A Study of Time Restricted Eating in Obese Adults

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight
• Intervention / Treatment: Behavioral: Early time-restricted eating; Behavioral: Late time-restricted eating

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to read and understand English
• BMI ≥ to 25.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight	Reported in kilograms (kg)	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c	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	Baseline, 12 weeks
Change in fasting glucose	Glucose (sugar) measured in the blood and reported in milligrams per deciliter (mg/dL).	Baseline, 12 weeks
Change in total cholesterol	Blood sample taken to measure the sum of blood's cholesterol content and reported in milligrams/deciliter (mg/dL)	Baseline, 12 weeks
Change in Low-density lipoprotein (LDL) cholesterol	LDL (bad) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)	Baseline, 12 weeks
Change in High-density lipoprotein (HDL) cholesterol	HDL (good) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)	Baseline, 12 weeks
Change in Triglycerides	Triglycerides levels measured in the blood and reported in milligrams/deciliter (mg/dL)	Baseline, 12 weeks
Subjects to complete study	Total number of subjects to complete study per protocol	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Bradley Bohn, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Body Mass Index (BMI) ≥ 25 kg/m^2; Early and late time-restricted eating
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight
• Other Study ID Numbers: 22-010547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No