Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
, 109 (Pt 1), 194-209

Safety Assessment of the Dietary Supplement OxyELITE™ Pro (New Formula) in Inbred and Outbred Mouse Strains

Affiliations

Safety Assessment of the Dietary Supplement OxyELITE™ Pro (New Formula) in Inbred and Outbred Mouse Strains

Isabelle R Miousse et al. Food Chem Toxicol.

Abstract

Herbal dietary supplements have gained wide acceptance as alternatives to conventional therapeutic agents despite concerns regarding their efficacy and safety. In 2013, a spate of severe liver injuries across the United States was linked to the dietary supplement OxyELITE Pro-New Formula (OEP-NF), a multi-ingredient product marketed for weight loss and exercise performance enhancement. The principal goal of this study was to assess the hepatotoxic potential of OEP-NF in outbred and inbred mouse models. In an acute toxicity study, significant mortality was observed after administering 10X and 3X mouse-equivalent doses (MED) of OEP-NF, respectively. Increases in liver/body weight ratio, ALT and AST were observed in female B6C3F1 mice after gavaging 2X and 1.5X MED of OEP-NF. Similar findings were observed in a 90-day feeding study. These alterations were paralleled by altered expression of gene- and microRNA-signatures of hepatotoxicity, including Cd36, Nqo1, Aldoa, Txnrd1, Scd1 and Ccng1, as well as miR-192, miR-193a and miR-125b and were most pronounced in female B6C3F1 mice. Body weight loss, observed at week 1, was followed by weight gain throughout the feeding studies. These findings bolster safety and efficacy concerns for OEP-NF, and argue strongly for implementation of pre-market toxicity studies within the dietary supplement industry.

Keywords: Dietary supplements; Drug-induced liver injury; Hepatotoxicity; Phytochemicals.

Figures

Fig. 1.
Fig. 1.
Effects of OEP-NF gavaging in male and female CD-1 and B6C3F1 mice. A) Liver to body weight ratio in mice after gavaging with 3X MED (4 h time-points) and 0.5X-2X MED (24 h time-point); B) Levels of ALT, and C) Levels of AST in mice 24 h after gavaging; D) Levels of miR-122 in the serum of mice 24 h after gavage, data expressed as fold-change from respective control values. Mean ± SD. Asterisks “*” denotes significant (p < 0.05), “**” (p < 0.01), and “***” (p < 0.001) difference from control.
Fig. 2.
Fig. 2.
Effects of feeding mice with OEP-NF for 4 weeks. A) Liver to body weight ratio; B) Mitotic figures in the liver of a mouse (ID# 291) fed 1X OEP-NF (magnification 40×); C) Levels of ALT, and D) Levels of AST in the serum of mice; E) Levels of miR-122 in the serum of mice, data expressed as fold-change from respective control values. Mean ± SD. Asterisks “*” denotes significant (p < 0.05) difference from control.
Fig. 3.
Fig. 3.
Body weight dynamics in mice fed OEP for 13 weeks. Data presented as a percent-change from control values at Week 0.
Fig. 4.
Fig. 4.
Effects of feeding mice with OEP-NF for 13 weeks. A) Liver to body weight ratio; B) Mitotic figures in the livers of mice (ID# 259 and 332) fed OEP-NF (magnification 40×); C) Levels of ALT, and D) Levels of AST in the serum of mice; E) Levels of miR-122 in the serum of mice, data expressed as fold-change from respective control values. Mean ± SD. Asterisks “*” denotes significant (p < 0.05), “**” (p < 0.01), and “***” (p < 0.001) difference from control.

Similar articles

See all similar articles

Cited by 7 articles

See all "Cited by" articles

MeSH terms

Feedback