Dose escalation of a curcuminoid formulation
1 Division of Hematology-Oncology, Department of Internal Medicine, University of Michigan,2150 CCGC, Ann Arbor, MI 48109-0930, USA
2 Department of Family Medicine, University of Michigan, 1018 Fuller St., Ann Arbor, MI 48109-0708
3 Biostatistics Core, Cancer Center, University of Michigan, Room 8D22, 300 North Ingalls Bldg., Ann Arbor, MI 48109-0473, USA
4 Cancer Prevention and Control Program. University of California, San Diego,9500 Gilman Drive, Dept. 0901, La Jolla, CA 92093-0901, USA
5 Division of Cancer Prevention, National Cancer Institute, National Institute of Health,9000 Rockville Pike, Bethesda, MD 20892, USA
6 Department of Family and Preventive Medicine, University of California, San Diego,9500 Gilman Drive, Dept. 0901, La Jolla, CA 92093-0901, USA
BMC Complementary and Alternative Medicine 2006, 6:10 doi:10.1186/1472-6882-6-10Published: 17 March 2006
Curcumin is the major yellow pigment extracted from turmeric, a commonly-used spice in India and Southeast Asia that has broad anticarcinogenic and cancer chemopreventive potential. However, few systematic studies of curcumin's pharmacology and toxicology in humans have been performed.
A dose escalation study was conducted to determine the maximum tolerated dose and safety of a single dose of standardized powder extract, uniformly milled curcumin (C3 Complex™, Sabinsa Corporation). Healthy volunteers were administered escalating doses from 500 to 12,000 mg.
Seven of twenty-four subjects (30%) experienced only minimal toxicity that did not appear to be dose-related. No curcumin was detected in the serum of subjects administered 500, 1,000, 2,000, 4,000, 6,000 or 8,000 mg. Low levels of curcumin were detected in two subjects administered 10,000 or 12,000 mg.
The tolerance of curcumin in high single oral doses appears to be excellent. Given that achieving systemic bioavailability of curcumin or its metabolites may not be essential for colorectal cancer chemoprevention, these findings warrant further investigation for its utility as a long-term chemopreventive agent.