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Combination of Probiotic and Calcium in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01033461
First received: December 15, 2009
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • faecal microbiota, cholesterol metabolism [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mineral status, immunological parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

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
intervention
 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
intervention
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033461

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

No publications provided by University of Jena

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gerhard Jahreis, Prof. Dr. habil, University of Jena
ClinicalTrials.gov Identifier: NCT01033461     History of Changes
Other Study ID Numbers: LSEP H33-08
Study First Received: December 15, 2009
Last Updated: November 6, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013