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The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

Not Applicable
Completed
Conditions
Biomarkers
Registration Number
NCT05837858
Lead Sponsor
Peking University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours.Baseline and 0-24 hours after intervention food intake

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.

Secondary Outcome Measures
NameTimeMethod
The influence of gut flora on whole grain markersafter the administration of the test meal

Gut flora abundance and metabolites level correlation analysis

Trial Locations

Locations (1)

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

🇨🇳

Beijing, China

Department of Nutrition and Food Hygiene, School of Public Health, Peking University
🇨🇳Beijing, China

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