Herbal Extract Study

Exclusion Criteria

• •1. Subject is unable to understand and/or perform required tests and questionnaires (i.e., subjects cannot complete the practice tests, or tasks).
• •2. Subject is color blind.
• •3. Subject has an abnormal laboratory test result of clinical significance, including, but not limited to creatinine ≥1.5 mg/dL and ALT or AST ≥1.5X upper limit of normal at visit 1 (day -14 to -2).
• •4. Subject has a known allergy or sensitivity to study products or any ingredients of the study products, standardized meals/snacks provided.
• •5. Subject has a gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
• •6. Subject has diagnosed depression, schizophrenia, or dementia in the last 2 years prior to visit 1 (day -14 to -2).
• •7. Subject has a history or presence of clinically important cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, and/or stroke), renal, hepatic, endocrine (including type 1 or type 2 diabetes mellitus), pulmonary, biliary, pancreatic, or neurologic disorders.
• •8. Subject has extreme dietary habits (e.g., vegan, Atkins diet, very high protein).
• •9. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the blood pressure measured at visit 1, (day -14 to -2). One re-test will be allowed on a separate day prior to visit 2 (day 0) for subjects whose blood pressure exceeds either of these cut points at visit 1.
• •10. Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• •11. Subject has signs/symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory infection). Test visits (visits 2, 3, and 4; days 0, 3, and 6) will be re-scheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 d.
• •12. Subject has recently used antibiotics (within 5 d of any test visit; Appendix 1). Test days (visits 2, 3, and 4; days 0, 3, and 6) will be rescheduled to allow the subject to be free of antibiotic therapy for at least 5 d.
• •13. Subject has a history of use of psychotropic medications within 6 months of visit 2 (day 0) and throughout study period.
• •14. Subject has used any other prescription medications, including over-the-counter medications within 2 weeks of visit 2 (day 0; Appendix 1) and throughout study period.
• •15. Subject has used any over-the-counter or prescription sleep aid products (including dietary supplements) within 2 weeks of visit 2 (day 0) and throughout study period.
• •16. Subject has a diagnosed sleep disorder (e.g., sleep apnea) or occupation where sleep during the overnight hours is irregular (e.g., 3rd shift or overnight workers).
• •17. Subject consumes excessive amounts of caffeine (\>4 cups of caffeinated coffee/d or \>400 mg caffeine/d from caffeine-containing products).
• •18. Subject is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
• •19. Subject has a recent history of (within 12 months of screening; visit 1, day -14 to -2) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
• •20. Subject has been exposed to any non-registered drug product within 30 d prior to screening.
• •21. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.