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Completed

NCT Number: NCT06358781

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

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.

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Key information

Conditions

Chronic Disease Prevention

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

Primary outcomes

  1. whole grain plasma and urine biomarkers discovery and identification

    Time frame: 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 outcomes

  1. Validate the performance of the potential WG biomarkers.

    Time frame: 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 outcomes

  1. Dose-response of WG wheat biomarkers.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2024
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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