Herbal dietary supplement (HDS)-induced hepato- and cardiotoxicity is an emerging clinical problem. In this study, we investigated the liver and heart toxicity of HDS OxyELITE-PRO™ New Formula (OEP-NF), a dietary supplement marketed for weight loss and performance enhancement that was recently withdrawn from the market. Using a novel NZO/HlLtJ obese mouse model, we demonstrated that administration of clinically relevant mouse equivalent doses (MED) of OEP-NF produced cardio- and hepatotoxic risks following both short- and long-term administration schedules. Specifically, gavaging female NZO/HlLtJ with up to 2X MED of OEP-NF resulted in 40% mortality within two weeks. Feeding mice with either 1X or 3X MED of OEP-NF for eight weeks, while not exhibiting significant effects on body weights, significantly altered hepatic gene expression, increased the number of apoptotic and mast cells in the heart and affected cardiac function. The degree of toxicity in NZO/HlLtJ mice was higher than that observed previously in non-obese CD-1 and B6C3F1 strains, suggesting that an overweight/obese condition can sensitize mice to OEP-NF. Adverse health effects linked to OEP-NF, together with a number of other hepato- and cardiotoxicity cases associated with HDS ingestion, argue strongly for introduction of quality standards and pre-marketing safety assessments for multi-ingredient HDS.

草药饮食补充剂（HDS）引起的肝毒性和心脏毒性是一个新兴的临床问题。在这项研究中，我们调查了HDS OxyELITE-PRO™新配方（OEP-NF）的肝脏和心脏毒性，该配方是为减肥和增强功能而销售的饮食补品，最近已从市场上撤出。使用新型的NZO / HlLtJ肥胖小鼠模型，我们证明，按照短期和长期给药方案，对OEP-NF进行临床相关的小鼠等效剂量（MED）给药会产生心脏和肝毒性风险。具体而言，用高达2X MED的OEP-NF灌胃雌性NZO / HlLtJ会在两周内导致40％的死亡率。用1X或3X MED的OEP-NF喂养小鼠八周，虽然对体重没有显着影响，但肝基因表达却发生了明显变化，增加了心脏中凋亡和肥大细胞的数量，并影响了心脏功能。NZO / HlLtJ小鼠的毒性程度高于以前在非肥胖CD-1和B6C3F1菌株中观察到的毒性，这表明超重/肥胖状况可使小鼠对OEP-NF敏感。与OEP-NF相关的不良健康影响，以及与HDS摄入有关的许多其他肝毒性和心脏毒性病例，强烈主张为多成分HDS引入质量标准和上市前安全性评估。