Erectile Dysfunction
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDietary Nitrate
Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)
DIETARY_SUPPLEMENTControl
Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)
Sponsors
University Hospital, Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded and randomised
Intervention model description
Parallel Assignment to intervention vs. control
Eligibility
Sex/Gender
MALE
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
Primary ContactChristos Rammos, MD
Outcome results
None listed