We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01571882
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Danone Research

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.

Condition or disease Intervention/treatment
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 Other: 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit Other: 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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
Study Start Date : June 2007
Primary Completion Date : September 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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) + 10 mg of policosanols per unit
1- Intervention with test product ( 1.6g of plant sterol + 10 mg of policosanols/ day)
Experimental: 2 = tested product 2 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)
Active Comparator: 3 = Active control product 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)




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01571882


Locations
United Kingdom
Guildford Clinical Pharmacology Unit Ltd. (Gcpl)
Guildford, Surrey, United Kingdom, GU2 7YG
Sponsors and Collaborators
Danone Research

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01571882     History of Changes
Other Study ID Numbers: NU235
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Danone Research:
Plant sterol - Policosanols - Hypercholesterolemia - Dairy

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Policosanol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Platelet Aggregation Inhibitors