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

Hellenic Atherosclerosis Society

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Stanol ester spread; Dietary Supplement: Mediterranean Diet; Dietary Supplement: Placebo spread

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00793364

171108

MINERVA 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

Stanol ester

Active Comparator group

Description:

Stanol-ester administration group

Treatment:

Dietary Supplement: Stanol ester spread

Placebo spread

Placebo Comparator group

Description:

Placebo spread group

Treatment:

Dietary Supplement: Placebo spread

Mediterranean diet group

Other group

Description:

Mediterranean diet group

Treatment:

Dietary Supplement: Mediterranean Diet