Immune SystemPRONCT00730626
Dose Response Study of a Fermented Yogurt on the Immune System and Gut Health
A study testing Yogurt with 1X10E9 BB-12 and LA-5 and Yogurt with 1X10E10 BB-12 and LA-5 in people with Immune System, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System
- What is being tested?
- Yogurt with 1X10E9 BB-12 and LA-5 and Yogurt with 1X10E10 BB-12 and LA-5
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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®
Who cannot join
- Pregnant or lactating woman
- Previous history of cardiovascular disease
- Diabetes
- Kidney or liver disease
- Gastrointestinal disorders or diseases
- Endocrine disorders or diseases
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Québec, Quebec, G1V 0A6
About this 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.
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.
Read the 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.
- Conditions
- Immune System
- Being tested
- Yogurt with 1X10E9 BB-12 and LA-5, Yogurt with 1X10E10 BB-12 and LA-5, Yogurt Placebo
- Keywords
- Probiotics, Immunity, Immune response, Intestinal microflora, Blood lipids, Phagocytosis activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt with 1X10E9 BB-12 and LA-5Dietary 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.
Yogurt with 1X10E10 BB-12 and LA-5Dietary 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.
Yogurt PlaceboDietary supplement
100g of yogurt placebo containing no probiotics and no green tea extract, once a day for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | L.acidophilus and B.lactis (1x10E9 of each probiotics) with 40 mg of green the extract Receives: 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 Receives: Dietary Supplement: Yogurt with 1X10E10 BB-12 and LA-5 |
| 3 | Placebo comparator | Placebo Receives: Dietary Supplement: Yogurt Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phagocytosis activity and oxidative metabolism in phagocytes.
Measured: 6 weeks after vaccination
Secondary outcomes (3)
antipneumococcics antibody specific serotype response to S. pneumoniae vaccination.
Measured: 6 weeks after yogurt consumption and vaccination
Intestinal microflora characteristics.
Measured: 4 weeks after yogurt consumption
Influence of blood lipids.
Measured: After 4 weeks and 10 weeks of yogurt consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Immune SystemStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Aliments ULTIMA Foods Inc., McGill University, TransBiothec
- Investigators
- Benoît Lamarche, PhD, Principal investigator, Institute of Nutraceuticals and Functional Foods (INAF), Laval University.Jacques Hébert, MD, Study director, Faculty of Medicine, Laval University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730626
- Sponsor's protocol ID
- INAF-119
- Acronym
- PRO
- Status last verified
- Jun 2009
- First submitted
- 6 Aug 2008
- Last updated
- 22 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.5414/cpp43318.
PubMed 16035374de 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.
PubMed 16844267Kukkonen 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.
PubMed 16925686Taylor 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.
PubMed 17014429Olivares 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.
PubMed 17352961Schiffrin 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.
PubMed 9250141Arunachalam 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.
PubMed 10713750Gill 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.
PubMed 11722966Roller 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.
PubMed 17349080Olivares 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.
PubMed 16636989Savard 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.
PubMed 21296446
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00730626
- Acronym / sponsor ID
- PRO / INAF-119
- Conditions
- Immune System
- Keywords
- Probiotics, Immunity, Immune response, Intestinal microflora, Blood lipids, Phagocytosis activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Aliments ULTIMA Foods Inc., McGill University, TransBiothec
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Yogurt with 1X10E9 BB-12 and LA-5L.acidophilus and B.lactis (1x10E9 of each probiotics) with 40 mg of green the extract |
| 2 | Experimental | Dietary Supplement: Yogurt with 1X10E10 BB-12 and LA-5L.acidophilus and B.lactis (1x 10E10 of each probiotics) with 40 mg of green tea extract |
| 3 | Placebo comparator | Dietary Supplement: Yogurt PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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®
Key exclusion criteria (9 listed)
- Pregnant or lactating woman
- Previous history of cardiovascular disease
- Diabetes
- Kidney or liver disease
- Gastrointestinal disorders or diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt with 1X10E9 BB-12 and LA-5100g 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. | Dietary supplement | 1 |
| Yogurt with 1X10E10 BB-12 and LA-5100g 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. | Dietary supplement | 2 |
| Yogurt Placebo100g of yogurt placebo containing no probiotics and no green tea extract, once a day for 10 weeks. | Dietary supplement | 3 |
Primary outcome
Phagocytosis activity and oxidative metabolism in phagocytes.
Time frame: 6 weeks after vaccination
3 secondary outcomes
antipneumococcics antibody specific serotype response to S. pneumoniae vaccination.
Time frame: 6 weeks after yogurt consumption and vaccination
Intestinal microflora characteristics.
Time frame: 4 weeks after yogurt consumption
Influence of blood lipids.
Time frame: After 4 weeks and 10 weeks of yogurt consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2009.
- Background: PubMed 16035374Winkler 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.
- Background: PubMed 16844267de 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.
- Background: PubMed 16925686Kukkonen 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.
- Background: PubMed 17014429Taylor 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.
- Background: PubMed 17352961Olivares 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.
- Background: PubMed 9250141Schiffrin 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.
- Background: PubMed 10713750Arunachalam 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.
- Background: PubMed 11722966Gill 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.
- Background: PubMed 17349080Roller 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.
- Background: PubMed 16636989Olivares 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.
- Derived from this study: PubMed 21296446Savard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît Lamarche, PhD principal investigator
Institute of Nutraceuticals and Functional Foods (INAF), Laval University.
Jacques Hébert, MD study director
Faculty of Medicine, Laval University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt with 1X10E9 BB-12 and LA-5 and Yogurt with 1X10E10 BB-12 and LA-5 in people with Immune System, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phagocytosis activity and oxidative metabolism in phagocytes. (time frame: 6 weeks after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00730626, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2009.