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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014