Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults

Study Overview
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Brief Summary
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The objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of product consumption versus active control product.

Official Title
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Effects of the Consumption of a no Added Sugar Fermented Milk Product Enriched With Plant Sterols and Policosanols on Hypercholesterolaemia Management in Moderately Hypercholesterolaemic Adults

Conditions
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Mildly Hypercholesterolemic Subjects

Intervention / Treatment
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* Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit
* Other: 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit
* Other: 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female aged 20-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL and 190 mg/dL (bounds included) stabilized for more than 3 months, without statin monotherapy or other hypocholesterolaemic drug treatment, accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines) Exclusion Criteria: serum triglyceride (TG) levels ≥ 4 mmol/L (3.5 g/L), having experienced any cardiovascular event in the last 6 months, receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters

Ages Eligible for Study
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Minimum Age: 20 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) + 10 mg of policosanols per unit<br>* 1- Intervention with test product ( 1.6g of plant sterol + 10 mg of policosanols/ day)<br>|
| Experimental: 2 = tested product 2<br> | Other: 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit<br>* 2- Intervention with test product (1.6g of plant sterol + 20 mg of policosanols/day)<br>|
| Active Comparator: 3 = Active control product<br> | Other: 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)<br>* 3- Intervention with active control product (1,6 g of plant sterol/ 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 - Policosanols - Hypercholesterolemia - Dairy