Plasma Levels of Different Curcuminoids PreparationsNCT05542394
Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study
A study testing Curcumin in people with Plasma Levels of Different Curcuminoids Preparations, run by University of Jordan at 1 site in Jordan.
Trial summary
This pilot study aims to investigate the pharmacokinetics of a novel curcuminoid preparation with suggested high bioavailability due to its solubility in water, compared to two standard hydrophobic formulations. The findings of this study will help the health care providers and community to select suitable formulation. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasma Levels of Different Curcuminoids Preparations
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJordan
- Study dates
- 20 Sep 2022to 30 Apr 2023
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female Apparently healthy adults
Who cannot join
- Postmenopausal women Smokers Overweight Chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study aims to investigate the pharmacokinetics of a novel curcuminoid preparation with suggested high bioavailability due to its solubility in water, compared to two standard hydrophobic formulations. The findings of this study will help the health care providers and community to select suitable formulation.
Read the detailed description
This pilot study is the first phase that must be followed, in the second phase, by longer clinical trials to support the findings and investigate the role of the novel preparation on health.The second phase will include an assessment of the effectiveness of several doses of curcumin preparation on health as well as an evaluation of the tolerance and possible adverse effects. The latter could not be evaluated at this stage of a single dose.
- Being tested
- Curcumin
- Keywords
- Curcumin H2O, Tumeric, piperine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Also called NFH
water soluble version of turmeric extract standardized to 10% curcuminoids
.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin H2O SAP | Experimental | Water soluble version of turmeric extract standardized to 10% curcuminoids will be administered orally (1 dose) Receives: Dietary Supplement: Curcumin |
| Tumeric with piperine SAP | Active comparator | Turmeric extract standardized to 95% curcuminoids in combination with 5 mg of piperine per capsule will be administered orally (1 dose) Receives: Dietary Supplement: Curcumin |
| Tumeric without piperine | Placebo comparator | Turmeric extract standardized to 95% curcuminoids without piperine will be administered orally (1 dose) Receives: Dietary Supplement: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentration of bisdemethoxycurcumin
plasma bisdemethoxycurcumin levels using LC MS/MS
Measured: [Time Frame: Change during 8 hours]
Blood concentration of desmethoxycurcumin
plasma desmethoxycurcumin levels using LC MS/MS
Measured: [Time Frame: Change during 8 hours]
Blood concentration of piperine-curcuminoids
plasma piperine-curcuminoids levels using LC MS/MS
Measured: [Time Frame: Change during 8 hours]
Blood concentration of hexahydrocurcumin
plasma hexahydrocurcumin levels using LC MS/MS
Measured: [Time Frame: Change during 8 hours]
Blood concentration of curcumin diethyl disuccinate
plasma curcumin diethyl disuccinate levels using LC MS/MS
Measured: [Time Frame: Change during 8 hours]
Blood concentration of tetrahydrocurcumin
plasma tetrahydrocurcumin levels using LC MS/MS
Measured: [Time Frame: Change during 8 hours]
Blood concentration of curcumin
plasma curcumin levels using LC MS/MS
Measured: [Time Frame: Change during 8 hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start20 Sep 2022
- Primary completion6 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Plasma Levels of Different Curcuminoids PreparationsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Collaborators
- Nutritional Fundamentals for Health
- Responsible party
- Principal investigator, Shatha Hammad, Assistant Professor, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542394
- Sponsor's protocol ID
- 10-2022/13342
- Status last verified
- Aug 2023
- First submitted
- 12 Sep 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahebkar A, Henrotin Y. Analgesic Efficacy and Safety of Curcuminoids in Clinical Practice: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Med. 2016 Jun;17(6):1192-202. doi: 10.1093/pm/pnv024. Epub 2015 Dec 14.
PubMed 26814259Schiborr C, Kocher A, Behnam D, Jandasek J, Toelstede S, Frank J. The oral bioavailability of curcumin from micronized powder and liquid micelles is significantly increased in healthy humans and differs between sexes. Mol Nutr Food Res. 2014 Mar;58(3):516-27. doi: 10.1002/mnfr.201300724. Epub 2014 Jan 9.
