Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque

Hypercholesterolemia Clinical Trial

— PHYTOPLAQUES  

Official title:

Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00720720
• Other study ID #: 2006-03
• Status: Withdrawn
• Phase: N/A
• Start date: December 16, 2009
• Est. completion date: February 24, 2010

Study information

• Verified date: September 2023
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 24, 2010
• Est. primary completion date: February 24, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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 margarine

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	Fondation Coeur et Artères

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque		8 weeks