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

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 Overview

• Status: Withdrawn
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: plant sterol enriched margarine; Dietary supplement: placebo margarine

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
  • Nantes, France, 44093
    • Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition
  • Paris, France, 75013
    • Groupe Hospitalier Pitié-Salpêtrière, Endocrinology and Metabolism Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque	8 weeks

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Collaborators: Fondation Coeur et Artères
• Investigators: Principal Investigator: Eric BRUCKERT, PU PH, APHP

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2009
• Primary Completion (Actual): February 24, 2010
• Study Completion (Actual): February 24, 2010

Study Registration Dates

• First Submitted: July 21, 2008
• First Submitted That Met QC Criteria: July 22, 2008
• First Posted (Estimated): July 23, 2008

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 2006-03