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Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Italy)

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ClinicalTrials.gov Identifier: NCT01574482
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Danone Research

Study Description
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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

Condition or disease Intervention/treatment Phase
Mildly Hypercholesterolemic Subjects Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults
Study Start Date : January 2007
Actual Primary Completion Date : April 2007
Actual Study Completion Date : June 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 = Tested product Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
1 = Intervention 1 (1 test product/day)
Placebo Comparator: 2 = Control product Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
2 = Intervention 2 (1 control product/day)


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574482


Locations
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Italy
Ospedale Silvestrini
Perugia, Italy, 06129
Sponsors and Collaborators
Danone Research
More Information
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Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01574482    
Other Study ID Numbers: NU216
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Keywords provided by Danone Research:
Plant sterol - Hypercholesterolemia - diet - dairy
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases