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

NCT03175757 | Completed

• 1 other identifier: CL086
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholesterol Health

Outcome Measures

Primary Outcomes (1)

• Total Cholesterol

  Mean change from Baseline/screening to Day 60

  60 days

Secondary Outcomes (23)

• LDL Cholesterol

  60 days

• Oxidized LDL

  60 days

• Triglycerides

  60 days

• HDL Cholesterol

  60 days

• C-reactive protein (hs-CRP)

  60 days

Study Arms (2)

Cholesterol Health Formulation

EXPERIMENTAL

Turmeric and black cumin seed preparation

Dietary Supplement: Turmeric and Black Cumin Seed

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Turmeric and Black Cumin Seed DIETARY_SUPPLEMENT

Turmeric and Black Cumin Seed formulation

Cholesterol Health Formulation

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Supplement Formulators, Inc.: lead

Study Sites (1)

Life Extension Clinical Research, Inc.

Fort Lauderdale, Florida, 33308, United States

Location

Related Publications (41)

• Ahmad S, Beg ZH. Hypolipidemic and antioxidant activities of thymoquinone and limonene in atherogenic suspension fed rats. Food Chem. 2013 Jun 1;138(2-3):1116-24. doi: 10.1016/j.foodchem.2012.11.109. Epub 2012 Dec 5.

  PMID: 23411222 BACKGROUND

• Al-Naqeep G, Al-Zubairi AS, Ismail M, Amom ZH, Esa NM. Antiatherogenic Potential of Nigella sativa Seeds and Oil in Diet-Induced Hypercholesterolemia in Rabbits. Evid Based Complement Alternat Med. 2011;2011:213628. doi: 10.1093/ecam/neq071. Epub 2011 Jun 16.

  PMID: 21792359 BACKGROUND

• Ali BH, Blunden G. Pharmacological and toxicological properties of Nigella sativa. Phytother Res. 2003 Apr;17(4):299-305. doi: 10.1002/ptr.1309.

  PMID: 12722128 BACKGROUND

• Amin F, Gilani AH, Mehmood MH, Siddiqui BS, Khatoon N. Coadministration of black seeds and turmeric shows enhanced efficacy in preventing metabolic syndrome in fructose-fed rats. J Cardiovasc Pharmacol. 2015 Feb;65(2):176-83. doi: 10.1097/FJC.0000000000000179.

  PMID: 25384193 BACKGROUND

• Amin F, Islam N, Anila N, Gilani AH. Clinical efficacy of the co-administration of Turmeric and Black seeds (Kalongi) in metabolic syndrome - a double blind randomized controlled trial - TAK-MetS trial. Complement Ther Med. 2015 Apr;23(2):165-74. doi: 10.1016/j.ctim.2015.01.008. Epub 2015 Jan 14.

  PMID: 25847554 BACKGROUND

• Asgary S, Sahebkar A, Goli-Malekabadi N. Ameliorative effects of Nigella sativa on dyslipidemia. J Endocrinol Invest. 2015 Oct;38(10):1039-46. doi: 10.1007/s40618-015-0337-0. Epub 2015 Jul 2.

  PMID: 26134064 BACKGROUND

• Bamosa AO, Ali BA, al-Hawsawi ZA. The effect of thymoquinone on blood lipids in rats. Indian J Physiol Pharmacol. 2002 Apr;46(2):195-201.

  PMID: 12500494 BACKGROUND

• Carroll RE, Benya RV, Turgeon DK, Vareed S, Neuman M, Rodriguez L, Kakarala M, Carpenter PM, McLaren C, Meyskens FL Jr, Brenner DE. Phase IIa clinical trial of curcumin for the prevention of colorectal neoplasia. Cancer Prev Res (Phila). 2011 Mar;4(3):354-64. doi: 10.1158/1940-6207.CAPR-10-0098.

  PMID: 21372035 BACKGROUND

• Chen FY, Zhou J, Guo N, Ma WG, Huang X, Wang H, Yuan ZY. Curcumin retunes cholesterol transport homeostasis and inflammation response in M1 macrophage to prevent atherosclerosis. Biochem Biophys Res Commun. 2015 Nov 27;467(4):872-8. doi: 10.1016/j.bbrc.2015.10.051. Epub 2015 Oct 19.

