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

Investigation of the Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level in Korean Adult

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; 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.	Other: Yoghurt drink containing plant stanol as esters
Placebo Comparator: Placebo group; Subjects randomized to the placebo group consumed yoghurt drink without plant stanol as ester for 1 per day for a period of 4 weeks.	Other: Yoghurt drink without plant stanol as esters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 A1 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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Estimate): May 23, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: LF_cholesterol