NCT07767162|Recruiting
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Sponsor study identifier
Secondary identifiers
NIH
interventional
16
1 country
1
Study Start
August 4, 2026
Actual (reported)Primary Completion
November 25, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 4, 2026
Actual (reported)August 11, 2026
Actual (reported)August 17, 2026
Actual (reported)November 25, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline through 48 hours after consumption of whole-grain product during pharmacokinetic study visit.
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.
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.
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.
Clinical Research Core (CRC)
Kannapolis, North Carolina, 28081, United States
First Submitted
August 11, 2026
First Posted
August 17, 2026
Study Start
August 4, 2026
Actual (reported)Primary Completion
November 25, 2026
EstimatedRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 24, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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