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

This study has been completed.
Sponsor:
Collaborator:
Minerva SA
Information provided by:
Hellenic Atherosclerosis Society
ClinicalTrials.gov Identifier:
NCT00793364
First received: November 17, 2008
Last updated: May 27, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Dietary Supplement: Stanol ester spread
Dietary Supplement: Placebo spread
Dietary Supplement: Mediterranean Diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hellenic Atherosclerosis Society:

Primary Outcome Measures:
  • Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines. [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: November 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stanol ester
Stanol-ester administration group
Dietary Supplement: Stanol ester spread
Stanol ester spread 20 g every day
Other Name: Dietary Supplement
Placebo Comparator: Placebo spread
Placebo spread group
Dietary Supplement: Placebo spread
Placebo spread 20 g every day
Other Name: Dietary Supplement
Mediterranean diet group
Mediterranean diet group
Dietary Supplement: Mediterranean Diet
Mediterranean Diet every day
Other Name: Dietary Supplement

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.
  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793364

Locations
Greece
Aristotelian University, Hippocration Hospital
Thessaloniki, Greece, 55132
Sponsors and Collaborators
Hellenic Atherosclerosis Society
Minerva SA
Investigators
Principal Investigator: Vasilios G Athyros, MD Hippocration Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vasilios G. Athyros, MD / Professor / Primary investigator, Hippocration Hospital
ClinicalTrials.gov Identifier: NCT00793364     History of Changes
Other Study ID Numbers: MINERVA 01, 171108
Study First Received: November 17, 2008
Last Updated: May 27, 2009
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Atherosclerosis Society:
Cholesterol, stanol-ester, mediterranean diet, cardiac risk

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014