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

NCT00793364 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2009-05-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Minerva SA

    collaborator INDUSTRY

  • Hellenic Atherosclerosis Society

    lead OTHER

Principal Investigators

  • Vasilios G Athyros, MD · Hippocration Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00793364 on ClinicalTrials.gov