Recruiting

Brown Rice

Sponsor:

North Carolina Agriculture & Technical State University

Code:

NCT07898137

Conditions

Healthy Adult Males

Healthy Adult Females

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Accepted

Interventions

Whole-Grain Brown Rice

Refined White Rice

Study Details

Brief summary:

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.

Conditions

Healthy Adult Males

Healthy Adult Females

Study ID

NCT07898137

Start date

Jan 15, 2027

Status verified date

Oct, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

May 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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
  • Normal blood and urine biochemical parameters
  • No antibiotic use within the past 6 months
  • Willing and able to comply with all study procedures, including dietary restrictions throughout the study period
  • No medical conditions or lifestyle factors that, in the opinion of the investigators, would interfere with the study objectives

Exclusion Criteria:

  • 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

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Whole-Grain brown rice → Refined white rice

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.

experimental: Refined white rice → Whole-Grain brown rice

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.

Interventions

Whole-Grain Brown Rice

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.

Refined White Rice

Participants will consume two servings of cooked refined white rice (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.

Primary outcome measure

  • Change From Baseline in Plasma and Urine Metabolite Concentration Following Whole-Grain Product Intake [ Time Frame: Baseline through 48 hours after consumption of whole-grain product during pharmacokinetic study visit. ]

Central Contacts and Locations

Central contacts

Shengmin Sang

704-250-5710ssang@ncat.edu

Locations

Clinical Research Core (CRC)

Recruiting

Kannapolis, North Carolina, United States, 28081

Contacts

Samantha Carroll

704-250-5083crc_studies@unc.edu

More Information

Sponsor

North Carolina Agriculture & Technical State University

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by North Carolina Agriculture & Technical State University on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.