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

Study Overview
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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.

Official Title
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A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit
* Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit
* Other: 3- Low fat drinkable fermented dairy product without plant sterols(control)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 = Tested product 1<br> | Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit<br>* 1 = Intervention 1 (1 test product/day)<br>|
| Experimental: 2 = tested product 2<br> | Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit<br>* 2 = Intervention 2 (1 test product/day)<br>|
| Placebo Comparator: 3 = Control product<br> | Other: 3- Low fat drinkable fermented dairy product without plant sterols(control)<br>* 3 = Intervention 3 (1 control product/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plant sterol, Hypercholesterolemia, diet, dairy, LDL-C, Mildly hypercholesterolemic subjects