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

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ClinicalTrials.gov Identifier: NCT01600820
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Danone Research ( Danone Spain )

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 in mildly hypercholesterolemic subjects treated or not by statins.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit Other: 3- Low fat drinkable fermented dairy product without plant sterols(control) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects
Study Start Date : February 2005
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 = Tested product 1 Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit
1 = Intervention 1 (1 test product/day)

Experimental: 2 = tested product 2 Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit
2 = Intervention 2 (1 test product/day)

Placebo Comparator: 3 = Control product Other: 3- Low fat drinkable fermented dairy product without plant sterols(control)
3 = Intervention 3 (1 control product/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
Criteria

Inclusion Criteria:

  • male and female aged 18-75 years;
  • BMI between 19 and 30 kg/m2 ,
  • LDL-cholesterol higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
  • higher than 100 mg/dl in individuals with a 10-year risk > 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
  • with or without statin monotherapy,
  • willing to respect the dietary advising delivered at the screening visit,
  • agreeing to a written informed consent

Exclusion Criteria:

  • subject with plasma triglycerides (TG) levels > 400 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),
  • presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
  • 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 efficacy or safety assessment of the study,
  • pregnant or breast feeding women

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): NCT01600820


Locations
Spain
Hospital de Sant Joan
Reus, Spain, 43201
Sponsors and Collaborators
Danone Spain

Responsible Party: Danone Spain
ClinicalTrials.gov Identifier: NCT01600820     History of Changes
Other Study ID Numbers: NU146
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Keywords provided by Danone Research ( Danone Spain ):
Plant sterol
Hypercholesterolemia
diet
dairy
LDL-C
Mildly hypercholesterolemic subjects

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases