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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: 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

• Registration Number: NCT01353820
• Lead Sponsor: Danone Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2008-12
• Study Completion: 2009-03
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 = Tested product	1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL	-
2 = Control product	2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus	-

Trial Locations

Locations (1)

AMED s.r.o (Poliklinika Budějovická); 🇨🇿 Praha, Czech Republic