Remote Ontario-wide
Toronto, Ontario, Canada
Location status: Recruiting
Location contact
Amy A Kirkham, PhD
CONTACT
Amy A Kirkham, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06118931
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.
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, Canada
Location status: Recruiting
Amy A Kirkham, PhD
CONTACT
Amy A Kirkham, PhD
PRINCIPAL_INVESTIGATOR
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 7 days
Assessed for 7 continuous days using a continuous glucose monitor.
Time frame: 7 days
Assessed for 7 continuous days using a continuous glucose monitor.
Time frame: 7 days
Assessed for 7 continuous evenings based on the sleep period identified by the Fitbit tracker using a continuous glucose monitor.
Time frame: 7 days
The average number of hours with glucose >10 mmol/L over 7 continuous days assessed with a continuous glucose monitor.
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.
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.
Time frame: 7 days
Patient acceptability will be assessed based on researcher-developed questions related to their experience with each TRE protocol.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Amy A Kirkham, PhD
CONTACT
Teresita Gormaz Clinical Trial coordinator, MsC
CONTACT
University of Toronto
Other
The Impact of Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control
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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