An open label, single arm, prospective clinical study to evaluate liver safety and tolerability of PUREMERIC™ (standardized extract from Curcuma longa) in healthy subjects

• Published in: Toxicology reports Vol. 8; pp. 1955 - 1959
• Main Authors: HV, Sudeep, V Thomas, Jestin, HS, Vasavi, K, Shyamprasad
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier B.V 01.01.2021; Elsevier
• Subjects: alanine transaminase; alkaline phosphatase; aspartate transaminase; bilirubin; blood serum; Cholestatic hepatitis; Curcumin; gamma-glutamyltransferase; Healthy subjects; hepatitis; lactate dehydrogenase; liver; liver function; polyphenols; Regular; Safety; toxicology; Turmeric; Turmeric; Healthy subjects; Curcumin; Cholestatic hepatitis; Safety
• ISSN: 2214-7500; 2214-7500
• DOI: 10.1016/j.toxrep.2021.11.022

[Display omitted] •PUREMERIC™ is a standardized turmeric extract containing not less than 95 % curcuminoids.•12-week supplementation of 1g/day of PUREMERIC did not alter the liver function parameters of healthy human volunteers.•The safety of the extract was further confirmed by the insignificant changes in the hematological parameters and vital signs.•No serious adverse events were recorded during the study. Turmeric is a culinary spice valued since ancient time for its medicinal properties, mostly attributed to curcumin, the major polyphenol present. The safety of curcumin is well established in humans. However, the tolerability of curcumin is largely determined either in subjects with existing health problems, or in healthy individuals at low doses. More recently the safety of turmeric supplementation is opposed following some case reports on the occurrence of acute hepatitis due to its consumption. Here we have investigated the safety and tolerability of a standardized turmeric extract containing 95 % curcuminoids (PUREMERIC™) in an open label, single arm, prospective clinical study. Twelve healthy subjects aged 18–50 years received 500 mg PUREMERIC capsules twice daily for 90 days. After PUREMERIC supplementation, the liver function parameters such as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total and direct bilirubin, gamma-glutamyl transpeptidase (GGT), and lactate dehydrogenase (LDH) were not significantly altered in the serum compared to baseline. The hematological parameters were within the normal range. Collectively, these data contradict the turmeric- induced liver damage and establishes the safety of the extract in healthy individuals.