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

Exclusion Criteria

• •1. Age \< 18 or \> 80 years.
• •2. BMI \< 21 or \> 29.9 kg/m2.
• •3. 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.
• •4. Current consumption of special diets (e.g. Atkins, keto, paleo, etc.).
• •5. Current participation or enrollment in another pharmaceutical, weight-loss or nutritional clinical study within the last 30 days. Device trials are exempted.
• •6. Uncontrolled hypertension defined as diastolic blood pressure ≥ 95 mmHg and/or systolic blood pressure ≥ 160 mmHg.
• •7. Fasting blood triglycerides \> 150 mg/dL.
• •8. Self-reported Type 2 Diabetes.
• •9. Fasting blood glucose \<50 mg/dL or \> 100 mg/dL.
• •10. Hemoglobin A1c levels ≥ 5.7%.
• •11. Current smoker or use of tobacco products within the last 180 days.
• •12. 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).
• •13. Substance abuse or dependence within the last 60 days.
• •14. Daily use of anti-inflammatory medications including NSAIDs and aspirin within the last 30 days.
• •15. Use of laxative medications or other products that promote colon cleansing within the last 30 days.
• •16. History of restricted diets or use of herbal supplements or medications that interfere with insulin metabolism within the last 30 days.
• •17. History of stroke, hepatic, gallbladder, kidney, thyroid disease, or cancer.
• •18. History of immune related disorders or Raynaud's disease.
• •19. Current clinically significant depression, anxiety, or other psychiatric condition.
• •20. History of malabsorption or GI tract disorders.
• •21. History of GI surgeries (e.g. lap band, gastric bypass, etc.).
• •22. Diarrhea or oral antibiotic intake within the last 30 days.
• •23. Weight change (\> 5%) within the last 30 days.
• •24. History of eating disorders such as bulimia, anorexia, or muscle dysmorphia.
• •25. Allergy or sensitivity to the study products.
• •26. Subject has not received a complete COVID-19 vaccine or is less than 6 weeks post-vaccine at the screening visit.
• •27. Any other condition which in the Investigator's opinion might adversely affect the subject's ability to complete the study or its measurements or which might pose significant risk to the subject.