title: Safety and toxicological evaluation of Meratrim®: an herbal formulation for weight management.
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.
authors: InterHealth Nutraceuticals Research Center, Benicia, CA, United States.
authors: Zainulabedin M
authors: ZM
authors: Saiyed
authors: Laila Nutraceuticals, Vijayawada, India.
authors: Krishanu
authors: K
authors: Sengupta
authors: Laila Nutraceuticals, Vijayawada, India.
authors: Alluri V
authors: AV
authors: Krishnaraju
authors: Laila Nutraceuticals, Vijayawada, India.
authors: Golakoti
authors: G
authors: Trimurtulu
authors: InterHealth Nutraceuticals Research Center, Benicia, CA, United States.
authors: Francis C
authors: FC
authors: Lau
authors: InterHealth Nutraceuticals Research Center, Benicia, CA, United States. Electronic address: jlugo@interhealthusa.com.
authors: James P
authors: JP
authors: Lugo
mesh_terms: D000818:Animals; D019440:Anti-Obesity Agents / Q000494:pharmacology*; D019659:Asteraceae / Q000737:chemistry; D001835:Body Weight / Q000187:drug effects; D004249:DNA Damage / Q000187:drug effects; D019587:Dietary Supplements / Q000032:analysis*; D004305:Dose-Response Relationship, Drug; D004353:Drug Evaluation, Preclinical; D005260:Female; D035264:Flowers / Q000737:chemistry; D005638:Fruit / Q000737:chemistry; D029760:Garcinia / Q000737:chemistry; D007928:Lethal Dose 50; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D017207:Rats, Sprague-Dawley; D012867:Skin / Q000187:drug effects; D018675:Toxicity Tests
chemical_list: D019440:Anti-Obesity Agents
keywords: Acute oral and dermal toxicity; Ames' bacterial reverse mutation assay; Mammalian erythrocyte micronucleus test; Meratrim; Primary skin and eye irritation; Repeated dose 13-week oral toxicity study