Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols
Not Applicable
Completed
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT01340287
- Lead Sponsor
- Danone Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Renstar Medical Research🇺🇸Ocala, Florida, United States