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Completed

NCT Number: NCT02779673

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

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.

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Key information

Conditions

LDL-cholesterol Level 130-159mg/dL

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoghurt drink containing plant stanol as esters

Other

Yoghurt drink without plant stanol as esters

Other

Primary outcomes

  1. Change from baseline LDL-cholesterol at 4-week

    Time frame: at baseline and 4-week follow-up

  2. Change from baseline total cholesterol at 4-week

    Time frame: at baseline and 4-week follow-up

  3. Change from baseline non-HDL-cholesterol at 4-week

    Time frame: at baseline and 4-week follow-up

Secondary outcomes

  1. Change from baseline triglyceride at 4-week

    Time frame: at baseline and 4-week follow-up

  2. Change from baseline HDL-cholesterol at 4-week

    Time frame: at baseline and 4-week follow-up

  3. Change from baseline Apolipoprotein A1 at 4-week

    Time frame: at baseline and 4-week follow-up

  4. Change from baseline Apolipoprotein B at 4-week

    Time frame: at baseline and 4-week follow-up

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 20, 2016
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.