Combination of Probiotic and Calcium in Healthy Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: calcium and probiotic
* Dietary Supplement: probiotic
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: calcium and probiotic<br>intervention | Dietary Supplement: calcium and probiotic<br>* 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<br>|
| Experimental: probiotic<br>intervention | Dietary Supplement: probiotic<br>* the subjects consumed a yoghurt drink enriched with 10e+10 cfu/d L. paracasei LPC 37 for 4 weeks<br>|
| Placebo Comparator: placebo<br>placebo, no intervention | Other: placebo<br>* the subjects consumed a yoghurt drink without L. paracasei LPC 37 and a bread without pentacalcium phosphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| faecal microbiota, cholesterol metabolism |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mineral status, immunological parameters |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, lactobacillus paracasei, calcium, faecal microbiota, cholesterol metabolism