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Comparison of Time-Restricted Feeding Versus Grazing (TIMED EATING)

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ClinicalTrials.gov Identifier: NCT01895179
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Courtney Peterson, Pennington Biomedical Research Center

Tracking Information
First Submitted Date  ICMJE July 3, 2013
First Posted Date  ICMJE July 10, 2013
Last Update Posted Date March 16, 2018
Study Start Date  ICMJE July 2013
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
Change in Glucose Tolerance [ Time Frame: Before and after 5 weeks on each feeding schedule ]
Glucose tolerance and indices of glucose homeostasis will be determined using an Oral Glucose Tolerance Test (OGTT).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
  • Change in Vascular Function [ Time Frame: Before and after 5 weeks on each feeding schedule ]
    Macro- and micro-vascular function will be assessed by Radial Artery Applanation Tonometry and by Orthogonal Polarization Spectroscopy. The endpoints measured by these two tests include aortic blood pressure, arterial stiffness, capillary density, and red blood cell velocity.
  • Change in Inflammation and Metabolic Markers [ Time Frame: Before and after 5 weeks on each feeding schedule ]
    Serum markers of inflammation, such as C-Reactive Protein (CRP) and inflammatory cytokines, and of metabolic processes will be measured (composite measure).
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 Comparison of Time-Restricted Feeding Versus Grazing
Official Title  ICMJE Time-Restricted Feeding to Improve Glucose Tolerance and Vascular Condition
Brief Summary

The purpose of this pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the body's ability to control blood sugar and to the health of its blood vessels.

The investigators hypothesize that time-restricted feeding will be more effective at improving glucose tolerance and vascular condition (inflammation and micro- and macro-vascular function) than grazing.

Detailed Description Each participant will eat according to one of the two eating schedules (grazing or time-restricted feeding) for 5 weeks, have a 7-week washout period, and then eat according to the other eating schedule for 5 weeks. Measurements of glucose homeostasis and vascular condition will be performed before and after a participant follows each eating schedule.
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
  • Prediabetes
  • Insulin Resistance
  • Vascular Diseases
Intervention  ICMJE
  • Other: Time-Restricted Feeding
    Time-restricted feeding is a variant of intermittent fasting that involves eating all of one's calories within a few hours each day (typically 4-9 hours), followed by a daily fast of 15-20 hours.
  • Other: Grazing
    Grazing involves eating meals spread out over the course of the day.
Study Arms  ICMJE
  • Experimental: Time-Restricted Feeding (early in the day eating)
    Participants will consume all meals early in the day and within a 6-hour window.
    Intervention: Other: Time-Restricted Feeding
  • Placebo Comparator: Grazing
    Participants will eat meals spread out over the course of the day.
    Intervention: Other: Grazing
Publications * 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:CD013496. doi: 10.1002/14651858.CD013496.pub2.

*   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: July 9, 2013)
8
Original Estimated Enrollment  ICMJE Same as current
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 male
  • Overweight: Have a body mass index between 25 and 50 kg/m^2 inclusive (a number calculated from height and weight)
  • Are 35-70 years of age
  • Have a hemoglobin A1C between 5.5 - 6.4% or prior medical indication of prediabetes
  • Have a blood sugar level between 140 and 199 mg/dL two hours after drinking a sugary solution (OGTT)
  • Have been eating dinner at least 8.5 hours after eating breakfast at least 90% of the time during the past year
  • Have not fasted (go for a day without any food) more than 12 days total during the past year
  • Be willing to eat most meals at Pennington Biomedical and/or under supervision
  • Not eat any food other than that served by Pennington Biomedical
  • Not drink any alcohol, juice, or other beverages that have calories other than what is served by Pennington Biomedical
  • Keep water and no-calorie drinks like tea or diet soda the same during both of the timed eating periods
  • Be willing to eat your meals according to the fixed schedules

Exclusion Criteria:

  • Have diabetes or are on anti-diabetes medication
  • Have evidence of cardiovascular disease
  • Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
  • Evidence of significant gastrointestinal issues or surgery that impacts nutrient absorption
  • Regularly use medications such as steroids, beta blockers, and adrenergic-stimulating agents
  • Are on any regular medicine that has not had the same dose for 1 month or longer
  • Have a clinically significant abnormality as measured by a blood test
  • Regularly drink alcohol (more than 2 servings per day)
  • Have to do any kind of heavy physical activity
  • Currently perform overnight shift work more than one day a week
  • Are not able to eat only the food served to you by Pennington Biomedical, while in the study
  • Are not able to stop drinking alcohol or other drinks with calories (e.g., soda, juice) other than what is served to you by Pennington Biomedical, while in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 70 Years   (Adult, Older 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 NCT01895179
Other Study ID Numbers  ICMJE PBRC 13017
Has Data Monitoring Committee Not Provided
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 Same as current
Current Study Sponsor  ICMJE Pennington Biomedical Research Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
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