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临床试验/NCT05122689
NCT05122689已完成不适用

Influence of Exogenous Dietary Inorganic Nitrate on Downstream Metabolites of the Enteral Microbiome

University Hospital, Essen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Change of the enteral microbiome composition

研究概览

简要总结

A growing body of data shows that the enteral microbiome has an effect on cardiovascular diseases. Exogenous inorganic dietary nitrate mediates cardioprotective effects and has been shown to have an influence on the oral microbiome. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate is abundant in our everyday diet.

Whether dietary nitrate influences the enteral microbiome and downstream metabolites like short-chain fatty acids (SCFA) and TMAO will be investigated in the present study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 40-80 years
  • no regular medication intake
  • no chronic diseases

排除标准

  • Regular systemic drug intake
  • Active smoking
  • Chronic diseases
  • Acute diarrhea or vomiting
  • Short gut syndrome
  • Pregnancy or breastfeeding

研究组 & 干预措施

Nitrate

Experimental

Dietary inorganic nitrate (0,12 mmol sodium-nitrate/kg BW/day) dissolved in 200 ml tap water. Supplementation for 30 days.

干预措施: Nitrate (Dietary Supplement)

结局指标

主要结局

Change of the enteral microbiome composition

时间窗: 30 days

Changes in enteral microbiome composition in stool samples at baseline and after 30 days of placebo/verum supplementation. The 16S rRNA amplicon reads obtained from an Illumina MiSeq System will be analyzed using pipeline QIIME2 (v. 2019.1).

次要结局

  • Change of the oral microbiome composition(30 days)
  • Change of circulating SCFA levels(30 days)

研究者

发起方
University Hospital, Essen
申办方类型
Other
责任方
Sponsor

研究点 (2)

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