Safety After Oral IntakeNCT03530436
Comparison of Curcumin Bioavailability
A study testing Native turmeric extract, Native turmeric extract with 7-9% volatile turmeric oils and Turmeric extract plus mixture of phytochemicals in people with Safety After Oral Intake and Pharmacokinetics After Oral Intake, run by University of Hohenheim at 1 site in Germany.
Trial summary
The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based on its natural low bioavailability and the number of its effects on human health, several approaches such as increasing its water… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety After Oral Intake, Pharmacokinetics After Oral Intake
- What is being tested?
- Native turmeric extract, Native turmeric extract with 7-9% volatile turmeric oils and Turmeric extract plus mixture of phytochemicals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jun 2018to 7 Nov 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers with blood chemistry values within normal ranges
- Body mass index in a normal range
Who cannot join
- Pregnancy or lactation
- Alcohol and or drug abuse
- Use of dietary supplements or any medications except contraceptives
- Any known malignant, metabolic and endocrine diseases
- Previous cardiac infarction
- Dementia
Show all 11Show fewer
- Blood pressure >140/90 mmHg
- Resting heart rate not within 50 to 90 beats per minute
- Participation in a clinical trial within the past 6 weeks
- Smoking
- Physical activity of more than 5 h per wk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans
The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based on its natural low bioavailability and the number of its effects on human health, several approaches such as increasing its water solubility or inhibiting its metabolism were taken to improve its bioavailability. Pharmacokinetics of curcumin from various supplements using those different mechanisms have been compared to the one of native curcumin. The investigator's study here will compare the bioavailability of curcumin from eight different curcumin formulations with native curcumin and between themselves. The study will folllow a single dose (in form of curcumin formulations, normalized to 207 mg curcumin), placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week washout periods. Plasma samples will be collected at intervals up to 24 hours after intake. Investigators will compare the pharmacokinetics between the different curcumin formulations and to native curcumin.
- Being tested
- Native turmeric extract, Native turmeric extract with 7-9% volatile turmeric oils, Turmeric extract plus mixture of phytochemicals, Cyclodextrin complex of curcuminoids, Turmeric oleoresin
- Keywords
- Bioavailability, Pharmacokinetics, Curcumin, Demethoxycurcumin, Bisdemethoxycurcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native turmeric extractDietary supplement
207 mg curcumin
Native turmeric extract with 7-9% volatile turmeric oilsDietary supplement
207 mg curcumin
Turmeric extract plus mixture of phytochemicalsDietary supplement
207 mg curcumin
Cyclodextrin complex of curcuminoidsDietary supplement
207 mg curcumin
Turmeric oleoresinDietary supplement
207 mg curcumin
Liposomal curcuminDietary supplement
207 mg curcumin
Phytosomal curcuminDietary supplement
207 mg curcumin
Micellar turmeric extractDietary supplement
207 mg curcumin
| Study group | Role | What they receive |
|---|---|---|
| Native turmeric extract | Other | 6 capsules of native curcumin (207 mg curcumin) Receives: Dietary Supplement: Native turmeric extract |
| Native turmeric extract with 7-9% volatile turmeric oils | Experimental | 6 capsules of the formulation; dosage normalized to 207 mg curcumin Receives: Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils |
| Turmeric extract plus mixture of phytochemicals | Experimental | 6 capsules of the formulation; dosage normalized to 207 mg curcumin Receives: Dietary Supplement: Turmeric extract plus mixture of phytochemicals |
| Cyclodextrin complex of curcuminoids | Experimental | 6 capsules of the formulation; dosage normalized to 207 mg curcumin Receives: Dietary Supplement: Cyclodextrin complex of curcuminoids |
| Turmeric oleoresin | Experimental | 6 capsules of the formulation; dosage normalized to 207 mg curcumin Receives: Dietary Supplement: Turmeric oleoresin |
| Liposomal curcumin | Experimental | 6 capsules of the formulation; dosage normalized to 207 mg curcumin Receives: Dietary Supplement: Liposomal curcumin |
| Phytosomal curcumin | Experimental | 6 capsules of the formulation; dosage normalized to 207 mg curcumin Receives: Dietary Supplement: Phytosomal curcumin |
| Micellar turmeric extract | Experimental | 6 capsules of the formulation; dosage normalized to 207 mg curcumin Receives: Dietary Supplement: Micellar turmeric extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h]
Total curcumin after deconjugation with β-glucuronidase
Measured: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h]
Total demethoxycurcumin after deconjugation with β-glucuronidase
Measured: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h]
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Measured: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
Total curcumin after deconjugation with β-glucuronidase
Measured: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
Total demethoxycurcumin after deconjugation with β-glucuronidase
Measured: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Measured: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
Total curcumin after deconjugation with β-glucuronidase
Measured: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
Total demethoxycurcumin after deconjugation with β-glucuronidase
Measured: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Measured: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start7 Jun 2018
- Primary completion10 Aug 2018
- Study completion7 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety After Oral IntakeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Frank, Prof. Dr., Principal investigator, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530436
