Dose Response Study of a Fermented Yogurt on the Immune System and Gut Health (PRO)

June 19, 2009 updated by: Laval University

Dose Response Study of the Impact of a Yogurt Containing Bifidobacterium Lactis BB-12 and Lactobacillus Acidophilus LA-5 on the Immune System and Gut Health.

The purpose of this study is to determine the dose-response effect of a yogurt containing a combination of bifidobacterium Lactis (BB-12) and Lactobacillus Acidophilus (LA-5) and green tea extract on markers of the immune system and gut health in healthy subjects. We hypothesize that the response of the immune function will be dose-dependent of the probiotics found in the fermented yogurt.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is an increasing list of food containing probiotics on the market. Several studies have emphasized the health benefits of single probiotics, particularly on the immune system. However, it is unclear how a combination of two different probiotics complemented with green tea extract can beneficially modify markers of the immune.

The aim of this study is to determine the dose-response effect of a yogurt containing a combination of bifidobacterium lactis (BB-12) and Lactobacillus Acidophilus LA-5 and green tea extract on immune system in healthy subjects. More specifically, this randomized, parallel placebo controlled study will investigate the impact of increasing doses (109 and 1010) of these probiotics on phagocytosis activity, oxidative metabolism and on the antipneumococcics antibody specific serotype response S. pneumoniae vaccination. Finally, this study will also examine the effect of increasing dose of these probiotics on intestinal microflora and blood lipids.

Study Type

Interventional

Enrollment (Actual)

58

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, Canada, G1V 0A6
        • Institute of Nutraceuticals and Functional Foods (INAF), Laval 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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 to 55 years
  • Healthy individuals, non-smokers
  • BMI between 18 and 35 kg/m2
  • Stable weight (+/- 5kg) for 3 months before randomisation
  • Agree to receive a vaccine Pneumovax 23®

Exclusion Criteria:

  • Pregnant or lactating woman
  • Previous history of cardiovascular disease
  • Diabetes
  • Kidney or liver disease
  • Gastrointestinal disorders or diseases
  • Endocrine disorders or diseases
  • Allergy
  • Subjects taking hypolipidemic drugs, antidepressant, medication for high blood pressure, for inflammation or auto-immune diseases.
  • Subject who have receive antipneumococcics vaccine in the year before randomisation.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
Dietary supplement: Yogurt Placebo
100g of yogurt placebo containing no probiotics and no green tea extract, once a day for 10 weeks.
Experimental: 1
L.acidophilus and B.lactis (1x10E9 of each probiotics) with 40 mg of green the extract
Dietary supplement: Yogurt with 1X10E9 BB-12 and LA-5
100g of yogurt containing the probiotics L.acidophilus and B.lactis (concentrations of 1x10E9 of each probiotics) with 40 mg of green tea extract, once a day for 10 weeks.
Experimental: 2
L.acidophilus and B.lactis (1x 10E10 of each probiotics) with 40 mg of green tea extract
Dietary supplement: Yogurt with 1X10E10 BB-12 and LA-5
100g of yogurt containing the probiotics L.acidophilus and B.lactis (concentrations of 1x10E10 of each probiotics) with 40 mg of green tea extract, once a day for 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phagocytosis activity and oxidative metabolism in phagocytes.
Time Frame: 6 weeks after vaccination
6 weeks after vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
antipneumococcics antibody specific serotype response to S. pneumoniae vaccination.
Time Frame: 6 weeks after yogurt consumption and vaccination
6 weeks after yogurt consumption and vaccination
Intestinal microflora characteristics.
Time Frame: 4 weeks after yogurt consumption
4 weeks after yogurt consumption
Influence of blood lipids.
Time Frame: After 4 weeks and 10 weeks of yogurt consumption
After 4 weeks and 10 weeks of yogurt consumption

Collaborators and Investigators

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

Sponsor

Laval University

Collaborators

McGill University
Aliments ULTIMA Foods Inc.
TransBiothec

Investigators

  • Principal Investigator: Benoît Lamarche, PhD, Institute of Nutraceuticals and Functional Foods (INAF), Laval University.
  • Study Director: Jacques Hébert, MD, Faculty of Medicine, Laval University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

June 22, 2009

Last Update Submitted That Met QC Criteria

June 19, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INAF-119

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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