NCT07898137|Recruiting
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Sponsor study identifier
Secondary identifiers
NIH
interventional
16
1 country
1
Study Start
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this research study is to identify biomarkers (measurable signs). in the body like substances in blood or urine) of whole-grain (WG) brown rice 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 brown rice. Investigators will then use a targeted metabolomics approach to identify the exposure markers of brown rice intake, further develop analytical methods to study its pharmacokinetics, build an in-house WG metabolite database, and use an untargeted metabolomics approach to investigate postprandial biomarkers of brown rice intake. At the completion of this study, the expectation is that investigators will identify brown rice phytochemicals and its metabolites as objective biomarkers of total and individual WGs that are commonly consumed by Americans.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2027
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.
October 13, 2026
Actual (reported)October 27, 2026
Actual (reported)January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2027
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 concentrations 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 brown rice. After a 6-day washout period, participants will cross over and consume refined white rice 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 white rice. After a 6-day washout period, participants will cross over and consume whole-grain brown rice 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 brown rice (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.
Participants will consume two servings of cooked refined white rice (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
October 13, 2026
First Posted
October 27, 2026
Study Start
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 15, 2027
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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