Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control
NCT ID: NCT06118931
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-06-28
2027-06-28
Brief Summary
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Detailed Description
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1. The early TRE window will result in the most favourable glycemic control outcomes but also the lowest participant acceptability followed by mid and delayed TRE.
2. There will be larger differences in glycemic control outcomes between the TRE window timings among those with type 2 diabetes compared to those at risk for type 2 diabetes.
3. TRE adherence and changes in glycemic control, and weight loss with all TRE window times (relative to control) will be higher in men vs women.
4. Energy, carbohydrate, and sugar intake, body weight, and blood pressure will decrease during TRE, but with no differences by window timing.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
No interventions assigned to this group
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
1. History of or referral for bariatric surgery
2. Weight loss \>5% in the last 3 months
3. Taking antiobesity (weight loss) medications
4. Body weight \>340lbs
5. Diagnosed cognitive disorder that precludes them from giving consent
6. Inability or unwillingness to change their eating window to follow those prescribed in the study
7. Currently eating during \<12 hour period on 5 or more days/week
8. Physician-diagnosed eating disorder
18 Years
ALL
No
Sponsors
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Diabetes Canada
OTHER
Wharton Medical Clinic
UNKNOWN
University of Toronto
OTHER
Responsible Party
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Amy Kirkham
Principal Investigator
Principal Investigators
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Amy A. Kirkham, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Remote Ontario-wide
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Amy A Kirkham, PhD
Role: primary
Other Identifiers
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44122
Identifier Type: -
Identifier Source: org_study_id
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