Status:
COMPLETED
Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols
Lead Sponsor:
Danone Global Research & Innovation Center
Conditions:
Mild Hypercholesterolemic Subjects
Eligibility:
All Genders
18-75 years
Phase:
NA
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 hypercholester...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01521156
Start Date
July 1 2009
End Date
February 1 2010
Last Update
October 27 2016
Active Locations (1)
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1
Harrison Clinical Research Clinical Unit
Munich, Germany, 80636