Clinical trial NCT00730626: Dose Response Study of a Fermented Yogurt on the Immune System and Gut Health
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune System
Keywords: Probiotics
Immunity
Immune response
Intestinal microflora
Blood lipids
Phagocytosis activity
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Aliments ULTIMA Foods Inc.
name: McGill University
name: TransBiothec
First posted: 2008-08-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phagocytosis activity and oxidative metabolism in phagocytes.
timeFrame: 6 weeks after vaccination
Secondary outcomes:
measure: antipneumococcics antibody specific serotype response to S. pneumoniae vaccination.
timeFrame: 6 weeks after yogurt consumption and vaccination
measure: Intestinal microflora characteristics.
timeFrame: 4 weeks after yogurt consumption
measure: Influence of blood lipids.
timeFrame: After 4 weeks and 10 weeks of yogurt consumption
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Study officials:
affiliation: Institute of Nutraceuticals and Functional Foods (INAF), Laval University.
name: Benoît Lamarche, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Laval University.
name: Jacques Hébert, MD
role: STUDY_DIRECTOR
References:
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citation: Olivares M, Diaz-Ropero MP, Gomez N, Lara-Villoslada F, Sierra S, Maldonado JA, Martin R, Rodriguez JM, Xaus J. The consumption of two new probiotic strains, Lactobacillus gasseri CECT 5714 and Lactobacillus coryniformis CECT 5711, boosts the immune system of healthy humans. Int Microbiol. 2006 Mar;9(1):47-52.
citation: Savard P, Lamarche B, Paradis ME, Thiboutot H, Laurin E, Roy D. Impact of Bifidobacterium animalis subsp. lactis BB-12 and, Lactobacillus acidophilus LA-5-containing yoghurt, on fecal bacterial counts of healthy adults. Int J Food Microbiol. 2011 Sep 1;149(1):50-7. doi: 10.1016/j.ijfoodmicro.2010.12.026. Epub 2011 Jan 15.