A research study has confirmed the long-term safety of Dolcas Biotech’s CURCUGEN curcumin formulation. With multiple scientific evaluations already having established the oleoresin-based turmeric (Curcuma longa-L.) formulation’s bioefficacy and bioavailability, this recent preclinical safety evaluation demonstrated that there is no indication of any general toxicity, genotoxicity or adverse events associated with long-term use.
The independently conducted, safety evaluation published in the Hindawi Journal of Biomedical Research International and led by Somashekara Nirvanashetty, PhD, et al., sought to establish the safety of CURCUGEN using a standard series of in vitro and in vivo safety studies, in accordance with OECD guidelines. This included the toxicological assessment of acute, oral, and 90-day repeated dosing.
The single dose of CURCUGEN administered orally to Sprague-Dawley (SD) rats demonstrated a non-lethal dose of as high as 5,000mg/kg body weight. A sub chronic assessment of CURCUGEN, as administered to SD rats over 90 days resulted in a no observed adverse effect level (NOAEL) at a dose of 2,000mg/kg body weight/day. This was confirmed through screening of blood serum markers encompassing organ function and urine analysis. Moreover, CURCUGEN did not elicit any genotoxic or mutagenic abnormalities with long-term use.
Confirming its safe and effective status, Dolcas Biotech president K. G. Rao remarked: “Not only does the knowledgeable, label-reading consumer of today demand to know what’s in the products they consume, they want to be reassured of their impeccable safety.”
CURCUGEN is a 100% turmeric-derived, bioavailability-enhanced, water-dispersible curcuminoids active patented for its unique, clean-label coextraction of polar-type resins from the oleoresin. The turmeric oleoresin is the matrix where curcuminoids, essential oils, and resins exist together in nature. The proprietary manufacturing process does not remove, further refine, and then reconstitute these active compounds, as do other formulations on the market. Instead, the process optimises their interaction—particularly with water—so that the otherwise lipid-soluble curcuminoids disperse for functional and biological activity.
CURCUGEN has been proven an effective supplement to support joint function and reduce pain secondary to inflammation. A study published last year revealed that the natural turmeric extract helps support mood and gut health, including helping to ease the symptoms of IBS. CURCUGEN is a patent-pending, food, beverage, and supplement-friendly, pure turmeric-sourced botanical. It is standardised to 50% curcuminoids, 1.5% retained turmeric essential oil, turmeric polysaccharides, and resins. Overall, it has demonstrated antioxidant and anti-inflammatory capacity at doses of only 500mg per day.
Unlike standard formulated curcumin products, CURCUGEN preserves the natural composition of curcuminoids with fidelity to the turmeric rhizome.
CURCUGEN has already attained Self-GRAS status, and the new study positions the company to apply for full FDA GRAS status later this year.
“The enhanced bioavailability of CURCUGEN, with its 39-times-greater free curcumin absorption profile, allows the consumer to feel confident knowing the product is completely safe and fully clean label,” Rao concluded.