints..
Change in cardiovascular reactivitybaseline to 21 daysChange in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.
Change in blood pressure and autonomic functionbaseline to 21 daysChange in mean arterial blood pressure and autonomic function, measured during acclimation, experimental and recovery timepoints.
Change in markers of inflammation and endothelial functionbaseline to 21 daysChange in markers of inflammation and endothelial function, measured during acclimation, experimental and recovery timepoints.
Change in electrocardiographic characteristicsbaseline to 21 daysChange in electrocardiographic characteristics, measured during acclimation, experimental and recovery timepoints.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026