The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

Biomarkers Clinical Trial

Official title:

Study on Biomarkers of Whole Grain Dietary Intake in Chinese Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05837858
• Other study ID #: xuyajun197673
• Status: Completed
• Phase: N/A
• 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
• 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;

Related Conditions & MeSH terms

• Biomarkers

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