Pharmacokinetics of Novel Curcumin FormulationsEarly Phase 1NCT01925287
Oral Bioavailability of Curcumin From Micronized Powder and Liquid Micelles in Healthy Young Women and Men
A Early Phase 1 study testing curcumin in people with Pharmacokinetics of Novel Curcumin Formulations and Safety of Novel Curcumin Formulations, run by University of Hohenheim at 1 site in Germany.
Trial summary
Background: The oral bioavailability of curcumin is low due to its limited intestinal uptake, rapid metabolism and excretion from the body. Considering its potent reported health-beneficial properties, researchers have tried to increase its bioavailability as a means to enhance its biological activities. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of Novel Curcumin Formulations, Safety of Novel 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
- Oct 2011to Jul 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers with routine blood chemistry values within the normal ranges
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 12Show fewer
- smoking
- frequent alcohol consumption (>20 g ethanol/d)
- adherence to a restrictive dietary regimen
- physical activity of more than 5 h/wk
- participation in a clinical trial within the past 3 months prior to recruitment
- known intolerance against curcuma
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
Background: The oral bioavailability of curcumin is low due to its limited intestinal uptake, rapid metabolism and excretion from the body. Considering its potent reported health-beneficial properties, researchers have tried to increase its bioavailability as a means to enhance its biological activities.
Objective: The aim of the project was to develop novel curcumin formulations with enhanced oral bioavailability and to study the safety of the formulations and potential sex-differences in humans.
Design: In this single-blind crossover study with three arms separated by ≥1-week washout periods, healthy subjects (13 women, 10 men) were provided standardized meals and took, in random order, a single oral dose of 500 mg curcumin as native powder, micronized powder, or liquid micelles. Blood and urine samples were collected in intervals for 24 h and total curcumin, demethoxycurcumin, and bis-demethoxycurcumin were quantified.
- Being tested
- curcumin
- Keywords
- bioavailability, curcumin, curcuma longa, healthy humans, safety, sex differences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcuminDietary supplement
500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles
| Study group | Role | What they receive |
|---|---|---|
| Native curcumin powder | Active comparator | 500 mg curcumin as native powder Receives: Dietary Supplement: curcumin |
| Micronized curcumin powder | Experimental | 500 mg curcumin as micronized powder Receives: Dietary Supplement: curcumin |
| Curcumin micelles | Experimental | 500 mg curcumin incorporated into liquid 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 2, 4, 6, 8 and 24 h post-dose
Secondary outcomes (39)
Serum aspartate transaminase activity [U/L]
Measured: Baseline
Serum aspartate transaminase activity [U/L]
Measured: 4 h post-dose
Serum aspartate transaminase activity [U/L]
Measured: 24 h post-dose
Serum alanine transaminase activity [U/L]
Measured: Baseline
Serum alanine transaminase activity [U/L]
Measured: 4 h post-dose
Serum alanine transaminase activity [U/L]
Measured: 24 h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Measured: Baseline
Serum gamma-glutamyl transferase activity [U/L]
Measured: 4 h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Measured: 24 h post-dose
Serum alkaline phosphatase activity [U/L]
Measured: Baseline
Serum alkaline phosphatase activity [U/L]
Measured: 4 h post-dose
Serum alkaline phosphatase activity [U/L]
Measured: 24 h post-dose
Serum bilirubin [mg/dL]
Measured: Baseline
Serum bilirubin [mg/dL]
Measured: 4 h post-dose
Serum bilirubin [mg/dL]
Measured: 24 h post-dose
Serum uric acid [mg/dL]
Measured: Baseline
Serum uric acid [mg/dL]
Measured: 4 h post-dose
Serum uric acid [mg/dL]
Measured: 24 h post-dose
Serum cystatin C [mg/L]
Measured: Baseline
Serum cystatin C [mg/L]
Measured: 4 h post-dose
Serum cystatin C [mg/L]
Measured: 24 h post-dose
Glomerular filtration rate [mL/min]
Measured: Baseline
Glomerular filtration rate [mL/min]
Measured: 4 h post-dose
Glomerular filtration rate [mL/min]
Measured: 24 h post-dose
Serum creatinine [mg/dL]
Measured: Baseline
Serum creatinine [mg/dL]
Measured: 4 h post-dose
Serum creatinine [mg/dL]
Measured: 24 h post-dose
Serum total cholesterol [mg/dL]
Measured: Baseline
Serum total cholesterol [mg/dL]
Measured: 4 h post-dose
Serum total cholesterol [mg/dL]
Measured: 24 h post-dose
Serum HDL cholesterol [mg/dL]
Measured: Baseline
Serum HDL cholesterol [mg/dL]
Measured: 4 h post-dose
Serum HDL cholesterol [mg/dL]
Measured: 24 h post-dose
Serum LDL cholesterol [mg/dL]
Measured: Baseline
Serum LDL cholesterol [mg/dL]
Measured: 4 h post-dose
Serum LDL cholesterol [mg/dL]
Measured: 24 h post-dose
Serum triacylglycerols [mg/dL]
Measured: Baseline
Serum triacylglycerols [mg/dL]
Measured: 4 h post-dose
Serum triacylglycerols [mg/dL]
Measured: 24 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJul 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 Novel 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
- NCT01925287
- Sponsor's protocol ID
- 01EA1334AHS1
- Status last verified
- Oct 2016
- First submitted
- 13 Aug 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Schiborr 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 24402825
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
- NCT01925287
- Acronym / sponsor ID
- 01EA1334AHS1
- Keywords
- bioavailability, curcumin, curcuma longa, healthy humans, safety, 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
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Aug 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.
