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

Laval University

Status: Completed

Conditions: Immune System

Treatments: Dietary Supplement: Yogurt with 1X10E9 BB-12 and LA-5; Dietary Supplement: Yogurt with 1X10E10 BB-12 and LA-5; Dietary Supplement: Yogurt Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00730626

INAF-119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

L.acidophilus and B.lactis (1x10E9 of each probiotics) with 40 mg of green the extract

Treatment:

Dietary Supplement: Yogurt with 1X10E9 BB-12 and LA-5

2

Experimental group

Description:

L.acidophilus and B.lactis (1x 10E10 of each probiotics) with 40 mg of green tea extract

Treatment:

Dietary Supplement: Yogurt with 1X10E10 BB-12 and LA-5

3

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Yogurt Placebo