Dose Response Study of a Fermented Yogurt on the Immune System and Gut Health (PRO)
|ClinicalTrials.gov Identifier: NCT00730626|
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : June 22, 2009
|Condition or disease||Intervention/treatment||Phase|
|Immune System||Dietary Supplement: Yogurt with 1X10E9 BB-12 and LA-5 Dietary Supplement: Yogurt with 1X10E10 BB-12 and LA-5 Dietary Supplement: Yogurt Placebo||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||August 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||May 2009|
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.
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.
Placebo Comparator: 3
Dietary Supplement: Yogurt Placebo
100g of yogurt placebo containing no probiotics and no green tea extract, once a day for 10 weeks.
- Phagocytosis activity and oxidative metabolism in phagocytes. [ Time Frame: 6 weeks after vaccination ]
- antipneumococcics antibody specific serotype response to S. pneumoniae vaccination. [ Time Frame: 6 weeks after yogurt consumption and vaccination ]
- Intestinal microflora characteristics. [ Time Frame: 4 weeks after yogurt consumption ]
- Influence of blood lipids. [ Time Frame: After 4 weeks and 10 weeks of yogurt consumption ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730626
|Institute of Nutraceuticals and Functional Foods (INAF), Laval University|
|Quebec, Canada, G1V 0A6|
|Principal Investigator:||Benoît Lamarche, PhD||Institute of Nutraceuticals and Functional Foods (INAF), Laval University.|
|Study Director:||Jacques Hébert, MD||Faculty of Medicine, Laval University.|