Mazo V K, Sidorova Yu S, Petrov N A, Vasilevskaya L S
Federal Research Centre of Nutrition, Biotechnology and Food Safety, 109240, Moscow, Russian Federation.
Vopr Pitan. 2020;89(4):52-59. doi: 10.24411/0042-8833-2020-10041. Epub 2020 Jul 29.
Preclinical physiological and biochemical studies of the effectiveness of the tested biologically active substances in the conditions of simulated pathology in laboratory animals are an important stage preceding the assessment of the clinical effectiveness of the created specialized foods for therapeutic or preventive nutrition. of this work is a brief review of the developed algorithm for preclinical assessment of the effectiveness of specialized foods, which includes a set of sequential stages of testing the safety, stability, bioavailability and effectiveness of biologically active substances in experiments on laboratory animals. . The paper presents a brief review of methodological approaches for in vivo preclinical assessment of the effectiveness of minor plant biologically active substances - polyphenols from bilberry fruits and leaves and phytoecdysteroids extracted from spinach. A beneficial effect of bilberry leaves' polyphenols on carbohydrate and lipid metabolism of male Zucker and Wistar rats was shown, which determined the necessity to increase the effectiveness of the developed polyphenolic ingredient by sorption on a food carrier. When evaluating the in vivo effects of polyphenols from blueberries and leaves sorbed on buckwheat flour, a pronounced hypoglycemic effect was found. The experiments aimed to the assessment of the adaptogenic effects of phytoecdysteroids from spinach leaves showed a significant decrease in the content of the main biomarkers of the stress system, which indicates a «smoothing» of the response of the animal organism to a strong stress impact. . The inclusion of minor biologically active substances into the composition of foods for preventive and therapeutic nutrition is the necessary condition to improve their effectiveness. The scientific and practical significance of the preclinical evaluation to a decisive extent depends on the presence of a correctly selected biomodel. Thus, the adequacy of the assessment of the effects of minor biologically active substances as functional food ingredients in the composition of the specialized food products depends on the reproducibility of pathological processes (clinical, biochemical and morphological disorders) characteristic for the studied disease on the selected in vivo model.
在实验动物模拟病理条件下，对受试生物活性物质有效性进行临床前生理和生化研究，是评估所研发的治疗或预防性营养专用食品临床有效性之前的重要阶段。本文简要回顾了所开发的专用食品有效性临床前评估算法，该算法包括在实验动物身上测试生物活性物质安全性、稳定性、生物利用度和有效性的一系列连续阶段。本文简要综述了对微量植物生物活性物质——越橘果实和叶片中的多酚以及从菠菜中提取的植物蜕皮甾酮进行体内临床前有效性评估的方法。结果表明，越橘叶多酚对雄性 Zucker 和 Wistar 大鼠的碳水化合物和脂质代谢具有有益作用，这决定了有必要通过吸附在食品载体上来提高所研发的多酚成分的有效性。在评估吸附在荞麦粉上的蓝莓和叶片中的多酚的体内作用时，发现了明显的降血糖作用。旨在评估菠菜叶中植物蜕皮甾酮适应原性作用的实验表明，应激系统主要生物标志物的含量显著降低，这表明动物机体对强烈应激影响的反应得到了“缓解”。将微量生物活性物质纳入预防和治疗营养食品的成分中是提高其有效性的必要条件。临床前评估的科学和实际意义在很大程度上取决于是否存在正确选择的生物模型。因此，作为专用食品产品成分的功能性食品成分，对微量生物活性物质作用评估的充分性取决于所选体内模型上所研究疾病特有的病理过程（临床、生化和形态学紊乱）的可重复性。
