Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols

December 6, 2016 updated by: Danone Research

Influence of a Meal on the Efficacy of Plant Sterol Given at Different Times of the Day in Management of Hypercholesterolemia

The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

  • Canada
    • Quebec
      • Ste-anne-de-bellevue, Quebec, Canada, H9X 3V9
        • McGill University

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

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male and post-menopausal female aged 40-80 years;
  • BMI between 22 and 32 kg/m2,
  • Non-smoker, Stabilized LDL-c over 3.0 mmol/L,
  • Not taking any medication known to affect lipid metabolism for at least the previous 3 month period,
  • Agree to follow the dietary recommendations in the context of their hypercholesterolemia,
  • Have to give written consent to take part in the study

Exclusion Criteria:

  • Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95<SBP>140 mmHg and/or 45<DBP>90 mmHg),
  • Previous history of symptomatic vascular disease, TG level > 2,8 g/l,
  • History of metabolic or gastrointestinal disease with the exception of appendicectomy,
  • Consumption of large amounts of alcohol,
  • Having undergone general anesthesia in the month prior to pre-selection,
  • Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
  • Having serious or acute disease likely to influence study results or involved in life time,
  • Presenting allergy or hypersensitivity to milk proteins, or refusing to consume them,
  • Refusing to stop his/her consumption of enriched plant sterol trade products during the study,
  • 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,
  • For female subjects: likely to change her hormonal substitutive treatment,
  • Currently in an exclusion period following participation in another clinical trial.

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: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1 = Tested product
Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit
1-Intervention with test product (morning, evening or snack)
PLACEBO_COMPARATOR: 2 = Control product
Other: 2- Low fat drinkable fermented dairy product without plant sterols (control)
2 - Intervention with control product (morning and/or evening)

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

April 1, 2005

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

April 1, 2006

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)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU142

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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