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临床试验/NCT01033461
NCT01033461已完成不适用

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

University of Jena2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
faecal microbiota, cholesterol metabolism

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy subjects
  • blood cholesterol concentration > 5 mmol/l

排除标准

  • pregnancy, lactation
  • intake of dietary supplements
  • intake of prebiotics and probiotics
  • chronic diseases

结局指标

主要结局

faecal microbiota, cholesterol metabolism

时间窗: 4 weeks

次要结局

  • mineral status, immunological parameters(4 weeks)

研究者

发起方
University of Jena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerhard Jahreis

Prof. Dr. habil

University of Jena

研究点 (2)

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