Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358781
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2024-04-07
Brief Title:
A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
Screening Whole Grain Dietary Intake Biomarkers and Validating the Dose-response Relationship in a Randomized Controlled Study in China
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Dose-response validation of whole grain dietary intake biomarkers remains limited and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations To address these issues the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial as well as to validate the markers dose-response relationship so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains
Detailed Description:
An acute randomized controlled trial was performed and the total study group is randomly divided into four groups the amounts of WG wheat flour administered were 0 g 25g 50 g and 100 g Experimental period with a total of 6 days was subdivided into two parts -5 days to 0 h defined as the run-in period 0-24 h after the dose-related test meal defined as the test day
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