Recruiting

Whole Grain Corn

Sponsor:

North Carolina Agriculture & Technical State University

Code:

NCT07767162

Conditions

Healthy Adult Females

Healthy Adult Males

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Accepted

Interventions

Whole-Grain Corn

Refined Corn

Study Details

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

Study ID

NCT07767162

Start date

Aug 4, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Whole-Grain Corn → 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.

experimental: Refined Corn → Whole-Grain 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.

Interventions

Whole-Grain Corn

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

Participants will consume two servings of cooked refined corn (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.

Primary outcome measure

  • Change From Baseline in Plasma and Urine Metabolite Concentration Following Whole-Grain Product Intake [ Time Frame: Baseline through 48 hours after consumption of whole-grain product during pharmacokinetic study visit. ]

Central Contacts and Locations

Central contacts

Shengmin Sang

704-250-5710ssang@ncat.edu

Locations

Clinical Research Core (CRC)

Recruiting

Kannapolis, North Carolina, United States, 28081

Contacts

Samantha Carroll

704-250-5083crc_studies@unc.edu

More Information

Sponsor

North Carolina Agriculture & Technical State University

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • whole grain corn

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Carolina Agriculture & Technical State University on 2026-08-24.