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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:
Collaborator:
AMED s.r.o.
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01353820
First received: May 13, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  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-Blind
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:

Study Start Date: September 2008
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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, with 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01353820

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

No publications provided

ClinicalTrials.gov Identifier: NCT01353820     History of Changes
Other Study ID Numbers: NU280
Study First Received: May 13, 2011
Last Updated: May 13, 2011
Health Authority: Czech Republic: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014