Effects of a Black Rice Extract and Anthocyanidin Metabolites on the Synthesis and Release of BDN… (NCT06594848) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of a Black Rice Extract and Anthocyanidin Metabolites on the Synthesis and Release of BDNF in Healthy Subjects
United States12 participantsStarted 2024-09-15
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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).
Exclusion criteria
What they're measuring
1
BDNF
Timeframe: Changes in circulating BDNF upon single consumption of black rice extract (4 hours kinetic)
✕. 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.