NCT00793364

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Hellenic Atherosclerosis Society · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Stanol ester spread	Stanol ester spread 20 g every day
DIETARY_SUPPLEMENT	Placebo spread	Placebo spread 20 g every day
DIETARY_SUPPLEMENT	Mediterranean Diet	Mediterranean Diet every day

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2008-11-19
• Last updated: 2009-05-28

Locations

1 site across 1 country: Greece