Cognition - OtherNCT06594848
Effects of a Black Rice Extract and Anthocyanidin Metabolites on the Synthesis and Release of BDNF in Healthy Subjects
A study testing Black rice extract in people with Cognition - Other and Depression, Anxiety, run by University of California, Davis at 1 site in United States.
Trial summary
The goal of this clinical trial is to investigate the effect of black rice extract (BRE) supplementation on levels of BDNF, which is a key molecule in cognition in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition - Other, Depression, Anxiety
- What is being tested?
- Black rice extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2024to 30 Nov 2026
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is healthy and, in the opinion of the investigator, free of any medical conditions that might affect study measurements.
- Male or female.
- Age between 18 - 80 years inclusive.
- BMI between 21 - 29.9 kg/m2.
- Female subject of childbearing potential has a negative urine pregnancy test result.
- Subject agrees to discontinue the use of pre- and/or probiotic and/or polyphenol supplements from 2 days prior to the screening and throughout the study.
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- Subject agrees to consume less than 1/2 cup/day of foods containing AC (such as blueberries, blackberries, bilberries, cherries, grapes, grape juice, pomegranate, raspberries, huckleberries, strawberries) and no more than 1 glass/day of red wine, 3 cups/day of tea or coffee, or 10 g/day of dark chocolate from 2 days prior to the screening and throughout the study.
- No known allergies to study products or components (rice).
- Subject is willing to consume a low fat/low flavonoid dinner the evening before study visits.
- Subject has received a complete COVID-19 vaccine and is at least 6 weeks post-vaccine at the pre-screening visit as verified by shot record or similar documentation.
- Subject has given voluntary, written, informed consent to participate in the study.
Who cannot join
- Age < 18 or > 80 years.
- BMI < 21 or > 29.9 kg/m2.
- Vegan, Vegetarian, or other dietary restrictions that would not allow the subject to easily consume a low polyphenol diet leading up to screening and study visits.
- Current consumption of special diets (e.g. Atkins, keto, paleo, etc.).
- Current participation or enrollment in another pharmaceutical, weight-loss or nutritional clinical study within the last 30 days. Device trials are exempted.
- Uncontrolled hypertension defined as diastolic blood pressure ≥ 95 mmHg and/or systolic blood pressure ≥ 160 mmHg.
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- Fasting blood triglycerides > 150 mg/dL.
- Self-reported Type 2 Diabetes.
- Fasting blood glucose <50 mg/dL or > 100 mg/dL.
- Hemoglobin A1c levels ≥ 5.7%.
- Current smoker or use of tobacco products within the last 180 days.
- Binge drinking (alcohol intake ≥ 5 alcoholic drinks for males or ≥ 4 alcoholic drinks for females on the same occasion, i.e. at the same time or within a couple of hours of each other).
- Substance abuse or dependence within the last 60 days.
- Daily use of anti-inflammatory medications including NSAIDs and aspirin within the last 30 days.
- Use of laxative medications or other products that promote colon cleansing within the last 30 days.
- History of restricted diets or use of herbal supplements or medications that interfere with insulin metabolism within the last 30 days.
- History of stroke, hepatic, gallbladder, kidney, thyroid disease, or cancer.
- History of immune related disorders or Raynaud's disease.
- Current clinically significant depression, anxiety, or other psychiatric condition.
- History of malabsorption or GI tract disorders.
- History of GI surgeries (e.g. lap band, gastric bypass, etc.).
- Diarrhea or oral antibiotic intake within the last 30 days.
- Weight change (> 5%) within the last 30 days.
- History of eating disorders such as bulimia, anorexia, or muscle dysmorphia.
- Allergy or sensitivity to the study products.
- Subject has not received a complete COVID-19 vaccine or is less than 6 weeks post-vaccine at the screening visit.
