Bio-availability of a New Liquid Tumeric Extract
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
| Estimated Enrollment: | 12 |
-
Drug: liquid tumeric/curcumin extract
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 |
Inclusion Criteria:
- Complete Healthy
- Able to attend two full days of study
Contacts and Locations| Contact: Shoshana Revel-Vilk, MD | 972-2-6777408 | shoshanav@hadassah.org.il |
| 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 | |
| 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 Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013