Effect of Phytosterol and Inulin-enriched Soymilk on LDL-cholesterol in Thai subjects
Not Applicable
Completed
- Conditions
- hypercholesterolemiaPhytosterol,Inulin,LDL-c,Lipid profile
- Registration Number
- TCTR20150417001
- Lead Sponsor
- Dairy Plus Company Limited.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the LDL-c levels before and after consumption of the phytosterol and inulin enriched soymilk 8 weeks enzymatic in vitro assay for direct determination using a MODULAR P800 analyzer,the LDL-c levels in the study group and the control group 8 weeks enzymatic in vitro assay for direct determination using a MODULAR P800 analyzer
- Secondary Outcome Measures
Name Time Method total cholesterol, triglyceride and HDL-c levels in the study groups and control groups 8 weeks enzymatic in vitro assay for direct determination using a MODULAR P800 analyzer,adverse event rate in the study group and control group every visit (2 weeks) questionnaire, fasting plasma glucose, liver function test