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
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Danone Research:

Enrollment: 72
Study Start Date: June 2007
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) + 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)

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
  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: NCT01571882

Locations
United Kingdom
Guildford Clinical Pharmacology Unit Ltd. (Gcpl)
Guildford, Surrey, United Kingdom, GU2 7YG
Sponsors and Collaborators
Danone Research
GUILDFORD CLINICAL PHARMACOLOGY UNIT LTD. (GCPL)
  More Information

No publications provided

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01571882     History of Changes
Other Study ID Numbers: NU235
Study First Received: April 3, 2012
Last Updated: April 4, 2012
Health Authority: United Kingdom: Research Ethics Committee

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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on August 27, 2014