NCT01521156CompletedNot Applicable
Cholesterol Lowering Effects of a Drinkable Low Fat Dairy Product Enriched With Plant Sterols
Danone Global Research & Innovation Center1 site in 1 country128 target enrollmentStarted: July 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 128
- 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 sterols after 3 weeks of daily consumption in midly hypercholesterolemic people.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
1 = Control product
Active Comparator
Intervention: 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). (Other)
2 = Tested product
Experimental
Intervention: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols). (Other)
Investigators
Study Sites (1)
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