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Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Corn

Sponsor: North Carolina Agriculture & Technical State University • ClinicalTrials.gov ID: NCT07767162

Registry updated: 2026-08-24

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Description

The purpose of this research study is to identify biomarkers of whole grain (WG) corn intake following an acute exposure in a pharmacokinetic (how the body absorbs, processes, and gets rid of a substance or ingredient) feeding study. In this aim, investigators will conduct a randomized crossover acute pharmacokinetic study of corn. Investigators will then use a targeted metabolomics approach to identify the exposure markers of corn intake, further develop analytical methods to study its pharmacokinetics, and build our in-house WG metabolite database and an untargeted metabolomics approach to investigate postprandial biomarkers of corn intake. At the completion of this study, our expectation is that investigators will identify corn phytochemicals and its metabolites as objective biomarkers of total and individual WG corn that are commonly consumed by Americans.

Interventions

Whole-Grain Corn (Dietary supplement)
Participants will consume two servings of cooked whole-grain corn (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.
Refined Corn (Dietary supplement)
Participants will consume two servings of cooked refined corn (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.

Eligibility criteria

Inclusion Criteria: * Adults aged 25-70 years * Body mass index (BMI) between 18 and 30 kg/m² * Able to read, speak, and understand English * No known allergy or intolerance to the test foods * Normal blood and urine biochemical parameters * No antibiotic use within the past 6 months * Willing and able to comply with all study procedures, including dietary restrictions throughout the study period * No medical conditions or lifestyle factors that, in the opinion of the investigators, would interfere with the study objectives Exclusion Criteria: * Active disease, including gout, heart disease, peripheral vascular disease, kidney disease, liver disease, cancer, diabetes, gastrointestinal disorders, or endocrine disorders that may interfere with the study * Current smoker or use of tobacco products * Unwilling or unable to comply with the required dietary restrictions during the study period

Conditions

Healthy Adult Females Healthy Adult Males

Locations

Clinical Research Core (CRC) — Kannapolis, North Carolina, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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