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| ID | Type | Description | Link |
|---|---|---|---|
| 171108 |
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| Name | Class |
|---|---|
| Minerva SA | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stanol ester | Active Comparator | Stanol-ester administration group |
|
| Placebo spread | Placebo Comparator | Placebo spread group |
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| Mediterranean diet group | Other | Mediterranean diet group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stanol ester spread | Dietary Supplement | Stanol ester spread 20 g every day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines. | three months |
| Measure | Description | Time 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 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with
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| Name | Affiliation | Role |
|---|---|---|
| Vasilios G Athyros, MD | Hippocration Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aristotelian University, Hippocration Hospital | Thessaloniki | 55132 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10593347 | Result | Nguyen TT, Dale LC, von Bergmann K, Croghan IT. Cholesterol-lowering effect of stanol ester in a US population of mildly hypercholesterolemic men and women: a randomized controlled trial. Mayo Clin Proc. 1999 Dec;74(12):1198-206. doi: 10.4065/74.12.1198. | |
| 19939653 | Derived | Athyros VG, Kakafika AI, Papageorgiou AA, Tziomalos K, Peletidou A, Vosikis C, Karagiannis A, Mikhailidis DP. Effect of a plant stanol ester-containing spread, placebo spread, or Mediterranean diet on estimated cardiovascular risk and lipid, inflammatory and haemostatic factors. Nutr Metab Cardiovasc Dis. 2011 Mar;21(3):213-21. doi: 10.1016/j.numecd.2009.08.014. Epub 2009 Nov 25. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo spread | Dietary Supplement | Placebo spread 20 g every day |
|
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| Mediterranean Diet | Dietary Supplement | Mediterranean Diet every day |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D000095500 |
| Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |