Clinical trial NCT01521156: Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols
Official title: Cholesterol Lowering Effects of a Drinkable Low Fat Dairy Product Enriched With Plant Sterols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Hypercholesterolemic Subjects
Keywords: Plant sterols - Hypercholesterolemia - Diet - Dairy
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterols after 3 weeks of daily consumption in midly hypercholesterolemic people.


Eligibility criteria: Inclusion Criteria:

* Male/female subject, aged from 18 to 75,with BMI between 18,5 and 30 kg/m², with LDL-cholesterol blood level between 130 mg/dL to 190 mg/dL without statin therapy.
* Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subject.
* Subject used to consume dairy products.
* For female subjects: effective contraceptive methods used.
* Subject having given written consent to take part in the study.

Exclusion Criteria:

* Subject with blood triglycerides levels above 350 mg/dL.
* Subject having experienced any cardiovascular event in the last 6 months.
* Subject having sitosterolemia.
* Subject taking any hypocholesterolemic treatment drugs.
* Intake of blood lipid-regulating supplementation of blood lipid-regulating dietary supplements or functional food during the last 2 weeks before study start.
* Diabetic subject (type I and type II).
* Subject smoking strictly more than 10 cigarettes / day.
* Subject with heavy alcohol intake (\> 40 g / day for men ; \> 30 g / day for women).
* Subject presenting known allergy or hypersensitivity to milk proteins.Subject with known soy allergy.
* Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product).
* Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
* Subject receiving a transplant and under immunosuppressor treatment.
* Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.
* 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.
* Subject with 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 be pregnant during the study.
* For female subject: subject likely to change her contraceptive method during the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Harrison Clinical Research Clinical Unit
Study officials:
References: