Dietary Nitrate and Erectile Dysfunction

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Dietary Nitrate on Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Dietary Supplement: Dietary Nitrate
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment to intervention vs. control
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrate<br>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 | Dietary Supplement: Dietary Nitrate<br>* Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)<br>|
| Placebo Comparator: Control<br>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 | Dietary Supplement: Control<br>* Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oral microbiome | Change in oral microbiome after dietary nitrate ingestion | 4 Weeks | 
| 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 |