Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Corn
North Carolina Agriculture & Technical State University
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, 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.
Description
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…
Eligibility
- Age range
- 25–70 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- Dietary SupplementWhole-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.
- Dietary SupplementRefined Corn
Participants will consume two servings of cooked refined corn (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.
Location
- Clinical Research Core (CRC)Kannapolis, North Carolina