A Study of Time Restricted Eating in Obese Adults

Overweight Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05660291
• Other study ID #: 22-010547
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Reported in kilograms (kg)	Baseline, 12 weeks
Secondary	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
Secondary	Change in fasting glucose	Glucose (sugar) measured in the blood and reported in milligrams per deciliter (mg/dL).	Baseline, 12 weeks
Secondary	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
Secondary	Change in Low-density lipoprotein (LDL) cholesterol	LDL (bad) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)	Baseline, 12 weeks
Secondary	Change in High-density lipoprotein (HDL) cholesterol	HDL (good) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)	Baseline, 12 weeks
Secondary	Change in Triglycerides	Triglycerides levels measured in the blood and reported in milligrams/deciliter (mg/dL)	Baseline, 12 weeks
Secondary	Subjects to complete study	Total number of subjects to complete study per protocol	Baseline, 12 weeks