Abstract

Non-alcoholic steatohepatitis (NASH) is a widespread disorder associated with a number of metabolic disorders. Lifestyle modification, including diet and physical activity are currently a first-line treatment for the disease. However, there is lack of specialized products (SP) with modified carbohydrate and fat composition, containing biologically active ingredients with proven physiological effects on the liver for this disorder. The aim of the paper is to summarize present knowledge on the biologically active ingredients with proven hepatoprotective effect and to describe the process of the development of two specialized products for clinical use in patients with NASH. Material and methods. Food ingredients containing soy and milk proteins, soluble dietary fiber, mono- and polyunsaturated fatty acids, vitamins, minerals, soy lecithin, L-carnitine, coenzyme Q10, α-lipoic acid, betaine, flavoring and aromatic additives were used in the development of SP formulations. The mass fraction of moisture in the SP was determined by the thermo-gravimetric method on a humidity analyzer, and the water activity was determined by measuring the dew point. The nutritional and energy value of the SP was calculated using data from chemical composition tables and information from manufacturers of food ingredients. Results and discussion. Taking into account the requirements for dietary therapy, the ingredient composition was scientifically justified and the formulations of two SP with a balanced amino acid composition were developed by using a combination of milk whey proteins, casein and soy protein isolate. The fat component included microencapsulated rapeseed oil, that is a source of mono- and polyunsaturated fatty acids (PUFAs) with the addition of ω-3 PUFAs. The carbohydrate composition was modified by eliminating mono- and disaccharides, traditionally used in sweet drinks, and adding maltodextrin in combination with sweeteners (polyols and natural sweeteners). Polydextrose, citrus pectin, inulin, and hydrolyzed guar gum are used as soluble dietary fibers. The SP included essential micronutrients (vitamins, mineral substances) and bioactive substances that have a proven physiological effect (coenzyme Q10, α-lipoic acid, L-carnitine, betaine hydrochloride, phospholipids). Technical documentation was developed and a pilot batch of SP-1 was developed for inclusion in the complex treatment of patients with NASH. Conclusion. The formulations and technology of SP (SP-1, SP-2) for therapeutic nutrition with a given chemical composition, designed to optimize the diet therapy of patients with NASH, have been developed. SP are sources of animal and vegetable proteins, soluble dietary fiber, mono- and polyunsaturated fatty acids, including ω-3 family, vitamins, minerals and trace elements, as well as bioactive substances with antioxidant, hepatoprotective and hypolipidemic effect. The technical documentation was developed and approved, according to which a pilot batch of SP-1 was produced to assess its effectiveness as a part of complex therapy of patients with NASH.

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