- Sponsor's protocol ID
- HS-CUV-2018
- Status last verified
- Jan 2019
- First submitted
- 25 Apr 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans
- ClinicalTrials.gov ID
- NCT03530436
- Acronym / sponsor ID
- HS-CUV-2018
- Keywords
- Bioavailability, Pharmacokinetics, Curcumin, Demethoxycurcumin, Bisdemethoxycurcumin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 21 May 2018 (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 curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based on its natural low bioavailability and the number of its effects on human health, several approaches such as increasing its water solubility or inhibiting its metabolism were taken to improve its bioavailability. Pharmacokinetics of curcumin from various supplements using those different mechanisms have been compared to the one of native curcumin. The investigator's study here will compare the bioavailability of curcumin from eight different curcumin formulations with native curcumin and between themselves. The study will folllow a single dose (in form of curcumin formulations, normalized to 207 mg curcumin), placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week washout periods. Plasma samples will be collected at intervals up to 24 hours after intake. Investigators will compare the pharmacokinetics between the different curcumin formulations and to native curcumin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Native turmeric extract | Other | Dietary Supplement: Native turmeric extract6 capsules of native curcumin (207 mg curcumin) |
| Native turmeric extract with 7-9% volatile turmeric oils | Experimental | Dietary Supplement: Native turmeric extract with 7-9% volatile turmeric oils6 capsules of the formulation; dosage normalized to 207 mg curcumin |
| Turmeric extract plus mixture of phytochemicals | Experimental | Dietary Supplement: Turmeric extract plus mixture of phytochemicals6 capsules of the formulation; dosage normalized to 207 mg curcumin |
| Cyclodextrin complex of curcuminoids | Experimental | Dietary Supplement: Cyclodextrin complex of curcuminoids6 capsules of the formulation; dosage normalized to 207 mg curcumin |
| Turmeric oleoresin | Experimental | Dietary Supplement: Turmeric oleoresin6 capsules of the formulation; dosage normalized to 207 mg curcumin |
| Liposomal curcumin | Experimental | Dietary Supplement: Liposomal curcumin6 capsules of the formulation; dosage normalized to 207 mg curcumin |
| Phytosomal curcumin | Experimental | Dietary Supplement: Phytosomal curcumin6 capsules of the formulation; dosage normalized to 207 mg curcumin |
| Micellar turmeric extract | Experimental | Dietary Supplement: Micellar turmeric extract6 capsules of the formulation; dosage normalized to 207 mg curcumin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Volunteers with blood chemistry values within normal ranges
- Body mass index in a normal range
Key exclusion criteria (11 listed)
- Pregnancy or lactation
- Alcohol and or drug abuse
- Use of dietary supplements or any medications except contraceptives
- Any known malignant, metabolic and endocrine diseases
- Previous cardiac infarction
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 |
|---|---|---|
| Native turmeric extract207 mg curcumin | Dietary supplement | Native turmeric extract |
| Native turmeric extract with 7-9% volatile turmeric oils207 mg curcumin | Dietary supplement | Native turmeric extract with 7-9% volatile turmeric oils |
| Turmeric extract plus mixture of phytochemicals207 mg curcumin | Dietary supplement | Turmeric extract plus mixture of phytochemicals |
| Cyclodextrin complex of curcuminoids207 mg curcumin | Dietary supplement | Cyclodextrin complex of curcuminoids |
| Turmeric oleoresin207 mg curcumin | Dietary supplement | Turmeric oleoresin |
| Liposomal curcumin207 mg curcumin | Dietary supplement | Liposomal curcumin |
| Phytosomal curcumin207 mg curcumin | Dietary supplement | Phytosomal curcumin |
| Micellar turmeric extract207 mg curcumin | Dietary supplement | Micellar turmeric extract |
Primary outcome
Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h]
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total curcumin after deconjugation with β-glucuronidase
Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h]
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total demethoxycurcumin after deconjugation with β-glucuronidase
Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h]
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total curcumin after deconjugation with β-glucuronidase
Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total demethoxycurcumin after deconjugation with β-glucuronidase
Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total curcumin after deconjugation with β-glucuronidase
Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total demethoxycurcumin after deconjugation with β-glucuronidase
Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
Time frame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
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 10 Jan 2019.
- Website of the research groupLink provided by the sponsor.
- 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.
Jan Frank, Prof. Dr. principal investigator
University of Hohenheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Native turmeric extract, Native turmeric extract with 7-9% volatile turmeric oils and Turmeric extract plus mixture of phytochemicals in people with Safety After Oral Intake and Pharmacokinetics After Oral Intake, 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 11 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 10 Jan 2019. 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.
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?
Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h] (time frame: 0, 1, 2, 4, 6, 8 and 24 hours 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?
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 10 Jan 2019.