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

November 23, 2016 updated by: Danone Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7YG
        • Guildford Clinical Pharmacology Unit Ltd. (Gcpl)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Estimate)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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