NCT01751581

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 2, 2013

Status Verified

December 1, 2011

Enrollment Period

1.1 years

First QC Date

June 6, 2012

Last Update Submit

August 1, 2013

Conditions

Keywords

ObesityResting Metabolic RateSleepEating

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 COMPARATOR

Women sleep 8 h/night throughout the study phase

Behavioral: Habitual sleep

Short Sleep

EXPERIMENTAL

Women sleep 4 h/night throughout the study phase

Behavioral: Short Sleep

Interventions

Short SleepBEHAVIORAL

Participants will be restricted in sleep and only allowed to sleep from 1 am to 5 am.

Short Sleep
Habitual sleepBEHAVIORAL

Participants sleep 8 h/night throughout the study phase (from 11 pm to 7 am)

Habitual Sleep

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-Pierre St. Onge, PhD

    St. Luke's Roosevelt Hospital/Columbia University

    PRINCIPAL INVESTIGATOR

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

Locations