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Combination of Probiotic and Calcium in Healthy Adults

This study has been completed.
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena Identifier:
First received: December 15, 2009
Last updated: November 6, 2012
Last verified: November 2012
The study was conducted to investigate the effect of the probiotic L. paracasei LPC 37 alone or in combination with a calcium supplement of the human microbiota and further physiological parameters.

Condition Intervention
Healthy Subjects
Dietary Supplement: calcium and probiotic
Dietary Supplement: probiotic
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of the Probiotic L. Paracasei LPC 37 Alone or in Combination With a Calcium Supplement in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • faecal microbiota, cholesterol metabolism [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • mineral status, immunological parameters [ Time Frame: 4 weeks ]

Enrollment: 32
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: calcium and probiotic
Dietary Supplement: calcium and probiotic
the subjects consumed for 4 weeks a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 and a bread enriched with 1 g pentacalcium phosphate per day
Experimental: probiotic
Dietary Supplement: probiotic
the subjects consumed a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 for 4 weeks
Placebo Comparator: placebo
placebo, no intervention
Other: placebo
the subjects consumed a yoghurt drink without L. paracasei LPC 37 and a bread without pentacalcium phosphate

Detailed Description:

Animal studies suggest that calcium beneficially influence the microbiota in the gut. This effect of calcium is due to the formation of amorphous calcium phosphate, which has the ability to bind bile acids and other cytotoxic substances in the gut. The precipitation of the cytotoxic substances leads to a less aggressive environment in the gut and might be stimulate the adhesion of the microbiota.

Thirty-two healthy men and women participated in a placebo-controlled, double-blind and cross over human study. The participants were randomly divided into two groups. All probands consumed a probiotic drink for four weeks (10e+10 CFU/d). Additionally, one group consumed a pentacalcium phosphate-enriched bread (1 g Ca/d) and the other group consumed a bread without pentacalcium phosphate. After a two-week wash-out and a two-week placebo period the invention changed for another four weeks (cross over). At the end of each intervention and placebo period, subjects consumed a defined diet for three days. Furthermore, there was a three-day quantitative stool and urine collection and a fasting venous blood sample was taken.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy subjects
  • blood cholesterol concentration > 5 mmol/l

Exclusion Criteria:

  • pregnancy, lactation
  • intake of dietary supplements
  • intake of prebiotics and probiotics
  • chronic diseases
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Please refer to this study by its identifier: NCT01033461

Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Principal Investigator: Gerhard Jahreis, Prof.Dr. Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gerhard Jahreis, Prof. Dr. habil, University of Jena Identifier: NCT01033461     History of Changes
Other Study ID Numbers: LSEP H33-08
Study First Received: December 15, 2009
Last Updated: November 6, 2012

Keywords provided by University of Jena:
lactobacillus paracasei
faecal microbiota
cholesterol metabolism

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 28, 2017