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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorNorth Carolina Agriculture & Technical State University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Whole-Grain Corn
  • Refined Corn

Treatment groups

16 Participants
are divided into 2 treatment groups

Sponsors and collaborators

North Carolina Agriculture & Technical State University

Lead sponsor

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

Collaborator