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NCT Number: NCT05660291

A Study of Time Restricted Eating in Obese Adults

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Primary outcomes

  1. Change in weight

    Time frame: Baseline, 12 weeks

    Reported in kilograms (kg)

Secondary outcomes

  1. Change in Hemoglobin A1c

    Time frame: 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

  2. Change in fasting glucose

    Time frame: Baseline, 12 weeks

    Glucose (sugar) measured in the blood and reported in milligrams per deciliter (mg/dL).

  3. Change in total cholesterol

    Time frame: Baseline, 12 weeks

    Blood sample taken to measure the sum of blood's cholesterol content and reported in milligrams/deciliter (mg/dL)

  4. Change in Low-density lipoprotein (LDL) cholesterol

    Time frame: Baseline, 12 weeks

    LDL (bad) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)

  5. Change in High-density lipoprotein (HDL) cholesterol

    Time frame: Baseline, 12 weeks

    HDL (good) cholesterol measured in the blood and reported in milligrams/deciliter (mg/dL)

  6. Change in Triglycerides

    Time frame: Baseline, 12 weeks

    Triglycerides levels measured in the blood and reported in milligrams/deciliter (mg/dL)

  7. Subjects to complete study

    Time frame: Baseline, 12 weeks

    Total number of subjects to complete study per protocol

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2022
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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