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History of Changes for Study: NCT01895179
Comparison of Time-Restricted Feeding Versus Grazing (TIMED EATING)
Latest version (submitted March 15, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 9, 2013 None (earliest Version on record)
2 August 28, 2013 Recruitment Status, Study Status, Contacts/Locations and Eligibility
3 February 21, 2014 Study Status and Eligibility
4 April 5, 2014 Study Status, Arms and Interventions, Eligibility, Study Description and Study Identification
5 October 17, 2014 Study Status and Eligibility
6 April 28, 2015 Study Status and Eligibility
7 November 12, 2015 Study Status
8 February 3, 2016 Study Status and Study Identification
9 August 15, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 March 15, 2018 Study Status
Comparison Format:

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Study NCT01895179
Submitted Date:  July 9, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: PBRC13017
Brief Title: Comparison of Time-Restricted Feeding Versus Grazing (TIMED EATING)
Official Title: Time-Restricted Feeding to Improve Glucose Tolerance and Vascular Condition in Obese Humans
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2013
Overall Status: Not yet recruiting
Study Start: July 2013
Primary Completion: September 2014 [Anticipated]
Study Completion: November 2014 [Anticipated]
First Submitted: July 3, 2013
First Submitted that
Met QC Criteria:
July 9, 2013
First Posted: July 10, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 9, 2013
Last Update Posted: July 10, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Pennington Biomedical Research Center
Responsible Party: Principal Investigator
Investigator: Courtney Peterson
Official Title: Instructor
Affiliation: Pennington Biomedical Research Center
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

The purpose of this pilot study is to find out what eating meals in a short time period (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.
Open or close this module Conditions
Conditions: Prediabetes
Insulin Resistance
Vascular Diseases
Keywords: Time-restricted feeding
Intermittent fasting
Prediabetes
Insulin resistance
Glucose tolerance
Insulin sensitivity
Circadian rhythms
Diurnal
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 8 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Condensed Eating (Time-Restricted Feeding)
Participants will consume all meals within about 6 hours each day.
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: Spread Out Eating (Grazing)
Participants will eat meals spread out over the course of the day.
Grazing
Grazing involves eating meals spread out over the course of the day.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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).
Secondary Outcome Measures:
1. 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.
2. 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).
Open or close this module Eligibility
Minimum Age: 30 Years
Maximum Age: 65 Years
Sex: Male
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Are male
  • Have a body mass index equal to or above 30 kg/m^2 (a number calculated from height and weight)
  • Are 30-65 years of age
  • Have a fasting blood sugar (glucose) level between 95 and 125 mg/dL
  • Have a blood sugar level between 140 and 180 mg/dL two hours after drinking a sugary solution (OGTT)
  • Have been eating 3 or more meals a day at least 90% of the time during the past year
  • Have been eating dinner at least 9.5 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
  • Exercise less than 3 hours per week
  • Have not gained or lost more than 5 pounds of weight during the last 3 months
  • Be willing to eat all meals at Pennington Biomedical
  • 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 a fasting blood sugar less than 95 mg/dL or greater than 125 mg/dL
  • Have a blood sugar level below 140 mg/dL or above 180 mg/dL two hours after drinking a sugary solution (OGTT)
  • Have evidence of cardiovascular disease
  • Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
  • Regularly use medications such as diuretics, 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) or smoke cigarettes (more than 1 cigarette per day)
  • Have to do any kind of heavy physical activity
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Courtney M Peterson, PhD, MSc
Telephone: 225-763-2785
Email: courtney.peterson@pbrc.edu
Locations: United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Contact:Principal Investigator: Courtney M Peterson, PhD, MSc
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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