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NCT Number: NCT06118931

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

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Remote Ontario-wide

Toronto, Ontario, Canada

Location status: Recruiting

Location contact

Amy A Kirkham, PhD

CONTACT

Amy A Kirkham, PhD

PRINCIPAL_INVESTIGATOR

About this study

The overarching aim of this study is to evaluate the interactions between TRE window timing, type 2 diabetes status, and sex among individuals with obesity. The first objective is to compare the effects of three 9-h TRE window times (early: 7:00-16:00 h, mid: 9:30-18:30 h, delayed: 12:00-21:00 h) on real-time, free-living glycemic control. The second objective is to determine if type 2 diabetes status (type 2 diabetes versus prediabetes or moderate+ risk for type 2 diabetes aka at risk for type 2 diabetes) modifies the effect of eating window timing on glycemic control outcomes. The exploratory objectives include: 1) determine whether sex modifies TRE adherence or the effect of TRE on metabolic changes relative to control; and 2) to compare changes in dietary intake, body weight, and blood pressure within and between early, mid, and delayed TRE. We have the following hypotheses related to these objectives:

  • 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.
  • 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.
  • 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.
  • Energy, carbohydrate, and sugar intake, body weight, and blood pressure will decrease during TRE, but with no differences by window timing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • History of or referral for bariatric surgery
  • Weight loss >3% in the last 3 months
  • Taking antiobesity (weight loss) medications
  • Body weight >390lbs
  • Diagnosed with severe cognitive disorder that precludes them from giving consent
  • Inability or unwillingness to change their eating window to follow those prescribed in the study
  • Currently consistently eating during <11.5 hour period .
  • Physician-diagnosed eating disorder
  • Having a pacemaker or receiving dialysis.
  • Not having access to a Lifelabs location.

Treatment and study plan

Early (7:00 - 16:00) TRE

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Average 24-hour glucose total area under the curve (AUC) over 7 days

    Time frame: 7 days

    Assessed for 7 continuous days using a continuous glucose monitor.

Secondary outcomes

  1. Average 24-hour glucose over 7 days

    Time frame: 7 days

    Assessed for 7 continuous days using a continuous glucose monitor.

  2. Average daily nocturnal glucose over 7 evenings

    Time frame: 7 days

    Assessed for 7 continuous evenings based on the sleep period identified by the Fitbit tracker using a continuous glucose monitor.

  3. Average daily time spent in hyperglycemia over 7 days

    Time frame: 7 days

    The average number of hours with glucose >10 mmol/L over 7 continuous days assessed with a continuous glucose monitor.

  4. Postprandial glucose

    Time frame: 2 hours

    Assessed on the morning after the 7th day of each TRE protocol. Participants will consume a standardized breakfast at a specified time, and glucose will be evaluated via continuous glucose monitor from the time they start consuming the breakfast for 2 hours.

  5. Glycemic viability

    Time frame: 7 days

    The average of each standard metrics of glycemic viability (standard deviation, coefficient of variation, mean amplitude of glycemic exercise, and continuous overall net glycemic action) will be calculated over 7 continuous days from continuous glucose monitors.

  6. Patient acceptability

    Time frame: 7 days

    Patient acceptability will be assessed based on researcher-developed questions related to their experience with each TRE protocol.

  7. TRE fasting duration adherence

    Time frame: 7 days

    Participants will receive twice daily text messages asking what time they started and stopped eating that day, which will be used to calculate the length of the fast each day. Adherence will be calculated as the % of days where the participant fasted for 15h or longer.

  8. TRE fasting window adherence

    Time frame: 7 days

    The proportion of days where participants began and ended their meal within 15 min or 30 min of their prescribed time.

Other outcomes

  1. Dietary intake

    Time frame: 7 days

    Participants will complete the ASA-24 at baseline, and during each of the intervention periods to assess changes in macro and micronutrient composition of their diet.

  2. Weight change

    Time frame: 7 days

    Participants will be asked to weigh themselves first thing in the morning, with minimal and no clothing on, after they have emptied their bowels once during the baseline period and on the last day of each of the intervention period.

  3. Blood pressure change

    Time frame: 7 days

    Participants will be asked to measure their blood pressure once during the baseline period, and on the last day of each intervention period.

  4. Physical Activity

    Time frame: 7 days

    Participants will be asked to wear a Fitbit for the duration of the study. We will average the amount of physical activity over 7 days of wear.

  5. Sleep

    Time frame: 7 days

    Participants will be asked to wear a Fitbit for the duration of the study. We will average the amount of sleep over 7 days of wear.

  6. Safety and Adverse Events

    Time frame: 7 days

    Participants will be given access to a questionnaire to report any symptoms throughout the intervention. We will compare the proportion of individuals who report these symptoms within each time period.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy A Kirkham, PhD

CONTACT

[email protected]

416-946-4069

Teresita Gormaz Clinical Trial coordinator, MsC

CONTACT

[email protected]

+1-416-946-0036

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Diabetes Canada
  • Wharton Medical Clinic

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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