Цель. Оценить эффективность модификации паттернов питания при помощи специализированного продукта (СПП), специально разработанного в ходе настоящей работы на основе анализа структуры питания больных неалкогольным стеатогепатитом (НАСГ). Материалы и методы. Разработан новый СПП (СПП2) для лечения больных НАСГ с включением в состав ω-3-полиненасыщенных жирных кислот, растворимых пищевых волокон, фосфолипидов, α-липоевой кислоты, коэнзима Q10, L-карнитина, комплекса витаминов. В исследование включены 25 больных НАСГ, рандомизированных в следующие группы: тех, кто получал только изокалорийную диету – ИКД [на основе определения энерготрат покоя методом непрямой калориметрии (Quarck RMR, Италия)] – группа ИКД (n=8); или ИКД в сочетании с СПП (2 порции СПП2 в день, 14 дней; группа ИКД+СПП, n=17). Эффективность лечения оценивалась на основании биохимических параметров крови и оценки состава тела биоимпедансным методом до лечения и на 15-й день исследования. Результаты. Группы пациентов не отличались по возрасту, половому составу, а также исходным параметрам состава тела. Приверженность рациону составила 87,5% в группе ИКД и 88,2% в группе ИКД+СПП (р=0,65). Комплаентность приему СПП составила 100%. В группе ИКД+СПП достигнуто значимое снижение массы тела (117,5±30,1 кг исходно в сравнении с 114,9±28,8 кг в конце исследования; p=0,007), в то время как в группе ИКД редукция массы тела не достигла статистически значимых отличий (106,7±22,1 кг в сравнении с 104,0±16,8 кг соответственно; р=0,07). В отличие от группы ИКД в группе ИКД+СПП выявлено значимое снижение уровней холестерина (5,3±1,3 ммоль/л исходно, 4,6±1,3 ммоль/л в конце исследования; р=0,003), липопротеидов низкой плотности (3,7±1,0 ммоль/л в сравнении с 3,3±1,0 ммоль/л; р=0,009), щелочной фосфатазы (132,6±99,1 в сравнении с 112,0±87,0 Е/л; р=0,04), γ-глутамилтрансферазы (54,5±33,2 в сравнении с 37,5±19,7 Е/л; р=0,04), индекса инсулинорезистентности (6,1±3,2 в сравнении с 3,2±1,5 соответственно; р=0,04). Заключение. Модификация паттернов питания с включением в состав изокалорийного рациона специализированного пищевого продукта позволяет достичь значимой редукции массы тела и улучшения показателей липидного и углеводного обмена, уменьшения выраженности синдрома холестаза у больных НАСГ.
Ключевые слова: паттерны питания, неалкогольная жировая болезнь печени, структура рациона, неалкогольный стеатогепатит, специализированный пищевой продукт
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Aim. To assess efficacy of dietary patterns’ modification with the use of specialized food in patients with non-alcoholic steatohepatitis (NASH). Materials and methods. We developed new specialized food (SPP2) based on literature data on the role of dietary patterns in pathogenesis of NASH. It contained ω-3 PUFAs, soluble dietary fiber, phospholipids, α-lipoic acid, coenzyme Q10, L-carnitine, complex of vitamins. Patients with NASH (per EASL guidelines), were invited to participate in the study and were randomly assigned to receive either isocaloric diet (ICD) alone (based on the results of indirect calorimetry – Cosmed, Italy) or isocaloric diet with specialized food (2 portions of SPP2 a day), for 14 days. Repeated examinations of body composition with phase angle analysis (InBody, Republic of Korea) and blood chemistry were performed at baseline (BL) and after 14 days (EOT). The patients were advised to follow usual physical activity during the study. Non-parametric statistics was used to compare BL and EOT characteristics in the groups. Results. The groups did not differ by age, proportion of females, and baseline characteristics of body composition. Adherence to the diet was 87.5% in the ICD group and 88.2% in the ICD+SPP group (p=0.65). Compliance with the use of SPP was 100%. In the ICD+SPP group significant reduction of body weight was achieved (117.5±30.1 kg initially, vs 114.9±28.8 kg at EOT; p=0.007), whereas in the ICD group it was not statistically significant (106.7±22.1 kg at BL vs 104.0±16.8 kg at EOT, respectively; p=0.07). In contrast to the ICD group, in those who received ICD+SPP significant decrease in cholesterol (5.3±1.3 mmol/L at BL vs 4.6±1.3 mmol/L at EOT; p=0.003), LDL (3.7±1.0 mmol/L vs 3.3±1.0 mmol/L, respectively; p=0.009), alkaline phosphatase (132.6±99.1 vs 112.0±87.0 U/L; p=0.04), GGT (54.5±33.2 vs 37.5±19.7 U/L; p=0.04), insulin resistance index (6.1±3.2 vs 3.2±1.5, respectively; p=0.04) was detected. Conclusion. Modification of dietary patterns with the use of a specialized food in combination with low-calorie diet allows achieving significant reduction of weight and improve lipid and carbohydrate metabolism, reduce severity of cholestasis in patients with NASH.
