Combination of Probiotic and Calcium in Healthy Adults

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Dietary Supplement: probiotic; Dietary Supplement: calcium and probiotic; Other: placebo

• Registration Number: NCT01033461
• Lead Sponsor: University of Jena

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.

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-06
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
probiotic	probiotic	intervention
calcium and probiotic	calcium and probiotic	intervention
placebo	placebo	placebo, no intervention

Primary Outcome Measures

Name	Time	Method
faecal microbiota, cholesterol metabolism	4 weeks

Secondary Outcome Measures

Name	Time	Method
mineral status, immunological parameters	4 weeks

Trial Locations

Locations (1)

Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology; 🇩🇪 Jena, Thuringia, Germany