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

French Cardiology Society

Status: Withdrawn

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: placebo margarine; Dietary Supplement: plant sterol enriched margarine

Study type: Interventional

Funder types: Other

Identifiers

NCT00720720

2006-03

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

plant sterol enriched margarine

Treatment:

Dietary Supplement: plant sterol enriched margarine

2

Placebo Comparator group

Description:

placebo margarine

Treatment:

Dietary Supplement: placebo margarine

Dietary Supplement: plant sterol enriched margarine