Background: The oral bioavailability of curcumin is low due to its limited intestinal uptake, rapid metabolism and excretion from the body. Considering its potent reported health-beneficial properties, researchers have tried to increase its bioavailability as a means to enhance its biological activities.
Objective: The aim of the project was to develop novel curcumin formulations with enhanced oral bioavailability and to study the safety of the formulations and potential sex-differences in humans.
Design: In this single-blind crossover study with three arms separated by ≥1-week washout periods, healthy subjects (13 women, 10 men) were provided standardized meals and took, in random order, a single oral dose of 500 mg curcumin as native powder, micronized powder, or liquid micelles. Blood and urine samples were collected in intervals for 24 h and total curcumin, demethoxycurcumin, and bis-demethoxycurcumin were quantified.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Native curcumin powder | Active comparator | Dietary Supplement: curcumin500 mg curcumin as native powder |
| Micronized curcumin powder | Experimental | Dietary Supplement: curcumin500 mg curcumin as micronized powder |
| Curcumin micelles | Experimental | Dietary Supplement: curcumin500 mg curcumin incorporated into liquid micelles |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers with routine blood chemistry values within the normal ranges
Key exclusion criteria (12 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 |
|---|---|---|
| curcumin500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles | Dietary supplement | Curcumin micelles, Micronized curcumin powder, Native curcumin powder |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h]
Time frame: 0, 0.5, 1, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 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, 1.5, 2, 4, 6, 8 and 24 h post-dose
Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase
39 secondary outcomes
Serum aspartate transaminase activity [U/L]
Time frame: Baseline
Serum aspartate transaminase activity [U/L]
Time frame: 4 h post-dose
Serum aspartate transaminase activity [U/L]
Time frame: 24 h post-dose
Serum alanine transaminase activity [U/L]
Time frame: Baseline
Serum alanine transaminase activity [U/L]
Time frame: 4 h post-dose
Serum alanine transaminase activity [U/L]
Time frame: 24 h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time frame: Baseline
Serum gamma-glutamyl transferase activity [U/L]
Time frame: 4 h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time frame: 24 h post-dose
Serum alkaline phosphatase activity [U/L]
Time frame: Baseline
Serum alkaline phosphatase activity [U/L]
Time frame: 4 h post-dose
Serum alkaline phosphatase activity [U/L]
Time frame: 24 h post-dose
Serum bilirubin [mg/dL]
Time frame: Baseline
Serum bilirubin [mg/dL]
Time frame: 4 h post-dose
Serum bilirubin [mg/dL]
Time frame: 24 h post-dose
Serum uric acid [mg/dL]
Time frame: Baseline
Serum uric acid [mg/dL]
Time frame: 4 h post-dose
Serum uric acid [mg/dL]
Time frame: 24 h post-dose
Serum cystatin C [mg/L]
Time frame: Baseline
Serum cystatin C [mg/L]
Time frame: 4 h post-dose
Serum cystatin C [mg/L]
Time frame: 24 h post-dose
Glomerular filtration rate [mL/min]
Time frame: Baseline
Glomerular filtration rate [mL/min]
Time frame: 4 h post-dose
Glomerular filtration rate [mL/min]
Time frame: 24 h post-dose
Serum creatinine [mg/dL]
Time frame: Baseline
Serum creatinine [mg/dL]
Time frame: 4 h post-dose
Serum creatinine [mg/dL]
Time frame: 24 h post-dose
Serum total cholesterol [mg/dL]
Time frame: Baseline
Serum total cholesterol [mg/dL]
Time frame: 4 h post-dose
Serum total cholesterol [mg/dL]
Time frame: 24 h post-dose
Serum HDL cholesterol [mg/dL]
Time frame: Baseline
Serum HDL cholesterol [mg/dL]
Time frame: 4 h post-dose
Serum HDL cholesterol [mg/dL]
Time frame: 24 h post-dose
Serum LDL cholesterol [mg/dL]
Time frame: Baseline
Serum LDL cholesterol [mg/dL]
Time frame: 4 h post-dose
Serum LDL cholesterol [mg/dL]
Time frame: 24 h post-dose
Serum triacylglycerols [mg/dL]
Time frame: Baseline
Serum triacylglycerols [mg/dL]
Time frame: 4 h post-dose
Serum triacylglycerols [mg/dL]
Time frame: 24 h 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 publication: 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.
- 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 Novel Curcumin Formulations and Safety of Novel 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 1 inclusion and 12 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, 1.5, 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 NCT01925287, 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.