Clinical trial NCT02779673: The Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level
Official title: Investigation of the Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level in Korean Adult
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LDL-cholesterol Level 130-159mg/dL
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of randomized, double-blind, placebo-controlled study was to determine whether yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.

Detailed description: The objective of clinical trial was to evaluate the effect of yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) on blood cholesterol level. A randomized, double-blinded, placebo-controlled study was conducted on subjects with LDL-cholesterol level 130-159mg/dL. The subjects were randomly assigned to either a group ingesting yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) or a placebo group (yoghurt drink without plant stanols) for 4-week. The investigators assessed blood cholesterol level.

Eligibility criteria: Inclusion Criteria:

• LDL-cholesterol level 130-159mg/dL (not taking cholesterol-lowering medications)

Exclusion Criteria:

* taking any medications (including anti-hypertensive, lipid lowering, anti-platelets, and anti-diabetic drugs)
* history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease
* history or presence of cancer
* history of a psychiatric disorder and/or drug or alcohol abuse or dependency;
* having a known intolerance to gluten or lactose
* having a known allergy to any ingredient in the investigational product
* women who are pregnant or desire to become pregnant during the study period or within 3 months of giving birth or breast feeding or within 3 months of cessation of breast feeding
* having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study

Primary outcomes:
measure: Change from baseline LDL-cholesterol at 4-week
timeFrame: at baseline and 4-week follow-up
measure: Change from baseline total cholesterol at 4-week
timeFrame: at baseline and 4-week follow-up
measure: Change from baseline non-HDL-cholesterol at 4-week
timeFrame: at baseline and 4-week follow-up
Secondary outcomes:
measure: Change from baseline triglyceride at 4-week
timeFrame: at baseline and 4-week follow-up
measure: Change from baseline HDL-cholesterol at 4-week
timeFrame: at baseline and 4-week follow-up
measure: Change from baseline Apolipoprotein A1 at 4-week
timeFrame: at baseline and 4-week follow-up
measure: Change from baseline Apolipoprotein B at 4-week
timeFrame: at baseline and 4-week follow-up
Other outcomes:
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