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

Immune System Clinical Trial

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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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730626
• Other study ID #: INAF-119
• Status: Completed
• Phase: N/A
• First received: August 6, 2008
• Last updated: June 19, 2009
• Start date: August 2008
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Immune System

Intervention

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

Locations

Country	Name	City	State
Canada	Institute of Nutraceuticals and Functional Foods (INAF), Laval University	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Laval University	Aliments ULTIMA Foods Inc., McGill University, TransBiothec

Country where clinical trial is conducted

Canada, 

References & Publications (10)

Arunachalam K, Gill HS, Chandra RK. Enhancement of natural immune function by dietary consumption of Bifidobacterium lactis (HN019). Eur J Clin Nutr. 2000 Mar;54(3):263-7. — View Citation

de Vrese M, Winkler P, Rautenberg P, Harder T, Noah C, Laue C, Ott S, Hampe J, Schreiber S, Heller K, Schrezenmeir J. Probiotic bacteria reduced duration and severity but not the incidence of common cold episodes in a double blind, randomized, controlled trial. Vaccine. 2006 Nov 10;24(44-46):6670-4. Epub 2006 Jun 6. — View Citation

Gill HS, Rutherfurd KJ, Cross ML, Gopal PK. Enhancement of immunity in the elderly by dietary supplementation with the probiotic Bifidobacterium lactis HN019. Am J Clin Nutr. 2001 Dec;74(6):833-9. — View Citation

Kukkonen K, Nieminen T, Poussa T, Savilahti E, Kuitunen M. Effect of probiotics on vaccine antibody responses in infancy--a randomized placebo-controlled double-blind trial. Pediatr Allergy Immunol. 2006 Sep;17(6):416-21. — View Citation

Olivares M, Díaz-Ropero MP, Gómez N, Lara-Villoslada F, Sierra S, Maldonado JA, Martín R, Rodríguez JM, Xaus J. The consumption of two new probiotic strains, Lactobacillus gasseri CECT 5714 and Lactobacillus coryniformis CECT 5711, boosts the immune system of healthy humans. Int Microbiol. 2006 Mar;9(1):47-52. — View Citation

Olivares M, Díaz-Ropero MP, Sierra S, Lara-Villoslada F, Fonollá J, Navas M, Rodríguez JM, Xaus J. Oral intake of Lactobacillus fermentum CECT5716 enhances the effects of influenza vaccination. Nutrition. 2007 Mar;23(3):254-60. — View Citation

Roller M, Clune Y, Collins K, Rechkemmer G, Watzl B. Consumption of prebiotic inulin enriched with oligofructose in combination with the probiotics Lactobacillus rhamnosus and Bifidobacterium lactis has minor effects on selected immune parameters in polypectomised and colon cancer patients. Br J Nutr. 2007 Apr;97(4):676-84. — View Citation

Schiffrin EJ, Brassart D, Servin AL, Rochat F, Donnet-Hughes A. Immune modulation of blood leukocytes in humans by lactic acid bacteria: criteria for strain selection. Am J Clin Nutr. 1997 Aug;66(2):515S-520S. — View Citation

Taylor AL, Hale J, Wiltschut J, Lehmann H, Dunstan JA, Prescott SL. Effects of probiotic supplementation for the first 6 months of life on allergen- and vaccine-specific immune responses. Clin Exp Allergy. 2006 Oct;36(10):1227-35. — View Citation

Winkler P, de Vrese M, Laue Ch, Schrezenmeir J. Effect of a dietary supplement containing probiotic bacteria plus vitamins and minerals on common cold infections and cellular immune parameters. Int J Clin Pharmacol Ther. 2005 Jul;43(7):318-26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phagocytosis activity and oxidative metabolism in phagocytes.		6 weeks after vaccination	No
Secondary	antipneumococcics antibody specific serotype response to S. pneumoniae vaccination.		6 weeks after yogurt consumption and vaccination	No
Secondary	Intestinal microflora characteristics.		4 weeks after yogurt consumption	No
Secondary	Influence of blood lipids.		After 4 weeks and 10 weeks of yogurt consumption	No