Effect of the Consumption of a Fermented Dairy Product 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 sterols after 3 weeks of daily consumption in midly hypercholesterolemic people.

Official Title
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Cholesterol Lowering Effects of a Drinkable Low Fat Dairy Product Enriched With Plant Sterols

Conditions
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Mild Hypercholesterolemic Subjects

Intervention / Treatment
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* Other: 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
* Other: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/female subject, aged from 18 to 75,with BMI between 18,5 and 30 kg/m², with LDL-cholesterol blood level between 130 mg/dL to 190 mg/dL without statin therapy. Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subject. Subject used to consume dairy products. For female subjects: effective contraceptive methods used. Subject having given written consent to take part in the study. Exclusion Criteria: Subject with blood triglycerides levels above 350 mg/dL. Subject having experienced any cardiovascular event in the last 6 months. Subject having sitosterolemia. Subject taking any hypocholesterolemic treatment drugs. Intake of blood lipid-regulating supplementation of blood lipid-regulating dietary supplements or functional food during the last 2 weeks before study start. Diabetic subject (type I and type II). Subject smoking strictly more than 10 cigarettes / day. Subject with heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women). Subject presenting known allergy or hypersensitivity to milk proteins.Subject with known soy allergy. Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product). Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters. Subject receiving a transplant and under immunosuppressor treatment. Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial. Subject 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. 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. For female subject: subject likely to change her contraceptive method during the study.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 = Control product<br> | Other: 1- 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>|
| Experimental: 2 = Tested product<br> | Other: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).<br>* 2 = Intervention 2 (1 test 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 sterols - Hypercholesterolemia - Diet - Dairy