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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Disease Prevention
• Intervention / Treatment: Other: Whole grain wheat flour

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunjia Yang; Phone Number: 13718132924; Email: greendayang@163.com

Study Locations

• China
  • Beijing, China
    • Department of Nutrition and Food Hygiene, School of Public Health, Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A (WG wheat flour intake= 0 g); 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.
Experimental: Group B (WG wheat flour intake= 25 g); 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.	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
Experimental: Group C (WG wheat flour intake= 50 g); 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.	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
Experimental: Group D (WG wheat flour intake= 100 g); 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	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 h after intervention food intake

Other Outcome Measures

Outcome Measure	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 h after intervention food intake

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Study Director: Yajun Xu, Peking University

Study record dates

Study Major Dates

• Study Start (Estimated): April 22, 2024
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Whole grain
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: xuyajun197673-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Shared results in a publication
• IPD Sharing Time Frame: Expected after publication (December 2024)
• IPD Sharing Access Criteria: In a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No