Health TrialsbyHealthPanel

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

ConditionsDiabetes Mellitus, Type 2ObesityPrediabetic StateHyperglycemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Toronto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

History of or referral for bariatric surgery

Weight loss >3% in the last 3 months

Taking antiobesity (weight loss) medications

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

123 Participants
are divided into 4 treatment groups
Group A: Early (7:00-16:00h) TREExperimental treatment 1 intervention
Group B: Mid (9:30-18:30h) TREExperimental treatment 1 intervention
Group C: Late (12:00-21:00h) TREExperimental treatment 1 intervention
Group D: ControlNo intervention 0 interventions

Trial outcomes

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.

Time frame
7 days

Secondary outcomes

1

Average 24-hour glucose over 7 days

Assessed for 7 continuous days using a continuous glucose monitor.

Time frame
7 days
2

Average daily nocturnal glucose over 7 evenings

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

Time frame
7 days
3

Average daily time spent in hyperglycemia over 7 days

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

Time frame
7 days
4

Postprandial glucose

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.

Time frame
2 hours

Other outcomes

1

Dietary intake

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.

Time frame
7 days
2

Weight change

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.

Time frame
7 days
3

Blood pressure change

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

Time frame
7 days
4

Physical Activity

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.

Time frame
7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Toronto

Lead sponsor

Diabetes Canada

Collaborator

Wharton Medical Clinic

Collaborator

Source ClinicalTrials.gov
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