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

Study Overview
=================
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.

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.

Conditions
-----------------
Immune System

Intervention / Treatment
-----------------
* Dietary Supplement: Yogurt with 1X10E9 BB-12 and LA-5
* Dietary Supplement: Yogurt with 1X10E10 BB-12 and LA-5
* Dietary Supplement: Yogurt Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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.<br>|
| Experimental: 2<br>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<br>* 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.<br>|
| Placebo Comparator: 3<br>Placebo | Dietary Supplement: Yogurt Placebo<br>* 100g of yogurt placebo containing no probiotics and no green tea extract, once a day for 10 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Immunity, Immune response, Intestinal microflora, Blood lipids, Phagocytosis activity