A Study of Time Restricted Eating in Obese Adults

Not Applicable

• Conditions: Overweight
• Interventions: Behavioral: Late time-restricted eating; Behavioral: Early time-restricted eating

• Registration Number: NCT05660291
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Study Start: 2023-02-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late time-restricted eating	Late time-restricted eating	Subjects window for eating would be between 12:00 PM (noon) and 8:00 PM
Early time-restricted eating	Early time-restricted eating	Subjects window for eating would be between 08:00 AM - 4:00 PM

Primary Outcome Measures

Name	Time	Method
Change in weight	Baseline, 12 weeks	Reported in kilograms (kg)

Secondary Outcome Measures

Name	Time	Method
Change in fasting glucose	Baseline, 12 weeks	Glucose (sugar) measured in the blood and reported in milligrams per 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 Triglycerides	Baseline, 12 weeks	Triglycerides levels measured in the blood and reported in milligrams/deciliter (mg/dL)
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 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 High-density lipoprotein (HDL) cholesterol	Baseline, 12 weeks	HDL (good) cholesterol 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

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States