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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Not Applicable

Locations

Czech Republic

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional basic science trial for Hypercholesterolemia focused on measuring Midly hypercholesterolemic subjects, Probiotic, Cholesterol lowering, Dairy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

AMED s.r.o (Poliklinika Budějovická)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

1 = Tested product

2 = Control product

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01353820

First Posted

May 13, 2011

Last Updated

October 26, 2016

Sponsor

Danone Research

1. Study Identification

Unique Protocol Identification Number

NCT01353820

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Danone Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

Midly hypercholesterolemic subjects, Probiotic, Cholesterol lowering, Dairy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 = Tested product

Arm Type

Active Comparator

Arm Title

2 = Control product

Arm Type

Sham Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

1- Intervention with test product ( >10E8 to <5.10E9 cfu/ml of L. delbruckii lactis )

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

2- Intervention with control product

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

AMED s.r.o (Poliklinika Budějovická)

City

Praha

ZIP/Postal Code

104 00

Country

Czech Republic

12. IPD Sharing Statement

Learn more about this trial

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

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