NCT02247076

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

September 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

3.1 years

First QC Date

September 19, 2014

Last Update Submit

March 15, 2018

Conditions

Meal Timing

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure (calories burned)

    2 days

Secondary Outcomes (1)

  • Blood sugar levels

    2 days

Study Arms (2)

Grazing

PLACEBO COMPARATOR

Participants will eat meals spread over the course of the day ("grazing").

Behavioral: Grazing

Time-restricted feeding (early eating)

EXPERIMENTAL

Participants will eat meals only in the early part of the day (early lunch and very early dinner).

Behavioral: Time-restricted feeding (early eating)

Interventions

GrazingBEHAVIORAL
Grazing
Time-restricted feeding (early eating)BEHAVIORAL
Time-restricted feeding (early eating)

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

  • Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

    PMID: 33512717DERIVED

  • Ravussin E, Beyl RA, Poggiogalle E, Hsia DS, Peterson CM. Early Time-Restricted Feeding Reduces Appetite and Increases Fat Oxidation But Does Not Affect Energy Expenditure in Humans. Obesity (Silver Spring). 2019 Aug;27(8):1244-1254. doi: 10.1002/oby.22518.

    PMID: 31339000DERIVED

Study Officials

  • Courtney M Peterson, PhD, MSc

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

September 19, 2014

First Posted

September 23, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

March 16, 2018

Record last verified: 2018-03

Locations

US(1)