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

NCT07767162 — Not applicable, Recruiting, 16 participants, North Carolina Agriculture & Technical State University

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Registry	NCT07767162
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	16 (Estimated)
Sponsor	North Carolina Agriculture & Technical State University (Other); collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions	Healthy Adult Females, Healthy Adult Males
Interventions	Whole-Grain Corn, Refined Corn (Dietary supplement)
Dates	start 2026-08-04, primary completion 2026-11-25 (estimated), completion 2026-12-31 (estimated), first posted 2026-08-17, last updated 2026-08-24
Locations	1 site in United States

-Summary

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.

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+Detailed description

Days 0-7: Healthy volunteers were recruited and instructed to avoid consuming any whole-grain products beginning one week before the intervention and continuing throughout the study period.

Day 8 - Pharmacokinetic (PK) Visit 1: Participants consumed two servings of either whole-grain or refined-grain (46 g of raw grain per serving; 92 g total). Blood and urine samples were collected at multiple time points over 48 hours, and baseline fecal samples were collected the day before the intervention.

Day 15 - Pharmacokinetic (PK) Visit 2: After a 6-day washout period, participants crossed over to the alternate treatment. Blood and urine samples were again collected at multiple time points over 48 hours.

+Arms and interventions

Arm	Type	Interventions	Description
Whole-Grain Corn → Refined Corn	Experimental	Dietary Supplement: Whole-Grain Corn; Dietary Supplement: Refined Corn	Participants will complete a 7-day wash-in period during which they will avoid consuming whole-grain products. During Pharmacokinetic (PK) Visit 1 (Day 8), participants will consume whole-grain corn. After a 6-day washout period, participants will cross over and consume refined corn during PK Visit 2 (Day 15). Blood and urine samples will be collected over 48 hours following each intervention.
Refined Corn → Whole-Grain Corn	Experimental	Dietary Supplement: Whole-Grain Corn; Dietary Supplement: Refined Corn	Participants will complete a 7-day wash-in period during which they will avoid consuming whole-grain products. During Pharmacokinetic (PK) Visit 1 (Day 8), participants will consume refined corn. After a 6-day washout period, participants will cross over and consume whole-grain corn during PK Visit 2 (Day 15). Blood and urine samples will be collected over 48 hours following each intervention.

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.

+Outcome measures

Primary outcomes

Change From Baseline in Plasma and Urine Metabolite Concentration Following Whole-Grain Product Intake [Baseline through 48 hours after consumption of whole-grain product during pharmacokinetic study visit.]: Metabolite concentration will be measured at baseline and at postprandial time points following consumption of the whole-grain products using untargeted and targeted metabolomics. Changes from baseline in metabolite concentrations will be reported to characterize the acute metabolic response to whole-grain products.

+Eligibility

Sex: All, ages: 25 Years to 70 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Clinical Research Core (CRC)	Kannapolis, North Carolina	United States	Recruiting

+Funding

NIH grants: R01DK143583