Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque (PHYTOPLAQUES)

This study has been terminated.
(Recruitment and organizational difficulties)
Sponsor:
Collaborator:
Fondation Coeur et Artères
Information provided by:
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT00720720
First received: July 21, 2008
Last updated: April 2, 2010
Last verified: July 2008
  Purpose

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.


Condition Intervention
Hypercholesterolemia
Dietary Supplement: plant sterol enriched margarine
Dietary Supplement: placebo margarine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Active Comparator: 1
plant sterol enriched margarine
Dietary Supplement: 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 Comparator: 2
placebo margarine
Dietary Supplement: 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.
Dietary Supplement: placebo margarine

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720720

Locations
France
Hôpital cardio-vasculaire et pneumologique Louis Pradel
Bron, France, 69677
Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition
Nantes, France, 44093
Groupe Hospitalier Pitié-Salpêtrière, Endocrinology and Metabolism Department
Paris, France, 75013
Sponsors and Collaborators
French Cardiology Society
Fondation Coeur et Artères
Investigators
Principal Investigator: Eric BRUCKERT, PU PH APHP
  More Information

No publications provided

Responsible Party: Anissa Bouzamondo, MD, French Society of Cardiology
ClinicalTrials.gov Identifier: NCT00720720     History of Changes
Other Study ID Numbers: 2006-03
Study First Received: July 21, 2008
Last Updated: April 2, 2010
Health Authority: France: Institutional Ethical Committee

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 23, 2014