Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control

NCT06118931 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-10-02

No results posted yet for this study

Summary

This study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.

Conditions

Interventions

BEHAVIORAL

Early (7:00 - 16:00) TRE

A standardized TRE Protocol where participants eat ad libitum between the hours of 7:00 to 16:00 for 7 days. On the 8th day, they will consume a meal replacement beverage at 7:00, and not consume anything else for two hours.

BEHAVIORAL

Mid (9:30 - 18:30) TRE

A standardized TRE Protocol where participants eat ad libitum between the hours of 9:30 to 18:30 for 7 days. On the 8th day, they will consume a meal replacement beverage at 9:30, and not consume anything else for two hours.

BEHAVIORAL

Late (12:00 - 21:00) TRE

A standardized TRE Protocol where participants eat ad libitum between the hours of 12:00 to 21:00 for 7 days. On the 8th day, they will consume a meal replacement beverage at 12:00, and not consume anything else for two hours.

Sponsors & Collaborators

  • Diabetes Canada

    collaborator OTHER
  • Wharton Medical Clinic

    collaborator UNKNOWN
  • University of Toronto

    lead OTHER

Principal Investigators

  • Amy A. Kirkham, PhD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-28
Primary Completion
2027-06-28
Completion
2027-06-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06118931 on ClinicalTrials.gov