A Study to Evaluate the Effects of a Turmeric and Black Cumin Seed Formulation on Cholesterol Levels

Exclusion Criteria

• •1. Having smoked any cigarette, electronic cigarette, cigar, pipe, or recreational drug in the past 30 days
• •2. History of allergy or sensitivity to any component of the study products
• •3. Donation of blood within 30 days prior Baseline/screening
• •4. Participation in another study within 30 days prior to Baseline/screening
• •5. Being pregnant, planning on becoming pregnant during study participation or breast feeding
• •6. Having the following medical condition(s): diabetes, hypotension, hypertension (changed antihypertensive medication or dose in the preceding 3 months and/or likely to do so during the study), cardiovascular disease (arrhythmia, edema with or without congestive heart failure, heart attack, stroke, abnormal EKG), gastrointestinal disease requiring daily prescribed medication (gastroesophageal reflux, gastritis, and peptic or duodenal ulcer), gallbladder disease or gallstones, biliary obstruction (past or present), endocrine disease (hyper- or hypothyroidism), psychiatric disorder (anxiety if untreated, eating disorder) neurologic disease (Parkinson's disease, intracranial hemorrhage, head injury, brain tumor, evidence of delirium, confusion, dementia, Alzheimer's disease, migraine headache (if last migraine headache was \< 3 years prior to Baseline/screening), urologic disease, chronic inflammatory or autoimmune disease, cancer (unless skin cancer other than melanoma which has been treated \> 3 years prior to Baseline/screening), liver and kidney disease, insomnia, blood coagulation disorder (anemia, thrombus, embolism), sleep apnea, or other condition(s) that would preclude participation in the study in the judgment of the investigator/sub-investigator (Sub-I).
• •7. Currently taking or having taken cholesterol-lowering medication(s) including HMGCR inhibitors, cholesterol binding resins, fibrates, or nicotinic acid \>1 gram/day within 30 days prior to screening
• •8. Currently taking or having taken a supplemental product that may affect cholesterol levels (red yeast rice, red mold dioscorea, guggulipid, policosanol, pantethine, beta-sitosterol, artichoke leaf, or supplemental fiber) within 30 days prior to Baseline/screening
• •9. Currently taking or having taken a fish oil or krill oil product within 30 days prior to Baseline/screening
• •10. Currently taking or having taken anxiolytics and sedative hypnotics, anticonvulsants, antineoplastics, anti-migraine medication(s), opioid analgesics, monoamine oxidase inhibitors (MAOIs), phosphodiesterase inhibitors, adenosine reuptake inhibitors, dopamine agonists, dopamine antagonists, or immunosuppressants within 30 days prior to Baseline/screening
• •11. Currently talking or having taken anti-inflammatory medication(s) within 14 days prior to screening (unless on a stable daily dose of aspirin 81mg for 3 months prior to screening and not likely to change dose during the study) or in the judgment of the PI/Sub-I would not preclude participation in the study
• •12. Having had a surgical procedure, pacemaker or any internal medical device other than artificial joints which, in the judgment of the PI/Sub-I, would preclude participation in the study
• •13. Having had a routine dental cleaning or other dental procedure within 14 days prior to Baseline/screening
• •14. Having screening laboratory test values: bilirubin \> 2.5 x ULN, AST/SGOT and ALT/SGPT \> 2.5 x ULN, serum creatinine \> 1.5 mg/dL, blood glucose \> 125 mg/dL, or any other lab test result(s) that would preclude participation in the study in the judgment of the PI/Sub-I
• •15. Having blood pressure readings at Baseline/screening \> 140 systolic or \> 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the PI/Sub-I
• •16. Currently consumes more than 6 standard alcoholic drinks per week (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
• •17. History of known alcohol or substance abuse (e.g., opiates, benzodiazepines, or amphetamines)
• •18. Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos
• •19. Having any other significant circumstance that would preclude study participation in the judgment of the PI/Sub-I