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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early time-restricted eating | Experimental | Subjects window for eating would be between 08:00 AM - 4:00 PM |
|
| Late time-restricted eating | Experimental | Subjects window for eating would be between 12:00 PM (noon) and 8:00 PM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early time-restricted eating | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Reported in kilograms (kg) | Baseline, 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Bohn, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Late time-restricted eating | Behavioral | 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). |
|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |