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
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
- Diabetes Mellitus, Type 2
- Obesity
- Prediabetic State
- Hyperglycemia
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
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