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

Not Applicable

Completed

• Conditions: Immune System
• Interventions: Dietary Supplement: Yogurt with 1X10E9 BB-12 and LA-5; Dietary Supplement: Yogurt with 1X10E10 BB-12 and LA-5; Dietary Supplement: Yogurt Placebo

• Registration Number: NCT00730626
• Lead Sponsor: Laval University

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-08
• Primary Completion: 2008-12
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-19
• Last Update Posted: 2009-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Yogurt with 1X10E9 BB-12 and LA-5	L.acidophilus and B.lactis (1x10E9 of each probiotics) with 40 mg of green the extract
2	Yogurt with 1X10E10 BB-12 and LA-5	L.acidophilus and B.lactis (1x 10E10 of each probiotics) with 40 mg of green tea extract
3	Yogurt Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Phagocytosis activity and oxidative metabolism in phagocytes.	6 weeks after vaccination

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Nutraceuticals and Functional Foods (INAF), Laval University; 🇨🇦 Quebec, Canada