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

NCT07767162 | Recruiting

• 2 other identifiers: 25-0108-1R01DK143583
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Females; Healthy Adult Males

Keywords

whole grain corn

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Plasma and Urine Metabolite Concentration Following Whole-Grain Product Intake

  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.

  Baseline through 48 hours after consumption of whole-grain product during pharmacokinetic study visit.

Study Arms (2)

Whole-Grain Corn → Refined Corn

EXPERIMENTAL

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.

Dietary Supplement: Whole-Grain Corn; Dietary Supplement: Refined Corn

Refined Corn → Whole-Grain Corn

EXPERIMENTAL

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.

Dietary Supplement: Whole-Grain Corn; Dietary Supplement: Refined Corn

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 → Whole-Grain Corn; Whole-Grain Corn → Refined Corn

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.

Refined Corn → Whole-Grain Corn; Whole-Grain Corn → Refined Corn

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Carolina Agriculture & Technical State University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Clinical Research Core (CRC)

Kannapolis, North Carolina, 28081, United States

RECRUITING

Central Study Contacts

Shengmin Sang

CONTACT

704-250-5710; ssang@ncat.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Functional Foods

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: August 4, 2026
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

US (1)