1. European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016;64(6):1388-402. DOI:10.1016/j.jhep.2015.11.004
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3. Pais R, Charlotte F, Fedchuk L, et al. A systematic review of follow-up biopsies reveals disease progression in patients with non-alcoholic fatty liver. J Hepatol. 2013;59(3):550-6. DOI:10.1016/j.jhep.2013.04.027
4. Younossi ZM. Non-alcoholic fatty liver disease – A global public health perspective. J Hepatol. 2019;70(3):531-54. DOI:10.1016/j.jhep.2018.10.033
5. Ye Q, Zou B, Yeo YH, et al. Global prevalence, incidence, and outcomes of non-obese or lean non-alcoholic fatty liver disease: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020;5(8):739-52. DOI:10.1016/S2468-1253(20)30077-7
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8. Powell EE, Wong VW, Rinella M. Non-alcoholic fatty liver disease. Lancet. 2021;397(10290):2212-24. DOI:10.1016/S0140-6736(20)32511-3
9. Ullah R, Rauf N, Nabi G, et al. Role of Nutrition in the Pathogenesis and Prevention of Non-alcoholic Fatty Liver Disease: Recent Updates. Int J Biol Sci. 2019;15(2):265-76. DOI:10.7150/ijbs.30121
10. Chiu S, Sievenpiper JL, de Souza RJ, et al. Effect of fructose on markers of non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of controlled feeding trials. Eur J Clin Nutr. 2014;68(4):416-23. DOI:10.1038/ejcn.2014.8
11. Barrera F, George J. The role of diet and nutritional intervention for the management of patients with NAFLD. Clin Liver Dis. 2014;18(1):91-112. DOI:10.1016/j.cld.2013.09.009
12. Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, et al. Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis. Gastroenterology. 2015;149(2):367-e15. DOI:10.1053/j.gastro.2015.04.005
13. Demirel-Yalciner T, Sozen E, Ozaltin E, et al. Alpha-Tocopherol supplementation reduces inflammation and apoptosis in high cholesterol mediated nonalcoholic steatohepatitis. Biofactors. 2021;47(3):403-13. DOI:10.1002/biof.1700
14. Jeon D, Son M, Shim J. Dynamics of Serum Retinol and Alpha-Tocopherol Levels According to Non-Alcoholic Fatty Liver Disease Status. Nutrients. 2021;13(5):1720. DOI:10.3390/nu13051720
15. Исаков В.А., Морозов СВ., Пилипенко В.И. Инновационные подходы к анализу состава рациона и диетотерапии функциональных заболеваний органов пищеварения. Вопросы питания. 2020;89(4):172-85 [Isakov VA, Morozov SV, Pilipenko VI. Innovative approaches to study food patterns in functional gastrointestinal disorders. Vopr Pitan. 2020;89(4):172-85 (in Russian)]. DOI:10.24411/0042-8833-2020-10051
16. Tucker KL. Dietary patterns, approaches, and multicultural perspective. Appl Physiol Nutr Metab. 2010;35(2):211-8. DOI:10.1139/H10-010
17. Sasunova A, Morozov S, Isakov V. Food patterns analysis in patients with NAFLD provide better informational status compared to traditional nutritional assessment. Hepatology. 2020. DOI:10.1002/HEP.31579
18. Sasunova AN, Morozov SV, Isakov VA. Dietary Patterns in Patients With Different Forms of Non-alcoholic Fatty Liver Disease. Current Developments in Nutrition. 2021;5(Suppl. 2):450. DOI:10.1093/cdn/nzab038_062
19. Сасунова А.Н., Морозов С.В., Соболев Р.В. Оценка эффективности использования специализированного пищевого продукта в составе диетотерапии пациентов с неалкогольным стеатогепатитом. Вопросы питания. 2022;91(2):31-42 [Sasunova AN, Morozov SV, Sobolev RV, et al. Efficacy of newly developed food for special dietary use in the diet of patients with non-alcoholic steatohepatitis. Voprosy pitaniia. 2022;91(2):31-42 (in Russian)]. DOI:10.33029/0042-8833-2022-91-2-31-42
20. Методические рекомендации MP 2.3.1.2432-08 «Нормы физиологических потребностей в энергии и пищевых веществах для различных групп населения Российской Федерации» (утв. Главным государственным санитарным врачом РФ 18 декабря 2008 г.) [Guidelines MP 2.3.1.2432-08 "Norms of physiological needs for energy and nutrients for various groups of the population of the Russian Federation" (approved by the Chief State Sanitary Doctor of the Russian Federation on December 18, 2008) (in Russian)].
