The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

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

Detailed Description
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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.

Official Title
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Study on Biomarkers of Whole Grain Dietary Intake in Chinese Population

Conditions
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Biomarkers

Intervention / Treatment
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* Other: whole grain-wheat flour food+standardized meals
* Other: refined wheat flour food+standardized meals


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whole grain-wheat flour food, then refined wheat flour food<br>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<br>* whole grain food made by 50 g whole grain wheat flour<br>Other: refined wheat flour food+standardized meals<br>* refined grain food made by 50 g refined wheat flour<br>|
| Experimental: refined wheat flour food, then whole grain-wheat flour food<br>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<br>* whole grain food made by 50 g whole grain wheat flour<br>Other: refined wheat flour food+standardized meals<br>* refined grain food made by 50 g refined wheat flour<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food biomarker, Whole grain, Chinese population