Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)
Not Applicable
Completed
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT01600820
- Lead Sponsor
- Danone Spain
- 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 in mildly hypercholesterolemic subjects treated or not by statins.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
Inclusion Criteria
- male and female aged 18-75 years;
- BMI between 19 and 30 kg/m2 ,
- LDL-cholesterol higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
- higher than 100 mg/dl in individuals with a 10-year risk > 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
- with or without statin monotherapy,
- willing to respect the dietary advising delivered at the screening visit,
- agreeing to a written informed consent
Exclusion Criteria
- subject with plasma triglycerides (TG) levels > 400 mg/dL,
- with any cardiovascular event in the last 6 months,
- subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,
- diabetic (type I and type II),
- presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
- receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
- with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,
- pregnant or breast feeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital de Sant Joan
🇪🇸Reus, Spain
Hospital de Sant Joan🇪🇸Reus, Spain