Dietary Nitrate and Erectile Dysfunction

Not Applicable

• Conditions: Erectile Dysfunction
• Interventions: Dietary Supplement: Control; Dietary Supplement: Dietary Nitrate

• Registration Number: NCT04116060
• Lead Sponsor: University Hospital, Essen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-04
• Study Start: 2020-02-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-25
• Primary Completion: 2021-06-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day) Dietary Supplement: Dietary sodium-chloride 200 ml tab water with 0,12 mmol/kgBW sodium-chloride
Nitrate	Dietary Nitrate	Dietary nitrate dissolved in water (0,12 mmol sodium-nitrate/kgBW/day) Dietary Supplement: Dietary nitrate 200 ml tab water with 0,12 mmol/kgBW sodium-nitrate

Primary Outcome Measures

Name	Time	Method
The changes of erectile function according to the international index of erectile function (IIEF5) score	4 Weeks	Erectile dysfunction improvement as measured by IIEF5 score (range 5-25)

Secondary Outcome Measures

Name	Time	Method
Change in oral microbiome	4 Weeks	Change in oral microbiome after dietary nitrate ingestion
Change in cardiac diastolic function,	4 weeks	Change in cardiac diastolic function as determined by echocardiography via measurement of E/A and E/e' aggregated to display diastolic function

Trial Locations

Locations (1)

University Hospital Essen; 🇩🇪 Essen, NRW, Germany