Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols

October 26, 2016 updated by: Danone Research

Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in midly hypercholesterolemic people not treated by statins.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

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 States
    • Florida
      • Ocala, Florida, United States
        • Renstar Medical Research

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

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male/female subject,
  • aged from 21 to 75 years,
  • BMI between 19 and 30 kg/m2,
  • LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy,
  • stabilized hypercholesterolemia,
  • accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
  • used to consume dairy products,
  • effective contraceptive methods used for female subjects,
  • having given written consent to take part in the study

Exclusion Criteria:

  • subject with plasma triglycerides (TG) levels ≥ 350 mg/dL,
  • having experienced any cardiovascular event in the last 6 months,
  • taking any hypocholesterolemic treatment,
  • diabetic subject (type I and type II),
  • smoking strictly more than 10 cigarettes / day,
  • heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women),
  • presenting known allergy or hypersensitivity to milk proteins,
  • known soy allergy,
  • refusing to stop the consumption of plant sterols-enriched products (other than the studied product),
  • receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
  • receiving a transplant and under immunosuppressor treatment,
  • currently involved in a clinical trial or in an exclusion period following participation in another clinical trial,
  • in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
  • with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,
  • for female subject: pregnancy, breast feeding or intention to be pregnant during the study or subject likely to change her contraceptive method during the study

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 = Tested product
Dietary supplement: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
1 = Intervention 1 (1 test product/day)
Sham Comparator: 2 = Control product
Dietary supplement: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
2 = Intervention 2 (1 control product/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

July 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU281

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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