Effect of Relora Supplement on Anxiety, Cognitive Performance & Mood Tested After Induced Stress

Exclusion Criteria

• •1. Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine (including Type 1 and Type 2 diabetes mellitus), pulmonary, biliary, pancreatic, or neurologic disorders.
• •2. Subject has a history of diagnosed generalized anxiety, and/or other major psychiatric disorder(s), other than diagnosed depression.
• •3. Subject has a history of diagnosed depression in the 2 years prior to visit 1 (day -6) and/or a score of 17 or higher on the Beck Depression Scale.
• •4. Subject has an abnormal comprehensive metabolic panel and/or complete blood count test result of clinical significance. A reflex HbA1C may be assessed on subjects with a blood glucose ≥126 mg/dL to determine glycemic status, at discretion of Investigator.
• •5. Subject tests positive for any of the substances included in urine drug screen (i.e., cocaine, tetrahyrdocannabinol, opiates, amphetamines, methamphetamines, phencyclidines, benzodiazepines, barbiturates, methadone, oxycodone, methylenedioxymethamphetamine, and propoxyphene).
• •6. Subject is unable to understand and/or perform required tests based on the practice test results.
• •7. Subject has a history of unconventional sleep patterns (e.g., night shift), a diagnosed sleep disorder, or a chronic medical condition that may impact mood and/or cognition levels, in the judgment of the Investigator.
• •8. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at visit 1 (day -6).
• •9. Subject has an active infection or signs/symptoms of an infection. Test visits will be re-scheduled to allow subject to be symptom-free from any type of systemic infection for at least 5 d.
• •10. Subject has a known allergy or sensitivity to any ingredients in the study products.
• •11. Subject has used recreational drugs or prescription medications with potential to influence mood, anxiety, cognitive function, and/or modulate the autonomic nervous system (including narcotic (opioid) pain medications) within 4 weeks of visit 1 (day -6).
• •12. Subject has used nicotine withdrawal/replacement therapy within 6 months of visit 1 (day -6).
• •13. Subject has used over-the-counter medications, supplements, and/or products, which may influence mood, anxiety, and/or cognitive function within 2 weeks of visit 1 (day -6).
• •14. Subject has a history of cancer within 5 years prior to visit 1 (day -6), except for non-melanoma skin cancer.
• •15. 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 use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
• •16. Subject has a current or recent history (past 12 months of visit 1, day -6) or strong potential for drug or alcohol abuse. Alcohol abuse will be defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
• •17. Subject has been exposed to any non-registered drug product within 30 d prior to visit 1 (day -6).
• •18. Individual has a condition the Investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results, or put the subject at undue risk.