Researchers from AIBMR Life Sciences (USA) and INTOX Pvt Ltd (India) performed prenatal development toxicity studies, as well as a six-month chronic repeat oral toxicity study, rather than a conventional three-month (90 day) oral toxicity study. The results are published in the International Journal of Toxicology.
Dr Alex Schauss, senior research director of Natural and Medicinal Products Research at AIBMR Life Sciences, Inc., and co-researcher on the study, told NutraIngredients-USA: “The outcomes reported for this series of independent third-party safety assessments of this extract are important because C. fimbriata extract has been shown to significantly reduce food palatability, hunger levels, and reduce waist circumference.
“Hence, it would attract consumers seeking a means to support weight management effects.”
“All studies were performed in Good Laboratory Practices (GLP) labs, utilizing OECD protocols, since previous safety assessment studies were not GLP compliant,” he added. “Based on the compilation of all studies reported, the NOEL is 1,000 mg/kg of body weight per day, which is the highest dose tested.”
The extract of C. fimbriata in supplements is positioned as an appetite-suppressant, and commercialized under the brand name Slimaluma by Gencor Pacific. Slimaluma was released into the US market back in 2006.
Commercial products formulated with Slimaluma are available from NOW Foods, Ultra Laboratories (Fruitrients brand), Swisse Wellness, Source Naturals, and Protocol For Life Balance in the health care practitioner channel.
The ingredient is a patented extract of C. Fimbriata, a cactus-like plant that has a long history of use in India, where it is grown as a vegetable and used as an ingredient in curries and chutneys. According to Gencor, it was also traditionally used by local tribes to ward off hunger when going into the hills or woods for long stretches of time.
The appetite-suppressing effects of C. Fimbriata were reported in a clinical trial with 50 Indian men and women in Appetite in 2007 (Vol. 48, pp. 338–344). A daily one gram dose of Slimaluma for 60 days was associated with appetite suppression and a reduction in waist circumference, compared to placebo.
For the new safety analysis, the researchers found that the C. fimbriata extracts did not produce any deaths or treatment-related toxicity during the 6-month chronic oral toxicity study in Sprague-Dawley rats. Three doses were tested - 100, 300, and 1000 mg per kg body weight per day.
In addition, no treatment-related external, visceral, or skeletal fetal abnormalities were observed following a prenatal developmental toxicity study using doses of 250, 500, and 1000 mg per kg of body weight per day.
“The compilation of toxicological studies supports the safety for the repeated oral consumption of the hydroethanolic extract of C. fimbriata,” concluded the researchers.
The study was funded by Gencor Pacific.
Source: International Journal of Toxicology
Published online ahead of print, doi: 10.1177/1091581813492827
“Safety Assessment of a Hydroethanolic Extract of Caralluma Fimbriata”
Authors: A.Y. Odendaal, N.S. Deshmukh, T.K. Marx, A.G. Schauss, J.R. Endres, A.E. Clewell