HealthyPhase 1NCT00542711
Bio-availability of a New Liquid Tumeric Extract
A Phase 1 study testing liquid tumeric/curcumin extract in people with Healthy, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Curcumin is a commonly-used spice and food coloring. Evidence suggests that curcumin can suppress tumor initiation, promotion and metastasis in a variety of tumor cell lines. The current available curcumin has low bioavailability restricting the effect of curcumin in non-colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- liquid tumeric/curcumin extract
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Complete Healthy
- Able to attend two full days of study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liquid Tumeric Extract for Increasing Bio-availability of Curcumin in the Human Body: Pharmacokinetic Study.
Curcumin is a commonly-used spice and food coloring. Evidence suggests that curcumin can suppress tumor initiation, promotion and metastasis in a variety of tumor cell lines. The current available curcumin has low bioavailability restricting the effect of curcumin in non-colon cancer. In this study we plan to test a new liquid tumeric/curcumin extract, Curcumol (patent pending, Israel Patent Application No. 181,121). We predict the bioavailability of the liquid tumeric/curcumin extract will be better compared to the currently used curcumin powder.
Read the detailed description
Twelve healthy participants enrolled to the study. All volunteers will have pre study evaluation to confirm healthy state. After enrollment, each participant will be tested twice, one with the liquid tumeric/curcumin (study drug) and once with the curcumin powder (control). The days of testing will be on two days, separated by two weeks wash-out period. The participants will be assigned to randomly receive study drug or control on the 1st day, with the other regimen administered at the 2nd day. Both study drug and control will be diluted in 150ml of water. The doe of study drug will be escalated from 30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). Blood sample will be collected at 0,0.25,0.5,0.75,1,2,3,4,5,6,8h post drug. Quantization of curcumin plasma levels will be done by the high pressure liquid chormatography method. A biomarker for the potential effect of curcumin, platelet function pre and post curcumin consumption will be tested.
- Conditions
- Healthy
- Being tested
- liquid tumeric/curcumin extract
- Keywords
- Curcumin, Bioavilability, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid tumeric/curcumin extractDrug
Also called Curcumol (patent pending, Israel Patent Application No. 181,121).
30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). one dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
Why it stopped: Technical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Shoshana Revel-Vilk, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542711
- Sponsor's protocol ID
- Curcumol-HMO-CTIL
- Status last verified
- Aug 2015
- First submitted
- 10 Oct 2007
- Last updated
- 20 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Tumeric Extract for Increasing Bio-availability of Curcumin in the Human Body: Pharmacokinetic Study.
- ClinicalTrials.gov ID
- NCT00542711
- Acronym / sponsor ID
- Curcumol-HMO-CTIL
- Conditions
- Healthy
- Keywords
- Curcumin, Bioavilability, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 11 Oct 2007 (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 is a commonly-used spice and food coloring. Evidence suggests that curcumin can suppress tumor initiation, promotion and metastasis in a variety of tumor cell lines. The current available curcumin has low bioavailability restricting the effect of curcumin in non-colon cancer. In this study we plan to test a new liquid tumeric/curcumin extract, Curcumol (patent pending, Israel Patent Application No. 181,121). We predict the bioavailability of the liquid tumeric/curcumin extract will be better compared to the currently used curcumin powder.
Detailed description
Twelve healthy participants enrolled to the study. All volunteers will have pre study evaluation to confirm healthy state. After enrollment, each participant will be tested twice, one with the liquid tumeric/curcumin (study drug) and once with the curcumin powder (control). The days of testing will be on two days, separated by two weeks wash-out period. The participants will be assigned to randomly receive study drug or control on the 1st day, with the other regimen administered at the 2nd day. Both study drug and control will be diluted in 150ml of water. The doe of study drug will be escalated from 30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). Blood sample will be collected at 0,0.25,0.5,0.75,1,2,3,4,5,6,8h post drug. Quantization of curcumin plasma levels will be done by the high pressure liquid chormatography method. A biomarker for the potential effect of curcumin, platelet function pre and post curcumin consumption will be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Complete Healthy
- Able to attend two full days of study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| liquid tumeric/curcumin extractAlso: Curcumol (patent pending, Israel Patent Application No. 181,121).30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). one dose. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
Related trials for Healthy
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
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.
Shoshana Revel-Vilk, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing liquid tumeric/curcumin extract in people with Healthy, run by Hadassah Medical Organization at 1 site in Israel.
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 0 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: withdrawn, as of the sponsor's last update on 20 Aug 2015. 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 Israel. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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.
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 20 Aug 2015; AzTrials last refreshed its copy on 1 Nov 2026.