  PMID: 26471308 BACKGROUND

• Cheng AL, Hsu CH, Lin JK, Hsu MM, Ho YF, Shen TS, Ko JY, Lin JT, Lin BR, Ming-Shiang W, Yu HS, Jee SH, Chen GS, Chen TM, Chen CA, Lai MK, Pu YS, Pan MH, Wang YJ, Tsai CC, Hsieh CY. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. Anticancer Res. 2001 Jul-Aug;21(4B):2895-900.

  PMID: 11712783 BACKGROUND

• Dahri AH, Chandiol AM, Rahoo AA, Memon RA. Effect of Nigella sativa (kalonji) on serum cholesterol of albino rats. J Ayub Med Coll Abbottabad. 2005 Apr-Jun;17(2):72-4.

  PMID: 16092657 BACKGROUND

• Dollah MA, Parhizkar S, Latiff LA, Bin Hassan MH. Toxicity effect of nigella sativa on the liver function of rats. Adv Pharm Bull. 2013;3(1):97-102. doi: 10.5681/apb.2013.016. Epub 2013 Feb 7.

  PMID: 24312819 BACKGROUND

• Dong SZ, Zhao SP, Wu ZH, Yang J, Xie XZ, Yu BL, Nie S. Curcumin promotes cholesterol efflux from adipocytes related to PPARgamma-LXRalpha-ABCA1 passway. Mol Cell Biochem. 2011 Dec;358(1-2):281-5. doi: 10.1007/s11010-011-0978-z. Epub 2011 Jul 12.

  PMID: 21748336 BACKGROUND

• Fan C, Wo X, Dou X, Xu L, Qian Y, Luo Y, Yan J. Regulation of LDL receptor expression by the effect of curcumin on sterol regulatory element pathway. Pharmacol Rep. 2006 Jul-Aug;58(4):577-81.

  PMID: 16963807 BACKGROUND

• Haas MJ, Onstead-Haas LM, Naem E, Wong NC, Mooradian AD. Induction of apolipoprotein A-I gene expression by black seed (Nigella sativa) extracts. Pharm Biol. 2014 Sep;52(9):1119-27. doi: 10.3109/13880209.2013.879187. Epub 2014 Mar 17.

  PMID: 24635344 BACKGROUND

• Heshmati J, Namazi N. Effects of black seed (Nigella sativa) on metabolic parameters in diabetes mellitus: a systematic review. Complement Ther Med. 2015 Apr;23(2):275-82. doi: 10.1016/j.ctim.2015.01.013. Epub 2015 Feb 9.

  PMID: 25847566 BACKGROUND

• Hosseinzadeh H, Parvardeh S, Asl MN, Sadeghnia HR, Ziaee T. Effect of thymoquinone and Nigella sativa seeds oil on lipid peroxidation level during global cerebral ischemia-reperfusion injury in rat hippocampus. Phytomedicine. 2007 Sep;14(9):621-7. doi: 10.1016/j.phymed.2006.12.005. Epub 2007 Feb 8.

  PMID: 17291733 BACKGROUND

• Ibrahim RM, Hamdan NS, Ismail M, Saini SM, Abd Rashid SN, Abd Latiff L, Mahmud R. Protective Effects of Nigella sativa on Metabolic Syndrome in Menopausal Women. Adv Pharm Bull. 2014;4(1):29-33. doi: 10.5681/apb.2014.005. Epub 2013 Dec 23.

  PMID: 24409406 BACKGROUND

• Kaatabi H, Bamosa AO, Lebda FM, Al Elq AH, Al-Sultan AI. Favorable impact of Nigella sativa seeds on lipid profile in type 2 diabetic patients. J Family Community Med. 2012 Sep;19(3):155-61. doi: 10.4103/2230-8229.102311.

  PMID: 23230380 BACKGROUND

• Kuptniratsaikul V, Dajpratham P, Taechaarpornkul W, Buntragulpoontawee M, Lukkanapichonchut P, Chootip C, Saengsuwan J, Tantayakom K, Laongpech S. Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study. Clin Interv Aging. 2014 Mar 20;9:451-8. doi: 10.2147/CIA.S58535. eCollection 2014.

