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Does Meal Timing Affect Energy Expenditure (GRAZING)

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ClinicalTrials.gov Identifier: NCT02247076
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
The Obesity Society
Information provided by (Responsible Party):
Courtney Peterson, Pennington Biomedical Research Center

Tracking Information
First Submitted Date  ICMJE September 19, 2014
First Posted Date  ICMJE September 23, 2014
Last Update Posted Date March 16, 2018
Study Start Date  ICMJE October 2014
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
Energy expenditure (calories burned) [ Time Frame: 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
Blood sugar levels [ Time Frame: 2 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Meal Timing Affect Energy Expenditure
Official Title  ICMJE Does Meal Timing Affect Energy Expenditure
Brief Summary The purpose of this study is to find out if meal timing affects calories burned and blood sugar levels.
Detailed Description 10 overweight adult men and women will eat according to two different eating schedules: grazing and time-restricting feeding ("early eating"). While on each eating schedule, metabolism (calories burned) will be measured during a 24-hour stay in a respiratory chamber. Glucose levels-as well as key diurnal rhythms such in heart rate-will also be measured continuously. This study requires two 1-week periods of participation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meal Timing
Intervention  ICMJE
  • Behavioral: Grazing
  • Behavioral: Time-restricted feeding (early eating)
Study Arms  ICMJE
  • Placebo Comparator: Grazing
    Participants will eat meals spread over the course of the day ("grazing").
    Intervention: Behavioral: Grazing
  • Experimental: Time-restricted feeding (early eating)
    Participants will eat meals only in the early part of the day (early lunch and very early dinner).
    Intervention: Behavioral: Time-restricted feeding (early eating)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2016)
11
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2014)
10
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are 20-45 years of age
  • Have a weight between 150 and 220 lbs
  • Have a body mass index between 25 and 35 kg/m2 inclusive (a number calculated from your height and weight)
  • If you are a female, have a regular menstrual cycle that is between 25 and 35 days long
  • If you are female, had your period within the last 35 days
  • Regularly go to sleep between 9:30 pm and 12:00 am
  • Regularly eat dinner 9 or more hours after eating breakfast
  • Are willing to have about 2/3 cup of your blood stored for future research related to this study

Exclusion Criteria:

  • Have diabetes or are on anti-diabetes medication
  • Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
  • Have stomach or intestinal problems
  • Regularly use medications such as steroids, beta blockers, adrenergic-stimulating agents, and laxatives
  • Take any medications or supplements known to affect sleep, circadian rhythms, or metabolism (with the exception that certain forms of birth control are allowed)
  • Have abnormal lab work that is clinically significant in the opinion of the study physician
  • Are pregnant or lactating
  • Take the Depo Provera shot, or use an Interuterine Device (IUD) or hormone patch for birth control
  • If you are on hormonal birth control, have been on a stable dose for less than 3 months
  • Have smoked or used nicotine/tobacco products within the last 3 months
  • Regularly do competitive sport training
  • Perform overnight shift work an average of one or more times per week
  • Have an irregular sleep schedule
  • Have an irregular eating schedule
  • Regularly drink 3 or more drinks of alcohol per day
  • Are not able or are unwilling to eat only the food and drink served to you by Pennington Biomedical, while in the study
  • Are not able or are unwilling to refrain from strenuous exercise while participating in the study
  • Are not able to spend 2 separate full days (for about 25 hours each) at Pennington Biomedical
  • Are not able to maintain a consistent sleep schedule while participating in the study
  • Are not able to maintain a consistent eating schedule while participating in the study
  • Are not able to stop drinking coffee and other caffeine-containing drinks on the day of and day prior to testing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02247076
Other Study ID Numbers  ICMJE PBRC 2014-038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Courtney Peterson, Pennington Biomedical Research Center
Original Responsible Party Pennington Biomedical Research Center
Current Study Sponsor  ICMJE Pennington Biomedical Research Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE The Obesity Society
Investigators  ICMJE
Principal Investigator: Courtney M Peterson, PhD, MSc Pennington Biomedical Research Center
PRS Account Pennington Biomedical Research Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP