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Completed

NCT Number: NCT01353820

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMED s.r.o (Poliklinika Budějovická)

Prague, 104 00, Czechia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 )

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

Dietary Supplement

2- Intervention with control product

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
May 16, 2011
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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