Black Rice Extract for Depression

Overseen By Patricia I Oteiza, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Anti-inflammatories, Laxatives

Disqualifiers: Diabetes, Hypertension, Depression, others

Compensation: Varies

Number of Visits: 3

Duration: 1 day

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it does require stopping pre- and/or probiotic and/or polyphenol supplements from 2 days before the screening and throughout the study.

What data supports the effectiveness of the treatment Black Rice Extract for depression?

Black rice extract has shown potential benefits in protecting brain cells and improving memory in mice, which might suggest it could help with brain-related conditions like depression. Additionally, its antioxidant properties have been demonstrated to protect cells from damage, which could be beneficial in managing depression. ^{1 2 3 4 5}

Is black rice extract safe for humans?

Studies on black rice extract in animals suggest it is generally safe, with no acute toxicity observed at high doses in rats. However, specific safety data in humans is limited. ^{4 5 6 7 8}

How does the treatment Black Rice Extract differ from other treatments for depression?

Black Rice Extract is unique because it contains high levels of anthocyanins, which are antioxidants that may help protect brain cells from damage. This is different from many traditional depression treatments that primarily focus on altering brain chemicals like serotonin. Additionally, Black Rice Extract is taken orally and may offer benefits for brain health beyond just mood improvement. ^{1 2 4 5 9}

Research Team

Eleonora Cremonini

Principal Investigator

UC Davis

Patricia I Oteiza

Principal Investigator

UC Davis

Eligibility Criteria

Healthy adults aged 18-80 with a BMI of 21-29.9, not allergic to rice, and willing to follow dietary restrictions before study visits can join this trial. Women must not be pregnant. Participants should have completed COVID-19 vaccination at least 6 weeks prior and agree to avoid certain foods and supplements.

Inclusion Criteria

I am either male or female.

I agree to limit my intake of certain foods and drinks high in AC.

I am healthy with no conditions that could affect the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of Black Rice Extract or placebo and are monitored for changes in BDNF levels

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 hours

1 visit (in-person)

Treatment Details

Interventions

• Black Rice Extract

Trial Overview This study tests if black rice extract (BRE) affects the levels of BDNF, important for cognition, in healthy people's blood compared to a placebo. It will check if one-time consumption changes BDNF amounts or gene expression related to it.

Participant Groups

Group I: Black rice extract Active Control 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

References

1. China pubmed.ncbi.nlm.nih.gov

[Inhibition effects of black rice pericarp extracts on cell proliferation of PC-3 cells]. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Protective Effects of Black Rice Extracts on Oxidative Stress Induced by tert-Butyl Hydroperoxide in HepG2 Cells. [2020]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Black rice extract protected HepG2 cells from oxidative stress-induced cell death via ERK1/2 and Akt activation. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of black rice extract on obesity in obese postmenopausal women: a 12-week randomized, double-blind, placebo-controlled preliminary clinical trial. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Black Rice (Oryza sativa L., Poaceae) Extract Reduces Hippocampal Neuronal Cell Death Induced by Transient Global Cerebral Ischemia in Mice. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Hypolipidaemic effects of cyanidin 3-glucoside rich extract from black rice through regulating hepatic lipogenic enzyme activities. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Gastroprotective Activities of Ethanol Extract of Black Rice Bran (Oryza sativa L.) in Rats. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Recent advances on bioactivities of black rice. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of germinated brown rice extracts with enhanced levels of GABA on cancer cell proliferation and apoptosis. [2022]