Bio-availability of a New Liquid Tumeric Extract

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00542711
First received: October 10, 2007
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: liquid tumeric/curcumin extract
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Liquid Tumeric Extract for Increasing Bio-availability of Curcumin in the Human Body: Pharmacokinetic Study.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 12
Intervention Details:
    Drug: liquid tumeric/curcumin extract
    30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). one dose.
    Other Name: Curcumol (patent pending, Israel Patent Application No. 181,121).
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Complete Healthy
  • Able to attend two full days of study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542711

Contacts
Contact: Shoshana Revel-Vilk, MD 972-2-6777408 shoshanav@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    0097226776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    0097226777572    lhadas@hadassah.org.il   
Principal Investigator: Shoshana Revel-Vilk, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Shoshana Revel-Vilk, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00542711     History of Changes
Other Study ID Numbers: Curcumol-HMO-CTIL
Study First Received: October 10, 2007
Last Updated: June 22, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Curcumin
Bioavilability
Healthy subjects

Additional relevant MeSH terms:
Curcumin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014