21. Воробьева В.М., Воробьева И.С., Морозов С.В., и др. Специализированные пищевые продукты для диетической коррекции рациона больных с неалкогольным стеатогепатитом. Вопросы питания. 2021;90(2):100-9 [Vorobyeva VM, Vorobyeva IS, Morozov SV, et al. Specialized products for dietary correction of the diet of patients with non-alcoholic steatohepatitis. Voprosy pitaniia. 2021;90(2):100-9 (in Russian)]. DOI:10.33029/0042-8833-2021-90-2-100-109
22. Morozov SV, Sasunova AN, Isakov VA. Dietary patterns in patients with simple steatosis and non-alcoholic steatohepatitis: prospective comparative trial. UEG Journal. 2021; 9(S8):660. DOI:10.1002/ueg2.12142
23. Попова А.Ю., Тутельян В.А., Никитюк Д.Б. О новых (2021) нормах физиологических потребностей в энергии и пищевых веществах для различных групп населения Российской Федерации. Вопросы питания. 2021;90(4):6-19 [Popova AY, Tutelyan VA, Nikityuk DV. On the new (2021) Norms of physiological requirements in energy and nutrients of various groups of the population of the Russian Federation. Voprosy pitaniia. 2021;90(4):6-19 (in Russian)]. DOI:10.33029/0042-8833-2021-90-4-6-19
24. Namazi N, Larijani B, Azadbakht L. Alpha-lipoic acid supplement in obesity treatment: A systematic review and meta-analysis of clinical trials. Clin Nutr. 2018;37(2):419-28. DOI:10.1016/j.clnu.2017.06.002
25. Sanyal AJ, Chalasani N, Kowdley KV, et al. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010;362(18):1675-85. DOI:10.1056/NEJMoa0907929
26. Castro-Barquero S, Ruiz-León AM, Sierra-Pérez M, et al. Dietary Strategies for Metabolic Syndrome: A Comprehensive Review. Nutrients. 2020;12(10):2983. DOI:10.3390/nu12102983
27. Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl. 2):S76-99. DOI:10.1161/01.cir.0000437740.48606.d1
28. McGuire S. U.S. Department of Agriculture and U.S. Department of Health and Human Services, Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, January 2011. Adv Nutr. 2011;2(3):293-4. DOI:10.3945/an.111.000430
29. Кропочев В.С., Морозов С.В., Ланцева М.А., и др. Анализ особенностей питания у больных гастроэзофагеальной рефлюксной болезнью: результаты пилотного исследования. Терапевтический архив. 2020;92(8):66-72 [Kropochev VS, Morozov SV, Lantseva MA, et al. Food patterns in Russian patients with gastroesophageal reflux disease: the results of pilot comparative study. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(8):66-72 (in Russian)]. DOI:10.26442/00403660.2020.08.000760
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31. Romero-Gómez M, Zelber-Sagi S, Trenell M. Treatment of NAFLD with diet, physical activity and exercise. J Hepatol. 2017;67(4):829-46. DOI:10.1016/j.jhep.2017.05.016
32. Trovato FM, Catalano D, Martines GF, et al. Mediterranean diet and non-alcoholic fatty liver disease: the need of extended and comprehensive interventions. Clin Nutr. 2015;34(1):86-8. DOI:10.1016/j.clnu.2014.01.018
33. Farhadnejad H, Darand M, Teymoori F, et al. The association of Dietary Approach to Stop Hypertension (DASH) diet with metabolic healthy and metabolic unhealthy obesity phenotypes. Sci Rep. 2019;9(1):18690. DOI:10.1038/s41598-019-55285-6
34. Doustmohammadian A, Clark CCT, Maadi M, et al. Favorable association between Mediterranean diet (MeD) and DASH with NAFLD among Iranian adults of the Amol Cohort Study (AmolCS). Sci Rep. 2022;12(1):2131. DOI:10.1038/s41598-022-06035-8
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1. European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016;64(6):1388-402. DOI:10.1016/j.jhep.2015.11.004
2. Lazebnik LB, Golovanova EV, Turkina SV, et al. Non-alcoholic fatty liver disease in adults: clinic, diagnostics, treatment. Guidelines for therapists, third version. Experimental and Clinical Gastroenterology. 2021;1(1):4-52 (in Russian). DOI:10.31146/1682-8658-ecg-185-1-4-52