  PMID: 24672232 BACKGROUND

• Lin XL, Liu MH, Hu HJ, Feng HR, Fan XJ, Zou WW, Pan YQ, Hu XM, Wang Z. Curcumin enhanced cholesterol efflux by upregulating ABCA1 expression through AMPK-SIRT1-LXRalpha signaling in THP-1 macrophage-derived foam cells. DNA Cell Biol. 2015 Sep;34(9):561-72. doi: 10.1089/dna.2015.2866. Epub 2015 Jun 23.

  PMID: 26102194 BACKGROUND

• Liu T, Li C, Sun H, Luo T, Tan Y, Tian D, Guo Z. Curcumin inhibits monocyte chemoattractant protein-1 expression and enhances cholesterol efflux by suppressing the c-Jun N-terminal kinase pathway in macrophage. Inflamm Res. 2014 Oct;63(10):841-50. doi: 10.1007/s00011-014-0758-9. Epub 2014 Jul 27.

  PMID: 25064633 BACKGROUND

• Mirzabeigi P, Mohammadpour AH, Salarifar M, Gholami K, Mojtahedzadeh M, Javadi MR. The Effect of Curcumin on some of Traditional and Non-traditional Cardiovascular Risk Factors: A Pilot Randomized, Double-blind, Placebo-controlled Trial. Iran J Pharm Res. 2015 Spring;14(2):479-86.

  PMID: 25901155 BACKGROUND

• Mooradian AD, Haas MJ. The effect of nutritional supplements on serum high-density lipoprotein cholesterol and apolipoprotein A-I. Am J Cardiovasc Drugs. 2014 Aug;14(4):253-74. doi: 10.1007/s40256-014-0068-1.

  PMID: 24604774 BACKGROUND

• Morrone Mda S, Schnorr CE, Behr GA, Gasparotto J, Bortolin RC, da Boit Martinello K, Saldanha Henkin B, Rabello TK, Zanotto-Filho A, Gelain DP, Moreira JC. Curcumin Supplementation Decreases Intestinal Adiposity Accumulation, Serum Cholesterol Alterations, and Oxidative Stress in Ovariectomized Rats. Oxid Med Cell Longev. 2016;2016:5719291. doi: 10.1155/2016/5719291. Epub 2015 Nov 23.

  PMID: 26640615 BACKGROUND

• Panahi Y, Hosseini MS, Khalili N, Naimi E, Soflaei SS, Majeed M, Sahebkar A. Effects of supplementation with curcumin on serum adipokine concentrations: A randomized controlled trial. Nutrition. 2016 Oct;32(10):1116-22. doi: 10.1016/j.nut.2016.03.018. Epub 2016 Mar 31.

  PMID: 27297718 BACKGROUND

• Panahi Y, Kianpour P, Mohtashami R, Jafari R, Simental-Mendia LE, Sahebkar A. Curcumin Lowers Serum Lipids and Uric Acid in Subjects With Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial. J Cardiovasc Pharmacol. 2016 Sep;68(3):223-9. doi: 10.1097/FJC.0000000000000406.

  PMID: 27124606 BACKGROUND

• Peschel D, Koerting R, Nass N. Curcumin induces changes in expression of genes involved in cholesterol homeostasis. J Nutr Biochem. 2007 Feb;18(2):113-9. doi: 10.1016/j.jnutbio.2006.03.007. Epub 2006 May 18.

  PMID: 16713233 BACKGROUND

• Ragheb A, Elbarbry F, Prasad K, Mohamed A, Ahmed MS, Shoker A. Attenuation of the development of hypercholesterolemic atherosclerosis by thymoquinone. Int J Angiol. 2008 Winter;17(4):186-92. doi: 10.1055/s-0031-1278307.

  PMID: 22477447 BACKGROUND

• Sanmukhani J, Satodia V, Trivedi J, Patel T, Tiwari D, Panchal B, Goel A, Tripathi CB. Efficacy and safety of curcumin in major depressive disorder: a randomized controlled trial. Phytother Res. 2014 Apr;28(4):579-85. doi: 10.1002/ptr.5025. Epub 2013 Jul 6.

  PMID: 23832433 BACKGROUND

• Sahebkar A, Beccuti G, Simental-Mendia LE, Nobili V, Bo S. Nigella sativa (black seed) effects on plasma lipid concentrations in humans: A systematic review and meta-analysis of randomized placebo-controlled trials. Pharmacol Res. 2016 Apr;106:37-50. doi: 10.1016/j.phrs.2016.02.008. Epub 2016 Feb 10.

