Comparison of Time-Restricted Feeding Versus Grazing

NCT ID: NCT01895179

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-11-30

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.

Conditions

Prediabetes; Insulin Resistance; Vascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Time-Restricted Feeding (early in the day eating)

Participants will consume all meals early in the day and within a 6-hour window.

Group Type: EXPERIMENTAL

Time-Restricted Feeding

Intervention Type: OTHER

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.

Grazing

Participants will eat meals spread out over the course of the day.

Group Type: PLACEBO_COMPARATOR

Grazing

Intervention Type: OTHER

Grazing involves eating meals spread out over the course of the day.

Interventions

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.

Intervention Type: OTHER

Grazing

Grazing involves eating meals spread out over the course of the day.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Courtney Peterson

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33512717 (View on PubMed)

Other Identifiers

PBRC 13017

Identifier Type: -

Identifier Source: org_study_id