RANDOMIZED STUDIES OF "FUNCTIONAL" FOODS ENRICHED WITH PLANT STEROLS AND STANOLS: EFFICIACY IN CORRECTION OF DYSLIPIDEMIA
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. 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. 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. 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.