Dose Response Study of a Fermented Yogurt on the Immune System and Gut Health - Full Text View

Sponsors and Collaborators:	Laval University Ultima Food Inc McGill University TransBiothec
Information provided by:	Laval University
ClinicalTrials.gov Identifier:	NCT00730626

Purpose

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.

Condition	Intervention
Immune System	Dietary Supplement: Yogurt with 1X10E9 BB-12 and LA-5 Dietary Supplement: Yogurt with 1X10E10 BB-12 and LA-5 Dietary Supplement: Yogurt Placebo

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Lipids Lactobacillus acidophilus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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.

Further study details as provided by Laval University:

Primary Outcome Measures:

Phagocytosis activity and oxidative metabolism in phagocytes. [ Time Frame: 6 weeks after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

antipneumococcics antibody specific serotype response to S. pneumoniae vaccination. [ Time Frame: 6 weeks after yogurt consumption and vaccination ] [ Designated as safety issue: No ]
Intestinal microflora characteristics. [ Time Frame: 4 weeks after yogurt consumption ] [ Designated as safety issue: No ]
Influence of blood lipids. [ Time Frame: After 4 weeks and 10 weeks of yogurt consumption ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental L.acidophilus and B.lactis (1x10E9 of each probiotics) with 40 mg of green the extract	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.
2: Experimental L.acidophilus and B.lactis (1x 10E10 of each probiotics) with 40 mg of green tea extract	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.
3: Placebo Comparator Placebo	Dietary Supplement: Yogurt Placebo 100g of yogurt placebo containing no probiotics and no green tea extract, once a day for 10 weeks.

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730626

Locations

Canada
Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Quebec, Canada, G1V 0A6

Sponsors and Collaborators

Laval University

Ultima Food Inc

McGill University

TransBiothec

Investigators

Principal Investigator:	Benoît Lamarche, PhD	Institute of Nutraceuticals and Functional Foods (INAF), Laval University.
Study Director:	Jacques Hébert, MD	Faculty of Medicine, Laval University.

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Responsible Party:	Institute of Nutraceuticals and Functional Foods (INAF), Laval University ( Benoît Lamarche, Study Principal Investigator )
Study ID Numbers:	INAF-119
Study First Received:	August 6, 2008
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00730626
Health Authority:	Canada: Health Canada

Keywords provided by Laval University:

Probiotics
Immunity
Immune response

Intestinal microflora
Blood lipids
Phagocytosis activity

ClinicalTrials.gov processed this record on February 06, 2009