Whole-Grain Brown Rice for Nutrient Absorption Study
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for healthy adult men and women. People with health conditions or on medications that could affect the study results are likely excluded.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Refined White Rice
- Whole-Grain Brown Rice
Trial Overview
The study compares how the body absorbs and processes substances from whole-grain brown rice versus refined white rice. Participants eat both types of rice in a randomized order, and researchers measure changes in blood and urine.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
North Carolina Agriculture & Technical State University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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