Hypercholesterolemia
Conditions
Keywords
Midly hypercholesterolemic subjects, Probiotic, Cholesterol lowering, Dairy
Brief summary
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.
Interventions
DIETARY_SUPPLEMENT1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL
1- Intervention with test product ( \>10E8 to \<5.10E9 cfu/ml of L. delbruckii lactis )
DIETARY_SUPPLEMENT2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus
2- Intervention with control product
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Countries
Czechia
Outcome results
None listed