Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque - Full Text View

Sponsors and Collaborators:	French Cardiology Society Fondation Coeur et Artères
Information provided by:	French Cardiology Society
ClinicalTrials.gov Identifier:	NCT00720720

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:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Dietary Supplements Diets

Drug Information available for: beta-Sitosterol Campesterol

U.S. FDA Resources

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 ]

Estimated Enrollment:	70
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator plant sterol enriched margarine	Dietary Supplement: plant sterol enriched margarine Each group will have to consume 20 grams of margarines in one or two catches per day, for 8 weeks.
2: Placebo Comparator placebo margarine	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

Contacts

Contact: Eric BRUCKERT, PU PH	(0)1 42 17 78 68 ext 00 33	eric.bruckert@psl.aphp.fr
Contact: Anissa BOUZAMONDO, MD	(0)1.43.22.13.79 ext 00	anissa.bouzamondo@cardio-sfc.org

Locations

France
Groupe Hospitalier Pitié-Salpêtrière, Endocrinology and Metabolism Department
PARIS, France, 75013
Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition
NANTES, France, 44093
Hôpital cardio-vasculaire et pneumologique Louis Pradel
BRON, France, 69677

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:	French Society of Cardiology ( Anissa Bouzamondo, MD )
Study ID Numbers:	2006-03
Study First Received:	July 21, 2008
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00720720 History of Changes
Health Authority:	France: Institutional Ethical Committee

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Phytosterol
Metabolic Disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Metabolic Diseases
Hyperlipidemias
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 09, 2009