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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05837858
Other study ID # xuyajun197673
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 28, 2023
Est. completion date May 24, 2023

Study information

Verified date April 2023
Source Peking University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 24, 2023
Est. primary completion date May 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
whole grain-wheat flour food+standardized meals
whole grain food made by 50 g whole grain wheat flour
refined wheat flour food+standardized meals
refined grain food made by 50 g refined wheat flour

Locations

Country Name City State
China Department of Nutrition and Food Hygiene, School of Public Health, Peking University Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours. 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. Baseline and 0-24 hours after intervention food intake
Secondary The influence of gut flora on whole grain markers Gut flora abundance and metabolites level correlation analysis after the administration of the test meal
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