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
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Jun 2025
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
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
First Submitted
Initial submission to the registry
October 31, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
June 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 28, 2027
October 2, 2025
September 1, 2025
2 years
October 31, 2023
September 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average 24-hour glucose total area under the curve (AUC) over 7 days
Assessed for 7 continuous days using a continuous glucose monitor.
7 days
Secondary Outcomes (8)
Average 24-hour glucose over 7 days
7 days
Average daily nocturnal glucose over 7 evenings
7 days
Average daily time spent in hyperglycemia over 7 days
7 days
Postprandial glucose
2 hours
Glycemic viability
7 days
- +3 more secondary outcomes
Other Outcomes (6)
Dietary intake
7 days
Weight change
7 days
Blood pressure change
7 days
- +3 more other outcomes
Study Arms (4)
Early (7:00-16:00h) TRE
EXPERIMENTALParticipants 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.
Mid (9:30-18:30h) TRE
EXPERIMENTALParticipants 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.
Late (12:00-21:00h) TRE
EXPERIMENTALParticipants 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.
Control
NO INTERVENTIONDuring 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Diabetes Canadacollaborator
- Wharton Medical Cliniccollaborator
Study Sites (1)
Remote Ontario-wide
Toronto, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy A. Kirkham, PhD
University of Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 31, 2023
First Posted
November 7, 2023
Study Start
June 28, 2025
Primary Completion (Estimated)
June 28, 2027
Study Completion (Estimated)
June 28, 2027
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share