## Protocol Section
### Identification Module
**NCT ID:** NCT01895179

**Acronym:** TIMED EATING

**Brief Title:** Comparison of Time-Restricted Feeding Versus Grazing

**Official Title:** Time-Restricted Feeding to Improve Glucose Tolerance and Vascular Condition

#### Organization Study ID Info
**ID:** PBRC 13017
#### Organization
**Class:** OTHER
**Full Name:** Pennington Biomedical Research Center
### Status Module
#### Completion Date
**Date:** 2017-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-03-16

**Type:** ACTUAL

**Last Update Submit Date:** 2018-03-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-11

**Type:** ACTUAL

#### Start Date
**Date:** 2013-07

**Status Verified Date:** 2018-03

#### Study First Post Date
**Date:** 2013-07-10
**Type:** ESTIMATED
**Study First Submit Date:** 2013-07-03
**Study First Submit QC Date:** 2013-07-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Pennington Biomedical Research Center

#### Responsible Party

**Investigator Affiliation:** Pennington Biomedical Research Center

**Investigator Full Name:** Courtney Peterson

**Investigator Title:** Instructor

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**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 Module

**Conditions:**

- Prediabetes

- Insulin Resistance

- Vascular Diseases

**Keywords:**

- Time-restricted feeding

- Intermittent fasting

- Prediabetes

- Insulin resistance

- Glucose tolerance

- Insulin sensitivity

- Circadian rhythms

- Diurnal

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 8

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Time-Restricted Feeding

**Label:** Time-Restricted Feeding (early in the day eating)

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Grazing

**Label:** Grazing

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Time-Restricted Feeding (early in the day eating)

**Description:** 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.

**Name:** Time-Restricted Feeding

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Grazing

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

**Name:** Grazing

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Change in Glucose Tolerance

**Time Frame:** Before and after 5 weeks on each feeding schedule

#### Secondary Outcomes

**Description:** 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.

**Measure:** Change in Vascular Function

**Time Frame:** Before and after 5 weeks on each feeding schedule

**Description:** Serum markers of inflammation, such as C-Reactive Protein (CRP) and inflammatory cytokines, and of metabolic processes will be measured (composite measure).

**Measure:** Change in Inflammation and Metabolic Markers

**Time Frame:** Before and after 5 weeks on each feeding schedule

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 35 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Baton Rouge

**Country:** United States

**Facility:** Pennington Biomedical Research Center

**State:** Louisiana

**Zip:** 70808

### References Module

#### References

**Citation:** 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 Section

### Condition Browse Module - Ancestors

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006943

- Term: Hyperglycemia

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

### Condition Browse Module - Browse Leaves

- ID: M10370

- Name: Insulin Resistance

- Relevance: HIGH

- As Found: Insulin Resistance

- ID: M17400

- Name: Vascular Diseases

- Relevance: HIGH

- As Found: Vascular Disease

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14117

- Name: Prediabetic State

- Relevance: HIGH

- As Found: Prediabetes

- ID: M20295

- Name: Glucose Intolerance

- Relevance: HIGH

- As Found: Prediabetes

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9994

- Name: Hyperglycemia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014652

- Term: Vascular Diseases

- ID: D000007333

- Term: Insulin Resistance

- ID: D000011236

- Term: Prediabetic State

- ID: D000018149

- Term: Glucose Intolerance

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
