Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Canada / NCT06118931
Recruiting Not applicable

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

NCT06118931 · tracked via the Priya Life Science Canada tracker
Sponsor
University of Toronto
Phase
Not applicable
Started
2025-06-28
Last updated
2026-06-30

Condition(s) studied

Diabetes Mellitus, Type 2ObesityPrediabetic StateHyperglycemia

Investigational drug(s) / intervention(s)

Early (7:00 - 16:00) TREMid (9:30 - 18:30) TRELate (12:00 - 21:00) TRE

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.

Study 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

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Aged 40 years or older * Body mass index \<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 self-report of pre-diabetes, a recent (within 12 months) measure of HbA1c between 5.7 and 6.4%, waist circumference (WC) that is BMI specific; for women: BMI \>= 18.5-24.9, WC \>= 80cm; BMI \>= 25-29.9, WC \>= 90cm; BMI \>= 30-34.9, WC \>= 105cm; BMI \>= 35+, WC \>= 115cm; for men: BMI \>= 18.5-24.9, WC \>= 90cm; BMI \>= 25-29.9, WC \>= 100cm; BMI \>= 30-34.9, WC \>= 110cm; BMI \>= 35+, WC \>= 125cm. Exclusion Criteria: * Individuals with type 2 diabetes will be excluded if: (1) currently on \>2 monotherapies for diabetes, (2) have had diabetes therapy medication or dosage changes \<3 months, (3) self-reported hemoglobin A1c \>9.0%, (4) taking exogenous insulin, or (5) taking sulfonylureas * The following exclusion criteria applies to all potential participants: 1. History of or referral for bariatric surgery 2. Weight loss \>3% in the last 3 months 3. Taking antiobesity (weight loss) medications 4. Body weight \>390lbs 5. Diagnosed with severe 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 consistently eating during \<11.5 hour period . 8. Physician-diagnosed eating disorder 9. Having a pacemaker or receiving dialysis. 10. Not having access to a Lifelabs location.

Primary outcome measure(s)

  • Average 24-hour glucose total area under the curve (AUC) over 7 days — 7 days
    Assessed for 7 continuous days using a continuous glucose monitor.

Trial sites (1)

FacilityCityRegionStatus
Remote Ontario-wide Toronto Ontario Recruiting

More University of Toronto trials in Canada

Menstrual Cycle vs. Oral Contraceptives: Effects on Muscle Protein Metabolism After Resistance Exercise Recruiting
Cardio-Oncology Rehabilitation Exercise Recruiting
Feasibility of Different Types of Exercise Training in Perimenopausal Females Recruiting
FueL Use During eXercise in Males and Females Recruiting
Physiotherapy and Deep Brain Stimulation in Parkinson's Disease Active, not recruiting

Other trials for the same condition

A Study to Evaluate ALN-6222 in Participants With Obesity Recruiting
Obesity Medicine Bank of the Quebec Heart and Lung Institute - Laval University (IUCPQ-ULaval) Starting soon
Impact of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults Recruiting
A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight Active, not recruiting
A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06118931 on ClinicalTrials.gov ↗ ← All trials in Canada