Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04692532
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-02
First Post:
2020-12-28
Brief Title:
Time Restricted Eating for Weight Management
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Time Restricted Eating for Weight Management
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
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:
A 12-month randomized controlled parallel-arm trial divided into 2 consecutive periods 1 6-month weight loss period and 2 6-month weight maintenance will be implemented Adults with obesity will be randomized to 1 of 3 groups 1 8h-TRE ad libitum food intake from 12pm to 8 pm fasting from 8 pm to 12 pm daily 2 CR 25 energy restriction every day or 3 control ad libitum food intake daily eating within more than 10 hours per day
Detailed Description:
Time restricted eating TRE has become a popular weight loss regimen The sudden rise in popularity of TRE is mostly likely due to is its sheer simplicity and the fact that it does not require individuals to count calories in order to lose weight Participants are simply asked to consume all food within a specified time frame and fast with energy free beverages for the remaining hours of the day Evidence shows that when people with obesity limit their eating window to 6 to 8 hours per day they naturally reduce energy intake by 350-500 calories From a clinical standpoint these findings are paramount One of the main reasons for subject attrition with traditional dieting ie daily calorie restriction CR is frustration with having to count calories every day TRE regimens are able to side-step this requirement by allowing participants to simply watch the clock instead of monitoring calories while still producing significant weight loss and metabolic health improvements This feature of TRE has the potential to improve long-term adherence to the diet and in turn produce lasting weight control in adults with obesity
Accordingly we conducted a one-year randomized controlled trial to compare the effects of late TRE eating all food between 1200 pm to 800 pm without calorie counting versus CR 25 energy restriction daily and a control group eating over a period of 10 or more hours on body weight and metabolic risk factors in a diverse group of American adults with obesity We hypothesized that the TRE group would achieve greater weight loss and experience more pronounced improvements in insulin sensitivity during the 6-month weight loss phase compared to CR and control participants We also hypothesized that the TRE group would better maintain their weight loss and sustain their improvements in insulin sensitivity during the 6-month weight maintenance phase when compared to the CR and control participants
Accordingly we conducted a one-year randomized controlled trial to compare the effects of late TRE eating all food between 1200 pm to 800 pm without calorie counting versus CR 25 energy restriction daily and a control group eating over a period of 10 or more hours on body weight and metabolic risk factors in a diverse group of American adults with obesity We hypothesized that the TRE group would achieve greater weight loss and experience more pronounced improvements in insulin sensitivity during the 6-month weight loss phase compared to CR and control participants We also hypothesized that the TRE group would better maintain their weight loss and sustain their improvements in insulin sensitivity during the 6-month weight maintenance phase when compared to the CR and control participants
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