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Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults

This study has been completed.
Sponsor:
Collaborator:
GUILDFORD CLINICAL PHARMACOLOGY UNIT LTD. (GCPL)
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01571882
First received: April 3, 2012
Last updated: April 4, 2012
Last verified: April 2012

April 3, 2012
April 4, 2012
June 2007
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Complete list of historical versions of study NCT01571882 on ClinicalTrials.gov Archive Site
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Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults
Effects of the Consumption of a no Added Sugar Fermented Milk Product Enriched With Plant Sterols and Policosanols on Hypercholesterolaemia Management in Moderately Hypercholesterolaemic Adults

The objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of product consumption versus active control product.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Mildly Hypercholesterolemic Subjects
  • Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit
    1- Intervention with test product ( 1.6g of plant sterol + 10 mg of policosanols/ day)
  • Other: 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit
    2- Intervention with test product (1.6g of plant sterol + 20 mg of policosanols/day)
  • Other: 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)
    3- Intervention with active control product (1,6 g of plant sterol/ day)
  • Experimental: 1 = Tested product 1
    Intervention: Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit
  • Experimental: 2 = tested product 2
    Intervention: Other: 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit
  • Active Comparator: 3 = Active control product
    Intervention: Other: 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
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Inclusion Criteria:

  • male and female aged 20-75 years;
  • BMI between 19 and 30 kg/m2 ,
  • LDL-cholesterol plasma level between 130 mg/dL and 190 mg/dL (bounds included) stabilized for more than 3 months,
  • without statin monotherapy or other hypocholesterolaemic drug treatment,
  • accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines)

Exclusion Criteria:

  • serum triglyceride (TG) levels ≥ 4 mmol/L (3.5 g/L), having experienced any cardiovascular event in the last 6 months,
  • receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
Both
20 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01571882
NU235
No
Danone Research
Danone Research
GUILDFORD CLINICAL PHARMACOLOGY UNIT LTD. (GCPL)
Not Provided
Danone Research
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP