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Completed

NCT Number: NCT05837858

The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

The goal of this food intervention study is to screen/validate the whole grain food intake biomarker in health Chinese's population.

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Key information

Conditions

Biomarkers

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

Although increased consumption of whole grains (WGs) is associated with improved health outcomes, the dietary intake assessment and health mechanisms for WGs or WG-containing food remain unresolved. In addition, information regarding its consumption and health effects in Chinese people is scarce. Biomarkers of WGs intake would allow a more accurate assessment of its consumption in nutrition studies. The investigators want to perform a crossover study where participants were subjected to a WG-wheat flour or a refine wheat-flour Chinese diet. Using a metabolomics approach, the investigators aimed to identify the WG-specific metabolites present in plasma/urine after consumption WG or WG foods, including new candidate biomarkers of WG intake.

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 food+standardized meals

Other

whole grain food made by 50 g whole grain wheat flour

refined wheat flour food+standardized meals

Other

refined grain food made by 50 g refined wheat flour

Primary outcomes

  1. Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours.

    Time frame: Baseline and 0-24 hours after intervention food intake

    Metabolite profiles analyzed using a non-targeted metabolomics approach and targeted metabolomics approach with a Orbitrap Mass Analyzer. Blood plasma samples collected at time 0 hours, 2 hours, 4 hours, and 24 hours. Urine fractions collected at 0-2 hours, 2-4 hours, 4-6 hours, 6-9 hours, 9-12 hours, 12-24 hours and 24-48 hours. Identification of biomarkers of acute intake of the foods of interest through the comparison of specific metabolomes after single dose of WG food or refined grain food in Chinese population.

Secondary outcomes

  1. The influence of gut flora on whole grain markers

    Time frame: after the administration of the test meal

    Gut flora abundance and metabolites level correlation analysis

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

Study on Biomarkers of Whole Grain Dietary Intake in Chinese Population

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 1, 2023
Registry last updated
Aug 3, 2023

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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