The Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level

Not Applicable

Completed

• Conditions: LDL-cholesterol Level 130-159mg/dL
• Interventions: Other: Yoghurt drink without plant stanol as esters; Other: Yoghurt drink containing plant stanol as esters

• Registration Number: NCT02779673
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-05
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-18
• Last Update Submitted: 2016-05-19
• Study First Posted: 2016-05-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Yoghurt drink without plant stanol as esters	Subjects randomized to the placebo group consumed yoghurt drink without plant stanol as ester for 1 per day for a period of 4 weeks.
Test group	Yoghurt drink containing plant stanol as esters	Subjects randomized to the test group consumed yoghurt drink containing 3.4g plant stanol as ester for 1 per day for a period of 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline LDL-cholesterol at 4-week	at baseline and 4-week follow-up
Change from baseline total cholesterol at 4-week	at baseline and 4-week follow-up
Change from baseline non-HDL-cholesterol at 4-week	at baseline and 4-week follow-up

Secondary Outcome Measures

Name	Time	Method
Change from baseline Apolipoprotein A1 at 4-week	at baseline and 4-week follow-up
Change from baseline triglyceride at 4-week	at baseline and 4-week follow-up
Change from baseline HDL-cholesterol at 4-week	at baseline and 4-week follow-up
Change from baseline Apolipoprotein B at 4-week	at baseline and 4-week follow-up