Hypercholesterolemia
Conditions
Keywords
Plant sterol, Hypercholesterolemia, diet, dairy, isoprostanes, Midly hypercholesterolemic subjects
Brief summary
The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in midly hypercholesterolemic people not treated by statins.
Interventions
DIETARY_SUPPLEMENT1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
1 = Intervention 1 (1 test product/day)
2 = Intervention 2 (1 control product/day)
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Countries
United States
Outcome results
None listed