- Any other condition which in the Investigator's opinion might adversely affect the subject's ability to complete the study or its measurements or which might pose significant risk to the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Research Center, Academic Surge II
Davis, California, 95616
About this study
Official title: Investigating the Effects of Dietary Supplementation With a Black Rice Anthocyanidin Rich Extract (BRE) and Anthocyanidin Metabolites on the Synthesis and Release of Brain Derived Neurotropic Factor (BDNF) in Healthy Subjects
The goal of this clinical trial is to investigate the effect of black rice extract (BRE) supplementation on levels of BDNF, which is a key molecule in cognition in healthy volunteers. The main questions to answer are:
Does single BRE consumption increase levels of BDNF in the circulation in healthy men and women? Does single BRE consumption impact BDNF gene expression in cells isolated from the blood?
Researchers will compare BRE to a placebo (a look-alike supplement that contains no BRE) to see if BRE increases levels of BDNF in blood.
Read the detailed description
The first study will be a cross over-double blind placebo controlled, the second will be and ex vivo study.
Subjects will initially be pre-screened for eligibility by a phone interview to determine if they meet basic study inclusion and exclusion criteria and wish to proceed with the in-person screening. Interested subjects that meet both inclusion and exclusion criteria based on the phone interview will be invited to the Ragle Facility (Ragle Human Nutrition Research Center, Academic Surge II, UCD main campus) for an in-person screening visit. During this visit, the aim of the study the participant chooses to be in and how it will be conducted will be explained and written. Informed consent will be obtained from the potential participants.
For the first study, subjects will be asked for: i) being fasted for at least 12 h; ii) determination of body weight, height, and blood pressure; iii) a finger stick blood sample to determine actual glucose and triglyceride concentrations; and iv) answering a health and habits questionnaire. The responses to the questionnaire and the results from the screening measurements (BMI and blood pressure, blood glucose and triglycerides) will be used to confirm that potential participants meet inclusion/exclusion criteria.
For the second study, subjects will be asked for: i) being fasted for at least 12 h; ii) determination of body weight, height, and blood pressure; iii) a finger stick blood sample to determine actual glucose and triglyceride concentrations; and iv) answering a health and habits questionnaire. The responses to the questionnaire and the results from the screening measurements (BMI, blood pressure, blood glucose and triglycerides) will be used to confirm that potential participants meet inclusion/exclusion criteria.
- Conditions
- Cognition - Other, Depression, Anxiety
- Being tested
- Black rice extract, Placebo
- Keywords
- Anthocyanin, cyanidin, BDNF, Metabolites
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black rice extractDietary supplement
Black rice extract is rich in a specific type of anthocyanins, cyanidin. It has been shown by our group that cyanidin-rich food can have beneficial health effects
PlaceboOther
The placebo for this study is composed by maltodextrin and food colorant
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo consists in 4 g of maltodextrin with food coloring (blue and green dyes) to match the color on the active comparator (Black Rice Extract). The placebo will be dissolved in 200 ml of water. Receives: Other: Placebo |
| Black rice extract | Active comparator | Active comparator consists in 2 g of Black Rice Extract and 2 g of maltodextrin. The Black Rice Extract will be dissolved in 200 ml of water. Receives: Dietary Supplement: Black rice extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF
BDNF will be measured in the serum using ELISA kit following the manufacturers' instruction
Measured: Changes in circulating BDNF upon single consumption of black rice extract (4 hours kinetic)
Secondary outcomes (1)
BDNF gene epxression in isolated blood cells
mRNA levels of BDNF will be measured using quantitative PCR
Measured: Changes in mRNA BDNF levels upon single consumption of black rice extract (4 hours kinetic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition - OtherStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleonora Cremonini, Principal investigator, UC DavisPatricia I Oteiza, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594848
- Sponsor's protocol ID
- 2186403
- Status last verified
- Jan 2026
- First submitted
- 10 Sep 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Dietary Supplementation With a Black Rice Anthocyanidin Rich Extract (BRE) and Anthocyanidin Metabolites on the Synthesis and Release of Brain Derived Neurotropic Factor (BDNF) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06594848
- Acronym / sponsor ID
- 2186403
- Conditions
- Cognition - Other, Depression, Anxiety
- Keywords
- Anthocyanin, cyanidin, BDNF, Metabolites
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to investigate the effect of black rice extract (BRE) supplementation on levels of BDNF, which is a key molecule in cognition in healthy volunteers. The main questions to answer are:
Does single BRE consumption increase levels of BDNF in the circulation in healthy men and women? Does single BRE consumption impact BDNF gene expression in cells isolated from the blood?
