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This will be a randomized clinical trial carried out on subjects with suboptimal control of cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus B6 and E vitamins), in order to evaluate the effects on lipid profile, endothelial function and PCSK9
In order to assess the mid term effects of vitaminized corn oil on endothelial function and on early markers of functional damage of the arterial wall, moderately hypercholesterolemic subjects will be supplemented for 8 weeks with 30 g/day of both a vitaminized corn oil (plus B6 and E vitamins) or olive oil. The two intervention periods will be spaced by a 4 week washout period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitaminized corn oil | Active Comparator | Vitaminized corn oil (plus B6 and E vitamins), 30 g per day, per 8 weeks, with meals (15 g per meal) |
|
| Olive oil | Placebo Comparator | Olive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitaminized corn oil | Other | Oil consumption at the two main meals, lunch and dinner (15gx2 per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period | At the beginning and after 8 weeks of both intervention periods (up to 24 weeks) | |
| 12 hour fasting lipid profile change from the baseline to the end of the intervention period | At the first visit (run-in) at the beginning, after 4 and 8 weeks of both intervention periods (up to 24 weeks) | |
| PCSK9 levels change from the baseline to the end of the intervention period | At the beginning and after 8 weeks of both intervention periods (up to 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period | At the beginning and after 8 weeks of both intervention periods (up to 24 weeks) | |
| Blood pressure change from the baseline to the end of the intervention period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. Orsola-Malpighi University Hospital | Bologna | BO | 40138 | Italy |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Olive oil | Other | Oil consumption at the two main meals, lunch and dinner (15gx2 per day) |
|
| 6 months |
| Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period | At the beginning and after 8 weeks of both intervention periods (up to 24 weeks) |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |