Healthy Adult FemalesNCT07767162
Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Corn
A study testing Whole-Grain Corn and Refined Corn in people with Healthy Adult Females and Healthy Adult Males, run by North Carolina Agriculture & Technical State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Females, Healthy Adult Males
- What is being tested?
- Whole-Grain Corn and Refined Corn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Research Core (CRC)
Kannapolis, North Carolina, 28081
Samantha Carroll, 704-250-5083, crc_studies@unc.edu
About this study
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.
Read the 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.
- Conditions
- Healthy Adult Females, Healthy Adult Males
- Being tested
- Whole-Grain Corn, Refined Corn
- Keywords
- whole grain corn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Grain CornDietary 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 CornDietary 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 group | Role | What they receive |
|---|---|---|
| Whole-Grain Corn → Refined Corn | Experimental | 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. Receives: Dietary Supplement: Whole-Grain Corn; Dietary Supplement: Refined Corn |
| Refined Corn → Whole-Grain Corn | Experimental | 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. Receives: Dietary Supplement: Whole-Grain Corn; Dietary Supplement: Refined Corn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Plasma and Urine Metabolite Concentration Following Whole-Grain Product Intake
Metabolite concentration will be measured at baseline and at postprandial time points following consumption of the whole-grain products using untargeted and targeted metabolomics. Changes from baseline in metabolite concentrations will be reported to characterize the acute metabolic response to whole-grain products.
Measured: Baseline through 48 hours after consumption of whole-grain product during pharmacokinetic study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start4 Aug 2026
- Primary completion25 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina Agriculture & Technical State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengmin Sang, North Carolina Agriculture & Technical State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767162
- Sponsor's protocol ID
- 25-0108-1
- Other IDs
- R01DK143583
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No