Trials / Completed
CompletedNCT00730626
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Laval University · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2008-12-01
- Completion
- 2009-05-01
- First posted
- 2008-08-08
- Last updated
- 2009-06-22
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00730626. Inclusion in this directory is not an endorsement.