Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Corn
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorNorth Carolina Agriculture & Technical State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Whole-Grain Corn
Dietary supplementParticipants 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 supplementParticipants will consume two servings of cooked refined corn (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Whole-Grain Corn → Refined CornExperimental treatment 2 interventions
Group B: Refined Corn → Whole-Grain CornExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline through 48 hours after consumption of whole-grain product during pharmacokinetic study visit.Sponsors and contacts
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North Carolina Agriculture & Technical State University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov