Effects of Lactobacillus Delbruckii Lactis DN111244 Ferme... | NCT01353820

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

NCT01353820

Sponsor

Danone Global Research & Innovation Center

Status

Completed

Last Update Posted

Oct 27, 2016Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Hypercholesterolemia

Interventions

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

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Mar 2009Actual

First Submitted Date

May 13, 2011

First Submission Date that Met QC Criteria

May 13, 2011

First Posted Date

May 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 = Tested product	Active Comparator		Dietary Supplement: 1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL
2 = Control product	Sham Comparator		Dietary Supplement: 2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL	Dietary Supplement	1- Intervention with test product ( >10E8 to <5.10E9 cfu/ml of L. delbruckii lactis )

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases