Effect of phytosterols and inulin-enriched soymilk on LDL-cholesterol in Thai subjects: a double-blinded randomized controlled trial
Noppadol Kietsiriroje*, Jirateep Kwankaew, Sunita Kitpakornsanti, ชูเกียรติ วิวัฒน์วงศ์เกษม
Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, 15 Kanjanavanish Rd, Hat Yai, Songkhla 90110, Thailand;E-mail: Knoppado@medicine.psu.ac.th
Background : Hypercholesterolemia, particularly high LDL-c and non-HDL-c levels, is a traditional risk for cardiovascular disease. Ingestion of diets containing phytosterols and inulin can reduce plasma LDL-c and triglyceride levels, respectively. Phytosterols and inulin-enriched soymilk may be an alternative for a supplemental diet to improve both LDL-c and non-HDL-c to reduce the risk of cardiovascular disease.
          Methods : Two hundred and forty subjects who were 18 years old or older and had a baseline LDL-c of 130 mg/dl or higher were enrolled into the double-blinded randomized controlled trial study. Subjects were randomly assigned into the study group that received 2 g/day of phytosterols and 10 g/day of inulin-enriched soymilk or into the control group that received standard soymilk. The lipid profile was measured every 2 weeks for 8 weeks. Primary outcomes were 1) to determine the LDL-c reduction after consumption of phytosterols and inulin-enriched soymilk for 8 weeks and 2) to compare the difference of the LDL-c levels between the study and control groups. The secondary outcomes were to compare the difference of TC, TG and HDL-c between the study and control groups.
          Results : At the end of the study, the median LDL-c levels decreased significantly from 165 (132, 254) mg/dl to 150 (105, 263) mg/dl in the study group (p < 0.001) and from 165 (130, 243) mg/dl to 159 (89, 277) mg/dl in the control group (p = 0.014). The LDL-c reduction was significantly better in the study group (-10.03 %, (-37.07, 36.00) vs -1.31 % (-53.40, 89.73), p < 0.001). TC also reduced significantly by 6.60 % in the study group while it reduced only by 1.76 % in the control group (p < 0.001). There were no statistical differences in TG and HDL-c level between both study groups. The adverse events in the study group and the control groups were not different (RR 1.33 [0.871-2.030, 95 % Cl]).
          Conclusion : Daily consumption of soymilk containing 2 g of phytosterols and 10 g of inulin reduced TC and LDL-c better than standard soymilk. It had no effect on TG and HDL-c levels compared to standard soymilk. Both soymilk products were comparably safe.
Lipid in Health and Disease ปี 2560, November ปีที่: 14 ฉบับที่ 146 หน้า 1-13
lipid profile, Phytosterols, LDL-c, Inulin