Atherosclerosis
Conditions
Brief summary
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
Detailed description
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.
Interventions
OTHERVitaminized corn oil
Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
OTHEROlive oil
Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Total cholesterol between 200 and 280 mg/dL and/or LDL cholesterol between 130 and 190 mg/dL * Triglycerides lower than 200 mg/dL * Cardiovascular risk at 10 years lower than 10% * Informed consent
Exclusion criteria
* Secundary prevention for cardiovascular diseases * BMI higher than 30 * Assumption of lipid lowering drug or supplement * Alcohol abuse * Alterations in thyroid, liver or kidney functions, muscle diseases
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | 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 | 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) |
Countries
Italy
Outcome results
None listed