Mild Hypercholesterolemic Subjects
Conditions
Keywords
Plant sterols - Hypercholesterolemia - Diet - Dairy
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.
Interventions
OTHER1- 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)
OTHER2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).
2 = Intervention 2 (1 test product/day)
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Countries
Germany
Outcome results
None listed