aterosklerozАтеросклерозAteroscleroz2078-256X2949-3633НИИТПМ-филиал ИЦиГ СО РАНateroskleroz-702Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESРандомизированные исследования «функциональных» продуктов, обогащенных растительными стеринами и станолами: эффективность в коррекции дислипидемийRandomized studies of «functional» foods enriched with plant sterols and stanols: efficiacy in correction of dyslipidemiaХучиеваМ. А.KhuchiyevaM. A.

Мадина Ахметовна Хучиева, младший научный сотрудник

ФГБУ «Государственный научно-исследовательский центр профилактической медицины»

отдел вторичной профилактики хронических неинфекционных заболеваний

101990

Петроверигский пер., 10

Москва

101990

Petroverigskij per., 10

Moskow

mad2997@yandex.ruПероваН. В.PerovaN. V.

Наталия Владимировна Перова, д-р мед. наук, проф., ведущий научный сотрудник

ФГБУ «Государственный научно-исследовательский центр профилактической медицины»

отдел изучения биохимических маркеров хронических неинфекционных заболеваний

101990

Петроверигский пер., 10

Москва

101990

Petroverigskij per., 10

Moskow

nperova@gnicpm.ruМинздрав РоссииState Research Center of Preventive Medicine201411042022102514Copyright © Хучиева М.А., Перова Н.В., 20222022Хучиева М.А., Перова Н.В.Khuchiyeva M.A., Perova N.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://ateroskleroz.elpub.ru/jour/article/view/702

   Цель краткосрочного, рандомизированного, плацебо-контролированного, двойного слепого клинического исследования: изучить действие «функциональных» продуктов, содержащих эфиры растительных стеринов или станолов на показатели системы липопротеинов и тромбообразования у российских больных ишемической болезнью сердца (ИБС) с умеренной гиперхолестеринемией.

   Материал и методы

   Материал и методы. В исследование включены 69 пациентов (обоего пола) 44–70 лет с уровнем общего холестерина (ХС) 5,0–6,5 ммоль/л. Из них холестерин липопротеинов низкой плотности (ХС ЛПНП) 3,4–5,0 ммоль/л имел 61 человек; «функциональные» продукты принимали 36 больных, сходные продукты без стеринов и станолов – плацебо – 25 человек. Ежедневная доза фитостеринов 1,6 г (в составе йогурта Данакор), фитостанолов – 2,0 г (в составе спреда Бенеколь). У всех больных исследовали гемодинамические параметры, уровень липидов и аполипопротеинов, нежелательные явления.

   Результаты

   Результаты. В группах плацебо не обнаружено изменений регистрируемых показателей; холестерин липопротеинов высокой плотности (ХС ЛПВП) во всех группах не изменялся. В группе, потреблявшей фитостерин-содержащий продукт, общий ХС снизился за три недели на 10 % по сравнению с изменениями на плацебо на 4,3 %; снизился ХС ЛПНП на 11,2 % по сравнению с плацебо на 7,1 %; уровень триглицеридов (ТГ) снизился на 17,5 %, ХС не-ЛПВП – на 12,5 %. Снизились уровень апоВ на 11,84 % и апопротеиновый индекс атерогенности апоВ/АI – с 0,94 до 0,88. Снизился фибриноген с 3,8 до 3,1 г/л. За четыре недели потребления спреда, обогащенного фитостанолами, снизились общий ХС на 8,6 %, ХС ЛПНП – на 7,6 % по сравнению с плацебо на 10,7 и 10,4 % соответственно; ТГ – на 17,0 %, ХС не-ЛПВП – на 11 %. Не изменились систолическое и диастолическое артериальное давление, частота сердечных сокращений, активность АСТ и АЛТ. Легкие нежелательные явления со стороны желудочно-кишечного тракта у трехпациентов прошли без вмешательства.

   Заключение

   Заключение. «Функциональные» пищевые продукты, обогащенные растительными стеринами и станолами, у российских больных ИБС с умеренной гиперхолестеринемией оказывают коррегирующее действие на липопротеины, сходное с обнаруженным в зарубежных программах по первичной профилактике. Очевидно, пищевые продукты, обогащенные фитостеринами и фитостанолами, могут использоваться в немедикаментозной вторичной профилактике у больных ИБС.

   The purpose of short-term, randomized, placebo-controlled, double-blind clinical trial was to study the effect of «functional» products containing plant sterols or stanols esters on lipoprotein and coagulation parameters in Russian CHD patients with moderate hypercholesterolemia.

   Materials and Methods

   Materials and Methods. The study included 69 patients aged 44–70 years with total CH 5.0–6.5 mmol/l; among them 61 patients had LDL CH 3.4–5.0 mmol/l. “Functional” foods containing sterols or stanols took 36 patients, 25 patients received similar products without sterols or stanols – placebo. A daily dose contained 1.6 g of phytosterols (yogurt Danakor) or 2.0 g phytostanols (spread Benekol). Parameters of gemodynamics, lipids and apolipoproteins and coagulation system were examined in all patients, adverse events were controled.

   Results

   Results. No HDL CH changes were found in any group. In group taking phytosterol-containing product, level of total CH decreased within 3 weeks by 10 %, vs by 4.3 % in placebo. LDL CH decreased by 11.2 % vs 7.1% on placebo; TG levels decreased by 17.5 %, non-HDL CH decreased – 12.5 %. The level of the major LDL apoprotein - apo B declined by 11.84 % and apo B/AI ratio dropped from 0.94 to 0.88. Fibrinogen decreased from 3.8 to 3.1 g/l. After 4 weeks of consumption of spread enriched with phytostanols, total CH decreased by 8.6 %, LDL CH – by 7.6 %, when compared with placebo – by 10.7 % and 10.4 %, respectively; TG decreased by 17.0 %, non-HDL CH – by 11 %. SBP, DBP, heart rate, AST and ALT activities of did not change. Three cases of light gastrointestinal adverse effects were detected.

   Conclusion

   Conclusion. Consumption of «functional» foods enriched with plant sterol and stanol in Russian CHD patients with moderate hypercholesterolemia have lipid lowering effect similar to that found in the international prevention programs. Obviously, foods enriched with phytosterols and phytostanols may be used as non-pharmacological approach for correction of moderate hypercholesterolemia in CHD patients.

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The authors declare that there are no conflicts of interest present.