Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Danone Global Research & Innovation Center
Age
21–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
male/female subject,
aged from 21 to 75 years,
BMI between 19 and 30 kg/m2,
LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy,
stabilized hypercholesterolemia,
accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
used to consume dairy products,
effective contraceptive methods used for female subjects,
having given written consent to take part in the study
You may not be if
subject with plasma triglycerides (TG) levels ≥ 350 mg/dL,
having experienced any cardiovascular event in the last 6 months,
taking any hypocholesterolemic treatment,
diabetic subject (type I and type II),
smoking strictly more than 10 cigarettes / day,
heavy alcohol intake (\> 40 g / day for men ; \> 30 g / day for women),
presenting known allergy or hypersensitivity to milk proteins,
known soy allergy,
refusing to stop the consumption of plant sterols-enriched products (other than the studied product),
receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
receiving a transplant and under immunosuppressor treatment,
currently involved in a clinical trial or in an exclusion period following participation in another clinical trial,
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,
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 or subject likely to change her contraceptive method during the study
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