Combination of Probiotic and Calcium in Healthy Adults

U

University of Jena

Status

Completed

Conditions

Healthy Subjects

Treatments

Dietary Supplement: probiotic
Dietary Supplement: calcium and probiotic
Other: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01033461
LSEP H33-08

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

32 participants in 3 patient groups, including a placebo group

calcium and probiotic
Experimental group
Description:
intervention
Treatment:
Dietary Supplement: calcium and probiotic
probiotic
Experimental group
Description:
intervention
Treatment:
Dietary Supplement: probiotic
placebo
Placebo Comparator group
Description:
placebo, no intervention
Treatment:
Other: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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