Researchers will compare BRE to a placebo (a look-alike supplement that contains no BRE) to see if BRE increases levels of BDNF in blood.
Detailed description
The first study will be a cross over-double blind placebo controlled, the second will be and ex vivo study.
Subjects will initially be pre-screened for eligibility by a phone interview to determine if they meet basic study inclusion and exclusion criteria and wish to proceed with the in-person screening. Interested subjects that meet both inclusion and exclusion criteria based on the phone interview will be invited to the Ragle Facility (Ragle Human Nutrition Research Center, Academic Surge II, UCD main campus) for an in-person screening visit. During this visit, the aim of the study the participant chooses to be in and how it will be conducted will be explained and written. Informed consent will be obtained from the potential participants.
For the first study, subjects will be asked for: i) being fasted for at least 12 h; ii) determination of body weight, height, and blood pressure; iii) a finger stick blood sample to determine actual glucose and triglyceride concentrations; and iv) answering a health and habits questionnaire. The responses to the questionnaire and the results from the screening measurements (BMI and blood pressure, blood glucose and triglycerides) will be used to confirm that potential participants meet inclusion/exclusion criteria.
For the second study, subjects will be asked for: i) being fasted for at least 12 h; ii) determination of body weight, height, and blood pressure; iii) a finger stick blood sample to determine actual glucose and triglyceride concentrations; and iv) answering a health and habits questionnaire. The responses to the questionnaire and the results from the screening measurements (BMI, blood pressure, blood glucose and triglycerides) will be used to confirm that potential participants meet inclusion/exclusion criteria.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo consists in 4 g of maltodextrin with food coloring (blue and green dyes) to match the color on the active comparator (Black Rice Extract). The placebo will be dissolved in 200 ml of water. |
| Black rice extract | Active comparator | Dietary Supplement: Black rice extractActive comparator consists in 2 g of Black Rice Extract and 2 g of maltodextrin. The Black Rice Extract will be dissolved in 200 ml of water. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subject is healthy and, in the opinion of the investigator, free of any medical conditions that might affect study measurements.
- Male or female.
- Age between 18 - 80 years inclusive.
- BMI between 21 - 29.9 kg/m2.
- Female subject of childbearing potential has a negative urine pregnancy test result.
Key exclusion criteria (27 listed)
- Age < 18 or > 80 years.
- BMI < 21 or > 29.9 kg/m2.
- Vegan, Vegetarian, or other dietary restrictions that would not allow the subject to easily consume a low polyphenol diet leading up to screening and study visits.
- Current consumption of special diets (e.g. Atkins, keto, paleo, etc.).
- Current participation or enrollment in another pharmaceutical, weight-loss or nutritional clinical study within the last 30 days. Device trials are exempted.
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 |
|---|---|---|
| Black rice extractBlack rice extract is rich in a specific type of anthocyanins, cyanidin. It has been shown by our group that cyanidin-rich food can have beneficial health effects | Dietary supplement | Black rice extract |
| PlaceboThe placebo for this study is composed by maltodextrin and food colorant | Other | Placebo |
Primary outcome
BDNF
Time frame: Changes in circulating BDNF upon single consumption of black rice extract (4 hours kinetic)
BDNF will be measured in the serum using ELISA kit following the manufacturers' instruction
1 secondary outcome
BDNF gene epxression in isolated blood cells
Time frame: Changes in mRNA BDNF levels upon single consumption of black rice extract (4 hours kinetic)
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 29 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Eleonora Cremonini principal investigator
UC Davis
Patricia I Oteiza principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black rice extract in people with Cognition - Other and Depression, Anxiety, run by University of California, Davis 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 11 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF (time frame: Changes in circulating BDNF upon single consumption of black rice extract (4 hours kinetic)). 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 29 Jan 2026.