Effects of Sleep Restriction on BAT Activation in Humans
NCT ID: NCT02770118
Last Updated: 2017-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
4 participants
INTERVENTIONAL
2016-01-31
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Sleep Restriction on Performance in Adults
NCT02960776
Sleep Timing on Energy Intake and Energy Expenditure
NCT05096585
Sleep Restriction and Obesity
NCT01580761
The Impact of Sleep Restriction on Gastric Emptying, Appetite and Energy Intake
NCT05953285
Sleep Deprivation and Energy Balance
NCT01334788
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PSR-TSD
Partial sleep restriction (PSR) followed by total sleep deprivation (TSD). Experimental procedures will begin with a 3-day period of habitual sleep (HS).
Partial Sleep Restriction
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 Deprivation
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 Sleep
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.
TSD-PSR
Total sleep deprivation (TSD) followed by partial sleep restriction (PSR). Experimental procedures will begin with a 3-day period of habitual sleep (HS).
Partial Sleep Restriction
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 Deprivation
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 Sleep
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Partial Sleep Restriction
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 Deprivation
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 Sleep
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pittsburgh Quality of Sleep Questionnaire
* Epworth Sleepiness Scale
* Berlin Questionnaire
* Sleep Disorders Inventory Questionnaire
* Beck Depression Inventory
* 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
Exclusion Criteria
* 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
* 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
20 Years
49 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
New York University
OTHER
Columbia University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marie-Pierre St-Onge
Assistant Professor of Nutritional Medicine, Dept of Medicine Endocrinology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marie-Pierre St-Onge, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Nutritional Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
New York Nutrition Obesity Research Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AAAQ1008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.