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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353820
First Posted: May 16, 2011
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Danone Research
  Purpose
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.

Condition Intervention
Hypercholesterolemia 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Proof of Concept -Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults.

Resource links provided by NLM:


Further study details as provided by Danone Research:

Enrollment: 100
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 = Tested product Dietary Supplement: 1- 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 )
Sham Comparator: 2 = Control product Dietary Supplement: 2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus
2- Intervention with control product

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353820


Locations
Czech Republic
AMED s.r.o (Poliklinika Budějovická)
Praha, Czech Republic, 104 00
Sponsors and Collaborators
Danone Research
  More Information

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01353820     History of Changes
Other Study ID Numbers: NU280
First Submitted: May 13, 2011
First Posted: May 16, 2011
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by Danone Research:
Midly hypercholesterolemic subjects
Probiotic
Cholesterol lowering
Dairy

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases