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Effect of Plant Stanol Esters on Blood Lipids

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00920894
First Posted: June 15, 2009
Last Update Posted: November 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Clinical Life Sciences Ltd.
  Purpose
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

Condition Intervention
Elevated Blood Lipids Dietary Supplement: plant stanol ester

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Plant Stanol Esters on Serum Total and Lipoproteins Lipids, Non-cholesterol Sterols and Apolipoproteins in Subjects With Elevated Blood Lipid Concentration

Further study details as provided by Clinical Life Sciences Ltd.:

Primary Outcome Measures:
  • plasma lipids [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • plasma lipoprotein lipids non-cholesterol sterols [ Time Frame: 10 weeks ]

Estimated Enrollment: 112
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920894


Locations
Finland
Clinical Life Sciences Ltd
Vuokatti, Finland, 88610
Sponsors and Collaborators
Clinical Life Sciences Ltd.
  More Information

Responsible Party: Päivi Cheney, MD, Clinical Life Sciences Ltd
ClinicalTrials.gov Identifier: NCT00920894     History of Changes
Other Study ID Numbers: Kainuu PlantStanol Ester Study
First Submitted: June 12, 2009
First Posted: June 15, 2009
Last Update Posted: November 5, 2009
Last Verified: November 2009