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Effect of Plant Stanol Ester-Containing Spread on Estimated Cardiovascular Risk in Comparison to Mediterranean Diet

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. Identifier: NCT00793364
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : May 28, 2009
Minerva SA
Information provided by:
Hellenic Atherosclerosis Society

Brief Summary:
Since it is very difficult to have the real thing (Mediterranean diet) we need to find an alternative to reduce cardiovascular disease (CVD) risk in subjects with moderate hypercholesterolaemia (a major CVD risk factor) living in western countries. Therefore, this proposed study is designed to assess if giving olive oil supplements, with or without stanol ester, is equivalent to following a Mediterranean diet. Furthermore, the stanol-olive oil combination may prove to be superior to olive oil alone.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Stanol ester spread Dietary Supplement: Placebo spread Dietary Supplement: Mediterranean Diet Phase 4

Detailed Description:

Design: Randomised, double blind, placebo controlled study Number of participants: 150 (3 groups with 50 subjects each). Intervention: One group will be assigned to stanol ester spread (2 g/day) based on olive oil, another on spread with olive oil containing placebo stanol ester (in identical containers with the stanol ester spread). In the third group, a structured effort will be made to improve adherence to Mediterranean diet by at least 2 points in a 10-level scale. Adherence to the Mediterranean diet will be improved by a dietician with detailed explanation of the composition of the diet, preparation of several week specific programs according to dietary preferences of the specific subject. Dietician interviews with a 5 day questionnaire on consumed foods will establish the degree of adherence to Mediterranean diet.

Duration: 16 weeks (4 weeks of lifestyle advice and 12 weeks of treatment).

Prespecified analyses:

  1. Postmenopausal women vs women with child bearing potential.
  2. Older (>65 years of age) vs younger subjects,
  3. Subjects with impaired fasting glucose levels.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Plant Stanol Ester-Containing Spread Based on Extra Virgin Olive Oil on Estimated Cardiovascular Risk, and Lipid-Inflammatory-Haemostatic Factors in Comparison to Mediterranean Diet: A Randomized, Placebo-Controlled Trial.
Study Start Date : November 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Stanol ester
Stanol-ester administration group
Dietary Supplement: Stanol ester spread
Stanol ester spread 20 g every day
Other Name: Dietary Supplement

Placebo Comparator: Placebo spread
Placebo spread group
Dietary Supplement: Placebo spread
Placebo spread 20 g every day
Other Name: Dietary Supplement

Mediterranean diet group
Mediterranean diet group
Dietary Supplement: Mediterranean Diet
Mediterranean Diet every day
Other Name: Dietary Supplement

Primary Outcome Measures :
  1. Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines. [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Change from baseline in major CVD risk factors [TC, LDL-C, HDL-C, TG, apoB], in an inflammatory marker [C-reactive protein], in hemostatic parameters (PAI-I, fibrinogen), liver function tests at the end of the study vs baseline. [ Time Frame: three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects over 45 years of age with mild hypercholesterolaemia (TC levels: 200 mg/dl - 230 mg/dl)

Exclusion Criteria:

Subjects with

  • Established CVD (coronary heart disease, peripheral arterial disease, aortic aneurysm, or symptomatic carotid artery disease) or T2DM
  • Chronic diseases (including liver diseases)
  • Pregnancy
  • Malignancies
  • Unwillingness to participate

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 identifier (NCT number): NCT00793364

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Aristotelian University, Hippocration Hospital
Thessaloniki, Greece, 55132
Sponsors and Collaborators
Hellenic Atherosclerosis Society
Minerva SA
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Principal Investigator: Vasilios G Athyros, MD Hippocration Hospital
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vasilios G. Athyros, MD / Professor / Primary investigator, Hippocration Hospital Identifier: NCT00793364    
Other Study ID Numbers: MINERVA 01
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: May 28, 2009
Last Verified: May 2009
Keywords provided by Hellenic Atherosclerosis Society:
Cholesterol, stanol-ester, mediterranean diet, cardiac risk
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases