Sleep DeprivationBATNCT02770118
Effects of Sleep Restriction on BAT Activation in Humans
A study testing Partial Sleep Restriction, Total Sleep Deprivation and Habitual Sleep in people with Sleep Deprivation and Obesity, run by Columbia University at 1 site in United States.
Trial summary
The goal of this proposed research is to test the hypothesis that long-term mild sleep restriction (SR), as occurs frequently in adults and adolescents, leads to a positive energy balance and weight gain. Aim 1. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Obesity
- What is being tested?
- Partial Sleep Restriction, Total Sleep Deprivation and Habitual Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jul 2017
- 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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal scores on:
- Pittsburgh Quality of Sleep Questionnaire
- Epworth Sleepiness Scale
- Berlin Questionnaire
- Sleep Disorders Inventory Questionnaire
- Beck Depression Inventory
Show all 12Show fewer
- Composite Scale of Morningness/Eveningness
- Three Factor Eating Questionnaire
- Sleep 7-9 hours in bed/night with no daytime nap
- Age 20-49 years, premenopausal women
- All racial/ethnic groups
- Body mass index 25-29.9 kg/m2
Who cannot join
- Smokers (any cigarettes or ex-smoker <3 years)
- Neurological, medical or psychiatric disorder, diabetics
- Eating and/or sleep disorders
- Contraindications for MRI scanning
- Travel across time zones within 4 weeks
- History of drug and alcohol abuse
Show all 10Show fewer
- Shift worker (or rotating shift worker)
- Caffeine intake >300 mg/d
- Pregnancy or within 1 y post-partum
- Heavy equipment operators Commercial long-distance drivers
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Nutrition Obesity Research Center
New York, New York, 10032
About this study
The goal of this proposed research is to test the hypothesis that long-term mild sleep restriction (SR), as occurs frequently in adults and adolescents, leads to a positive energy balance and weight gain.
Aim 1. To determine the effects of SR, relative to habitual sleep (HS), on food choice and energy intake (EI) in adults at risk of obesity.
Read more
- Hypothesis 1a. EI, assessed by multiple weekly 24-hour recalls, will be greater during a period of SR relative to HS. This will be mostly due to increased fat and carbohydrate intakes.
- Hypothesis 1b. Neuronal responses to food stimuli, assessed by functional MRI (fMRI) after 6 weeks of SR or HS, will indicate increased activity in networks associated with reward and food valuation (insula, orbitofrontal cortex) during a period of SR relative to HS. These responses will be correlated with intakes of high carbohydrate and high fat foods (hypothesis 1a) and neuropeptide Y (NPY). Moreover, activation of the default mode network (DMN) will be suppressed to a lesser extent after SR compared to HS.
Aim 2. To determine the effects of SR, relative to HS, on energy expenditure (EE) via independent and complementary approaches.
- Hypothesis 2a. EE, assessed by doubly-labeled water (DLW), and physical activity level, monitored daily by actigraphy, will be lower during SR relative to HS.
- Hypothesis 2b. Brown adipose tissue (BAT), assessed by positron emission tomography and magnetic resonance combined scanner (PET/MR) using 18F-fluorodeoxyglucose (18FDG-PET) and fat fraction (FF) measurement under cold stimulation, will be greater after SR relative to HS. This would suggest higher adaptive thermogenesis after SR compared to HS. BAT activation will also be correlated with NPY.
Aim 3. To determine whether SR alters body weight and adiposity relative to HS.
- Hypothesis 3a. SR will lead to weight gain and increased total adiposity, as assessed using magnetic resonance imaging (MRI), relative to HS.
- Hypothesis 3b. Increased adiposity after SR will be correlated to an adverse cardio-metabolic risk profile (increased glucose, insulin, triglycerides, leptin, reduced high-density lipoprotein cholesterol and adiponectin) and neuronal responses to food stimuli (Hypothesis 1b), and EE (Hypothesis 2a \& 2b). Failure to stimulate BAT with SR will be associated with greater gain in adiposity.
Read the detailed description
There is an association between short sleep duration (SSD) and obesity. Moreover, short sleepers (<7 hours sleep/night) gain more weight over time than normal sleepers (7-8 hours sleep/night). These relationships are increasingly supported by clinical data showing that restricting sleep duration in healthy, normal weight adults, increases energy intake (EI).
