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

Study Overview
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Brief Summary
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The purpose of this study is to assess the effects of a turmeric and black cumin seed formulation on cholesterol levels.

Detailed Description
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This study is a randomized, single-blind, placebo-controlled study to evaluate the effects of a turmeric and black cumin seed formulation on cholesterol levels. Each subject will receive a specific dose of the formulation or placebo twice daily. Participants will undergo assessments of blood tests, vital signs, body weight, waist circumference, hip circumference and waist-to-hip ratio with completion of a questionnaire. The primary objective of the study is to assess the effects of the turmeric and black cumin seed formulation on fasting levels of Total Cholesterol. Secondary objectives include assessment of the effects of turmeric and black cumin seed formulation on: fasting levels of: LDL Cholesterol, parameters in the NMR LipoProfile®, Oxidized LDL, Triglycerides, HDL cholesterol, C-reactive protein, blood glucose, Insulin and Hemoglobin A1c, as well as the assessments of the values/scores of body weight, waist circumference, hip circumference, waist-to-hip ratio, blood pressure and the SF-36 survey scores.

Official Title
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A Randomized, Single-blind, Placebo-controlled Study to Evaluate the Effects of a Turmeric and Black Cumin Seed Formulation on Cholesterol Levels Among Generally Healthy Participants

Conditions
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Cholesterol Health

Intervention / Treatment
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* Dietary Supplement: Turmeric and Black Cumin Seed
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory, male or female, between 40 and 75 years of age Meeting one of the following two criteria: Having a BMI between 25.0 and 34.9 Waist circumference > 40.0 inches in males and > 35.0 inches in females Having Total Cholesterol levels at Baseline/screening of between 190 and 239 mg/dl Generally healthy and having no difficulty with digestion or absorption of food Willing and able to give written informed consent Clearly understands the procedures and requirements for the study Able to maintain stable physical activity and dietary habits throughout the study Willing and able to comply with all study procedures and data recording obligations Having the capability of communicating, including reading in English Exclusion Criteria: Having smoked any cigarette, electronic cigarette, cigar, pipe, or recreational drug in the past 30 days History of allergy or sensitivity to any component of the study products Donation of blood within 30 days prior Baseline/screening Participation in another study within 30 days prior to Baseline/screening Being pregnant, planning on becoming pregnant during study participation or breast feeding 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). 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 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 Currently taking or having taken a fish oil or krill oil product within 30 days prior to Baseline/screening 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 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 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 Having had a routine dental cleaning or other dental procedure within 14 days prior to Baseline/screening 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 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 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) History of known alcohol or substance abuse (e.g., opiates, benzodiazepines, or amphetamines) Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos Having any other significant circumstance that would preclude study participation in the judgment of the PI/Sub-I

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholesterol Health Formulation<br>Turmeric and black cumin seed preparation | Dietary Supplement: Turmeric and Black Cumin Seed<br>* Turmeric and Black Cumin Seed formulation<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol | Mean change from Baseline/screening to Day 60 | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL Cholesterol | Mean change from Baseline/screening to Day 60 | 60 days | 
| Oxidized LDL | Mean change from Baseline/screening to Day 60 | 60 days | 
| Triglycerides | Mean change from Baseline/screening to Day 60 | 60 days | 
| HDL Cholesterol | Mean change from Baseline/screening to Day 60 | 60 days | 
| C-reactive protein (hs-CRP) | Mean change from Baseline/screening to Day 60 | 60 days | 
| Blood glucose | Mean change from Baseline/screening to Day 60 | 60 days | 
| Insulin | Mean change from Baseline/screening to Day 60 | 60 days | 
| Hemoglobin A1C | Mean change from Baseline/screening to Day 60 | 60 days | 
| Body weight | Mean change from Day 1 (Enrollment) to Day 60 | 60 days | 
| Blood pressure | Mean change from Day 1 (Enrollment) to Day 60 | 60 days | 
| SF-36 health survey scores | Mean change from Day 1 (Enrollment) to Day 60 | 60 days | 
| Waist circumference | Mean change from Day 1 (Enrollment) to Day 60 | 60 days | 
| Hip circumference | Mean change from Day 1 (Enrollment) to Day 60 | 60 days | 
| Waist-to-Hip ratio | Mean change from Day 1 (Enrollment) to Day 60 | 60 days | 
| LDL-P (NMR Lipoprofile) | Mean change from Baseline/screening to Day 60 | 60 days | 
| LDL-C (NMR Lipoprofile) | Mean change from Baseline/screening to Day 60 | 60 days | 
| HDL-C (NMR Lipoprofile) | Mean change from Baseline/screening to Day 60 | 60 days | 
| Triglycerides (NMR Lipoprofile) | Mean change from Baseline/screening to Day 60 | 60 days | 
| Cholesterol, Total (NMR Lipoprofile) | Mean change from Baseline/screening to Day 60 | 60 days | 
| HDL-P (Total) (NMR Lipoprofile) | Mean change from Baseline/screening to Day 60 | 60 days | 
| Small LDL-P (NMR Lipoprofile) | Mean change from Baseline/screening to Day 60 | 60 days | 
| LDL Size (NMR Lipoprofile) | Mean change from Baseline/screening to Day 60 | 60 days | 
| LP-IR Score (NMR Lipoprofile) | Mean change from Baseline/screening to Day 60 | 60 days |