A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake

Chronic Disease Prevention Clinical Trial

Official title:

Screening Whole Grain Dietary Intake Biomarkers and Validating the Dose-response Relationship in a Randomized Controlled Study in China.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358781
• Other study ID #: xuyajun197673-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Peking University
• Contact: Yunjia Yang
• Phone: 13718132924
• Email: greendayang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Disease Prevention

Intervention

Other:
• Whole 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

Locations

Country	Name	City	State
China	Department of Nutrition and Food Hygiene, School of Public Health, Peking University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 h after intervention food intake
Primary	whole grain plasma and urine biomarkers discovery and identification	Discovery 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 h after intervention food intake
Secondary	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 h after intervention food intake