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

Danone

Status

Completed

Conditions

Hypercholesterolemia

Treatments

Dietary Supplement: 2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus

Dietary Supplement: 1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01353820

NU280

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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