HypercholesterolemiaPHYTOPLAQUESNCT00720720
Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque
A study testing plant sterol enriched margarine in people with Hypercholesterolemia, run by French Cardiology Society at 3 sites in France.
Trial summary
The objective of this exploratory study is to analyse in humans any qualitative changes of carotid artery atherosclerotic plaque under the influence of plant sterols consumption. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- plant sterol enriched margarine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Dec 2009to 24 Feb 2010
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, men and women, aged between 40 to 75 ans (limits included) willing to participate to the study and have signed informed consent for its participation in the study
- Displaying a non serious chirurgical indication of clinical asymptomatic carotid stenosis defined by:
- atherosclerotic stenosis of 60 to 75% on one on the two carotid junction (external carotid excluded) according to criteria from NASCET
- without constituted or transitory recent cerebral vascular accident. The discovery of an ischaemic after-effect on a systematic scanner is not a criterion of exclusion
- Subject with normal body weight or in over weight (Body Mass Index ranged between 19 and 30 kg/m2, [limits included])
- Subject willing to follow dietary recommendations advised during hypercholesterolemia (according to AFSSAPS' recommendations)
- Subject with social insurance or equivalent.
Who cannot join
- Subject who, according to AFSSAPS' recommendations, should received a hypocholesterolemic therapy before the end of the study.
- Subject with a history of diabetes
- Subject with cardiac disease such as unstable angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft surgery, or moderate or severe congestive heart failure within the last 6 months.
- Subject with plasma triglyceride levels higher than 2,5 g/l [limit included],
- Subject taking any drugs known to affect the evaluation of studied parameters
- Subject with severe or acute disease that could affect the results of the study or subject safety
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- Subject with regular consumption of phytosterol enriched foods products during the study.
- Subject with any other medical condition or laboratory abnormality prior to recruitment that in the opinion of the principal investigator could affect subject safety or render unlikely trial to be conducted to the end.
- For women: pregnancy or breast feeding or subject likely to be pregnant during the study.
- For women: subject likely to modify their hormonal therapy during the study
- Subject in exclusion period after its participation in an other clinical trial
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital cardio-vasculaire et pneumologique Louis Pradel
Bron, 69677
Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition
Nantes, 44093
Groupe Hospitalier Pitié-Salpêtrière, Endocrinology and Metabolism Department
Paris, 75013
About this study
The objective of this exploratory study is to analyse in humans any qualitative changes of carotid artery atherosclerotic plaque under the influence of plant sterols consumption.
- Conditions
- Hypercholesterolemia
- Being tested
- plant sterol enriched margarine, placebo margarine
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant sterol enriched margarineDietary supplement
Each group will have to consume 20 grams of margarines (either placebo or enriched in plant sterols) in one or two catches per day, for 8 weeks.
placebo margarineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | plant sterol enriched margarine Receives: Dietary Supplement: plant sterol enriched margarine |
| 2 | Placebo comparator | placebo margarine Receives: Dietary Supplement: plant sterol enriched margarine; Dietary Supplement: placebo margarine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study start16 Dec 2009
- Primary completion24 Feb 2010
- Study completion24 Feb 2010
Why it stopped: Recruitment and organizational difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Coeur et Artères
- Responsible party
- Sponsor
- Investigators
- Eric BRUCKERT, PU PH, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720720
- Sponsor's protocol ID
- 2006-03
- Acronym
- PHYTOPLAQUES
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2008
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque
- ClinicalTrials.gov ID
- NCT00720720
- Acronym / sponsor ID
- PHYTOPLAQUES / 2006-03
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment and organizational difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Fondation Coeur et Artères
- Study start
- 16 Dec 2009 (actual)
- Primary completion
- 24 Feb 2010 (actual)
- Study completion
- 24 Feb 2010 (actual)
- First posted
- 23 Jul 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.
The objective of this exploratory study is to analyse in humans any qualitative changes of carotid artery atherosclerotic plaque under the influence of plant sterols consumption.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: plant sterol enriched margarineplant sterol enriched margarine |
| 2 | Placebo comparator | Dietary Supplement: plant sterol enriched margarine, Dietary Supplement: placebo margarineplacebo margarine |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient, men and women, aged between 40 to 75 ans (limits included) willing to participate to the study and have signed informed consent for its participation in the study
- Displaying a non serious chirurgical indication of clinical asymptomatic carotid stenosis defined by:
- Subject with normal body weight or in over weight (Body Mass Index ranged between 19 and 30 kg/m2, [limits included])
- Subject willing to follow dietary recommendations advised during hypercholesterolemia (according to AFSSAPS' recommendations)
- Subject with social insurance or equivalent.
Key exclusion criteria (11 listed)
- Subject who, according to AFSSAPS' recommendations, should received a hypocholesterolemic therapy before the end of the study.
- Subject with a history of diabetes
- Subject with cardiac disease such as unstable angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft surgery, or moderate or severe congestive heart failure within the last 6 months.
- Subject with plasma triglyceride levels higher than 2,5 g/l [limit included],
- Subject taking any drugs known to affect the evaluation of studied parameters
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 |
|---|---|---|
| plant sterol enriched margarineEach group will have to consume 20 grams of margarines (either placebo or enriched in plant sterols) in one or two catches per day, for 8 weeks. | Dietary supplement | 1, 2 |
| placebo margarine | Dietary supplement | 2 |
Primary outcome
Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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.
Eric BRUCKERT, PU PH principal investigator
APHP
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plant sterol enriched margarine in people with Hypercholesterolemia, run by French Cardiology Society at 3 sites in France.
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 7 inclusion and 11 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: withdrawn, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque (time frame: 8 weeks). 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 13 Sep 2023.