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Effect of Phytosterol and Inulin-enriched Soymilk on LDL-cholesterol in Thai subjects

Effect of phytosterol and inulin-enriched soymilk on LDL-cholesterol in Thai subjects : A Double-blinded Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20150417001
Enrollment
Unknown
Registered
2015-04-17
Start date
2013-05-28
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypercholesterolemia Phytosterol&#44

Interventions

phytosterols and inulin enriched soymilk,standard soymilk
subjects had to consume phytosterol and inulin&#45
enriched soymilk contained 1 g of phytosterols and 5 g of inulin twice daily for 8 weeks,subjects had to consume standard soymilk twice daily for 8 weeks
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement

Sponsors

Dairy Plus Company Limited.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactNoppadol Kietsiriroje

faculty of medicine, Prince of Songkla University

knoppado@medicine.psu.ac.th6674451463

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026