PubMed 24402825Kocher A, Bohnert L, Schiborr C, Frank J. Highly bioavailable micellar curcuminoids accumulate in blood, are safe and do not reduce blood lipids and inflammation markers in moderately hyperlipidemic individuals. Mol Nutr Food Res. 2016 Jul;60(7):1555-63. doi: 10.1002/mnfr.201501034. Epub 2016 May 23.
PubMed 26909743Fanca-Berthon P, Tenon M, Bouter-Banon SL, Manfre A, Maudet C, Dion A, Chevallier H, Laval J, van Breemen RB. Pharmacokinetics of a Single Dose of Turmeric Curcuminoids Depends on Formulation: Results of a Human Crossover Study. J Nutr. 2021 Jul 1;151(7):1802-1816. doi: 10.1093/jn/nxab087.
PubMed 33877323Kocher A, Schiborr C, Behnam D, Frank J: The oral bioavailability of curcuminoids in healthy humans is markedly enhanced by micellar solubilisation but not further improved by simultaneous ingestion of sesamin, ferulic acid, naringenin and xanthohumol.Journal of functional foods 2015, 14:183-191.
Baum L, Cheung SK, Mok VC, Lam LC, Leung VP, Hui E, Ng CC, Chow M, Ho PC, Lam S, Woo J, Chiu HF, Goggins W, Zee B, Wong A, Mok H, Cheng WK, Fong C, Lee JS, Chan MH, Szeto SS, Lui VW, Tsoh J, Kwok TC, Chan IH, Lam CW. Curcumin effects on blood lipid profile in a 6-month human study. Pharmacol Res. 2007 Dec;56(6):509-14. doi: 10.1016/j.phrs.2007.09.013. Epub 2007 Sep 18.
PubMed 17951067Carroll 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 21372035Dhillon N, Aggarwal BB, Newman RA, Wolff RA, Kunnumakkara AB, Abbruzzese JL, Ng CS, Badmaev V, Kurzrock R. Phase II trial of curcumin in patients with advanced pancreatic cancer. Clin Cancer Res. 2008 Jul 15;14(14):4491-9. doi: 10.1158/1078-0432.CCR-08-0024.
PubMed 18628464
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study
- ClinicalTrials.gov ID
- NCT05542394
- Acronym / sponsor ID
- 10-2022/13342
- Keywords
- Curcumin H2O, Tumeric, piperine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Collaborators
- Nutritional Fundamentals for Health
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 15 Sep 2022 (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.
This pilot study aims to investigate the pharmacokinetics of a novel curcuminoid preparation with suggested high bioavailability due to its solubility in water, compared to two standard hydrophobic formulations. The findings of this study will help the health care providers and community to select suitable formulation.
Detailed description
This pilot study is the first phase that must be followed, in the second phase, by longer clinical trials to support the findings and investigate the role of the novel preparation on health.The second phase will include an assessment of the effectiveness of several doses of curcumin preparation on health as well as an evaluation of the tolerance and possible adverse effects. The latter could not be evaluated at this stage of a single dose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Curcumin H2O SAP | Experimental | Dietary Supplement: CurcuminWater soluble version of turmeric extract standardized to 10% curcuminoids will be administered orally (1 dose) |
| Tumeric with piperine SAP | Active comparator | Dietary Supplement: CurcuminTurmeric extract standardized to 95% curcuminoids in combination with 5 mg of piperine per capsule will be administered orally (1 dose) |
| Tumeric without piperine | Placebo comparator | Dietary Supplement: CurcuminTurmeric extract standardized to 95% curcuminoids without piperine will be administered orally (1 dose) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female Apparently healthy adults
Key exclusion criteria (1 listed)
- Postmenopausal women Smokers Overweight Chronic diseases
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 |
|---|---|---|
| CurcuminAlso: NFHwater soluble version of turmeric extract standardized to 10% curcuminoids . | Dietary supplement | Curcumin H2O SAP, Tumeric with piperine SAP, Tumeric without piperine |
Primary outcome
Blood concentration of bisdemethoxycurcumin
Time frame: [Time Frame: Change during 8 hours]
plasma bisdemethoxycurcumin levels using LC MS/MS
Blood concentration of desmethoxycurcumin
Time frame: [Time Frame: Change during 8 hours]
plasma desmethoxycurcumin levels using LC MS/MS
Blood concentration of piperine-curcuminoids
Time frame: [Time Frame: Change during 8 hours]
plasma piperine-curcuminoids levels using LC MS/MS
Blood concentration of hexahydrocurcumin
Time frame: [Time Frame: Change during 8 hours]
plasma hexahydrocurcumin levels using LC MS/MS
Blood concentration of curcumin diethyl disuccinate
Time frame: [Time Frame: Change during 8 hours]
plasma curcumin diethyl disuccinate levels using LC MS/MS
Blood concentration of tetrahydrocurcumin
Time frame: [Time Frame: Change during 8 hours]
plasma tetrahydrocurcumin levels using LC MS/MS
Blood concentration of curcumin
Time frame: [Time Frame: Change during 8 hours]
plasma curcumin levels using LC MS/MS
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 29 Aug 2023.
