Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04884659
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2021-05-07
Brief Title:
Time-Restricted Feeding
Sponsor:
Rockefeller University
Organization:
Rockefeller University
Study Overview
Official Title:
The Impact of Time-Restricted Feeding on Metabolism and Inflammation in Obesity TRIO Study
Status:
COMPLETED
Status Verified Date:
2022-08
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:
TRIO
Brief Summary:
We propose to conduct a randomized 6-day isocaloric crossover feeding study in humans with prediabetes and obesity We will study the effect of restricting the timing of caloric intake to earlier in the day TRF versus later in the day usual feeding pattern UFP on glycemia and inflammation in an inpatient setting
Detailed Description:
Time Restricted Feeding TRF is a variant of intermittent fasting that confines caloric intake to active daytime hours and involves fasting for 12 to 14 hours Circadian misalignment caused by changes in sleeping and eating behaviors has emerged as having a detrimental impact on weight glucose homeostasis and other cardiovascular disease-related outcomes Feeding during active periods appears to be advantageous for weight glucose metabolism and lipid profiles whereas feeding during the inactive period confers deleterious effects on these outcomes Therefore TRF shows great promise as a novel intervention for addressing obesity and related cardiovascular outcomes
Animal studies suggest that timing of feeding including intermittent fasting or TRF decreases inflammation and causes ketosis Human studies that examined time restricted feeding for improvement in glycemia in as little as 4 days did not observe changes in clinical markers of inflammarion such as hsCRP Moreover systemic and adipose tissue inflammation as it occurs in obesity shows dynamic changes in the context of weight loss that would not be clearly apparent in a weight stable state A potential mechanistic link between glycemic improvement and systemic inflammation would be the Receptor for Advanced Glycation End-Products RAGE and its soluble form sRAGEThis form of inflammation has not been measured in reported eTRF studies and its relationship with eTRFwould bea significant contribution from the proposed study
Animal studies suggest that timing of feeding including intermittent fasting or TRF decreases inflammation and causes ketosis Human studies that examined time restricted feeding for improvement in glycemia in as little as 4 days did not observe changes in clinical markers of inflammarion such as hsCRP Moreover systemic and adipose tissue inflammation as it occurs in obesity shows dynamic changes in the context of weight loss that would not be clearly apparent in a weight stable state A potential mechanistic link between glycemic improvement and systemic inflammation would be the Receptor for Advanced Glycation End-Products RAGE and its soluble form sRAGEThis form of inflammation has not been measured in reported eTRF studies and its relationship with eTRFwould bea significant contribution from the proposed study
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