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Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)

NCT ID: NCT01574469

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-08-31

Brief Summary

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The purpose of this study is to investigate the effect on cholesterolemia profile of a low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins.

Detailed Description

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Conditions

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Mildly Hypercholesterolemic Subjects

Keywords

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Plant sterol - Cholesterol absorption - diet - dairy - LDL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 = Tested product

Group Type ACTIVE_COMPARATOR

1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)

Intervention Type OTHER

1 = Intervention 1 (2 test products / day)

2 = Control product

Group Type PLACEBO_COMPARATOR

2-Low fat fermented dairy product (control)

Intervention Type OTHER

2 = Intervention 2 (2 control products/day)

Interventions

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1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)

1 = Intervention 1 (2 test products / day)

Intervention Type OTHER

2-Low fat fermented dairy product (control)

2 = Intervention 2 (2 control products/day)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* male and female aged 18-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy and without any other hypocholesterolemic treatment, accepting to follow the AFSSAPS dietary recommendations for hypercholesterolemic patients, affiliated to a health coverage system, agreeing to a written informed consent

Exclusion Criteria

* Subject with plasma triglycerides (TG) levels\>250 mg/dL, with any cardiovascular event in the last 6 months, taking any hypocholesterolemic treatment) other than statin in monotherapy, Diabetic (type I and type II), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with any acute or chronic disease which could impact on results of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

Countries

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France

Other Identifiers

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NU114

Identifier Type: -

Identifier Source: org_study_id