Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults
Not Applicable
Completed
- Conditions
- Mildly Hypercholesterolemic Subjects
- Registration Number
- NCT01571882
- Lead Sponsor
- Danone Research
- Brief Summary
The objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of product consumption versus active control product.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- male and female aged 20-75 years;
- BMI between 19 and 30 kg/m2 ,
- LDL-cholesterol plasma level between 130 mg/dL and 190 mg/dL (bounds included) stabilized for more than 3 months,
- without statin monotherapy or other hypocholesterolaemic drug treatment,
- accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines)
Exclusion Criteria
- serum triglyceride (TG) levels ≥ 4 mmol/L (3.5 g/L), having experienced any cardiovascular event in the last 6 months,
- receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Guildford Clinical Pharmacology Unit Ltd. (Gcpl)
🇬🇧Guildford, Surrey, United Kingdom
Guildford Clinical Pharmacology Unit Ltd. (Gcpl)🇬🇧Guildford, Surrey, United Kingdom