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

NCT06358781 | Completed

• 1 other identifier: xuyajun197673-002
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease Prevention

Keywords

Whole grain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Validate the performance of the potential WG biomarkers.

  Baseline and 0~24 hours after intervention food intake

Other Outcomes (1)

• Dose-response of WG wheat biomarkers.

  Baseline and 0~24 hours after intervention food intake

Study Arms (4)

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.

Other: Whole grain wheat flour

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.

Other: Whole grain wheat flour

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.

Other: Whole grain wheat flour

Interventions

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

Group B (WG wheat flour intake= 25 g); Group C (WG wheat flour intake= 50 g); Group D (WG wheat flour intake= 100 g)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• age 18-40 years
• BMI 18.5-23.9 kg/m2.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

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

Beijing, China

Location

Study Officials

• Yajun Xu

  Peking University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: April 19, 2024
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Expected after publication (December 2024)
• Access Criteria: In a publication

Locations

CN (1)