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

This study has been completed.
Sponsor:
Collaborators:
Ultima Food Inc
McGill University
TransBiothec
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00730626
First received: August 6, 2008
Last updated: June 19, 2009
Last verified: June 2009

August 6, 2008
June 19, 2009
August 2008
December 2008   (final data collection date for primary outcome measure)
Phagocytosis activity and oxidative metabolism in phagocytes. [ Time Frame: 6 weeks after vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00730626 on ClinicalTrials.gov Archive Site
  • antipneumococcics antibody specific serotype response to S. pneumoniae vaccination. [ Time Frame: 6 weeks after yogurt consumption and vaccination ] [ Designated as safety issue: No ]
  • Intestinal microflora characteristics. [ Time Frame: 4 weeks after yogurt consumption ] [ Designated as safety issue: No ]
  • Influence of blood lipids. [ Time Frame: After 4 weeks and 10 weeks of yogurt consumption ] [ Designated as safety issue: No ]
  • Antipneumoccocis antibody specific serotype response to S. pneumoniae vaccination. [ Time Frame: 6 weeks after yogurt consumption and vaccination ] [ Designated as safety issue: No ]
  • Intestinal microflora characteristics. [ Time Frame: 4 weeks after yogurt consumption ] [ Designated as safety issue: No ]
  • Influence of blood lipids. [ Time Frame: After 4 weeks and 10 weeks of yogurt consumption ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Dose Response Study of a Fermented Yogurt on the Immune System and Gut Health
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Immune System
  • 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.
  • 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.
  • 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
    Intervention: Dietary Supplement: Yogurt with 1X10E9 BB-12 and LA-5
  • Experimental: 2
    L.acidophilus and B.lactis (1x 10E10 of each probiotics) with 40 mg of green tea extract
    Intervention: Dietary Supplement: Yogurt with 1X10E10 BB-12 and LA-5
  • Placebo Comparator: 3
    Placebo
    Intervention: Dietary Supplement: Yogurt Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
May 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00730626
INAF-119
No
Benoît Lamarche, Study Principal Investigator, Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Laval University
  • Ultima Food Inc
  • McGill University
  • TransBiothec
Principal Investigator: Benoît Lamarche, PhD Institute of Nutraceuticals and Functional Foods (INAF), Laval University.
Study Director: Jacques Hébert, MD Faculty of Medicine, Laval University.
Laval University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP