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

Conditions

• Healthy Adult Females
• Healthy Adult Males

Eligibility Criteria

Sex

ALL

Age

25 Years - 70 Years

Healthy Volunteers

Accepted

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 — 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.

Study Details

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.

Key Dates

First listed

Aug 17, 2026

Start date

Aug 4, 2026

Status verified

Aug 2026

Primary completion

Nov 25, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

16 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

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.

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

• Shengmin Sang
  704-250-5710
  [email protected]

Locations (1)

Find similar trials in Kannapolis, NC

Related Studies

• Examining Olive Oil Extract on Knee Comfort and Function
  Recruiting · Applied Food Sciences Inc. · San Francisco, California