Overweight
Conditions
Keywords
Body Mass Index (BMI) ≥ 25 kg/m^2, Early and late time-restricted eating
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.
Interventions
BEHAVIORALEarly 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).
BEHAVIORALLate 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).
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | Baseline, 12 weeks | Reported in kilograms (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting glucose | Baseline, 12 weeks | Glucose (sugar) measured in the blood and reported in milligrams per deciliter (mg/dL). |
| 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 Low-density lipoprotein (LDL) cholesterol | Baseline, 12 weeks | LDL (bad) cholesterol 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 Triglycerides | Baseline, 12 weeks | Triglycerides levels 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 |
| Change in High-density lipoprotein (HDL) cholesterol | Baseline, 12 weeks | HDL (good) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL) |
Countries
United States
Outcome results
None listed