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Completed

NCT Number: NCT01033461

Combination of Probiotic and Calcium in Healthy Adults

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calcium and probiotic

Dietary Supplement

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

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. faecal microbiota, cholesterol metabolism

    Time frame: 4 weeks

Secondary outcomes

  1. mineral status, immunological parameters

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 16, 2009
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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