Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Corn
Purpose
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
Eligibility
- Eligible Ages
- Between 25 Years and 70 Years
- Eligible Sex
- All
- Accepts 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, 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Kannapolis, North Carolina 28081
More Details
- Status
- Recruiting
- Sponsor
- North Carolina Agriculture & Technical State University
Detailed 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 the alternate treatment. Blood and urine samples were again collected at multiple time points over 48 hours.