title: Effect of phytosterols and inulin-enriched soymilk on LDL-cholesterol in Thai subjects: a double-blinded randomized controlled trial.
abstract: 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 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]).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Thai Clinical Trial Registry: TCTR20150417001 date: April 17, 2015.
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, 15 Kanjanavanish Rd, Hat Yai, Songkhla, 90110, Thailand. Knoppado@medicine.psu.ac.th.
authors.forename: Noppadol
authors.initials: N
authors.lastname: Kietsiriroje
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, 15 Kanjanavanish Rd, Hat Yai, Songkhla, 90110, Thailand. jirateep023@yahoo.com.|Internal Medicine Clinic, Samitivej Srinakarin Hospital, Bangkok, 10250, Thailand. jirateep023@yahoo.com.
authors.forename: Jirateep
authors.initials: J
authors.lastname: Kwankaew
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, 15 Kanjanavanish Rd, Hat Yai, Songkhla, 90110, Thailand. ta_med24@hotmail.com.|Division of Internal Medicine, Trang Hospital, Trang, 92000, Thailand. ta_med24@hotmail.com.
authors.forename: Sunita
authors.initials: S
authors.lastname: Kitpakornsanti
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, 15 Kanjanavanish Rd, Hat Yai, Songkhla, 90110, Thailand. Lrattana@medicine.psu.ac.th.
authors.forename: Rattana
authors.initials: R
authors.lastname: Leelawattana
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D008078:Cholesterol, LDL / Q000097:blood*; D004311:Double-Blind Method; D005260:Female; D005527:Food, Fortified; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy*; D007444:Inulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010840:Phytosterols / Q000008:administration & dosage*; D045730:Soy Foods; D013785:Thailand; D055815:Young Adult
chemical_list: D008078:Cholesterol, LDL; D010840:Phytosterols; D007444:Inulin