Combination of Probiotic and Calcium in Healthy Adults
The Effect of the Probiotic L. Paracasei LPC 37 Alone or in Combination With a Calcium Supplement in Healthy Subjects
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 15, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedNovember 7, 2012
November 1, 2012
5 months
December 15, 2009
November 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
faecal microbiota, cholesterol metabolism
4 weeks
Secondary Outcomes (1)
mineral status, immunological parameters
4 weeks
Study Arms (3)
calcium and probiotic
EXPERIMENTALintervention
probiotic
EXPERIMENTALintervention
placebo
PLACEBO COMPARATORplacebo, no intervention
Interventions
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
the subjects consumed a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 for 4 weeks
the subjects consumed a yoghurt drink without L. paracasei LPC 37 and a bread without pentacalcium phosphate
Eligibility Criteria
You may qualify if:
- healthy subjects
- blood cholesterol concentration \> 5 mmol/l
You may not qualify if:
- pregnancy, lactation
- intake of dietary supplements
- intake of prebiotics and probiotics
- chronic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
Jena, Thuringia, 07743, Germany
Related Publications (1)
Trautvetter U, Ditscheid B, Kiehntopf M, Jahreis G. A combination of calcium phosphate and probiotics beneficially influences intestinal lactobacilli and cholesterol metabolism in humans. Clin Nutr. 2012 Apr;31(2):230-7. doi: 10.1016/j.clnu.2011.09.013. Epub 2011 Oct 20.
PMID: 22019281DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Jahreis, Prof.Dr.
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. habil
Study Record Dates
First Submitted
December 15, 2009
First Posted
December 16, 2009
Study Start
March 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
November 7, 2012
Record last verified: 2012-11