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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (WG wheat flour intake= 0 g) | No Intervention | An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group A were 0 g. | |
| Group B (WG wheat flour intake= 25 g) | Experimental | An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group B were 25 g. |
|
| Group C (WG wheat flour intake= 50 g) | Experimental | An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group C were 50 g. |
|
| Group D (WG wheat flour intake= 100 g) | Experimental | An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group D were 100 g. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole grain wheat flour | Other | Group A: whole grain flour: 0 g Group B: Whole grain flour: 25 g Group C: Whole grain flour: 50 g Group D: whole grain flour: 100g |
|
| Measure | Description | Time Frame |
|---|---|---|
| whole grain plasma and urine biomarkers discovery and identification | Discovery of whole grain plasma and urine biomarkers after acute intakes of WG wheat food using LC-MS untargeted metabolomics approach in a designed study, identify the specific biomarkers for WG wheat with high confidence levels. | Baseline and 0~24 hours after intervention food intake |
| Measure | Description | Time Frame |
|---|---|---|
| Validate the performance of the potential WG biomarkers. | The receiver operating characteristic analysis was used to validate the performance of the potential WG biomarkers in the dose-response validation set | Baseline and 0~24 hours after intervention food intake |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-response of WG wheat biomarkers. | Linear regression analysis was performed between WGs amount consumed and the average concentration for each WG biomarkers, giving a regression equation and r2 values. | Baseline and 0~24 hours after intervention food intake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yajun Xu | Peking University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition and Food Hygiene, School of Public Health, Peking University | Beijing | China |
Shared results in a publication
Expected after publication (December 2024)
In a publication
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