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

This study has been completed.
Sponsor:
Collaborator:
DEPARTMENT OF INTERNAL MEDICINE. HOSPITAL DE SANT JOAN
Information provided by (Responsible Party):
Danone Research ( Danone Spain )
ClinicalTrials.gov Identifier:
NCT01600820
First received: May 15, 2012
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Danone Research:

Enrollment: 126
Study Start Date: February 2005
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600820

Locations
Spain
Hospital de Sant Joan
Reus, Spain, 43201
Sponsors and Collaborators
Danone Spain
DEPARTMENT OF INTERNAL MEDICINE. HOSPITAL DE SANT JOAN
  More Information

No publications provided

Responsible Party: Danone Research ( Danone Spain )
ClinicalTrials.gov Identifier: NCT01600820     History of Changes
Other Study ID Numbers: NU146
Study First Received: May 15, 2012
Last Updated: May 16, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

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

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

ClinicalTrials.gov processed this record on April 17, 2014