The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

Sponsor

Peking University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05837858

Collaborator

(none)

Enrollment

Location

Arms

8.1

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Biomarkers	Other: whole grain-wheat flour food+standardized meals Other: refined wheat flour food+standardized meals	N/A

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. We 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, we 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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized Crossover AssignmentRandomized Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Study on Biomarkers of Whole Grain Dietary Intake in Chinese Population

Anticipated Study Start Date :

Apr 26, 2023

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

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. they 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. they 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

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. they 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. they 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

Outcome Measures

Primary Outcome Measures

Changes in metabolite profiles present in blood serum and urine before the dietary intervention and in kinetics over 24 hours. [Baseline and 0~24 h after intervention food intake]
Metabolite profiles analyzed using a non-targeted metabolomics approach and targeted metabolomics approach with a LC-orbitrap MS or LC-MS/MS platform. Blood serum samples collected at time 0, 2 hour, 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. 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 Outcome Measures

The influence of gut flora on whole grain markers [after the administration of the test meal]
Gut flora abundance and metabolites level correlation analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy men and women; age 18-40 y; 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutrition and Food Hygiene, School of Public Health, Peking University	Beijing		China

Sponsors and Collaborators

Peking University

Investigators

Principal Investigator: Yunjia yang, Peking University
Principal Investigator: Yalin Zhou, Peking University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking University

ClinicalTrials.gov Identifier:

NCT05837858

Other Study ID Numbers:

xuyajun197673

First Posted:

May 1, 2023

Last Update Posted:

May 1, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking University

Food biomarker, whole grain, Chinese population

Study Results

No Results Posted as of May 1, 2023