Sleep Restriction and Energy Expenditure
The Effect of Sleep Reduction on Daily Energy Expenditure, Thermic Effect of Food, and Substrate Oxidation in Overweight Women
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
December 18, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedAugust 2, 2013
December 1, 2011
1.1 years
June 6, 2012
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
32 hours
Secondary Outcomes (1)
Post Prandial Energy Expenditure and Thermic Effect of Food
8 hours on day 4
Study Arms (2)
Habitual Sleep
ACTIVE COMPARATORWomen sleep 8 h/night throughout the study phase
Short Sleep
EXPERIMENTALWomen sleep 4 h/night throughout the study phase
Interventions
Participants will be restricted in sleep and only allowed to sleep from 1 am to 5 am.
Participants sleep 8 h/night throughout the study phase (from 11 pm to 7 am)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Luke's Hospital
New York, New York, 10026, United States
Related Publications (1)
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.
PMID: 24088722DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-Pierre St. Onge, PhD
St. Luke's Roosevelt Hospital/Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2012
First Posted
December 18, 2012
Study Start
November 1, 2011
Primary Completion
December 1, 2012
Study Completion
April 1, 2013
Last Updated
August 2, 2013
Record last verified: 2011-12