Sleep Deprivation and Energy Balance (Sleep)

February 22, 2011 updated by: St. Luke's-Roosevelt Hospital Center
Observational and epidemiological studies have found a link between obesity and short sleep duration with the prevalence of both increasing in the past decades. At this time, it is unknown whether short sleep is a cause of obesity and how short sleep would lead to obesity. Some studies associate short sleep with increased levels of hormone that stimulate appetite. This study will examine how food intake and energy expenditure can be modified by sleep duration as a means of understanding a potential causal pathway.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent epidemiological studies show that short sleep duration (≤5-7 h/night) correlates with overweight and obesity, such that individuals with short sleep periods tend to have a higher body mass index (BMI) than those who sleep 8-9 h/night. The mechanism for this relationship is currently unknown. However, energy balance must be disrupted to produce weight gain. Therefore, the purpose of this study is to examine the impact of short sleep duration, 4 h/night, relative to habitual sleep duration of 8-9 h/night, on energy balance. The major aims of this study are to compare energy expenditure and energy intake during the periods of habitual and short sleep duration and to examine the neural and hormonal pathways involved in eating behavior under periods of habitual and short sleep. Men and women, 30-45 y and BMI 22-25 kg/m2, will be recruited to participate in this randomized, crossover study of short and habitual sleep periods. During each period of 5 nights, subjects will be required to sleep at the laboratory under supervision. During this time, subjects will be total inpatients to ensure compliance with the protocol. Each sleep duration period will be separated by a 2-4-wk washout period. On the first day of each phase, subjects will be given a dose of doubly-labeled water to measure free-living energy expenditure over the 6-d period. During the first 4 days, energy intake will be controlled and meals served at fixed times. The last 2 days will be ad libitum feeding of self-selected meals. Hormones, including leptin, insulin, ghrelin, PYY, adiponectin, and GLP-1 will be assessed daily in the fasted state and, on day 4, over a 24-hour period, while subjects are consuming a controlled diet with fixed meal times. Functional magnetic resonance imaging measurements of brain activity in response to food stimuli will be done on day 5 to examine brain regions associated with motivation to eat. On day 5, subjects will undergo measurements of basal metabolic rate using indirect calorimetry. Ad libitum energy intakes will be assessed on days 5 and 6. Polysomnographic monitoring will be performed nightly to assess sleep duration. Mediation analyses will allow us to determine whether hormone levels are related to and predictive of energy expenditure and energy intake data. The measurements performed in this study will allow us to determine how reduced sleep periods can impact energy balance and potentially lead to changes in body weight. As such, it will provide comprehensive information of the neural, physiological, hormonal, and behavioral networks related to energy balance and which are affected by sleep duration.

Study Type

Interventional

Enrollment (Anticipated)

30

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, 10019
        • Clinilabs
      • New York, New York, United States, 10025
        • St. Luke's/Roosevelt Hospital
      • New York, New York, United States, 10036
        • Columbia University

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

30 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index 22-25 kg/m2
  • Right-handed
  • Sleep 7-9 hours/night
  • Normal score on Pittsburgh Quality of Sleep questionnaire, Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness

Exclusion Criteria:

  • Smoker
  • Neurological, medical, or psychiatric disorder
  • Diabetics
  • History of eating disorders
  • Sleep disorders
  • Travel across time zones within 4 weeks of the study
  • History of drug and alcohol abuse
  • Shift worker
  • Caffeine intake > 300 mg/d
  • Excessive daytime sleepiness
  • Regular napping
  • History of drowsy driving
  • Pregnancy or within 1 y post-partum
  • Heavy equipment operator or commercial long-distance driver
  • Contra-indications for MRI scanning

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: Short Sleep
Subjects are permitted to spend 4 hours in bed per night for 5 consecutive nights. Subjects are inpatients for a period of 6 days.
Behavioral: Sleep
Subjects are randomly assigned to one of 2 arms sequence: short followed by regular or regular followed by short. Each arm is 6 days in length and separated by a 2-4 week washout period.
Active Comparator: Regular Sleep
Subjects are permitted to spend 9 hours in bed per night for 5 nights. Subjects are inpatients for a period of 6 days.
Behavioral: Sleep
Subjects are randomly assigned to one of 2 arms sequence: short followed by regular or regular followed by short. Each arm is 6 days in length and separated by a 2-4 week washout period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resting metabolic rate
Time Frame: Day 5 of each arm
Day 5 of each arm
Food intake
Time Frame: Days 5-6 of each arm
Days 5-6 of each arm
Hormone Measurements
Time Frame: Daily fasting, and every 2 hours on day 4 of each arm
Daily fasting, and every 2 hours on day 4 of each arm
Regional brain activity
Time Frame: Day 6 of each arm
Day 6 of each arm
Energy expenditure
Time Frame: Each 6 day arm
Each 6 day arm

Collaborators and Investigators

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

Sponsor

St. Luke's-Roosevelt Hospital Center

Collaborators

Columbia University
National Institutes of Health (NIH)
Clinilabs, Inc.

Investigators

  • Principal Investigator: Marie-Pierre St-Onge, Ph.D, St. Luke's-Roosevelt Hospital Center

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.

General Publications

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

November 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 8, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL091352-01A1 (U.S. NIH Grant/Contract)

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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