Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols

Study Overview
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Brief Summary
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The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.

Official Title
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Influence of a Meal on the Efficacy of Plant Sterol Given at Different Times of the Day in Management of Hypercholesterolemia

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) per unit
* Other: 2- Low fat drinkable fermented dairy product without plant sterols (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and post-menopausal female aged 40-80 years; BMI between 22 and 32 kg/m2, Non-smoker, Stabilized LDL-c over 3.0 mmol/L, Not taking any medication known to affect lipid metabolism for at least the previous 3 month period, Agree to follow the dietary recommendations in the context of their hypercholesterolemia, Have to give written consent to take part in the study Exclusion Criteria: Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95<SBP>140 mmHg and/or 45<DBP>90 mmHg), Previous history of symptomatic vascular disease, TG level > 2,8 g/l, History of metabolic or gastrointestinal disease with the exception of appendicectomy, Consumption of large amounts of alcohol, Having undergone general anesthesia in the month prior to pre-selection, Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, Having serious or acute disease likely to influence study results or involved in life time, Presenting allergy or hypersensitivity to milk proteins, or refusing to consume them, Refusing to stop his/her consumption of enriched plant sterol trade products during the study, 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, For female subjects: likely to change her hormonal substitutive treatment, Currently in an exclusion period following participation in another clinical trial.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 = Tested product<br> | Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit<br>* 1-Intervention with test product (morning, evening or snack)<br>|
| Placebo Comparator: 2 = Control product<br> | Other: 2- Low fat drinkable fermented dairy product without plant sterols (control)<br>* 2 - Intervention with control product (morning and/or evening)<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 - dairy - meal