The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

Peking University24 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Biomarkers

Interventions

whole grain-wheat flour food+standardized mealsOTHER

whole grain food made by 50 g whole grain wheat flour

refined wheat flour food+standardized mealsOTHER

refined grain food made by 50 g refined wheat flour

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Department of Nutrition and Food Hygiene, School of Public Health, Peking University

Beijing, China

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 0-24 hours after intervention food intake

Secondary Outcomes

The influence of gut flora on whole grain markers

Gut flora abundance and metabolites level correlation analysis

Time frame: after the administration of the test meal

Data from ClinicalTrials.gov

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