Safety and toxicological evaluation of Meratrim®: An herbal formulation for weight management. (April 2015)

• Record Type: Journal Article
• Authors: Saiyed, Zainulabedin M.; Sengupta, Krishanu; Krishnaraju, Alluri V.; Trimurtulu, Golakoti; Lau, Francis C.; Lugo, James P.
• Is Part Of: Food and chemical toxicology. Volume 78(2015)
• Page Start: 122
• Page End: 129
• Publication Date: 2015-04
• Subjects: Meratrim -- Acute oral and dermal toxicity -- Primary skin and eye irritation -- Ames' bacterial reverse mutation assay -- Mammalian erythrocyte micronucleus test -- Repeated dose 13-week oral toxicity study; Toxicology -- Periodicals; Food poisoning -- Periodicals; Food Poisoning -- Periodicals; Toxicology -- Periodicals; Toxicologie -- Périodiques; Intoxications alimentaires -- Périodiques; Food poisoning; Toxicology; Periodicals; Electronic journals; 615.9
• DOI: 10.1016/j.fct.2015.02.010
• Languages: English
• ISSNs: 0278-6915

Abstract

Highlights: Meratrim is an herbal formulation for weight management. Safety of Meratrim was assessed in a battery of in vitro and in vivo toxicity studies. Genotoxicity studies showed that Meratrim is non-mutagenic. Acute oral LD50 of Meratrim was determined to be >5000 mg/kg in rats. NOAEL for Meratrim was determined to be 1000 mg/kg/day in rats. Abstract: Meratrim is a unique dietary ingredient consisting of extracts from Sphaeranthus indicus flower heads and Garcinia mangostana fruit rind. Clinical studies have demonstrated that Meratrim is effective and well-tolerated in weight management. Herein we assessed the broad spectrum safety of Meratrim in a battery of in vitro and animal toxicological studies including a sub-chronic repeated-dose 13-week oral toxicity study to determine the no-observable-adverse-effect-level (NOAEL). The LD50 levels of Meratrim in Sprague-Dawley (SD) rats, as determined by the acute oral and dermal toxicity studies, were >5000 and >2000 mg/kg body weight, respectively. The primary skin and eye irritation tests classified Meratrim as non-irritating to the skin and mildly irritating to the eye. Genotoxicity studies showed that Meratrim is non-mutagenic. In the repeated-dose 13-week oral toxicity study, SD rats were orally gavaged with Meratrim at 0, 250, 500 or 1000 mg/kg/day. No morbidity, mortality, or significant adverse events were observed either during the course of the study or on the 13th week. The NOAEL of Meratrim was concluded to be 1000 mg/kg of body weight/day in male and female SD rats. These results, combined with the tolerability of Meratrim in the human clinical trials, demonstrate the broad spectrum safety of Meratrim.