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

NCT01353820 | Completed

• 1 other identifier: NU280
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

Midly hypercholesterolemic subjects; Probiotic; Cholesterol lowering; Dairy

Study Arms (2)

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

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 )

1 = Tested product

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

2- Intervention with control product

2 = Control product

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

AMED s.r.o (Poliklinika Budějovická)

Prague, 104 00, Czechia

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 16, 2011
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

CZ (1)