Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque
NCT ID: NCT00720720
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2009-12-16
2010-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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1
plant sterol enriched margarine
plant sterol enriched margarine
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.
2
placebo margarine
plant sterol enriched margarine
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 margarine
Interventions
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plant sterol enriched margarine
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 margarine
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
40 Years
75 Years
ALL
No
Sponsors
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Fondation Coeur et Artères
OTHER
French Cardiology Society
OTHER
Responsible Party
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Principal Investigators
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Eric BRUCKERT, PU PH
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
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Hôpital cardio-vasculaire et pneumologique Louis Pradel
Bron, , France
Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition
Nantes, , France
Groupe Hospitalier Pitié-Salpêtrière, Endocrinology and Metabolism Department
Paris, , France
Countries
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Other Identifiers
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2006-03
Identifier Type: -
Identifier Source: org_study_id
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