Back to resultsA Study of Time Restricted Eating in Obese Adults
Primary Purpose
Overweight
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early time-restricted eating
Late time-restricted eating
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Body Mass Index (BMI) ≥ 25 kg/m^2, Early and late time-restricted eating
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early time-restricted eating
Late time-restricted eating
Arm Description
Subjects window for eating would be between 08:00 AM - 4:00 PM
Subjects window for eating would be between 12:00 PM (noon) and 8:00 PM
Outcomes
Primary Outcome Measures
Change in weight
Reported in kilograms (kg)
Secondary Outcome Measures
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
Change in fasting glucose
Glucose (sugar) measured in the blood and reported in milligrams per deciliter (mg/dL).
Change in total cholesterol
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
LDL (bad) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)
Change in High-density lipoprotein (HDL) cholesterol
HDL (good) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)
Change in Triglycerides
Triglycerides levels measured in the blood and reported in milligrams/deciliter (mg/dL)
Subjects to complete study
Total number of subjects to complete study per protocol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05660291
Brief Title
A Study of Time Restricted Eating in Obese Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Body Mass Index (BMI) ≥ 25 kg/m^2, Early and late time-restricted eating
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early time-restricted eating
Arm Type
Experimental
Arm Description
Subjects window for eating would be between 08:00 AM - 4:00 PM
Arm Title
Late time-restricted eating
Arm Type
Experimental
Arm Description
Subjects window for eating would be between 12:00 PM (noon) and 8:00 PM
Intervention Type
Behavioral
Intervention Name(s)
Early time-restricted eating
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Late time-restricted eating
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in weight
Description
Reported in kilograms (kg)
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change in Hemoglobin A1c
Description
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
Time Frame
Baseline, 12 weeks
Title
Change in fasting glucose
Description
Glucose (sugar) measured in the blood and reported in milligrams per deciliter (mg/dL).
Time Frame
Baseline, 12 weeks
Title
Change in total cholesterol
Description
Blood sample taken to measure the sum of blood's cholesterol content and reported in milligrams/deciliter (mg/dL)
Time Frame
Baseline, 12 weeks
Title
Change in Low-density lipoprotein (LDL) cholesterol
Description
LDL (bad) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)
Time Frame
Baseline, 12 weeks
Title
Change in High-density lipoprotein (HDL) cholesterol
Description
HDL (good) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)
Time Frame
Baseline, 12 weeks
Title
Change in Triglycerides
Description
Triglycerides levels measured in the blood and reported in milligrams/deciliter (mg/dL)
Time Frame
Baseline, 12 weeks
Title
Subjects to complete study
Description
Total number of subjects to complete study per protocol
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Bohn, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Time Restricted Eating in Obese Adults
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