Combination of Probiotic and Calcium in Healthy Adults

Healthy Subjects Clinical Trial

Official title:

The Effect of the Probiotic L. Paracasei LPC 37 Alone or in Combination With a Calcium Supplement in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033461
• Other study ID #: LSEP H33-08
• Status: Completed
• Phase: N/A
• First received: December 15, 2009
• Last updated: November 6, 2012
• Start date: March 2008
• Est. completion date: August 2008

Study information

• Verified date: November 2012
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Subjects

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
• probiotic
the subjects consumed a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 for 4 weeks

Other:
• placebo
the subjects consumed a yoghurt drink without L. paracasei LPC 37 and a bread without pentacalcium phosphate

Locations

Country	Name	City	State
Germany	Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	faecal microbiota, cholesterol metabolism		4 weeks	Yes
Secondary	mineral status, immunological parameters		4 weeks	Yes