Effects of Sleep Restriction on BAT Activation in Humans (BAT)

July 17, 2017 updated by: Marie-Pierre St-Onge, Columbia University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

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

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York Nutrition Obesity Research Center

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

20 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal scores on:

    • 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:

  • 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
  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Behavioral: 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.
Other Names:
  • PSR
Behavioral: 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.
Other Names:
  • TSD
Behavioral: 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 Names:
  • HS
Experimental: 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).
Behavioral: 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.
Other Names:
  • PSR
Behavioral: 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.
Other Names:
  • TSD
Behavioral: 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 Names:
  • HS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in weight from baseline at 6 weeks
Time Frame: 6 weeks
Assessed by body composition and anthropometric measurements.
6 weeks
Difference in Glucose level from baseline at 6 weeks
Time Frame: 6 weeks
Assessed by fasting blood samples
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

New York University

Investigators

  • Principal Investigator: Marie-Pierre St-Onge, Ph.D, Assistant Professor of Nutritional Medicine

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 (Actual)

January 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAQ1008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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