NCT06594848

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Black rice extract	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
OTHER	Placebo	The placebo for this study is composed by maltodextrin and food colorant

Timeline

• Start date: 2024-09-15
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2024-09-19
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States