Comparison of Time-Restricted Feeding Versus Grazing

NCT01895179 | Completed

• 1 other identifier: PBRC 13017
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes; Insulin Resistance; Vascular Diseases

Keywords

Time-restricted feeding; Intermittent fasting; Prediabetes; Insulin resistance; Glucose tolerance; Insulin sensitivity; Circadian rhythms; Diurnal

Outcome Measures

Primary Outcomes (1)

• Change in Glucose Tolerance

  Glucose tolerance and indices of glucose homeostasis will be determined using an Oral Glucose Tolerance Test (OGTT).

  Before and after 5 weeks on each feeding schedule

Secondary Outcomes (2)

• Change in Vascular Function

  Before and after 5 weeks on each feeding schedule

• Change in Inflammation and Metabolic Markers

  Before and after 5 weeks on each feeding schedule

Study Arms (2)

Time-Restricted Feeding (early in the day eating)

EXPERIMENTAL

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

Other: Time-Restricted Feeding

Grazing

PLACEBO COMPARATOR

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

Other: Grazing

Interventions

Time-Restricted Feeding 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.

Time-Restricted Feeding (early in the day eating)

Grazing OTHER

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

Grazing

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• 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: 33512717 DERIVED

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Vascular Diseases; Intermittent Fasting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Cardiovascular Diseases; Fasting; Feeding Behavior; Behavior

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: July 3, 2013
• First Posted: July 10, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 16, 2018

Record last verified: 2018-03

Locations

US (1)