NCT05660291

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Feb 2023Dec 2026

First Submitted

Initial submission to the registry

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 24, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

December 13, 2022

Last Update Submit

September 24, 2025

Conditions

Keywords

Body Mass Index (BMI) ≥ 25 kg/m^2Early and late time-restricted eating

Outcome Measures

Primary Outcomes (1)

  • Change in weight

    Reported in kilograms (kg)

    Baseline, 12 weeks

Secondary Outcomes (7)

  • Change in Hemoglobin A1c

    Baseline, 12 weeks

  • Change in fasting glucose

    Baseline, 12 weeks

  • Change in total cholesterol

    Baseline, 12 weeks

  • Change in Low-density lipoprotein (LDL) cholesterol

    Baseline, 12 weeks

  • Change in High-density lipoprotein (HDL) cholesterol

    Baseline, 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Early time-restricted eating

EXPERIMENTAL

Subjects window for eating would be between 08:00 AM - 4:00 PM

Behavioral: Early time-restricted eating

Late time-restricted eating

EXPERIMENTAL

Subjects window for eating would be between 12:00 PM (noon) and 8:00 PM

Behavioral: Late time-restricted eating

Interventions

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).

Early 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).

Late time-restricted eating

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to read and understand English
  • BMI ≥ to 25.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bradley Bohn, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 21, 2022

Study Start

February 24, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations