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

This study has been completed.
Sponsor:
Collaborators:
Ultima Food Inc
McGill University
TransBiothec
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00730626
First received: August 6, 2008
Last updated: June 19, 2009
Last verified: June 2009
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 58
Study Start Date: August 2008
Study Completion Date: May 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benoît Lamarche, Study Principal Investigator, Institute of Nutraceuticals and Functional Foods (INAF), Laval University
ClinicalTrials.gov Identifier: NCT00730626     History of Changes
Other Study ID Numbers: INAF-119
Study First Received: August 6, 2008
Last Updated: June 19, 2009
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 August 26, 2014