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

Not Applicable

Completed

• Conditions: Chronic Disease Prevention
• Interventions: Other: Whole grain wheat flour

• Registration Number: NCT06358781
• Lead Sponsor: Peking University

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-07
• Study First Posted: 2024-04-11
• Study Start: 2024-04-19
• Primary Completion: 2024-05-13
• Study Completion: 2024-05-13
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C (WG wheat flour intake= 50 g)	Whole grain wheat flour	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 B (WG wheat flour intake= 25 g)	Whole grain wheat flour	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 D (WG wheat flour intake= 100 g)	Whole grain wheat flour	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Nutrition and Food Hygiene, School of Public Health, Peking University; 🇨🇳 Beijing, China