Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols

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 of daily consumption in midly hypercholesterolemic people not treated by statins.

Official Title
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Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
* Dietary Supplement: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male/female subject, aged from 21 to 75 years, BMI between 19 and 30 kg/m2, LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy, stabilized hypercholesterolemia, accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines), used to consume dairy products, effective contraceptive methods used for female subjects, having given written consent to take part in the study Exclusion Criteria: subject with plasma triglycerides (TG) levels ≥ 350 mg/dL, having experienced any cardiovascular event in the last 6 months, taking any hypocholesterolemic treatment, diabetic subject (type I and type II), smoking strictly more than 10 cigarettes / day, heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women), presenting known allergy or hypersensitivity to milk proteins, known soy allergy, refusing to stop the consumption of plant sterols-enriched products (other than the studied product), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, receiving a transplant and under immunosuppressor treatment, currently involved in a clinical trial or in an exclusion period following participation in another clinical trial, in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject, with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product, for female subject: pregnancy, breast feeding or intention to be pregnant during the study or subject likely to change her contraceptive method during the study

Ages Eligible for Study
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Minimum Age: 21 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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 = Tested product<br> | Dietary Supplement: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).<br>* 1 = Intervention 1 (1 test product/day)<br>|
| Sham Comparator: 2 = Control product<br> | Dietary Supplement: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters<br>* 2 = Intervention 2 (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, isoprostanes, Midly hypercholesterolemic subjects