Trial | NCT00793364  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    phytosterol ...

  • Study Participants

    150
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.
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.
Study Started
Nov 30
2008
Primary Completion
Mar 31
2009
Study Completion
Apr 30
2009
Last Update
May 28
2009
Estimate

Dietary Supplement Stanol ester spread

Stanol ester spread 20 g every day

  • Other names: Dietary Supplement

Dietary Supplement Placebo spread

Placebo spread 20 g every day

  • Other names: Dietary Supplement

Dietary Supplement Mediterranean Diet

Mediterranean Diet every day

  • Other names: Dietary Supplement

Stanol ester Active Comparator

Stanol-ester administration group

Placebo spread Placebo Comparator

Placebo spread group

Mediterranean diet group Other

Mediterranean diet group

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
No Results Posted