- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01580761
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
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.
Helpful Links
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
Additional Relevant MeSH Terms
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
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
Clinical Trials on Sleep restriction
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São Paulo; Associação Fundo de Incentivo...Completed
-
Lance BollingerNational Aeronautics and Space Administration (NASA)CompletedMuscle Weakness | Sleep Disturbance | Quadriceps Muscle AtrophyUnited States
-
Esther WerthCompletedIdiopathic Hypersomnia | Narcolepsy 1Switzerland
-
University of ZurichFonds für Verkehrssicherheit FVSCompletedSleep Deprivation | Sleepiness | Insufficient Sleep SyndromeSwitzerland
-
University of Missouri-ColumbiaRecruiting
-
University School of Physical Education, Krakow...Jagiellonian UniversityRecruitingSleep | Sleep RestrictionPoland
-
Oregon Health and Science UniversityRecruitingObesity | Glucose Intolerance | Sleep Deprivation | Weight Gain | Food SelectionUnited States
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University of ChicagoCompleted
-
Institut de Recherche Biomedicale des ArmeesCompleted