3. Pais R, Charlotte F, Fedchuk L, et al. A systematic review of follow-up biopsies reveals disease progression in patients with non-alcoholic fatty liver. J Hepatol. 2013;59(3):550-6. DOI:10.1016/j.jhep.2013.04.027
4. Younossi ZM. Non-alcoholic fatty liver disease – A global public health perspective. J Hepatol. 2019;70(3):531-54. DOI:10.1016/j.jhep.2018.10.033
5. Ye Q, Zou B, Yeo YH, et al. Global prevalence, incidence, and outcomes of non-obese or lean non-alcoholic fatty liver disease: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020;5(8):739-52. DOI:10.1016/S2468-1253(20)30077-7
6. Ivashkin VT, Drapkina OM, Maev IV, et al. Рasprostranennost' nealkogol'noi zhirovoi bolezni pecheni u patsientov ambulatorno-poliklinicheskoi praktiki v Rossiiskoi Federatsii: rezul'taty issledovaniia DIREG 2. Rosiiskii zhurnal gastroenterologii, gepatologii, koloproktologii. 2015;6:31-41 (in Russian).
7. Masharova AA, Danilevskaya NN. Nealkogol'nyi steatogepatit: ot patogeneza k terapii. RMZ Gastroenterologiia. 2013;31:1642-5 (in Russian).
8. Powell EE, Wong VW, Rinella M. Non-alcoholic fatty liver disease. Lancet. 2021;397(10290):2212-24. DOI:10.1016/S0140-6736(20)32511-3
9. Ullah R, Rauf N, Nabi G, et al. Role of Nutrition in the Pathogenesis and Prevention of Non-alcoholic Fatty Liver Disease: Recent Updates. Int J Biol Sci. 2019;15(2):265-76. DOI:10.7150/ijbs.30121
10. Chiu S, Sievenpiper JL, de Souza RJ, et al. Effect of fructose on markers of non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of controlled feeding trials. Eur J Clin Nutr. 2014;68(4):416-23. DOI:10.1038/ejcn.2014.8
11. Barrera F, George J. The role of diet and nutritional intervention for the management of patients with NAFLD. Clin Liver Dis. 2014;18(1):91-112. DOI:10.1016/j.cld.2013.09.009
12. Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, et al. Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis. Gastroenterology. 2015;149(2):367-e15. DOI:10.1053/j.gastro.2015.04.005
13. Demirel-Yalciner T, Sozen E, Ozaltin E, et al. Alpha-Tocopherol supplementation reduces inflammation and apoptosis in high cholesterol mediated nonalcoholic steatohepatitis. Biofactors. 2021;47(3):403-13. DOI:10.1002/biof.1700
14. Jeon D, Son M, Shim J. Dynamics of Serum Retinol and Alpha-Tocopherol Levels According to Non-Alcoholic Fatty Liver Disease Status. Nutrients. 2021;13(5):1720. DOI:10.3390/nu13051720
15. Isakov VA, Morozov SV, Pilipenko VI. Innovative approaches to study food patterns in functional gastrointestinal disorders. Vopr Pitan. 2020;89(4):172-85 (in Russian). DOI:10.24411/0042-8833-2020-10051
16. Tucker KL. Dietary patterns, approaches, and multicultural perspective. Appl Physiol Nutr Metab. 2010;35(2):211-8. DOI:10.1139/H10-010
17. Sasunova A, Morozov S, Isakov V. Food patterns analysis in patients with NAFLD provide better informational status compared to traditional nutritional assessment. Hepatology. 2020. DOI:10.1002/HEP.31579
18. Sasunova AN, Morozov SV, Isakov VA. Dietary Patterns in Patients With Different Forms of Non-alcoholic Fatty Liver Disease. Current Developments in Nutrition. 2021;5(Suppl. 2):450. DOI:10.1093/cdn/nzab038_062
19. Sasunova AN, Morozov SV, Sobolev RV, et al. Efficacy of newly developed food for special dietary use in the diet of patients with non-alcoholic steatohepatitis. Voprosy pitaniia. 2022;91(2):31-42 (in Russian). DOI:10.33029/0042-8833-2022-91-2-31-42
20. Guidelines MP 2.3.1.2432-08 "Norms of physiological needs for energy and nutrients for various groups of the population of the Russian Federation" (approved by the Chief State Sanitary Doctor of the Russian Federation on December 18, 2008) (in Russian).