- Conditions
- Sleep Deprivation, Obesity
- Being tested
- Partial Sleep Restriction, Total Sleep Deprivation, Habitual Sleep
- Keywords
- sleep restriction, obesity, brown adipose tissue
- Medical subject headings
- Sleep Deprivation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Sleep RestrictionBehavioural
Also called PSR
4 hour time in bed (TIB), participants will go to bed 4 hours later than during the HS condition. Wake-up times will be the same. During the in-lab portion of the PSR, meals, fulfilling weight-maintenance energy requirements, will be supplied by the research staff as BOOST shakes.
Total Sleep DeprivationBehavioural
Also called TSD
0 hour time in bed (TIB), participants will remain awake throughout the night. Meals will be provided as BOOST shakes at the same meal.
Habitual SleepBehavioural
Also called HS
8 hours time in bed (TIB), for 3 nights, with fixed bed and wake times, while at home. During the 3-d HS phase, participants will be provided will BOOST meal replacement shakes in amounts required to achieve weight maintenance.
| Study group | Role | What they receive |
|---|---|---|
| PSR-TSD | Experimental | Partial sleep restriction (PSR) followed by total sleep deprivation (TSD). Experimental procedures will begin with a 3-day period of habitual sleep (HS). Receives: Behavioral: Partial Sleep Restriction; Behavioral: Total Sleep Deprivation; Behavioral: Habitual Sleep |
| TSD-PSR | Experimental | Total sleep deprivation (TSD) followed by partial sleep restriction (PSR). Experimental procedures will begin with a 3-day period of habitual sleep (HS). Receives: Behavioral: Partial Sleep Restriction; Behavioral: Total Sleep Deprivation; Behavioral: Habitual Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Brown adipose tissue (BAT) in 6 weeks
Assessed by positron emission tomography and magnetic resonance combined scanner (PET/MR) using 18F-fluorodeoxyglucose (18FDG-PET). Fat fraction (FF) measurement under cold stimulation is to be measured.
Measured: 6 weeks
Secondary outcomes (2)
Difference in weight from baseline at 6 weeks
Assessed by body composition and anthropometric measurements.
Measured: 6 weeks
Difference in Glucose level from baseline at 6 weeks
Assessed by fasting blood samples
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- New York University
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, Ph.D, Principal investigator, Assistant Professor of Nutritional Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770118
- Sponsor's protocol ID
- AAAQ1008
- Acronym
- BAT
- Status last verified
- Jul 2017
- First submitted
- 10 Feb 2016
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Restriction on BAT Activation in Humans
- ClinicalTrials.gov ID
- NCT02770118
- Acronym / sponsor ID
- BAT / AAAQ1008
- Conditions
- Sleep Deprivation, Obesity
- Keywords
- sleep restriction, obesity, brown adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- New York University
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 May 2016 (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.
The goal of this proposed research is to test the hypothesis that long-term mild sleep restriction (SR), as occurs frequently in adults and adolescents, leads to a positive energy balance and weight gain.
Aim 1. To determine the effects of SR, relative to habitual sleep (HS), on food choice and energy intake (EI) in adults at risk of obesity.
- Hypothesis 1a. EI, assessed by multiple weekly 24-hour recalls, will be greater during a period of SR relative to HS. This will be mostly due to increased fat and carbohydrate intakes.
- Hypothesis 1b. Neuronal responses to food stimuli, assessed by functional MRI (fMRI) after 6 weeks of SR or HS, will indicate increased activity in networks associated with reward and food valuation (insula, orbitofrontal cortex) during a period of SR relative to HS. These responses will be correlated with intakes of high carbohydrate and high fat foods (hypothesis 1a) and neuropeptide Y (NPY). Moreover, activation of the default mode network (DMN) will be suppressed to a lesser extent after SR compared to HS.
Aim 2. To determine the effects of SR, relative to HS, on energy expenditure (EE) via independent and complementary approaches.
- Hypothesis 2a. EE, assessed by doubly-labeled water (DLW), and physical activity level, monitored daily by actigraphy, will be lower during SR relative to HS.
