Effect of Phytosterol and Inulin-enriched Soymilk on LDL-cholesterol in Thai subjects (EPISLDLT)
Study ID: TCTR20150417001
Current status: Completed
Last Updated: November 21, 2015
Tracking Information
Date of Registration in Primary Registry: April 17, 2015
Date of First Enrollment: May 28, 2013 (Actual)
Target Sample Size: 240
Last Updated Date: November 21, 2015
Primary Outcome(s):
  • Outcome name: the LDL-c levels before and after consumption of the phytosterol and inulin enriched soymilk
       Metric/method of measurement: enzymatic in vitro assay for direct determination using a MODULAR P800 analyzer
       Time point: 8 weeks
       Safety Issue?: No


  • Outcome name: the LDL-c levels in the study group and the control group
       Metric/method of measurement: enzymatic in vitro assay for direct determination using a MODULAR P800 analyzer
       Time point: 8 weeks
       Safety Issue?: No


  • Key Secondary Outcomes:
  • Outcome name: total cholesterol, triglyceride and HDL-c levels in the study groups and control groups
       Metric/method of measurement: enzymatic in vitro assay for direct determination using a MODULAR P800 analyzer
       Time point: 8 weeks
       Safety Issue?: No


  • Outcome name: adverse event rate in the study group and control group
       Metric/method of measurement: questionnaire, fasting plasma glucose, liver function test
       Time point: every visit (2 weeks)
       Safety Issue?: Yes


  • Descriptive Information
    Public Title: Effect of Phytosterol and Inulin-enriched Soymilk on LDL-cholesterol in Thai subjects
    Scientific Title: Effect of phytosterol and inulin-enriched soymilk on LDL-cholesterol in Thai subjects : A Double-blinded Randomized Controlled Trial (EPISLDLT)
    Brief Summary: 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. Phytosterol 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.
    Detailed Description: 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 (study group) 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 phytosterol 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 1) to compare the difference of total cholesterol, triglyceride and HDL-c between the study and control groups and 2) to observe the adverse event rates that occurred in both groups.
    Study Design: Allocation: Randomized controlled trial
    Control: Placebo
    Study Endpoint Classification: Safety/Efficacy Study
    Intervention Model: Parallel
    Number of Arms: 2
    Masking: Double Blind (Masked Roles: Subject, Investigator)
    Primary Purpose: Prevention
    Study Phase: N/A
    Health Condition(s) or Problem(s) Studied: hypercholesterolemia
    Study Arms:
  • Arm: 1
  • Intervention Name: phytosterols and inulin enriched soymilk
    Type: Experimental
    Classification: Dietary Supplement
    Descriptions: subjects had to consume phytosterol and inulin-enriched soymilk contained 1 g of phytosterols and 5 g of inulin twice daily for 8 weeks
  • Arm: 2
  • Intervention Name: standard soymilk
    Type: Placebo Comparator
    Classification: Dietary Supplement
    Descriptions: subjects had to consume standard soymilk twice daily for 8 weeks
    Recruitment Information
    Recruitment Status: Completed
    Estimated Enrollment: 240
    Study Start Date (First enrollment): May 28, 2013
    Primary Completion Date: June 05, 2014
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 18 Years : Maximum 0 N/A (No limit)
    1 subjects who were 18 years old or older
    2 subjects who had never used statin or were taking a stable dose of statin for at least 3 months and whose LDL c levels were 130 mg dl or higher
    Exclusion Criteria
    1 subjects who had established cardiovascular disease
    2 subjects who had any type of diabetes mellitus
    3 subjects who had gastrointestinal dysmotility
    4 subjects who had abnormal gastrointestinal digestion or absorption
    5 subjects who had an allergy to soymilk
    6 subjects who had secondary hyperlipidemia such as hypothyroidism nephrotic syndrome or hepatic disease
    Accept Healthy Volunteers: No
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Noppadol Kietsiriroje
    Degree: MD
    Phone: 6674451463
    Email: knoppado@medicine.psu.ac.th
    Postal Address: 15, Kanjanavanish Rd., Kho Hong, Hat Yai
    State/Province: Songkhla        Postal Code: 90110
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20150417001
    Secondary Identifying Numbers: 56-135-14-1-1
    Source(s) of Monetary or Material Supports: Dairy Plus Company Limited.
    Study Primary Sponsor: Dairy Plus Company Limited.
    Study Secondary Sponsor: 1.) none
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Noppadol Kietsiriroje
    Degree: MD
    Phone: 6674451463
    Email: knoppado@medicine.psu.ac.th
    Postal Address: 15, Kanjanavanish Rd., Kho Hong, Hat Yai
    State/Province: Songkhla        Postal Code: 90110
    Country: Thailand
    Track changes

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