NCT03175757
Completed
Not Applicable
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
ConditionsCholesterol Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cholesterol Health
- Sponsor
- Supplement Formulators, Inc.
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Total Cholesterol
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to assess the effects of a turmeric and black cumin seed formulation on cholesterol levels.
Detailed Description
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Total Cholesterol
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
Secondary Outcomes
- Oxidized LDL(60 days)
- HDL Cholesterol(60 days)
- Hemoglobin A1C(60 days)
- SF-36 health survey scores(60 days)
- LDL Cholesterol(60 days)
- Triglycerides(60 days)
- Insulin(60 days)
- Body weight(60 days)
- Blood glucose(60 days)
- C-reactive protein (hs-CRP)(60 days)
- Blood pressure(60 days)
- Waist-to-Hip ratio(60 days)
- LDL-P (NMR Lipoprofile)(60 days)
- Waist circumference(60 days)
- Hip circumference(60 days)
- Triglycerides (NMR Lipoprofile)(60 days)
- Cholesterol, Total (NMR Lipoprofile)(60 days)
- HDL-P (Total) (NMR Lipoprofile)(60 days)
- Small LDL-P (NMR Lipoprofile)(60 days)
- LP-IR Score (NMR Lipoprofile)(60 days)
- LDL-C (NMR Lipoprofile)(60 days)
- HDL-C (NMR Lipoprofile)(60 days)
- LDL Size (NMR Lipoprofile)(60 days)
Study Sites (1)
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