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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged \>18 years

• Body mass index \>30 kg/m2 and \<50 kg/m2

• Have access to an Apple or Android cellphone with Bluetooth.

• Have type 2 diabetes or be at risk for type 2 diabetes (defined as high (33+) Canadian Diabetes Risk Score)

Locations
Other Locations
Canada
Remote Ontario-wide
RECRUITING
Toronto
Contact Information
Primary
Amy A Kirkham, PhD
amy.kirkham@utoronto.ca
416-946-4069
Backup
Rebecca AG Christensen, PhD
Rebecca.christensen@mail.utoronto.ca
Time Frame
Start Date: 2025-06-28
Estimated Completion Date: 2027-06-28
Participants
Target number of participants: 120
Treatments
Experimental: Early (7:00-16:00h) TRE
Participants will be asked to eat ad libitum between the hours of 7:00 - 16:00 each day for seven days, and then only drink water or other no calorie beverages for the rest of the day. On the 8th day, they will consume one meal replacement beverage at 7:00 and be instructed to not consume anything else for two hours. After the two hours they will be instructed to return to their normal baseline eating habits.
Experimental: Mid (9:30-18:30h) TRE
Participants will be asked to eat ad libitum between the hours of 9:30 - 18:30 each day for seven days, and then only drink water or other no calorie beverages for the rest of the day. On the 8th day, they will consume one meal replacement beverage at 9:30 and be instructed to not consume anything else for two hours. After the two hours they will be instructed to return to their normal baseline eating habits.
Experimental: Late (12:00-21:00h) TRE
Participants will be asked to eat ad libitum between the hours of 12:00 - 21:00 each day for seven days, and then only drink water or other no calorie beverages for the rest of the day. On the 8th day, they will consume one meal replacement beverage at 12:00 and be instructed to not consume anything else for two hours. After the two hours they will be instructed to return to their normal baseline eating habits.
No_intervention: Control
During the first week of the study, participants will be asked to eat as they normally do, and to not make any changes regarding when they are stopping or starting eating.
Related Therapeutic Areas
Sponsors
Leads: University of Toronto
Collaborators: Wharton Medical Clinic, Diabetes Canada

This content was sourced from clinicaltrials.gov