- Background: PubMed 26814259Sahebkar A, Henrotin Y. Analgesic Efficacy and Safety of Curcuminoids in Clinical Practice: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Med. 2016 Jun;17(6):1192-202. doi: 10.1093/pm/pnv024. Epub 2015 Dec 14.
- Background: PubMed 24402825Schiborr C, Kocher A, Behnam D, Jandasek J, Toelstede S, Frank J. The oral bioavailability of curcumin from micronized powder and liquid micelles is significantly increased in healthy humans and differs between sexes. Mol Nutr Food Res. 2014 Mar;58(3):516-27. doi: 10.1002/mnfr.201300724. Epub 2014 Jan 9.
- Background: PubMed 26909743Kocher A, Bohnert L, Schiborr C, Frank J. Highly bioavailable micellar curcuminoids accumulate in blood, are safe and do not reduce blood lipids and inflammation markers in moderately hyperlipidemic individuals. Mol Nutr Food Res. 2016 Jul;60(7):1555-63. doi: 10.1002/mnfr.201501034. Epub 2016 May 23.
- Background: PubMed 33877323Fanca-Berthon P, Tenon M, Bouter-Banon SL, Manfre A, Maudet C, Dion A, Chevallier H, Laval J, van Breemen RB. Pharmacokinetics of a Single Dose of Turmeric Curcuminoids Depends on Formulation: Results of a Human Crossover Study. J Nutr. 2021 Jul 1;151(7):1802-1816. doi: 10.1093/jn/nxab087.
- BackgroundKocher A, Schiborr C, Behnam D, Frank J: The oral bioavailability of curcuminoids in healthy humans is markedly enhanced by micellar solubilisation but not further improved by simultaneous ingestion of sesamin, ferulic acid, naringenin and xanthohumol.Journal of functional foods 2015, 14:183-191.
- Background: PubMed 17951067Baum L, Cheung SK, Mok VC, Lam LC, Leung VP, Hui E, Ng CC, Chow M, Ho PC, Lam S, Woo J, Chiu HF, Goggins W, Zee B, Wong A, Mok H, Cheng WK, Fong C, Lee JS, Chan MH, Szeto SS, Lui VW, Tsoh J, Kwok TC, Chan IH, Lam CW. Curcumin effects on blood lipid profile in a 6-month human study. Pharmacol Res. 2007 Dec;56(6):509-14. doi: 10.1016/j.phrs.2007.09.013. Epub 2007 Sep 18.
- 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 18628464Dhillon N, Aggarwal BB, Newman RA, Wolff RA, Kunnumakkara AB, Abbruzzese JL, Ng CS, Badmaev V, Kurzrock R. Phase II trial of curcumin in patients with advanced pancreatic cancer. Clin Cancer Res. 2008 Jul 15;14(14):4491-9. doi: 10.1158/1078-0432.CCR-08-0024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Plasma Levels of Different Curcuminoids Preparations, run by University of Jordan at 1 site in Jordan.
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 1 inclusion and 1 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 29 Aug 2023. 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 Jordan. 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?
Blood concentration of bisdemethoxycurcumin (time frame: [Time Frame: Change during 8 hours]). The study lists 7 primary outcomes in all. 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 NCT05542394, which also lists 8 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 29 Aug 2023.