Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05800730
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2023-03-23
Brief Title:
Westlake Precision Nutrition Study 2 WePrecision2
Sponsor:
Westlake University
Organization:
Westlake University
Study Overview
Official Title:
Westlake Precision Nutrition Study 2 Diet Challenges for Glucose Metabolism
Status:
COMPLETED
Status Verified Date:
2023-03
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:
WePrecision2
Brief Summary:
This is a dietary intervention study which aims to explore different diet challenges for glucose metabolism including carbohydrates and fasting dietary pattern Considering the glucose responses to the same food are largely heterogeneous among people this study integrates the concepts of precision nutrition and N-of-1 design The study also aims to discover the different impact of the time-restricted diet TRD and the energy-restricted diet ERD on host metabolic health and our hair growth
Detailed Description:
The project is mainly based on classic field trial study design to compare impacts of different fasting patterns on host metabolic health Under the condition of controlled diet background individual N-of-1 study design is also organically integrated to compare personalized responses for standard meal tests Participants will be required to wear continuous glucose monitoring CGM for 14 days The diet intervention will be carried out after wearing CGM on Day 1 Then all participants will be divided into three groups energy-restricted diet ERD 186 time-restricted diet TRD and normal diet ND During Day 3 to Day 12 ERD restricts daily total energy intake within 1200-1500 kcal without meal timing limits while TRD restricts the daily feeding window from 1000 to 1600 without total energy intake restriction ND will maintain volunteers original eating habits and rhythms as the control group Individual N-of-1 trial design will be employed to all participants during Day 3 to Day 12 to compare the difference of postprandial glucose response to white bread or plain oats These two standard breakfasts will appear in pseudo-random order The TRD group needs to adjust the breakfast time to after 1000 in the intervention periods
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