Combination of Probiotic and Calcium in Healthy Adults

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

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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