HypercholesterolemiaPhase 4NCT00793364
Effect of Plant Stanol Ester-Containing Spread on Estimated Cardiovascular Risk in Comparison to Mediterranean Diet
A Phase 4 study testing Stanol ester spread and Mediterranean Diet in people with Hypercholesterolemia, run by Hellenic Atherosclerosis Society at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Stanol ester spread and Mediterranean Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2008to Apr 2009
- Phase
- Phase 4
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects over 45 years of age with mild hypercholesterolaemia (TC levels: 200 mg/dl - 230 mg/dl)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Aristotelian University, Hippocration Hospital
Thessaloniki, 55132
About this study
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.
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.
Read the 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:
- Postmenopausal women vs women with child bearing potential.
- Older (>65 years of age) vs younger subjects,
- Subjects with impaired fasting glucose levels.
- Conditions
- Hypercholesterolemia
- Being tested
- Stanol ester spread, Placebo spread, Mediterranean Diet
- Keywords
- Cholesterol, stanol-ester, mediterranean diet, cardiac risk
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stanol ester spreadDietary supplement
Also called Dietary Supplement
Stanol ester spread 20 g every day
Placebo spreadDietary supplement
Also called Dietary Supplement
Placebo spread 20 g every day
Mediterranean DietDietary supplement
Also called Dietary Supplement
Mediterranean Diet every day
| Study group | Role | What they receive |
|---|---|---|
| Stanol ester | Active comparator | Stanol-ester administration group Receives: Dietary Supplement: Stanol ester spread |
| Placebo spread | Placebo comparator | Placebo spread group Receives: Dietary Supplement: Placebo spread |
| Mediterranean diet group | Other | Mediterranean diet group Receives: Dietary Supplement: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines.
Measured: three months
Secondary outcomes (1)
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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Atherosclerosis Society
- Sponsor type
- University, hospital or other
- Collaborators
- Minerva SA
- Investigators
- Vasilios G Athyros, MD, Principal investigator, Hippocration Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793364
- Sponsor's protocol ID
- MINERVA 01
- Other IDs
- 171108
- Status last verified
- May 2009
- First submitted
- 17 Nov 2008
- Last updated
- 28 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10593347Athyros 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.
PubMed 19939653
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00793364
- Acronym / sponsor ID
- MINERVA 01
- Conditions
- Hypercholesterolemia
- Keywords
- Cholesterol, stanol-ester, mediterranean diet, cardiac risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hellenic Atherosclerosis SocietyUniversity, hospital or other
- Collaborators
- Minerva SA
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Nov 2008 (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.
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.
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:
- Postmenopausal women vs women with child bearing potential.
- Older (>65 years of age) vs younger subjects,
- Subjects with impaired fasting glucose levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stanol ester | Active comparator | Dietary Supplement: Stanol ester spreadStanol-ester administration group |
| Placebo spread | Placebo comparator | Dietary Supplement: Placebo spreadPlacebo spread group |
| Mediterranean diet group | Other | Dietary Supplement: Mediterranean DietMediterranean diet group |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female subjects over 45 years of age with mild hypercholesterolaemia (TC levels: 200 mg/dl - 230 mg/dl)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Stanol ester spreadAlso: Dietary SupplementStanol ester spread 20 g every day | Dietary supplement | Stanol ester |
| Placebo spreadAlso: Dietary SupplementPlacebo spread 20 g every day | Dietary supplement | Placebo spread |
| Mediterranean DietAlso: Dietary SupplementMediterranean Diet every day | Dietary supplement | Mediterranean diet group |
Primary outcome
Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines.
Time frame: three months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2009.
- Results publication: PubMed 10593347Nguyen 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.
- Derived from this study: PubMed 19939653Athyros 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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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.
Vasilios G Athyros, MD principal investigator
Hippocration Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stanol ester spread and Mediterranean Diet in people with Hypercholesterolemia, run by Hellenic Atherosclerosis Society at 1 site in Greece.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 28 May 2009. 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 Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines. (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00793364, which also lists 2 linked publications.
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 28 May 2009; AzTrials last refreshed its copy on 6 Nov 2026.