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

Sponsors and Collaborators:	Hellenic Atherosclerosis Society Minerva SA
Information provided by:	Hellenic Atherosclerosis Society
ClinicalTrials.gov Identifier:	NCT00793364

Purpose

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	Intervention	Phase
Hypercholesterolemia	Dietary Supplement: Stanol ester spread Dietary Supplement: Placebo spread Dietary Supplement: Mediterranean Diet	Phase IV

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Dietary Supplements

Drug Information available for: Cholest-5-en-3-ol (3beta)- Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Hellenic Atherosclerosis Society:

Primary Outcome Measures:

Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines. [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	November 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stanol ester: Active Comparator Stanol-ester administration group	Dietary Supplement: Stanol ester spread Stanol ester spread 20 g every day
Placebo spread: Placebo Comparator Placebo spread group	Dietary Supplement: Placebo spread Placebo spread 20 g every day
Mediterranean diet group Mediterranean diet group	Dietary Supplement: Mediterranean Diet Mediterranean Diet every day

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:

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

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793364

Contacts

Contact: Vasilios G Athyros, MD	+30 2310 6972848776 ext -	athyros@med.auth.gr
Contact: Asterios - Karagiannis, MD	+30 2310 6972011271 ext -	astkar@med.auth.gr

Locations

Greece
Aristotelian University, Hippocration Hospital	Recruiting
Thessaloniki, Greece, 55132
Sub-Investigator: Athanasios A Papageorgiou, MD

Sponsors and Collaborators

Hellenic Atherosclerosis Society

Minerva SA

Investigators

Principal Investigator:

Vasilios G Athyros, MD

Hippocration Hospital

More Information

Publications of Results:

Nguyen TT, Dale LC, von Bergmann K, Croghan IT. Cholesterol-lowering effect of stanol ester in a US population of mildly hypercholesterolemic men and women: a randomized controlled trial. Mayo Clin Proc. 1999 Dec;74(12):1198-206.

Responsible Party:	Hippocration Hospital ( Vasilios G. Athyros, MD / Professor / Primary investigator )
Study ID Numbers:	MINERVA 01, 171108
Study First Received:	November 17, 2008
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00793364
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Atherosclerosis Society:

Cholesterol, stanol-ester, mediterranean diet, cardiac risk

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009