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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

Brief Summary:
The purpose of this study is to find out if meal timing affects calories burned and blood sugar levels.

Condition or disease Intervention/treatment Phase
Meal Timing Behavioral: Grazing Behavioral: Time-restricted feeding (early eating) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Meal Timing Affect Energy Expenditure
Study Start Date : October 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Placebo Comparator: Grazing
Participants will eat meals spread over the course of the day ("grazing").
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).
Behavioral: Time-restricted feeding (early eating)



Primary Outcome Measures :
  1. Energy expenditure (calories burned) [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Blood sugar levels [ Time Frame: 2 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247076


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
The Obesity Society
Investigators
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Principal Investigator: Courtney M Peterson, PhD, MSc Pennington Biomedical Research Center

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Responsible Party: Courtney Peterson, Instructor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02247076     History of Changes
Other Study ID Numbers: PBRC 2014-038
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018