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

Study Overview
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Brief Summary
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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.

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

Official Title
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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.

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Stanol ester spread
* Dietary Supplement: Placebo spread
* Dietary Supplement: Mediterranean Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stanol ester<br>Stanol-ester administration group | Dietary Supplement: Stanol ester spread<br>* Stanol ester spread 20 g every day<br>* Other names: Dietary Supplement;|
| Placebo Comparator: Placebo spread<br>Placebo spread group | Dietary Supplement: Placebo spread<br>* Placebo spread 20 g every day<br>* Other names: Dietary Supplement;|
| Other: Mediterranean diet group<br>Mediterranean diet group | Dietary Supplement: Mediterranean Diet<br>* Mediterranean Diet every day<br>* Other names: Dietary Supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines. |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, stanol-ester, mediterranean diet, cardiac risk