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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 3, 2012
Last Updated Date	April 4, 2012
Start Date ^ICMJE	June 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01571882 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
Condition ^ICMJE	Mildly Hypercholesterolemic Subjects
Intervention ^ICMJE	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)
Study Arm (s)	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	72
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 75 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01571882
Other Study ID Numbers ^ICMJE	NU235
Has Data Monitoring Committee	No
Responsible Party	Danone Research
Study Sponsor ^ICMJE	Danone Research
Collaborators ^ICMJE	GUILDFORD CLINICAL PHARMACOLOGY UNIT LTD. (GCPL)
Investigators ^ICMJE	Not Provided
Information Provided By	Danone Research
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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