The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

Study on Biomarkers of Whole Grain Dietary Intake in Chinese Population

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

Study Overview

• Status: Completed
• Conditions: Biomarkers
• Intervention / Treatment: Other: whole grain-wheat flour food+standardized meals; Other: refined wheat flour food+standardized meals

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yajun Xu; Phone Number: 01082802552; Email: xuyajun@bjmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Department of Nutrition and Food Hygiene, School of Public Health, Peking University
    • Contact: xuyajun197673; Phone Number: 01082802552; Email: xuyajun@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: whole grain-wheat flour food, then refined wheat flour food; Participants first received food made by 50 g whole grain wheat flour during breakfast in a fasting state. Standardized meals were provided to the volunteers from the dinner of the day before the intervention day, as well as up to 48 h after the administration of the test food. After a washout period of 5 days, volunteers followed a 2-day restricted diet before the intervention day. Participants then received food made by 50 g refined grain wheat flour in a fasting state.	Other: whole grain-wheat flour food+standardized meals; whole grain food made by 50 g whole grain wheat flour; Other: refined wheat flour food+standardized meals; refined grain food made by 50 g refined wheat flour
Experimental: refined wheat flour food, then whole grain-wheat flour food; Participants first received food made by 50 g refined grain wheat flour during breakfast in a fasting state. Standardized meals were provided to the volunteers from the dinner of the day before the intervention day, as well as up to 48 h after the administration of the test food. After a washout period of 5 days, volunteers followed a 2-day restricted diet before the intervention day. Participants then received food made by 50 g whole grain wheat flour in a fasting state.	Other: whole grain-wheat flour food+standardized meals; whole grain food made by 50 g whole grain wheat flour; Other: refined wheat flour food+standardized meals; refined grain food made by 50 g refined wheat flour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The influence of gut flora on whole grain markers	Gut flora abundance and metabolites level correlation analysis	after the administration of the test meal

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Yunjia yang, Peking University; Principal Investigator: Yalin Zhou, Peking University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Actual): May 24, 2023
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Whole grain; Chinese population; Food biomarker
• Other Study ID Numbers: xuyajun197673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Shared IPD that underlie results in a publication
• IPD Sharing Time Frame: December 30, 2023
• IPD Sharing Access Criteria: In a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No