Cholesterol HealthNCT03175757
A Study to Evaluate the Effects of a Turmeric and Black Cumin Seed Formulation on Cholesterol Levels
A study testing Turmeric and Black Cumin Seed in people with Cholesterol Health, run by Supplement Formulators, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of a turmeric and black cumin seed formulation on cholesterol levels. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholesterol Health
- What is being tested?
- Turmeric and Black Cumin Seed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2017to 16 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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).
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, 33308
About this study
Official title: 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
The purpose of this study is to assess the effects of a turmeric and black cumin seed formulation on cholesterol levels.
Read the 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.
- Conditions
- Cholesterol Health
- Being tested
- Turmeric and Black Cumin Seed, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turmeric and Black Cumin SeedDietary supplement
Turmeric and Black Cumin Seed formulation
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cholesterol Health Formulation | Experimental | Turmeric and black cumin seed preparation Receives: Dietary Supplement: Turmeric and Black Cumin Seed |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol
Mean change from Baseline/screening to Day 60
Measured: 60 days
Secondary outcomes (23)
LDL Cholesterol
Mean change from Baseline/screening to Day 60
Measured: 60 days
Oxidized LDL
Mean change from Baseline/screening to Day 60
Measured: 60 days
Triglycerides
Mean change from Baseline/screening to Day 60
Measured: 60 days
HDL Cholesterol
Mean change from Baseline/screening to Day 60
Measured: 60 days
C-reactive protein (hs-CRP)
Mean change from Baseline/screening to Day 60
Measured: 60 days
Blood glucose
Mean change from Baseline/screening to Day 60
Measured: 60 days
Insulin
Mean change from Baseline/screening to Day 60
Measured: 60 days
Hemoglobin A1C
Mean change from Baseline/screening to Day 60
Measured: 60 days
Body weight
Mean change from Day 1 (Enrollment) to Day 60
Measured: 60 days
Blood pressure
Mean change from Day 1 (Enrollment) to Day 60
Measured: 60 days
SF-36 health survey scores
Mean change from Day 1 (Enrollment) to Day 60
Measured: 60 days
Waist circumference
Mean change from Day 1 (Enrollment) to Day 60
Measured: 60 days
Hip circumference
Mean change from Day 1 (Enrollment) to Day 60
Measured: 60 days
Waist-to-Hip ratio
Mean change from Day 1 (Enrollment) to Day 60
Measured: 60 days
LDL-P (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Measured: 60 days
LDL-C (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Measured: 60 days
HDL-C (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Measured: 60 days
Triglycerides (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Measured: 60 days
Cholesterol, Total (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Measured: 60 days
HDL-P (Total) (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Measured: 60 days
Small LDL-P (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Measured: 60 days
LDL Size (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Measured: 60 days
LP-IR Score (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start12 May 2017
- Primary completion10 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Cholesterol HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supplement Formulators, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Joyal, M.D., Principal investigator, Life Extension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175757
- Sponsor's protocol ID
- CL086
- Status last verified
- Sep 2018
- First submitted
- 31 May 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23411222Al-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.
PubMed 21792359Ali BH, Blunden G. Pharmacological and toxicological properties of Nigella sativa. Phytother Res. 2003 Apr;17(4):299-305. doi: 10.1002/ptr.1309.
PubMed 12722128Amin 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.
PubMed 25384193Amin 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.
PubMed 25847554Asgary 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.
PubMed 26134064Bamosa 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.
PubMed 12500494Carroll 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.
PubMed 21372035Chen 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.
PubMed 26471308Cheng 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.
PubMed 11712783Dahri 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.
PubMed 16092657Dollah 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.
PubMed 24312819Dong 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.
PubMed 21748336Fan 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.
PubMed 16963807Haas 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.
PubMed 24635344
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03175757
- Acronym / sponsor ID
- CL086
- Conditions
- Cholesterol Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Supplement Formulators, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2017 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholesterol Health Formulation | Experimental | Dietary Supplement: Turmeric and Black Cumin SeedTurmeric and black cumin seed preparation |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ambulatory, male or female, between 40 and 75 years of age
- Meeting one of the following two criteria:
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turmeric and Black Cumin SeedTurmeric and Black Cumin Seed formulation | Dietary supplement | Cholesterol Health Formulation |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Total Cholesterol
Time frame: 60 days
Mean change from Baseline/screening to Day 60
23 secondary outcomes
LDL Cholesterol
Time frame: 60 days
Oxidized LDL
Time frame: 60 days
Triglycerides
Time frame: 60 days
HDL Cholesterol
Time frame: 60 days
C-reactive protein (hs-CRP)
Time frame: 60 days
Blood glucose
Time frame: 60 days
Insulin
Time frame: 60 days
Hemoglobin A1C
Time frame: 60 days
Body weight
Time frame: 60 days
Blood pressure
Time frame: 60 days
SF-36 health survey scores
Time frame: 60 days
Waist circumference
Time frame: 60 days
Hip circumference
Time frame: 60 days
Waist-to-Hip ratio
Time frame: 60 days
LDL-P (NMR Lipoprofile)
Time frame: 60 days
LDL-C (NMR Lipoprofile)
Time frame: 60 days
HDL-C (NMR Lipoprofile)
Time frame: 60 days
Triglycerides (NMR Lipoprofile)
Time frame: 60 days
Cholesterol, Total (NMR Lipoprofile)
Time frame: 60 days
HDL-P (Total) (NMR Lipoprofile)
Time frame: 60 days
Small LDL-P (NMR Lipoprofile)
Time frame: 60 days
LDL Size (NMR Lipoprofile)
Time frame: 60 days
LP-IR Score (NMR Lipoprofile)
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Background: PubMed 23411222Ahmad 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.
- Background: PubMed 21792359Al-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.
- Background: PubMed 12722128Ali BH, Blunden G. Pharmacological and toxicological properties of Nigella sativa. Phytother Res. 2003 Apr;17(4):299-305. doi: 10.1002/ptr.1309.
- Background: PubMed 25384193Amin 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.
- Background: PubMed 25847554Amin 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.
- Background: PubMed 26134064Asgary 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.
- Background: PubMed 12500494Bamosa 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.
- Background: PubMed 21372035Carroll 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.
- Background: PubMed 26471308Chen 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.
- Background: PubMed 11712783Cheng 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.
- Background: PubMed 16092657Dahri 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.
- Background: PubMed 24312819Dollah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Joyal, M.D. principal investigator
Life Extension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turmeric and Black Cumin Seed in people with Cholesterol Health, run by Supplement Formulators, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175757, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.