Safety and toxicological evaluation of a novel anti-obesity formulation LI85008F in animals

Abstract

LI85008F is a novel synergistic composition of Moringa oleifera, Murraya koenigi, and Curcuma longa. These herbs are well recognized and widely used in ayurvedic system of medicine for treating a variety of diseases and are also have been used for culinary purposes for thousands of years. LI85008F inhibits preadipocyte differentiation and potentiates lipid breakdown in mature adipocytes. In diet-induced obese rats, LI85008F significantly reduced weight gain and improved serum adiponectin levels. These findings motivated the authors to determine the broad-spectrum safety of LI85008F. Acute oral toxicity, acute dermal toxicity, primary skin irritation, primary eye irritation, and dose-dependent 28-day sub-acute toxicity studies were conducted. The acute oral LD50 of LI85008F was greater than 5000 mg/kg in female SD rats and no changes in body weight or adverse effects were observed following necropsy. Acute dermal LD50 of LI85008F was greater than 2000 mg/kg. LI85008F was classified as non-irritating to skin in a primary dermal irritation study conducted using New Zealand Albino rabbits. LI85008F caused minimal irritation to eyes in a primary eye irritation test conducted on New Zealand Albino rabbits. A dose-dependent 28-day sub-acute toxicity study demonstrated no significant changes in selected organ weights. Evaluations on hematology, clinical chemistry, and histopathology did not show any significant adverse changes. The NOAEL of LI85008F was found to be greater than 2500 mg/kg body weight. These results demonstrate the broad spectrum safety of LI85008F in animal models.

Efficacy and tolerability of a novel herbal formulation for weight management in obese subjects: a randomized double blind placebo controlled clinical study

“…Interestingly, the formulation LI85008F showed significant anti-obese efficacy in high fat diet induced obesity in Sprague Dawley rats (unpublished observation). Previously, we demonstrated a broad spectrum safety of LI85008F in appropriate animal models [10]. In this current double blind, randomized, placebo controlled clinical study (clinical trial registration no.…”

“…In addition, LI85008F enhanced triglyceride mobilization from the fat cells or promoted lipolysis [9]. Further, we also have demonstrated broad-spectrum safety of LI85008F in various animal models [10]. …”

Efficacy of an herbal formulation LI10903F containing Dolichos biflorus and Piper betle extracts on weight management

“…A twenty-eight day sub chronic toxicity study was conducted following the protocol as described earlier [12]. Forty healthy Sprague Dawley rats (20 males and 20 females) were equally divided into four groups.…”

Influence of Moringa oleifera on pharmacokinetic disposition of rifampicin using HPLC‐PDA method: a pre‐clinical study

“…Moringa oleifera exhibited the antispasmodic, anti inflammatory, diuretic (Caceres et al, 1992), anti-obesity (Mehta et al, 2003;Krishnaraju et al, 2010) and anti-inflammatory activity in ovalbumin-induced airway inflammation in a guinea pig model of asthma (Mahajan et al, 2009) and reduced the arsenic-induced toxicity in rats . Aqueous extracts of M. oleifera seeds lowered plasma fluoride concentrations in rabbits receiving fluorinated drinking water (Ranjan et al, 2009) and its flacculent mechanism is due to its content of low-molecular-mass protein (Kwaambwa et al, 2010).…”

“…Moringa oleifera exhibited the antispasmodic, anti inflammatory, diuretic (Caceres et al ., 1992), anti‐obesity (Mehta et al ., 2003; Krishnaraju et al ., 2010) and anti‐inflammatory activity in ovalbumin‐induced airway inflammation in a guinea pig model of asthma (Mahajan et al ., 2009) and reduced the arsenic‐induced toxicity in rats (Gupta et al ., 2005). Aqueous extracts of M .…”