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

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00793364
Enrollment
150
Registered
2008-11-19
Start date
2008-11-30
Completion date
2009-04-30
Last updated
2009-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Cholesterol, stanol-ester, mediterranean diet, cardiac risk

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.

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.

Interventions

DIETARY_SUPPLEMENTStanol ester spread

Stanol ester spread 20 g every day

DIETARY_SUPPLEMENTPlacebo spread

Placebo spread 20 g every day

DIETARY_SUPPLEMENTMediterranean Diet

Mediterranean Diet every day

Sponsors

Minerva SA
CollaboratorINDUSTRY
Hellenic Atherosclerosis Society
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines.three months

Secondary

MeasureTime 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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026