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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate | Experimental | 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 |
|
| Control | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Nitrate | Dietary Supplement | Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Patients with erectile Dysfunction (IIEF5: 8-21) PDE-5 Inhibitors Responder Aged 30-80 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christos Rammos, MD | Contact | 020172384808 | Christos.Rammos@uk-essen.de |
| Name | Affiliation | Role |
|---|---|---|
| Tienush Rassaf, Prof | University Hospital, Essen | Study Director |
| Christos Rammos, MD | University Hospital, Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Essen | Recruiting | Essen | North Rhine-Westphalia | 45122 | Germany |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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Parallel Assignment to intervention vs. control
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Double blinded and randomised
| Control | Dietary Supplement | Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day) |
|
| 4 weeks |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |