Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque

NCT00720720 | Withdrawn DMC

• 1 other identifier: 2006-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque

  8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

plant sterol enriched margarine

Dietary Supplement: plant sterol enriched margarine

2

PLACEBO COMPARATOR

placebo margarine

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

Interventions

plant sterol enriched margarine DIETARY_SUPPLEMENT

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.

1; 2

placebo margarine DIETARY_SUPPLEMENT

2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• French Cardiology Society: lead
• Fondation Coeur et Artères: collaborator

Study Sites (3)

Hôpital cardio-vasculaire et pneumologique Louis Pradel

Bron, 69677, France

Location

Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition

Nantes, 44093, France

Location

Groupe Hospitalier Pitié-Salpêtrière, Endocrinology and Metabolism Department

Paris, 75013, France

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eric BRUCKERT, PU PH

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: December 16, 2009
• Primary Completion: February 24, 2010
• Study Completion: February 24, 2010
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

FR (3)