Bio-Availability of a New Liquid Tumeric Extract - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00542711

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 I

Drug Information available for: Curcumin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-availability Study
Official Title:	Liquid Tumeric Extract for Increasing Bio-Availability of Curcumin in the Human Body: Pharmacokinetic Study.

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment:

12

Intervention Details:

30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). one dose.

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

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
Jerusalem, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Shoshana Revel-Vilk, MD

Hadassah Medical Organization

More Information

Study ID Numbers:	Curcumol-HMO-CTIL
Study First Received:	October 10, 2007
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00542711
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Curcumin
Bioavilability
Healthy subjects

Study placed in the following topic categories:

Curcumin
Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009