A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.

Official Title
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A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink

Conditions
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Healthy, Mild Hypercholesterolemia

Intervention / Treatment
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* Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
* Other: 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 subjects, aged 20-65 years old, triglycerides (TG) levels under 400 mg/dL, total cholesterol plasma level under 240 mg/dL (with half the subjects at entry under 200 mg/dL), LDL-cholesterol plasma level under 160 mg/dL (with half the subjects at entry under 120 mg/dL), non diabetic and non hypertensive, accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (Japan Atherosclerosis Society guidelines), effective contraceptive methods used for female subjects, having given written consent to take part in the study Exclusion Criteria: subjects with sitosterolemia, subjects with 200 ml of blood taken within the past month or 400 ml or more within the past 3 months, taking any hypocholesterolemic treatment, presenting known allergy or hypersensitivity to plant sterols, dairy products and lactose, subject with heavy alcohol intake (> 60g/day), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, subjects receiving a transplant or under immunosuppressor treatment, receiving treatment for any serious pathology. for female subject: pregnancy, breast feeding or intention to be pregnant during the study

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 = Tested product<br> | Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).<br>* 1 = Intervention 1 (3 test products/day)<br>|
| Placebo Comparator: 2 = Control product<br> | Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters<br>* 2 = Intervention 2 (3 control products/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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dairy, Plant sterol, Hypercholesterolemia