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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black rice extract | Dietary 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BDNF | BDNF will be measured in the serum using ELISA kit following the manufacturers' instruction | Changes in circulating BDNF upon single consumption of black rice extract (4 hours kinetic) |
| Measure | Description | Time Frame |
|---|---|---|
| BDNF gene epxression in isolated blood cells | mRNA levels of BDNF will be measured using quantitative PCR | Changes in mRNA BDNF levels upon single consumption of black rice extract (4 hours kinetic) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eleonora Cremonini | UC Davis | Principal Investigator |
| Patricia I Oteiza | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ragle Human Nutrition Research Center, Academic Surge II | Davis | California | 95616 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Placebo | Other | The placebo for this study is composed by maltodextrin and food colorant |
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