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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06118931
• Other study ID #: 44122
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2023
• Source: University of Toronto
• Contact: Amy A Kirkham, PhD
• Phone: 416-946-4069
• Email: amy.kirkham[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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: 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged >18 years
• 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:

• Individuals with type 2 diabetes will be excluded if: (1) currently on >3 monotherapies for diabetes, (2) have had diabetes therapy 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 >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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Obesity
• Prediabetic State

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Remote Ontario-wide	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Diabetes Canada, Wharton Medical Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	7 days
Other	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.	7 days
Other	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.	7 days
Other	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.	7 days
Other	Sleep	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.	7 days
Other	Safety and Adverse Events	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.	7 days
Primary	Average 24-hour glucose total area under the curve (AUC) over 7 days	Assessed for 7 continuous days using a continuous glucose monitor.	7 days
Secondary	Average 24-hour glucose over 7 days	Assessed for 7 continuous days using a continuous glucose monitor.	7 days
Secondary	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.	7 days
Secondary	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.	7 days
Secondary	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.	2 hours
Secondary	Glycemic viability	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.	7 days
Secondary	Patient acceptability	Patient acceptability will be assessed based on researcher-developed questions related to their experience with each TRE protocol.	7 days
Secondary	TRE fasting duration adherence	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.	7 days
Secondary	TRE fasting window adherence	The proportion of days where participants began and ended their meal within 15 min or 30 min of their prescribed time.	7 days