Safety assessment of a highly bioavailable curcumin-galactomannoside complex (CurQfen) in healthy volunteers, with a special reference to the recent hepatotoxic reports of curcumin supplements: A 90-days prospective study.

Recently, there is a growing concern about the use of curcumin supplements owing to a few reported hepatotoxicity related adverse events among some of the long-term consumers. Even though no clear evidence was elucidated for the suspected toxicity, the addition of adjuvants that inhibits body's essential detoxification pathways, adulteration with synthetic curcumin, and presence of contaminants including heavy metals, chromate, illegal dyes, non-steroidal anti-inflammatory agents, and pyrrole alkaloids were suggested as plausible reasons. Considering these incidences and speculations, there is a need to critically evaluate the safety of curcumin supplements for prolonged intake. The present study is an evaluation of the safety of curcumin-galactomannoside complex (CGM), a highly bioavailable curcumin formulation with demonstrated high free curcuminoids delivery. Twenty healthy human volunteers were evaluated for toxic manifestations of CGM when supplemented with 1000 mg per day (∼380 mg curcuminoids) for 90-days. CGM supplementation did not cause any adverse effects or clinically significant variations in the vital signs, hematological parameters, lipid profile and renal function markers of the volunteers, indicating its safety. Liver function enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and bilirubin were in the normal range after 90-day supplementation of CGM. In summary, no adverse effects were observed under the conditions of the study. CGM can be considered as a safe curcumin supplement for regular consumption and is devoid of any adulterants or contaminants.