21. Vorobyeva VM, Vorobyeva IS, Morozov SV, et al. Specialized products for dietary correction of the diet of patients with non-alcoholic steatohepatitis. Voprosy pitaniia. 2021;90(2):100-9 (in Russian). DOI:10.33029/0042-8833-2021-90-2-100-109
22. Morozov SV, Sasunova AN, Isakov VA. Dietary patterns in patients with simple steatosis and non-alcoholic steatohepatitis: prospective comparative trial. UEG Journal. 2021; 9(S8):660. DOI:10.1002/ueg2.12142
23. Popova AY, Tutelyan VA, Nikityuk DV. On the new (2021) Norms of physiological requirements in energy and nutrients of various groups of the population of the Russian Federation. Voprosy pitaniia. 2021;90(4):6-19 (in Russian). DOI:10.33029/0042-8833-2021-90-4-6-19
24. Namazi N, Larijani B, Azadbakht L. Alpha-lipoic acid supplement in obesity treatment: A systematic review and meta-analysis of clinical trials. Clin Nutr. 2018;37(2):419-28. DOI:10.1016/j.clnu.2017.06.002
25. Sanyal AJ, Chalasani N, Kowdley KV, et al. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010;362(18):1675-85. DOI:10.1056/NEJMoa0907929
26. Castro-Barquero S, Ruiz-León AM, Sierra-Pérez M, et al. Dietary Strategies for Metabolic Syndrome: A Comprehensive Review. Nutrients. 2020;12(10):2983. DOI:10.3390/nu12102983
27. Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl. 2):S76-99. DOI:10.1161/01.cir.0000437740.48606.d1
28. McGuire S. U.S. Department of Agriculture and U.S. Department of Health and Human Services, Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, January 2011. Adv Nutr. 2011;2(3):293-4. DOI:10.3945/an.111.000430
29. Kropochev VS, Morozov SV, Lantseva MA, et al. Food patterns in Russian patients with gastroesophageal reflux disease: the results of pilot comparative study. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(8):66-72 (in Russian). DOI:10.26442/00403660.2020.08.000760
30. Lantseva MA, Sasunova AN, Vlasova AV, et al. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(8):79-85 (in Russian). DOI:10.26442/00403660.2020.08.000771
31. Romero-Gómez M, Zelber-Sagi S, Trenell M. Treatment of NAFLD with diet, physical activity and exercise. J Hepatol. 2017;67(4):829-46. DOI:10.1016/j.jhep.2017.05.016
32. Trovato FM, Catalano D, Martines GF, et al. Mediterranean diet and non-alcoholic fatty liver disease: the need of extended and comprehensive interventions. Clin Nutr. 2015;34(1):86-8. DOI:10.1016/j.clnu.2014.01.018
33. Farhadnejad H, Darand M, Teymoori F, et al. The association of Dietary Approach to Stop Hypertension (DASH) diet with metabolic healthy and metabolic unhealthy obesity phenotypes. Sci Rep. 2019;9(1):18690. DOI:10.1038/s41598-019-55285-6
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