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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02247076
Other study ID # PBRC 2014-038
Secondary ID
Status Completed
Phase N/A
First received September 19, 2014
Last updated March 15, 2018
Start date October 2014
Est. completion date November 2017

Study information

Verified date March 2018
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Grazing

Time-restricted feeding (early eating)


Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Pennington Biomedical Research Center The Obesity Society

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Energy expenditure (calories burned) 2 days
Secondary Blood sugar levels 2 days
See also
  Status Clinical Trial Phase
Completed NCT05391438 - Impact of Meal Timing on Glycemic Profile in Latino Adolescents With Obesity N/A
Recruiting NCT05276739 - Role of Photic and Non-photic Time Cues in Resetting Circadian Rhythms N/A