Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults

Study Overview
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Brief Summary
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The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus control product.

Official Title
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Proof of Concept -Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults.

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: 1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL
* Dietary Supplement: 2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female aged 18-75 years; BMI between 19 and 30 kg/m2, LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy, stabilized hypercholesterolemia (since more than 3 months), accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines), used to consume dairy products, for female: effective contraceptive methods used, agreeing to a written informed consent Exclusion Criteria: plasma triglycerides (TG) levels > 350 mg/dL (4 mmol//L), any cardiovascular event (infarction, angina, surgical or endocoronary intervention, stroke, peripheral arteriosclerosis, etc) in the last 6 months, known allergy or hypersensitivity to milk proteins, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, subject currently involved in a clinical trial or in an exclusion period following participation in another clinical tria, 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, diabetic subjects (type I and type II), 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 become pregnant during the study, for female subject: subject likely to change her contraceptive method during the study, active heavy cigarette smokers (reported more than 20 cigarettes / day), subjects who are actively participating in a weight loss program or have participated in a weight loss program in the three months prior to screening for 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 = Tested product<br> | Dietary Supplement: 1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL<br>* 1- Intervention with test product ( >10E8 to <5.10E9 cfu/ml of L. delbruckii lactis )<br>|
| Sham Comparator: 2 = Control product<br> | Dietary Supplement: 2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus<br>* 2- Intervention with control product<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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Midly hypercholesterolemic subjects, Probiotic, Cholesterol lowering, Dairy