Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)
This study has been completed.
Sponsor:
Danone Research
ClinicalTrials.gov Identifier:
NCT01574469
First Posted: April 10, 2012
Last Update Posted: December 7, 2016
Information provided by (Responsible Party):
Danone Research
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Purpose
The purpose of this study is to investigate the effect on cholesterolemia profile of a 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 | Intervention |
|---|---|
| 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) |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Danone Research:
| Enrollment: | 194 |
| Study Start Date: | September 2004 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Information from the National Library of Medicine
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
Locations
| France | |
| Hôpital Pitié-Salpêtrière | |
| Paris, France, 75013 | |
Sponsors and Collaborators
Danone Research
More Information
| Responsible Party: | Danone Research |
| ClinicalTrials.gov Identifier: | NCT01574469 History of Changes |
| Other Study ID Numbers: |
NU114 |
| First Submitted: | April 7, 2012 |
| First Posted: | April 10, 2012 |
| Last Update Posted: | December 7, 2016 |
| Last Verified: | December 2016 |
Keywords provided by Danone Research:
|
Plant sterol - Cholesterol absorption - diet - dairy - LDL |