Long-term Effectiveness Study on Cholesterol-reducing Activity

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of consumption of a drinkable low fat fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol (LDL-cholesterol) concentration during 12 weeks of product consumption.

Official Title
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Clinical Study for Evaluating the Plasma Cholesterol-reducing Activity of a Plant Sterol-enriched Yoghurt Drink - Effectiveness and Long-term Safety Study

Conditions
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Normal and Mild Hypercholesterolemic Subjects

Intervention / Treatment
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* Other: 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols).
* Other: 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).
* Other: 3 - low-fat dairy fermented product (drinkable) without plant sterols.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with total cholesterol plasma level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160 mg/dL. Subject aged from 20 to 65 years (bounds included) Subject with BMI between 19 - 30 kg/m² (bounds included) Subject with triglycerides under 400 mg/dL (4.6 mmol/L) Non diabetic subjects (BS≤125 mg/dL) Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg) Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent and subject having signed the written consent to take part in the study Exclusion Criteria: Subject currently involved in a clinical trial. Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates) Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study. For female subject: pregnancy or intention to be pregnant during the study. For female subject: breast feeding. Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products. Subject having lactose intolerance. Subjects having sitosterolemia Diabetic subject (Type I and type II) Subject with heavy alcohol intake (>60g/day) Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters Subject receiving a transplant or under immunosuppressor treatment Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders. Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angina pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months Subject deemed unsuitable by the investigator.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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 dose 1<br> | Other: 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols).<br>* 1 = Intervention with test product 1 (0,8g of plant sterol/day)<br>|
| Active Comparator: 2 = Tested product dose 2<br> | Other: 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).<br>* 2 = Intervention with test product 2 (1,6g of plant sterol/day)<br>|
| Sham Comparator: 3 = Control product<br> | Other: 3 - low-fat dairy fermented product (drinkable) without plant sterols.<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