  PMID: 26875640 BACKGROUND

• Shafiq H, Ahmad A, Masud T, Kaleem M. Cardio-protective and anti-cancer therapeutic potential of Nigella sativa. Iran J Basic Med Sci. 2014 Dec;17(12):967-79.

  PMID: 25859300 BACKGROUND

• Sharma RA, McLelland HR, Hill KA, Ireson CR, Euden SA, Manson MM, Pirmohamed M, Marnett LJ, Gescher AJ, Steward WP. Pharmacodynamic and pharmacokinetic study of oral Curcuma extract in patients with colorectal cancer. Clin Cancer Res. 2001 Jul;7(7):1894-900.

  PMID: 11448902 BACKGROUND

• Shuid AN, Mohamed N, Mohamed IN, Othman F, Suhaimi F, Mohd Ramli ES, Muhammad N, Soelaiman IN. Nigella sativa: A Potential Antiosteoporotic Agent. Evid Based Complement Alternat Med. 2012;2012:696230. doi: 10.1155/2012/696230. Epub 2012 Sep 3.

  PMID: 22973403 BACKGROUND

• Singh V, Jain M, Misra A, Khanna V, Rana M, Prakash P, Malasoni R, Dwivedi AK, Dikshit M, Barthwal MK. Curcuma oil ameliorates hyperlipidaemia and associated deleterious effects in golden Syrian hamsters. Br J Nutr. 2013 Aug 28;110(3):437-46. doi: 10.1017/S0007114512005363. Epub 2013 May 15.

  PMID: 23673139 BACKGROUND

• Singh V, Rana M, Jain M, Singh N, Naqvi A, Malasoni R, Dwivedi AK, Dikshit M, Barthwal MK. Curcuma oil attenuates accelerated atherosclerosis and macrophage foam-cell formation by modulating genes involved in plaque stability, lipid homeostasis and inflammation. Br J Nutr. 2015 Jan 14;113(1):100-13. doi: 10.1017/S0007114514003195. Epub 2014 Nov 13.

  PMID: 25391643 BACKGROUND

• Tai MH, Chen PK, Chen PY, Wu MJ, Ho CT, Yen JH. Curcumin enhances cell-surface LDLR level and promotes LDL uptake through downregulation of PCSK9 gene expression in HepG2 cells. Mol Nutr Food Res. 2014 Nov;58(11):2133-45. doi: 10.1002/mnfr.201400366. Epub 2014 Sep 19.

  PMID: 25164566 BACKGROUND

• Yang YS, Su YF, Yang HW, Lee YH, Chou JI, Ueng KC. Lipid-lowering effects of curcumin in patients with metabolic syndrome: a randomized, double-blind, placebo-controlled trial. Phytother Res. 2014 Dec;28(12):1770-7. doi: 10.1002/ptr.5197. Epub 2014 Aug 6.

  PMID: 25131839 BACKGROUND

• Zaoui A, Cherrah Y, Alaoui K, Mahassine N, Amarouch H, Hassar M. Effects of Nigella sativa fixed oil on blood homeostasis in rat. J Ethnopharmacol. 2002 Jan;79(1):23-6. doi: 10.1016/s0378-8741(01)00342-7.

  PMID: 11744291 BACKGROUND

• Zhao JF, Ching LC, Huang YC, Chen CY, Chiang AN, Kou YR, Shyue SK, Lee TS. Molecular mechanism of curcumin on the suppression of cholesterol accumulation in macrophage foam cells and atherosclerosis. Mol Nutr Food Res. 2012 May;56(5):691-701. doi: 10.1002/mnfr.201100735.

  PMID: 22648616 BACKGROUND

• Zingg JM, Hasan ST, Meydani M. Molecular mechanisms of hypolipidemic effects of curcumin. Biofactors. 2013 Jan-Feb;39(1):101-21. doi: 10.1002/biof.1072. Epub 2013 Jan 22.

  PMID: 23339042 BACKGROUND

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Steven Joyal, M.D.

  Life Extension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 5, 2017
• Study Start: May 12, 2017
• Primary Completion: August 10, 2018
• Study Completion: August 16, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)