Toxicological safety evaluation of a novel highly bioavailable turmeric extract formulation

Abstract

Turmeric (Curcuma longa L.) extracts have a long history of use worldwide, but a major limitation of these extracts is their extremely low oral bioavailability, caused by low absorption, rapid metabolism and rapid excretion following ingestion. Thus, a new highly bioavailable turmeric extract formulation (comprising turmeric extract, acacia gum, sunflower oil and quillaia extract) has been developed and is intended for use as a food ingredient. Safety of this novel extract was evaluated using the standard Tier 1 battery of in vitro genotoxicity tests (bacterial reverse mutation test and an in vitro mammalian cell micronucleus test) followed by repeated‐dose 28‐ and 90‐day oral toxicity studies in rats. In the 90‐day study, male and female Sprague‐Dawley rats were dosed once daily, by oral gavage, either with the vehicle or the test item at 500, 1500 or 3000 mg/kg body weight/day. Clinical examinations were conducted regularly, and body weights and food consumption were recorded weekly throughout the study. At the end of the study, blood samples were analyzed for clinical pathology parameters, before a macroscopic necropsy was conducted and a full list of tissues were examined histopathologically. There was no evidence of genotoxicity in vitro. No test item‐related adverse effects were observed in the 28‐ or 90‐day studies; therefore, 3000 mg/kg body weight/day (the maximum feasible dose and highest dose tested in rats) was established as the no‐observed‐adverse‐effect level.

Effect of Co-Administration of Curcumin with Amlodipine in Hypertension

“…[ 41 ]. In a toxicity evaluation experiment of a curcuminoid–essential oil complex (CEC) containing 95% curcuminoid, CEC showed no toxicity even at a dose of 5000 mg/kg [ 42 ], and a turmeric extract formulation (comprising turmeric) that was developed to increase bioavailability showed no side effects even at 3000 mg/kg of administration [ 43 ]. Therefore, our results suggest that the co-administration of curcumin or turmeric with amlodipine is safe and without side effects.…”

Microbial Production of Curcumin

“…As a food agent, curcumin is recognized as "generally safe" by the Food and Drug Administration (FDA) (Phipps et al 2020) with an adequate daily intake value recommended of up to 3 mg per kg of body weight by Joint FAO-WHO Expert Committee Report on Food Additives (JEFCA) (Kocaadam and Şanlier 2017) and European Food Safety Authority (EFSA) (European Food Safety Authority 2014). Other investigations reported that this compound is safe for humans up to 12 g/day without any side effects (Lao et al 2006).…”

Degradation of curcumin‐mediated photodynamic technology (PDT) on polycyclic aromatic hydrocarbons in oysters and toxicity evaluation of PDT‐treated oysters

“…Photodynamic technology (PDT) is a novel non‐thermal sterilisation technology to inactive microorganisms via cytotoxic reactive oxygen species (ROS) produced by the non‐toxic photoactive compound (photosensitiser) after harmless visible light irradiation (Cossu et al ., 2021). Curcumin is a polyphenolic compound isolated from the traditional Chinese herbal medicine‐turmeric (Rahman et al ., 2015), which has diverse biological activities and is recognised as a safe and non‐toxic natural food additive (Phipps et al ., 2020; Hou et al ., 2022). In recent years, curcumin has been widely used as a photosensitiser for PDT due to its good photosensitivity properties (Corrêa et al ., 2020; Seidi Damyeh et al ., 2020; Wang et al ., 2021).…”