- Hypothesis 2b. Brown adipose tissue (BAT), assessed by positron emission tomography and magnetic resonance combined scanner (PET/MR) using 18F-fluorodeoxyglucose (18FDG-PET) and fat fraction (FF) measurement under cold stimulation, will be greater after SR relative to HS. This would suggest higher adaptive thermogenesis after SR compared to HS. BAT activation will also be correlated with NPY.
Aim 3. To determine whether SR alters body weight and adiposity relative to HS.
- Hypothesis 3a. SR will lead to weight gain and increased total adiposity, as assessed using magnetic resonance imaging (MRI), relative to HS.
- Hypothesis 3b. Increased adiposity after SR will be correlated to an adverse cardio-metabolic risk profile (increased glucose, insulin, triglycerides, leptin, reduced high-density lipoprotein cholesterol and adiponectin) and neuronal responses to food stimuli (Hypothesis 1b), and EE (Hypothesis 2a \& 2b). Failure to stimulate BAT with SR will be associated with greater gain in adiposity.
Detailed description
There is an association between short sleep duration (SSD) and obesity. Moreover, short sleepers (<7 hours sleep/night) gain more weight over time than normal sleepers (7-8 hours sleep/night). These relationships are increasingly supported by clinical data showing that restricting sleep duration in healthy, normal weight adults, increases energy intake (EI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSR-TSD | Experimental | Behavioral: Partial Sleep Restriction, Behavioral: Total Sleep Deprivation, Behavioral: Habitual SleepPartial sleep restriction (PSR) followed by total sleep deprivation (TSD). Experimental procedures will begin with a 3-day period of habitual sleep (HS). |
| TSD-PSR | Experimental | Behavioral: Partial Sleep Restriction, Behavioral: Total Sleep Deprivation, Behavioral: Habitual SleepTotal sleep deprivation (TSD) followed by partial sleep restriction (PSR). Experimental procedures will begin with a 3-day period of habitual sleep (HS). |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Normal scores on:
- Sleep 7-9 hours in bed/night with no daytime nap
- Age 20-49 years, premenopausal women
- All racial/ethnic groups
- Body mass index 25-29.9 kg/m2
Key exclusion criteria (10 listed)
- Smokers (any cigarettes or ex-smoker <3 years)
- Neurological, medical or psychiatric disorder, diabetics
- Eating and/or sleep disorders
- Contraindications for MRI scanning
- Travel across time zones within 4 weeks
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 |
|---|---|---|
| Partial Sleep RestrictionAlso: PSR4 hour time in bed (TIB), participants will go to bed 4 hours later than during the HS condition. Wake-up times will be the same. During the in-lab portion of the PSR, meals, fulfilling weight-maintenance energy requirements, will be supplied by the research staff as BOOST shakes. | Behavioural | PSR-TSD, TSD-PSR |
| Total Sleep DeprivationAlso: TSD0 hour time in bed (TIB), participants will remain awake throughout the night. Meals will be provided as BOOST shakes at the same meal. | Behavioural | PSR-TSD, TSD-PSR |
| Habitual SleepAlso: HS8 hours time in bed (TIB), for 3 nights, with fixed bed and wake times, while at home. During the 3-d HS phase, participants will be provided will BOOST meal replacement shakes in amounts required to achieve weight maintenance. | Behavioural | PSR-TSD, TSD-PSR |
Primary outcome
Change from baseline Brown adipose tissue (BAT) in 6 weeks
Time frame: 6 weeks
Assessed by positron emission tomography and magnetic resonance combined scanner (PET/MR) using 18F-fluorodeoxyglucose (18FDG-PET). Fat fraction (FF) measurement under cold stimulation is to be measured.
2 secondary outcomes
Difference in weight from baseline at 6 weeks
Time frame: 6 weeks
Difference in Glucose level from baseline at 6 weeks
Time frame: 6 weeks
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 19 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Marie-Pierre St-Onge, Ph.D principal investigator
Assistant Professor of Nutritional Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial Sleep Restriction, Total Sleep Deprivation and Habitual Sleep in people with Sleep Deprivation and Obesity, run by Columbia University 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 12 inclusion and 10 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 19 Jul 2017. 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 from baseline Brown adipose tissue (BAT) in 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2017.