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The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

Study on Biomarkers of Whole Grain Dietary Intake in Chinese Population

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05837858
Enrollment
24
Registered
2023-05-01
Start date
2023-04-28
Completion date
2023-05-24
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers

Keywords

Food biomarker, Whole grain, Chinese population

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.

Interventions

OTHERwhole grain-wheat flour food+standardized meals

whole grain food made by 50 g whole grain wheat flour

OTHERrefined wheat flour food+standardized meals

refined grain food made by 50 g refined wheat flour

Sponsors

Peking University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Randomized Crossover Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
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 intakeMetabolite 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

MeasureTime frameDescription
The influence of gut flora on whole grain markersafter the administration of the test mealGut flora abundance and metabolites level correlation analysis

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026