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

NCT00730626 | Completed

• 1 other identifier: INAF-119
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune System

Keywords

Probiotics; Immunity; Immune response; Intestinal microflora; Blood lipids; Phagocytosis activity

Outcome Measures

Primary Outcomes (1)

• Phagocytosis activity and oxidative metabolism in phagocytes.

  6 weeks after vaccination

Secondary Outcomes (3)

• 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

Study Arms (3)

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

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

3

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Yogurt Placebo

Interventions

Yogurt with 1X10E9 BB-12 and LA-5 DIETARY_SUPPLEMENT

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.

1

Yogurt with 1X10E10 BB-12 and LA-5 DIETARY_SUPPLEMENT

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.

2

Yogurt Placebo DIETARY_SUPPLEMENT

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

3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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®

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• Aliments ULTIMA Foods Inc.: collaborator
• McGill University: collaborator
• TransBiothec: collaborator

Study Sites (1)

Institute of Nutraceuticals and Functional Foods (INAF), Laval University

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (11)

• 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. doi: 10.5414/cpp43318.

  PMID: 16035374 BACKGROUND

• 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. doi: 10.1016/j.vaccine.2006.05.048. Epub 2006 Jun 6.

  PMID: 16844267 BACKGROUND

• 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. doi: 10.1111/j.1399-3038.2006.00420.x.

  PMID: 16925686 BACKGROUND

• 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. doi: 10.1111/j.1365-2222.2006.02553.x.

  PMID: 17014429 BACKGROUND

• Olivares M, Diaz-Ropero MP, Sierra S, Lara-Villoslada F, Fonolla J, Navas M, Rodriguez JM, Xaus J. Oral intake of Lactobacillus fermentum CECT5716 enhances the effects of influenza vaccination. Nutrition. 2007 Mar;23(3):254-60. doi: 10.1016/j.nut.2007.01.004.

  PMID: 17352961 BACKGROUND

• 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. doi: 10.1093/ajcn/66.2.515S.

  PMID: 9250141 BACKGROUND

• 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. doi: 10.1038/sj.ejcn.1600938.

  PMID: 10713750 BACKGROUND

• 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. doi: 10.1093/ajcn/74.6.833.

  PMID: 11722966 BACKGROUND

• 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. doi: 10.1017/S0007114507450292.

  PMID: 17349080 BACKGROUND

• Olivares M, Diaz-Ropero MP, Gomez N, Lara-Villoslada F, Sierra S, Maldonado JA, Martin R, Rodriguez 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.

  PMID: 16636989 BACKGROUND

• Savard P, Lamarche B, Paradis ME, Thiboutot H, Laurin E, Roy D. Impact of Bifidobacterium animalis subsp. lactis BB-12 and, Lactobacillus acidophilus LA-5-containing yoghurt, on fecal bacterial counts of healthy adults. Int J Food Microbiol. 2011 Sep 1;149(1):50-7. doi: 10.1016/j.ijfoodmicro.2010.12.026. Epub 2011 Jan 15.

  PMID: 21296446 DERIVED

MeSH Terms

Interventions

Yogurt

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Benoît Lamarche, PhD

  Institute of Nutraceuticals and Functional Foods (INAF), Laval University.

  PRINCIPAL INVESTIGATOR

• Jacques Hébert, MD

  Faculty of Medicine, Laval University.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: May 1, 2009
• Last Updated: June 22, 2009

Record last verified: 2009-06

Locations

CA (1)