PRO: Dose Response Study of a Fermented Yogurt on the Immune System and Gut Health
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 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.
|
| Experimental: 2 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.
|
| Placebo Comparator: 3 Placebo |
Dietary Supplement: Yogurt Placebo
100g of yogurt placebo containing no probiotics and no green tea extract, once a day for 10 weeks.
|
Outcome Measures
Primary Outcome Measures
- Phagocytosis activity and oxidative metabolism in phagocytes. [6 weeks after vaccination]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 18 to 55 years
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Healthy individuals, non-smokers
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BMI between 18 and 35 kg/m2
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Stable weight (+/- 5kg) for 3 months before randomisation
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Agree to receive a vaccine Pneumovax 23®
Exclusion Criteria:
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Pregnant or lactating woman
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Previous history of cardiovascular disease
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Diabetes
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Kidney or liver disease
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Gastrointestinal disorders or diseases
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Endocrine disorders or diseases
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Allergy
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Subjects taking hypolipidemic drugs, antidepressant, medication for high blood pressure, for inflammation or auto-immune diseases.
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Subject who have receive antipneumococcics vaccine in the year before randomisation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Nutraceuticals and Functional Foods (INAF), Laval University | Quebec | Canada | G1V 0A6 |
Sponsors and Collaborators
- Laval University
- Aliments ULTIMA Foods 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.
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- INAF-119