跳至主要内容
临床试验/NCT04116060
NCT04116060Unknown不适用

Impact of Dietary Nitrate on Erectile Dysfunction

University Hospital, Essen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年2月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
The changes of erectile function according to the international index of erectile function (IIEF5) score

研究概览

简要总结

An expanding number of studies suggest a therapeutic role for nitrate and nitrite, most notably in treatment and prevention of cardiovascular disease including ischemia-reperfusion injury and hypertension. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate is abundant in our everyday diet. Nitrate improves vascular functions in old adults and improves ischemia reperfusion injury in experimental models.

Whether dietary nitrate improves erectile dysfunction is not known and 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)

盲法说明

Double blinded and randomised

入排标准

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

入选标准

  • Patients with erectile Dysfunction (IIEF5: 8-21) PDE-5 Inhibitors Responder Aged 30-80 years

排除标准

  • Spinal cord disease
  • Insulin dependent Diabetes mellitus
  • Prostate cancer after operation, radiotherapy and hormone therapy
  • Treatment with NO-Donators or sGC-Activators
  • Chronic kidney disease (Stage IV-V)
  • Advanced liver dysfunction

结局指标

主要结局

The changes of erectile function according to the international index of erectile function (IIEF5) score

时间窗: 4 Weeks

Erectile dysfunction improvement as measured by IIEF5 score (range 5-25)

次要结局

  • Change in oral microbiome(4 Weeks)
  • Change in cardiac diastolic function,(4 weeks)

研究者

发起方
University Hospital, Essen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fadi Al-Rashid

MD, Principal Investigator

University Hospital, Essen

研究点 (2)

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