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Completed

NCT Number: NCT00730626

Dose Response Study of a Fermented Yogurt 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Yogurt Placebo

Dietary Supplement

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

Primary outcomes

  1. Phagocytosis activity and oxidative metabolism in phagocytes.

    Time frame: 6 weeks after vaccination

Secondary outcomes

  1. antipneumococcics antibody specific serotype response to S. pneumoniae vaccination.

    Time frame: 6 weeks after yogurt consumption and vaccination

  2. Intestinal microflora characteristics.

    Time frame: 4 weeks after yogurt consumption

  3. Influence of blood lipids.

    Time frame: After 4 weeks and 10 weeks of yogurt consumption

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Aliments ULTIMA Foods Inc.
  • McGill University
  • TransBiothec

Registry information

Official study 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.

Acronym: PRO

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Aug 8, 2008
Registry last updated
Jun 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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