Clinical Research Core (CRC)
Kannapolis, North Carolina, 28081, United States
Location status: Recruiting
NCT Number: NCT07767162
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.
Interested in participating?
Request Info25 year–70 year
All sexes
Interventional
Not applicable
Kannapolis, North Carolina, 28081, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will consume two servings of cooked whole-grain corn (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.
Participants will consume two servings of cooked refined corn (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.
Time frame: Baseline to 48 hours after each pharmacokinetic study visit.
Identification of metabolites associated with acute whole-grain products intake using untargeted and targeted metabolomics analyses following a single dietary exposure.
Contact information is provided by the study sponsor or research team.
North Carolina Agriculture & Technical State University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07511439
Healthy Adult Females, The Focus of the Study is to Investigate Reversible Effects of Combined Oral Contraceptive Use on Serotonergic Neurotransmission
Copenhagen, Denmark
View Trial DetailsNCT07644000
Healthy Adult Females
Olomouc, Czechia
View Trial DetailsNCT07632300
Healthy Adult Females, Healthy Adult Male
Ho Chi Minh City, Hồ Chí Minh, Vietnam
View Trial DetailsNCT07459465
Healthy Adult Females
Ottawa, Ontario, Canada
View Trial Details