A Study of Time Restricted Eating in Obese Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight

Intervention / Treatment
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* Behavioral: Early time-restricted eating
* Behavioral: Late time-restricted eating


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early time-restricted eating<br>Subjects window for eating would be between 08:00 AM - 4:00 PM | Behavioral: Early time-restricted eating<br>* 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).<br>|
| Experimental: Late time-restricted eating<br>Subjects window for eating would be between 12:00 PM (noon) and 8:00 PM | Behavioral: Late time-restricted eating<br>* 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).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Mass Index (BMI) ≥ 25 kg/m^2, Early and late time-restricted eating