NCT01574482CompletedNot Applicable
Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults
Danone Global Research & Innovation Center1 site in 1 country116 target enrollmentStarted: January 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 116
- Locations
- 1
Study Overview
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 mildly hypercholesterolemic people treated or not by statins
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •male and female aged 20-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without any statin monotherapy, with stabilized hypercholesterolemia (since more than 3 months), accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines), used to consume dairy products, agreeing to a written informed consent, for female: effective contraceptive methods used
Exclusion Criteria
- •Subject with plasma triglycerides (TG) levels > or = 350 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), smoking strictly more than 20 cigarettes/day, presenting known allergy or hypersensitivity to milk proteins, and soy, 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 the evaluation of efficiency or safety of the product , pregnant and breast feeding women
Arms & Interventions
1 = Tested product
Experimental
Intervention: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). (Other)
2 = Control product
Placebo Comparator
Intervention: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters (Other)
Investigators
Study Sites (1)
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