Abstract
BackgroundHypercholesterolemia, 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.MethodsTwo 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.ResultsAt 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 levels 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 % CI]).ConclusionDaily 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.Trial registrationThai Clinical Trial Registry: TCTR20150417001 date: April 17, 2015Electronic supplementary materialThe online version of this article (doi:10.1186/s12944-015-0149-4) contains supplementary material, which is available to authorized users.
Highlights
Hypercholesterolemia, high low-density lipoprotein cholesterol (LDL-c) and non-highdensity lipoprotein cholesterol (HDL-c) levels, is a traditional risk for cardiovascular disease
The strengths of the present study were 1) the subjects included in the study were randomized well as indicated by the comparable baseline characteristics in both groups, 2) the soymilk products were blinded to both subjects and investigators, 3) overall 94.58 % of the data were complete and 4) all subjects enrolled into the study were statin-naïve, so the present study proved the pure effect of phytosterols
Limitations of the present study were 1) all subjects enrolled into the study were statin-naïve, we could not determine additional or synergistic effect of phytosterols on those who had prior statin-use, 2) the aim of the study was to determine the short term effect on lipid profile, so the benefit on cardiovascular outcome was undetermined by the present study and 3) the homogeneity of subjects who were non-DM and metabolically lean limited the application of the study to type 2 diabetes mellitus (T2DM) or metabolic syndrome subjects
Summary
Hypercholesterolemia, high LDL-c and non-HDL-c levels, is a traditional risk for cardiovascular disease. Micelles containing phytosterols are absorbed into the enterocytes through the NiemannPick C1-like 1 (NPC1L1) dependent pathway but phytosterols will efflux back into the intestinal lumen through heterodimeric sterol transporter ABCG5/ ABCG8 [ATP-binding cassette (ABC) transporters G5 and G8] [7]. With this process, the ingestion of 2–2.5 g/ day of phytosterols in the diet can reduce plasma LDL-c levels by 8-15 % in patients with or without a concomitant statin [8, 9]. Phytosterols-enriched soymilk is an alternative method to increase the total phytosterols intake to meet the adequate amount recommended in the guidelines
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