Dietary Nitrate and Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Impact of Dietary Nitrate on Erectile Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04116060
• Other study ID #: Nitrate E.D.
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: January 2021
• Source: University Hospital, Essen
• Contact: Christos Rammos, MD
• Phone: 020172384808
• Email: Christos.Rammos[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Dietary Supplement:
• Dietary Nitrate
Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)
• Control
Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of erectile function according to the international index of erectile function (IIEF5) score	Erectile dysfunction improvement as measured by IIEF5 score (range 5-25)	4 Weeks
Secondary	Change in oral microbiome	Change in oral microbiome after dietary nitrate ingestion	4 Weeks
Secondary	Change in cardiac diastolic function,	Change in cardiac diastolic function as determined by echocardiography via measurement of E/A and E/e' aggregated to display diastolic function	4 weeks