Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)
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ClinicalTrials.gov Identifier: NCT01574469 |
Recruitment Status :
Completed
First Posted : April 10, 2012
Last Update Posted : December 7, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mildly Hypercholesterolemic Subjects | Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test) Other: 2-Low fat fermented dairy product (control) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 194 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Official Title: | Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | December 2004 |
Actual Study Completion Date : | August 2005 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1 = Tested product |
Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)
1 = Intervention 1 (2 test products / day) |
Placebo Comparator: 2 = Control product |
Other: 2-Low fat fermented dairy product (control)
2 = Intervention 2 (2 control products/day) |

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- male and female aged 18-75 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 statin monotherapy and without any other hypocholesterolemic treatment, accepting to follow the AFSSAPS dietary recommendations for hypercholesterolemic patients, affiliated to a health coverage system, agreeing to a written informed consent
Exclusion Criteria:
- Subject with plasma triglycerides (TG) levels>250 mg/dL, with any cardiovascular event in the last 6 months, taking any hypocholesterolemic treatment) other than statin in monotherapy, Diabetic (type I and type II), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with any acute or chronic disease which could impact on results of the study

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): NCT01574469
France | |
Hôpital Pitié-Salpêtrière | |
Paris, France, 75013 |
Responsible Party: | Danone Research |
ClinicalTrials.gov Identifier: | NCT01574469 |
Other Study ID Numbers: |
NU114 |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | December 7, 2016 |
Last Verified: | December 2016 |
Plant sterol - Cholesterol absorption - diet - dairy - LDL |