Effect of Plant Stanol Esters on Blood Lipids

November 4, 2009 updated by: Clinical Life Sciences Ltd.

The Effect of Plant Stanol Esters on Serum Total and Lipoproteins Lipids, Non-cholesterol Sterols and Apolipoproteins in Subjects With Elevated Blood Lipid Concentration

This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.

This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Vuokatti, Finland, 88610
        • Clinical Life Sciences Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elevated blood lipids
  • Body Mass Index < 35 kg/m2
  • Stable body weight

Exclusion Criteria:

  • Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
  • Severe obesity
  • Hyperglycemia
  • Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
  • Hepatic, kidney or thyroid disease or disorder
  • Pregnancy or breast feeding
  • Severe intolerance or allergy to any ingredient of test product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: yoghurt type minidrink containing plant stanol ester
Dietary supplement: plant stanol ester
the effect of plant stanol esters on plasma lipids
Placebo Comparator: yoghurt type minidrink without plant stanol ester
Dietary supplement: plant stanol ester
the effect of plant stanol esters on plasma lipids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma lipids
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
plasma lipoprotein lipids non-cholesterol sterols
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Life Sciences Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 12, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (Estimate)

June 15, 2009

Study Record Updates

Last Update Posted (Estimate)

November 5, 2009

Last Update Submitted That Met QC Criteria

November 4, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • Kainuu PlantStanol Ester Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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