A Study of Time Restricted Eating in Obese Adults

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05660291

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this pilot study is to understand the difference between early and late time-restricted eating on weight and body mass index (BMI), and evaluate the barriers encountered and the effect on quality of life.

Condition or Disease	Intervention/Treatment	Phase
Overweight	Behavioral: Early time-restricted eating Behavioral: Late time-restricted eating	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Time Restricted Eating on Obesity: Comparing Windows of Eating to Achieve Weight Loss in Overweight and Obese Adults; a Pilot Study

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early time-restricted eating Subjects window for eating would be between 08:00 AM - 4:00 PM	Behavioral: Early time-restricted eating Subjects can eat whatever they want between the hours of 8:00 AM and 4:00 PM and can only consume water, black coffee/tea, or other zero calorie drinks (artificial sweeteners are okay) outside your designated eating window (from 4:00 PM to 8:00 AM).
Experimental: Late time-restricted eating Subjects window for eating would be between 12:00 PM (noon) and 8:00 PM	Behavioral: Late time-restricted eating Subjects can eat whatever they want between the hours of 12:00 PM and 8:00 PM and can only consume water, black coffee/tea, or other zero calorie drinks (artificial sweeteners are okay) outside your designated eating window (from 8:00 PM to noon).

Arm

Intervention/Treatment

Experimental: Early time-restricted eating

Subjects window for eating would be between 08:00 AM - 4:00 PM

Behavioral: Early time-restricted eating

Subjects can eat whatever they want between the hours of 8:00 AM and 4:00 PM and can only consume water, black coffee/tea, or other zero calorie drinks (artificial sweeteners are okay) outside your designated eating window (from 4:00 PM to 8:00 AM).

Experimental: Late time-restricted eating

Subjects window for eating would be between 12:00 PM (noon) and 8:00 PM

Behavioral: Late time-restricted eating

Subjects can eat whatever they want between the hours of 12:00 PM and 8:00 PM and can only consume water, black coffee/tea, or other zero calorie drinks (artificial sweeteners are okay) outside your designated eating window (from 8:00 PM to noon).

Outcome Measures

Primary Outcome Measures

Change in weight [Baseline, 12 weeks]
Reported in kilograms (kg)

Secondary Outcome Measures

Change in Hemoglobin A1c [Baseline, 12 weeks]
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin
Change in fasting glucose [Baseline, 12 weeks]
Glucose (sugar) measured in the blood and reported in milligrams per deciliter (mg/dL).
Change in total cholesterol [Baseline, 12 weeks]
Blood sample taken to measure the sum of blood's cholesterol content and reported in milligrams/deciliter (mg/dL)
Change in Low-density lipoprotein (LDL) cholesterol [Baseline, 12 weeks]
LDL (bad) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)
Change in High-density lipoprotein (HDL) cholesterol [Baseline, 12 weeks]
HDL (good) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)
Change in Triglycerides [Baseline, 12 weeks]
Triglycerides levels measured in the blood and reported in milligrams/deciliter (mg/dL)
Subjects to complete study [Baseline, 12 weeks]
Total number of subjects to complete study per protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI ≥ to 25.

Exclusion Criteria:

Regularly skip meals.
Are unwilling or unable to limit eating to an 8-hour window.
Have a current cancer diagnosis.
Currently breastfeeding.
Pregnant, or planned to be pregnant within 3 months.
Are taking insulin or sulfonylurea drugs.
Are taking weight loss medications.
Have a history of eating disorders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Bradley Bohn, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Bradley A. Bohn, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05660291

Other Study ID Numbers:

22-010547

First Posted:

Dec 21, 2022

Last Update Posted:

Dec 21, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bradley A. Bohn, Principal Investigator, Mayo Clinic

Body Mass Index (BMI) ≥ 25 kg/m^2

Early and late time-restricted eating

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Dec 21, 2022