Effects of a Black Rice Extract and Anthocyanidin Metabolites on the Synthesis and Release of BDNF in Healthy Subjects

NCT06594848 | Active Not Recruiting

• 1 other identifier: 2186403
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognition - Other; Depression, Anxiety

Keywords

Anthocyanin; cyanidin; BDNF; Metabolites

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• BDNF gene epxression in isolated blood cells

  Changes in mRNA BDNF levels upon single consumption of black rice extract (4 hours kinetic)

Study Arms (2)

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.

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.

Dietary Supplement: Black rice extract

Interventions

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

Black rice extract

Placebo OTHER

The placebo for this study is composed by maltodextrin and food colorant

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Ragle Human Nutrition Research Center, Academic Surge II

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Eleonora Cremonini

  UC Davis

  PRINCIPAL INVESTIGATOR

• Patricia I Oteiza

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)