Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118931
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-31
Brief Title:
Time-restricted Eating Window Timing Type 2 Diabetes Status and Sex on Glycemic Control
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
The Impact of Time-restricted Eating Window Timing Type 2 Diabetes Status and Sex on Glycemic Control
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 700-1600 h mid 930-1830 h delayed 1200-2100 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None