The Fynder Group, Inc. DBA Nature's Fynd, Chicago, IL, 60609, USA.
Product Safety Labs, Dayton, NJ, 08810, USA.
Food Chem Toxicol. 2022 Aug;166:113005. doi: 10.1016/j.fct.2022.113005. Epub 2022 May 27.
Fy Protein™ (Nutritional Fungi Protein) is a macro-ingredient produced from the fermentation of the fungal microorganism Fusarium strain flavolapis, isolated from springs in Yellowstone National Park. Fy Protein contains all of the essential amino acids plus fiber, fat, carbohydrates, vitamins, and minerals and is developed as an alternative to animal-based protein foods such as meat and dairy. Fy Protein's nutritional, digestibility, genotoxicity, allergenicity, toxicity, secondary metabolites, and pathogenicity were evaluated. Fy Protein did not show mutagenic or genotoxic potential in in vitro tests. In an allergenicity review, Fy Protein was found to be of low allergenic potential. In a 90-day sub chronic dietary study in rats, administration of Fy Protein did not produce any significant toxicologic manifestations, and the no observed effect level (NOAEL) was the highest-level fed of 150,000 ppm (15% in the diet). Regulated secondary metabolites from fungi (termed mycotoxins) were non-detectable and below regulated levels using quantitative analytical techniques. A literature review was completed to identify the potential human pathogenicity of Fusarium sp., showing that Fusarium rarely infects humans, with infections seldom developing even in immunocompromised individuals. The results of these studies confirm that Fy Protein from fermented F. str. flavolapis has low toxicological, genotoxic, pathogenic, and allergenic potential under the conditions tested and anticipated use.
Fy Protein™（营养真菌蛋白）是一种从黄石国家公园温泉中分离出的真菌微生物 Fusarium flavolapis 发酵产生的宏观成分。Fy Protein 含有所有必需氨基酸，加上纤维、脂肪、碳水化合物、维生素和矿物质，是作为动物蛋白食品（如肉类和奶制品）的替代品而开发的。对 Fy Protein 的营养、消化率、遗传毒性、变应原性、毒性、次生代谢物和致病性进行了评估。在体外试验中，Fy Protein 没有显示出诱变或遗传毒性潜力。在变应原性评估中，发现 Fy Protein 变应原性低。在大鼠 90 天亚慢性饮食研究中，给予 Fy Protein 没有产生任何明显的毒性表现，未观察到效应水平（NOAEL）为最高喂养量 150,000 ppm（饮食中 15%）。使用定量分析技术，可检测到受管制的真菌次生代谢物（称为霉菌毒素）低于可检测水平。完成了文献综述，以确定 Fusarium sp. 的潜在人类致病性，结果表明 Fusarium 很少感染人类，即使在免疫功能低下的个体中，感染也很少发生。这些研究的结果证实，在所测试和预期使用的条件下，发酵的 F. flavolapis 产生的 Fy Protein 具有低毒性、遗传毒性、致病性和变应原性潜力。
