RecruitingNot ApplicableNCT06118931

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

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


Sponsor

University of Toronto

Enrollment

120 participants

Start Date

Jun 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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)

Exclusion Criteria9

  • Individuals with type 2 diabetes will be excluded if: (1) currently on \>3 monotherapies for diabetes, (2) have had diabetes therapy dosage changes \<3 months, (3) self-reported hemoglobin A1c \>9.0%, (4) taking exogenous insulin, or (5) taking sulfonylureas
  • History of or referral for bariatric surgery
  • Weight loss \>5% in the last 3 months
  • Taking antiobesity (weight loss) medications
  • Body weight \>340lbs
  • Diagnosed cognitive disorder that precludes them from giving consent
  • Inability or unwillingness to change their eating window to follow those prescribed in the study
  • Currently eating during \<12 hour period on 5 or more days/week
  • Physician-diagnosed eating disorder

Interventions

BEHAVIORALEarly (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.

BEHAVIORALMid (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.

BEHAVIORALLate (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.


Locations(1)

Remote Ontario-wide

Toronto, Ontario, Canada

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NCT06118931


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