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

NCT ID: NCT01600820

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

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-07-31

Brief Summary

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The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.

Detailed Description

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Conditions

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Hypercholesterolemia

Keywords

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Plant sterol Hypercholesterolemia diet dairy LDL-C Mildly hypercholesterolemic subjects

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 1

Group Type EXPERIMENTAL

1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit

Intervention Type OTHER

1 = Intervention 1 (1 test product/day)

2 = tested product 2

Group Type EXPERIMENTAL

2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit

Intervention Type OTHER

2 = Intervention 2 (1 test product/day)

3 = Control product

Group Type PLACEBO_COMPARATOR

3- Low fat drinkable fermented dairy product without plant sterols(control)

Intervention Type OTHER

3 = Intervention 3 (1 control product/day)

Interventions

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1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit

1 = Intervention 1 (1 test product/day)

Intervention Type OTHER

2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit

2 = Intervention 2 (1 test product/day)

Intervention Type OTHER

3- Low fat drinkable fermented dairy product without plant sterols(control)

3 = Intervention 3 (1 control product/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 higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
* higher than 100 mg/dl in individuals with a 10-year risk \> 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
* with or without statin monotherapy,
* willing to respect the dietary advising delivered at the screening visit,
* agreeing to a written informed consent

Exclusion Criteria

* subject with plasma triglycerides (TG) levels \> 400 mg/dL,
* with any cardiovascular event in the last 6 months,
* subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,
* diabetic (type I and type II),
* presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,
* pregnant or breast feeding women
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Spain

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de Sant Joan

Reus, , Spain

Site Status

Countries

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Spain

Other Identifiers

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NU146

Identifier Type: -

Identifier Source: org_study_id