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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00730626
Acronym
PRO
Enrollment
58
Registered
2008-08-08
Start date
2008-08-31
Completion date
2009-05-31
Last updated
2009-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune System

Keywords

Probiotics, Immunity, Immune response, Intestinal microflora, Blood lipids, Phagocytosis activity

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.

Interventions

DIETARY_SUPPLEMENTYogurt 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_SUPPLEMENTYogurt 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_SUPPLEMENTYogurt Placebo

100g of yogurt placebo containing no probiotics and no green tea extract, once a day for 10 weeks.

Sponsors

Aliments ULTIMA Foods Inc.
CollaboratorINDUSTRY
McGill University
CollaboratorOTHER
TransBiothec
CollaboratorUNKNOWN
Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Phagocytosis activity and oxidative metabolism in phagocytes.6 weeks after vaccination

Secondary

MeasureTime 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026