ObesityNCT01580761
Sleep Restriction and Obesity
A study testing Sleep restriction in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Sleep restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Sleep restriction
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep restrictionBehavioural
14 days of sleep restriction, 4 hours of sleep per day.
| Study group | Role | What they receive |
|---|---|---|
| Sleep restriction | Experimental | Sleep restriction Receives: Behavioral: Sleep restriction |
| Normal sleep | No intervention | Normal sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caloric intake and hunger
Change in caloric intake and hunger, measured during acclimation, experimental and recovery timepoints.
Measured: baseline to 21 days
Change in energy expenditure
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..
Measured: baseline to 21 days
Change in fat tissue characteristics and body composition
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.
Measured: baseline to 21 days
Change in metabolic hormones
Change in metabolic hormones measured during acclimation, experimental and recovery timepoints.
Measured: baseline to 21 days
Secondary outcomes (6)
Change in neurocognitive deficits
Change in neurocognitive function measured by battery, measured during acclimation, experimental and recovery timepoints..
Measured: baseline to 21 days
Change in blood pressure and autonomic function
Change in mean arterial blood pressure and autonomic function, measured during acclimation, experimental and recovery timepoints.
Measured: baseline to 21 days
Change in markers of inflammation and endothelial function
Change in markers of inflammation and endothelial function, measured during acclimation, experimental and recovery timepoints.
Measured: baseline to 21 days
Change in electrocardiographic characteristics
Change in electrocardiographic characteristics, measured during acclimation, experimental and recovery timepoints.
Measured: baseline to 21 days
Change in arterial stiffness
Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.
Measured: baseline to 21 days
Change in cardiovascular reactivity
Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.
Measured: baseline to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startJul 2012
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend Somers, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580761
- Sponsor's protocol ID
- 11-007272
- Status last verified
- Jan 2022
- First submitted
- 17 Apr 2012
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Covassin N, Singh P, McCrady-Spitzer SK, St Louis EK, Calvin AD, Levine JA, Somers VK. Effects of Experimental Sleep Restriction on Energy Intake, Energy Expenditure, and Visceral Obesity. J Am Coll Cardiol. 2022 Apr 5;79(13):1254-1265. doi: 10.1016/j.jacc.2022.01.038.
PubMed 35361348
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Restriction and Obesity
- ClinicalTrials.gov ID
- NCT01580761
- Acronym / sponsor ID
- 11-007272
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep restriction | Experimental | Behavioral: Sleep restrictionSleep restriction |
| Normal sleep | No intervention | –Normal sleep |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep restriction14 days of sleep restriction, 4 hours of sleep per day. | Behavioural | Sleep restriction |
Primary outcome
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.
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..
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.
Change in metabolic hormones
Time frame: baseline to 21 days
Change in metabolic hormones measured during acclimation, experimental and recovery timepoints.
6 secondary outcomes
Change in neurocognitive deficits
Time frame: baseline to 21 days
Change in blood pressure and autonomic function
Time frame: baseline to 21 days
Change in markers of inflammation and endothelial function
Time frame: baseline to 21 days
Change in electrocardiographic characteristics
Time frame: baseline to 21 days
Change in arterial stiffness
Time frame: baseline to 21 days
Change in cardiovascular reactivity
Time frame: baseline to 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Derived from this study: PubMed 35361348Covassin N, Singh P, McCrady-Spitzer SK, St Louis EK, Calvin AD, Levine JA, Somers VK. Effects of Experimental Sleep Restriction on Energy Intake, Energy Expenditure, and Visceral Obesity. J Am Coll Cardiol. 2022 Apr 5;79(13):1254-1265. doi: 10.1016/j.jacc.2022.01.038.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virend Somers, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep restriction in people with Obesity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in caloric intake and hunger (time frame: baseline to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01580761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.