Pharmacokinetics of New Curcumin FormulationsEarly Phase 1NCT01982734
Improved Oral Bioavailability of Curcumin Incorporated Into Micelles
A Early Phase 1 study testing curcumin in people with Pharmacokinetics of New Curcumin Formulations and Safety of New Curcumin Formulations, run by University of Hohenheim at 1 site in Germany.
Trial summary
Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous health-promoting activities. The oral bioavailability of curcumin is low due to its poor aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of New Curcumin Formulations, Safety of New Curcumin Formulations
- What is being tested?
- curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Apr 2013
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers with routine blood chemistry values within the normal ranges
- Age: 18-35 years or > 60 years
Who cannot join
- overweight (BMI >30 kg/m2)
- metabolic and endocrine diseases
- pregnancy
- lactation
- drug abuse
- use of dietary supplements or any form of medication (with the exception of oral contraceptives)
Show all 10Show fewer
- smoking
- frequent alcohol consumption (>20 g ethanol/d)
- adherence to a restrictive dietary regimen
- physical activity of more than 5 h/wk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Strategies for the Enhancement of the Potency of Nutraceuticals With Low Oral Bioavailability and Their Application in Novel Functional Foods for Optimum Protection of the Aging Brain
Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous health-promoting activities. The oral bioavailability of curcumin is low due to its poor aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion. Therefore, we tested, in a randomized crossover study, simultaneous application of phytochemicals and micellar solubilisation, alone and together, as strategies to enhance the absorption of curcumin into the body. Furthermore, we investigated age and sex differences in curcumin pharmacokinetics.
- Being tested
- curcumin
- Keywords
- bioavailability, curcumin, pharmacokinetic, curcuma longa, age differences, sex differences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcuminDietary supplement
80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals
| Study group | Role | What they receive |
|---|---|---|
| Native curcumin | Active comparator | 80 mg curcumin as native powder Receives: Dietary Supplement: curcumin |
| Native curcumin plus phytochemicals | Experimental | 80 mg curcumin as native powder plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid and 40 mg xanthohumol Receives: Dietary Supplement: curcumin |
| Curcumin micelles | Experimental | 80 mg curcumin incorporated into liquid micelles Receives: Dietary Supplement: curcumin |
| Curcumin micelles plus phytochemicals | Experimental | 80 mg curcumin incorporated into liquid micelles plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid, 40 mg xanthohumol incorporated into micelles Receives: Dietary Supplement: curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h]
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h]
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Area under the plasma concentration versus time curve (AUC) of total bisdemethoxycurcumin [nmol/L*h]
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Secondary outcomes (11)
Serum aspartate transaminase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum alanine transaminase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum bilirubin [mg/dL]
Measured: 0, 4, 24h post-dose
Serum uric acid [mg/dL]
Measured: 0, 4, 24h post-dose
Serum creatinine [mg/dL]
Measured: 0, 4, 24h post-dose
Serum total cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum HDL cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum LDL cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum triacylglycerols [mg/dL]
Measured: 0, 4, 24h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharmacokinetics of New Curcumin FormulationsStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Jan Frank, Ph.D., Principal investigator, University of Hohenheim, Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982734
- Sponsor's protocol ID
- 051113-HS2
- Status last verified
- Oct 2016
- First submitted
- 5 Nov 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kocher, A., Schiborr, C., Behnam, D., & Frank, J. (2015). 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. J Funct Foods 14: 183-19.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Strategies for the Enhancement of the Potency of Nutraceuticals With Low Oral Bioavailability and Their Application in Novel Functional Foods for Optimum Protection of the Aging Brain
- ClinicalTrials.gov ID
- NCT01982734
- Acronym / sponsor ID
- 051113-HS2
- Keywords
- bioavailability, curcumin, pharmacokinetic, curcuma longa, age differences, sex differences
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Nov 2013 (estimated)
- 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.
Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous health-promoting activities. The oral bioavailability of curcumin is low due to its poor aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion. Therefore, we tested, in a randomized crossover study, simultaneous application of phytochemicals and micellar solubilisation, alone and together, as strategies to enhance the absorption of curcumin into the body. Furthermore, we investigated age and sex differences in curcumin pharmacokinetics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Native curcumin | Active comparator | Dietary Supplement: curcumin80 mg curcumin as native powder |
| Native curcumin plus phytochemicals | Experimental | Dietary Supplement: curcumin80 mg curcumin as native powder plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid and 40 mg xanthohumol |
| Curcumin micelles | Experimental | Dietary Supplement: curcumin80 mg curcumin incorporated into liquid micelles |
| Curcumin micelles plus phytochemicals | Experimental | Dietary Supplement: curcumin80 mg curcumin incorporated into liquid micelles plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid, 40 mg xanthohumol incorporated into micelles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy volunteers with routine blood chemistry values within the normal ranges
- Age: 18-35 years or > 60 years
Key exclusion criteria (10 listed)
- overweight (BMI >30 kg/m2)
- metabolic and endocrine diseases
- pregnancy
- lactation
- drug abuse
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 |
|---|---|---|
| curcumin80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals | Dietary supplement | Curcumin micelles, Curcumin micelles plus phytochemicals, Native curcumin, Native curcumin plus phytochemicals |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h]
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h]
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Area under the plasma concentration versus time curve (AUC) of total bisdemethoxycurcumin [nmol/L*h]
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
11 secondary outcomes
Serum aspartate transaminase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum alanine transaminase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum bilirubin [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum uric acid [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum creatinine [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum total cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum HDL cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum LDL cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum triacylglycerols [mg/dL]
Time frame: 0, 4, 24h post-dose
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 25 Oct 2016.
- Results publicationKocher, A., Schiborr, C., Behnam, D., & Frank, J. (2015). 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. J Funct Foods 14: 183-19.
- Website of the research groupLink provided by the sponsor.
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.
Jan Frank, Ph.D. principal investigator
University of Hohenheim, Stuttgart, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing curcumin in people with Pharmacokinetics of New Curcumin Formulations and Safety of New Curcumin Formulations, run by University of Hohenheim at 1 site in Germany.
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 2 inclusion and 10 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 25 Oct 2016. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h] (time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose). The study lists 9 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 NCT01982734, which also lists 1 linked publication.
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 25 Oct 2016.