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

NCT ID: NCT02779673

Last Updated: 2016-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

LDL-cholesterol Level 130-159mg/dL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Yoghurt drink containing plant stanol as esters

Intervention Type: OTHER

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.

Group Type: PLACEBO_COMPARATOR

Yoghurt drink without plant stanol as esters

Intervention Type: OTHER

Interventions

Yoghurt drink containing plant stanol as esters

Intervention Type: OTHER

Yoghurt drink without plant stanol as esters

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LF_cholesterol

Identifier Type: -

Identifier Source: org_study_id