Healthy Adult MalesNCT07898137
Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Brown Rice
A study testing Whole-Grain Brown Rice and Refined White Rice in people with Healthy Adult Males and Healthy Adult Females, run by North Carolina Agriculture & Technical State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Males, Healthy Adult Females
- What is being tested?
- Whole-Grain Brown Rice and Refined White Rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2027to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Research Core (CRC)
Kannapolis, North Carolina, 28081
Samantha Carroll, 704-250-5083, crc_studies@unc.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy Adult Males, Healthy Adult Females
- Being tested
- Whole-Grain Brown Rice, Refined White Rice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Grain Brown RiceDietary supplement
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 RiceDietary supplement
Participants will consume two servings of cooked refined white rice (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.
| Study group | Role | What they receive |
|---|---|---|
| Whole-Grain brown rice → Refined white rice | Experimental | 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. Receives: Dietary Supplement: Whole-Grain Brown Rice; Dietary Supplement: Refined White Rice |
| Refined white rice → Whole-Grain brown rice | Experimental | 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. Receives: Dietary Supplement: Whole-Grain Brown Rice; Dietary Supplement: Refined White Rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 48 hours after consumption of whole-grain product during pharmacokinetic study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start15 Jan 2027 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina Agriculture & Technical State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengmin Sang, North Carolina Agriculture & Technical State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898137
- Sponsor's protocol ID
- 25-0108-3
- Other IDs
- R01DK143583
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Brown Rice
- ClinicalTrials.gov ID
- NCT07898137
- Acronym / sponsor ID
- 25-0108-3
- Conditions
- Healthy Adult Males, Healthy Adult Females
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- North Carolina Agriculture & Technical State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-Grain brown rice → Refined white rice | Experimental | Dietary Supplement: Whole-Grain Brown Rice, Dietary Supplement: Refined White RiceParticipants 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. |
| Refined white rice → Whole-Grain brown rice | Experimental | Dietary Supplement: Whole-Grain Brown Rice, Dietary Supplement: Refined White RiceParticipants 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-Grain Brown RiceParticipants will consume two servings of cooked whole-grain brown rice (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit. | Dietary supplement | Refined white rice → Whole-Grain brown rice, Whole-Grain brown rice → Refined white rice |
| Refined White RiceParticipants will consume two servings of cooked refined white rice (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit. | Dietary supplement | Refined white rice → Whole-Grain brown rice, Whole-Grain brown rice → Refined white rice |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Grain Brown Rice and Refined White Rice in people with Healthy Adult Males and Healthy Adult Females, run by North Carolina Agriculture & Technical State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengmin Sang (704-250-5710, ssang@ncat.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.