Dose escalation of a curcuminoid formulation

TLDR

Curcumin, the major yellow pigment of turmeric, is widely used in India and Southeast Asia and has broad anticarcinogenic and chemopreventive potential, yet systematic human pharmacology and toxicology studies are scarce. The study aimed to determine the maximum tolerated dose and safety of a single dose of standardized, uniformly milled curcumin (C3 Complex™) in healthy volunteers. Healthy volunteers received escalating single oral doses ranging from 500 mg to 12,000 mg. Seven of 24 subjects (30%) experienced only minimal, non‑dose‑related toxicity, and curcumin was undetectable in serum up to 8,000 mg, with low levels at 10,000–12,000 mg, indicating excellent tolerance and supporting further study as a long‑term chemopreventive agent.

Abstract

Abstract Background 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. Methods 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 ( C 3 Complex ™, Sabinsa Corporation). Healthy volunteers were administered escalating doses from 500 to 12,000 mg. Results 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. Conclusion 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.