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NCT Number: NCT07767162

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

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, we will conduct a randomized crossover acute pharmacokinetic study of corn. We 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 we will identify corn phytochemicals and its metabolites as objective biomarkers of total and individual WG corn that are commonly consumed by Americans.

Recruiting

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Core (CRC)

Kannapolis, North Carolina, 28081, United States

Location status: Recruiting

Location contact

Samantha Carroll

CONTACT

[email protected]

704-250-5083

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Biomarkers of Whole-Grain products Intake

    Time frame: Baseline to 48 hours after each pharmacokinetic study visit.

    Identification of metabolites associated with acute whole-grain products intake using untargeted and targeted metabolomics analyses following a single dietary exposure.

Study contacts

Contact information is provided by the study sponsor or research team.

Shengmin Sang

CONTACT

[email protected]

704-250-5710

Sponsors and collaborators

Lead sponsor

North Carolina Agriculture & Technical State University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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