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Sleep Restriction and Energy Expenditure

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short Sleep
Habitual sleep
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Resting Metabolic Rate, Sleep, Eating

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 21-45 yrs
  • Non-pregnant, non-lactating female subjects
  • Body mass index (BMI) 25-28 kg/m2
  • Weight stable (± 2.5 kg) for at least 3 mo prior to evaluation
  • If a woman of child-bearing potential, must be willing to adhere to an acceptable form of contraception
  • Non-smoker
  • Regularly sleeps 7-8.5 hours/night
  • If taking any form of medication, other than those listed in the exclusion criteria, must have been stable and remain on the same medication and medication dose throughout the study

Exclusion Criteria:

  • Diabetes, uncontrolled hypertension
  • Attempted to lose weight in past 3 months
  • Eating disorder
  • Stroke, seizure disorder, or other significant neurological disease;
  • HIV positive by self-report
  • Unstable or uncontrolled medical illness including active malignancies within past 5 yrs
  • Untreated or unstable hypothyroidism
  • Hyperthyroidism
  • A score on the Brief Psychiatric Inventory that exceeds the 90th percentile;
  • Subjects with psychoses, bipolar disorder, major depression, severe personality disorders, suicidal
  • Alcohol or substance abuse in the past 6 mo
  • Pregnant, planning pregnancy in the next 6 mo, or breast-feeding
  • Participating in a commercial diet or behavior modification program (e.g., Weight Watchers), or plans to participate
  • Shift worker, commercial long-distance driver, heavy equipment operator, history of drowsy driving
  • Takes naps regularly
  • Has traveled across time zones in the past 4 weeks or plans to during the weeks of the study
  • Excessive caffeine intake

Sites / Locations

  • St. Luke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Habitual Sleep

Short Sleep

Arm Description

Women sleep 8 h/night throughout the study phase

Women sleep 4 h/night throughout the study phase

Outcomes

Primary Outcome Measures

Resting Metabolic Rate
Metabolic rate from 11 pm on day 2 until 7 am on the morning of day 4 will be measured in a metabolic chamber. The metabolic chamber is an air-tight room (22,000 l volume) equipped with a bed, chair, desk, television, VCR, telephone, treadmill, sink and toilet. All meals and snacks will be served at the scheduled time. Subjects will be asked to perform 30 min of light physical activity at 1500 h and 2030 h. Physical activity will consist of 30 min of cycling at 12 mi/h. Bedtimes will be the same as the previous night and actigraph monitoring will be used to confirm compliance with the sleep protocol. Women will exit the chamber at 0700 h the following day.

Secondary Outcome Measures

Post Prandial Energy Expenditure and Thermic Effect of Food
Energy expenditure will be measured from 8 am until approximately 2:30 pm on day. Resting metabolic rate over 45 minutes will be measured at 8 am, followed by breakfast and resumption of energy expenditure measurements postprandially. Participants will be given 15 min to consume a high-fat breakfast (50% of energy from fat) and post-prandial thermogenesis and substrate oxidation will be measured for the next 6 h.

Full Information

First Posted
June 6, 2012
Last Updated
August 1, 2013
Sponsor
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT01751581
Brief Title
Sleep Restriction and Energy Expenditure
Official Title
The Effect of Sleep Reduction on Daily Energy Expenditure, Thermic Effect of Food, and Substrate Oxidation in Overweight Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Each 4-day period will follow the same protocol. Basically, for the entire study, we will prepare all of the subject's food and will require him or her to eat all of the food that we give at the times we tell them to eat. The subject will arrive at the hospital on the evening of day 1, and become inpatients. On day 2, the subject will be permitted to leave the hospital campus under the supervision of the research staff. On day 3, they will be required to stay in a small room called a metabolic chamber for 24 hours. This room measures how many calories you burn in one day. On day 4, we will measure the subject's energy expenditure in response to a breakfast meal. They will be given breakfast and the number of calories that they burn after that meal will be measured over a 6-hour period. Then the subject will be discharged at the end of the test. The 2 study periods will differ only in bedtimes and wakeup times. During one period, the subject will go to bed at 1 am and wake up at 5 am and during the other period they will go to bed at 11 pm and wake up at 7 am.
Detailed Description
Sleeping metabolic rate will be measured using a metabolic chamber on the night of day 2. During day 3, 24-hour energy expenditure (including a second night of measurement) will be measured in the metabolic chamber. On this day, the participant will perform 2 bouts of physical activity on a stationary bicycle for 15 minutes each bout. This will give us a measurement of physical activity energy expenditure. On day 4, at 7 am, the participant will exit the metabolic chamber and will enter a different, smaller metabolic chamber for the measurement of energy expenditure in response to a meal. This measurement will start at approximately 8 am with assessment of the resting metabolic rate (45 minutes). The participant will then be given a high-fat meal replacement to consume over 10 minutes. Energy expenditure measurements continue in the metabolic chamber for a 6-hour period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Resting Metabolic Rate, Sleep, Eating

