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
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.
|Condition or disease||Intervention/treatment||Phase|
|Prediabetes Insulin Resistance Vascular Diseases||Other: Time-Restricted Feeding Other: Grazing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Time-Restricted Feeding to Improve Glucose Tolerance and Vascular Condition|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Experimental: Time-Restricted Feeding (early in the day eating)
Participants will consume all meals early in the day and within a 6-hour window.
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.
Placebo Comparator: Grazing
Participants will eat meals spread out over the course of the day.
Grazing involves eating meals spread out over the course of the day.
- 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).
- 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).
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): NCT01895179
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|