Chronic Disease Prevention
Conditions
Keywords
Whole grain
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.
Interventions
OTHERWhole grain wheat flour
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
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men and women * age 18-40 years * BMI 18.5-23.9 kg/m2.
Exclusion criteria
* pregnancy or breastfeeding * vegetarian; * smokers; * acute and chronic diseases; * allergic to wheat; * frequent nutrients supplement use; * medication use of antibiotics within 1-month; * more than 3 kg weight change within 3-month; * unwillingness to follow dietary restrictions;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| whole grain plasma and urine biomarkers discovery and identification | Baseline and 0~24 hours after intervention food intake | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validate the performance of the potential WG biomarkers. | Baseline and 0~24 hours after intervention food intake | The receiver operating characteristic analysis was used to validate the performance of the potential WG biomarkers in the dose-response validation set |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dose-response of WG wheat biomarkers. | Baseline and 0~24 hours after intervention food intake | Linear regression analysis was performed between WGs amount consumed and the average concentration for each WG biomarkers, giving a regression equation and r2 values. |
Countries
China
Outcome results
None listed