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Effect of Plant Stanol Esters on Blood Lipids

This study has been completed.
Sponsor:
Information provided by:
Clinical Life Sciences Ltd.
ClinicalTrials.gov Identifier:
NCT00920894
First received: June 12, 2009
Last updated: November 4, 2009
Last verified: November 2009
History of Changes
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma lipoprotein lipids non-cholesterol sterols [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920894

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

No publications provided

Responsible Party: Päivi Cheney, MD, Clinical Life Sciences Ltd
ClinicalTrials.gov Identifier: NCT00920894     History of Changes
Other Study ID Numbers: Kainuu PlantStanol Ester Study
Study First Received: June 12, 2009
Last Updated: November 4, 2009
Health Authority: Finland: Ethics Committee

ClinicalTrials.gov processed this record on May 23, 2013