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Habitual Sleep
Arm Type
Active Comparator
Arm Description
Women sleep 8 h/night throughout the study phase
Arm Title
Short Sleep
Arm Type
Experimental
Arm Description
Women sleep 4 h/night throughout the study phase
Intervention Type
Behavioral
Intervention Name(s)
Short Sleep
Intervention Description
Participants will be restricted in sleep and only allowed to sleep from 1 am to 5 am.
Intervention Type
Behavioral
Intervention Name(s)
Habitual sleep
Intervention Description
Participants sleep 8 h/night throughout the study phase (from 11 pm to 7 am)
Primary Outcome Measure Information:
Title
Resting Metabolic Rate
Description
Metabolic rate from 11 pm on day 2 until 7 am on the morning of day 4 will be measured in a metabolic chamber. The metabolic chamber is an air-tight room (22,000 l volume) equipped with a bed, chair, desk, television, VCR, telephone, treadmill, sink and toilet. All meals and snacks will be served at the scheduled time. Subjects will be asked to perform 30 min of light physical activity at 1500 h and 2030 h. Physical activity will consist of 30 min of cycling at 12 mi/h. Bedtimes will be the same as the previous night and actigraph monitoring will be used to confirm compliance with the sleep protocol. Women will exit the chamber at 0700 h the following day.
Time Frame
32 hours
Secondary Outcome Measure Information:
Title
Post Prandial Energy Expenditure and Thermic Effect of Food
Description
Energy expenditure will be measured from 8 am until approximately 2:30 pm on day. Resting metabolic rate over 45 minutes will be measured at 8 am, followed by breakfast and resumption of energy expenditure measurements postprandially. Participants will be given 15 min to consume a high-fat breakfast (50% of energy from fat) and post-prandial thermogenesis and substrate oxidation will be measured for the next 6 h.
Time Frame
8 hours on day 4

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 21-45 yrs Non-pregnant, non-lactating female subjects Body mass index (BMI) 25-28 kg/m2 Weight stable (± 2.5 kg) for at least 3 mo prior to evaluation If a woman of child-bearing potential, must be willing to adhere to an acceptable form of contraception Non-smoker Regularly sleeps 7-8.5 hours/night If taking any form of medication, other than those listed in the exclusion criteria, must have been stable and remain on the same medication and medication dose throughout the study Exclusion Criteria: Diabetes, uncontrolled hypertension Attempted to lose weight in past 3 months Eating disorder Stroke, seizure disorder, or other significant neurological disease; HIV positive by self-report Unstable or uncontrolled medical illness including active malignancies within past 5 yrs Untreated or unstable hypothyroidism Hyperthyroidism A score on the Brief Psychiatric Inventory that exceeds the 90th percentile; Subjects with psychoses, bipolar disorder, major depression, severe personality disorders, suicidal Alcohol or substance abuse in the past 6 mo Pregnant, planning pregnancy in the next 6 mo, or breast-feeding Participating in a commercial diet or behavior modification program (e.g., Weight Watchers), or plans to participate Shift worker, commercial long-distance driver, heavy equipment operator, history of drowsy driving Takes naps regularly Has traveled across time zones in the past 4 weeks or plans to during the weeks of the study Excessive caffeine intake
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre St. Onge, PhD
Organizational Affiliation
St. Luke's Roosevelt Hospital/Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10026
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24088722
Citation
Shechter A, Rising R, Albu JB, St-Onge MP. Experimental sleep curtailment causes wake-dependent increases in 24-h energy expenditure as measured by whole-room indirect calorimetry. Am J Clin Nutr. 2013 Dec;98(6):1433-9. doi: 10.3945/ajcn.113.069427. Epub 2013 Oct 2.
Results Reference
derived

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Sleep Restriction and Energy Expenditure

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