AtherosclerosisECLIPSENCT03005535
Effects of Corn Oil Plus Vitamin E and B6 on LIpids, PcSk9 and Endothelial Function
A study testing Vitaminized corn oil and Olive oil in people with Atherosclerosis, run by University of Bologna at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Vitaminized corn oil and Olive oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Clinical Trial to Assess the Medium-term Effect of 30 g/Day of a Vitaminised Corn Oil or Olive Oil, on Lipid Parameters, Vascular Risk Markers Blood Pressure and Endothelial Function, in Moderately Hypercholesterolemic Subjects
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
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- Vitaminized corn oil, Olive oil
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitaminized corn oilOther
Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
Olive oilOther
Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Vitaminized corn oil |
| Olive oil | Placebo comparator | Olive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal) Receives: Other: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period
Measured: 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
Measured: 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
Measured: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
Secondary outcomes (3)
Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period
Measured: 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
Measured: 6 months
Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period
Measured: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Borghi, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005535
- Sponsor's protocol ID
- ECLIPSE_2016
- Acronym
- ECLIPSE
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial to Assess the Medium-term Effect of 30 g/Day of a Vitaminised Corn Oil or Olive Oil, on Lipid Parameters, Vascular Risk Markers Blood Pressure and Endothelial Function, in Moderately Hypercholesterolemic Subjects
- ClinicalTrials.gov ID
- NCT03005535
- Acronym / sponsor ID
- ECLIPSE / ECLIPSE_2016
- Conditions
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitaminized corn oil | Active comparator | Other: Vitaminized corn oilVitaminized corn oil (plus B6 and E vitamins), 30 g per day, per 8 weeks, with meals (15 g per meal) |
| Olive oil | Placebo comparator | Other: Olive oilOlive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitaminized corn oilOil consumption at the two main meals, lunch and dinner (15gx2 per day) | Other | Vitaminized corn oil |
| Olive oilOil consumption at the two main meals, lunch and dinner (15gx2 per day) | Other | Olive oil |
Primary outcome
Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period
Time frame: 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
Time frame: 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
Time frame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
3 secondary outcomes
Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period
Time frame: 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
Time frame: 6 months
Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period
Time frame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitaminized corn oil and Olive oil in people with Atherosclerosis, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period (time frame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.