Toxicological evaluation of a saponin-rich standardized extract of fenugreek seeds (FenuSMART®): Acute, sub-chronic and genotoxicity studies

The present study investigated the safety of a saponin-rich standardized extract of fenugreek seeds (FenuSMART®; FHE), that has been clinically shown to be effective in ameliorating the postmenopausal discomforts and establishing hormonal balance. The safety was assessed by oral acute (2500 mg/kg b. wt. for 14 days) and subchronic (250, 500 and 1000 mg/kg b. wt. for 90 days) toxicity studies on Wistar rats and mutagenicity studies employing Salmonella typhimurium strains. Administration of FHE did not produce any toxicologically significant changes in clinical/behavioral observations, ophthalmic examinations, body weight, organ weight, feed consumption, urinalysis, hematology and clinical biochemistry parameters when compared to the untreated control group of animals. Highest dose recovery group (1000 mg/kg b. wt.) of animals also showed no mortality or adverse events; with hematological and biochemical parameters at par with those of controls. Terminal autopsy revealed no alterations in relative organ weight or any treatment-related histopathology changes. FHE also showed no mutagenicity upon Ames test employing TA-98, TA-100 and TA-102 Salmonella typhimurium strains with or without metabolic activation. Based on the results of the study, the no observed-adverse-effect level (NOAEL) of FHE was determined as 1000 mg/kg b. wt./day, the highest dose tested. Keywords: Fenugreek extract, Trigonella foenum graecum, Phytoestrogen, Menopause, Subchronic toxicity, Genotoxicit

Safety assessment of a standardized polyphenolic extract of clove buds: Subchronic toxicity and mutagenicity studies

Despite the various reports on the toxicity of clove oil and its major component eugenol, systematic evaluations on the safety of polyphenolic extracts of clove buds have not been reported. Considering the health beneficial pharmacological effects and recent use of clove polyphenols as dietary supplements, the present study investigated the safety of a standardized polyphenolic extract of clove buds (Clovinol), as assessed by oral acute (5 g/kg b.wt. for 14 days) and subchronic (0.25, 0.5 and 1 g/kg b.wt. for 90 days) toxicity studies on Wistar rats and mutagenicity studies employing Salmonella typhimurium strains. Administration of Clovinol did not result in any toxicologically significant changes in clinical/behavioural observations, ophthalmic examinations, body weights, organ weights, feed consumption, urinalysis, hematology and clinical biochemistry parameters when compared to the untreated control group of animals, indicating the no observed-adverse-effect level (NOAEL) as 1000 mg/kg b.wt./day; the highest dose tested. Terminal necropsy did not reveal any treatment-related histopathology changes. Clovinol did not show genotoxicity when tested on TA-98, TA-100 and TA-102 with or without metabolic activation; rather exhibited significant antimutagenic potential against the known mutagens, sodium azide, NPD and tobacco as well as against 2-acetamidoflourene, which needed metabolic activation for mutagenicity. Keywords: Syzygium aromaticum, Clove bud extract, Polyphenol, Subchronic toxicity, Mutagenicity, Genotoxicit

Beyond the flavor: A green formulation of Ferula asafoetida oleo-gum-resin with fenugreek dietary fibre and its gut health potential

Albeit the fact that asafotida is a popular kitchen spice and Indian folklore medicine for gut disorders, its consumption at physiologically relevant dosage is greatly challenged by the unpleasant flavor characteristics. Herein we report a green approach to derive stable powder formulations of asafoetida gum with minimized taste and odor suitable for dietary applications and gut health-related disorders. Employing a water based ultrasound mediated gel-phase dispersion of asafoetida gum on fenugreek derived soluble galactomannan fibre matrix. Microencapsulated particles (1 ± 0.3 μm) of asafoetida was prepared as water dispersible free flowing powder (Asafin). Fourier-transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM), accelerated stability and in vitro dissolution studies confirmed the stability, sustained release and microencapsulated structure of Asafin. Further investigations revealed significant (p < 0.01) reduction in acetic acid-induced writings and inhibition of ethanol-induced ulcer (94.1%) in rats orally administered with Asafin at 250 mg kgâ1 b.w. Asafin also exhibited anti-inflammatory effects (p < 0.01), in acute and chronic paw edema mice models. The safety of Asafin was further demonstrated by acute toxicity studies at 4 g kgâ1  b.w. and by 28 days of sub-acute toxicity studies at 2.0 g kgâ1 b.w. Keywords: Ferula asafoetida, Green formulation, Oral delivery, Gastroprotective, Ethanol-induced ulcer, Gut healt