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Dietary Nitrate and Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dietary Nitrate
Control
Sponsored by
University Hospital, Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Erectile Dysfunction

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital EssenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nitrate

Control

Arm Description

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 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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in oral microbiome
Change in oral microbiome after dietary nitrate ingestion
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

Full Information

First Posted
October 3, 2019
Last Updated
January 20, 2021
Sponsor
University Hospital, Essen
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1. Study Identification

Unique Protocol Identification Number
NCT04116060
Brief Title
Dietary Nitrate and Erectile Dysfunction
Official Title
Impact of Dietary Nitrate on Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Essen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment to intervention vs. control
Masking
ParticipantInvestigator
Masking Description
Double blinded and randomised
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nitrate
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Nitrate
Intervention Description
Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)
Primary Outcome Measure Information:
Title
The changes of erectile function according to the international index of erectile function (IIEF5) score
Description
Erectile dysfunction improvement as measured by IIEF5 score (range 5-25)
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Change in oral microbiome
Description
Change in oral microbiome after dietary nitrate ingestion
Time Frame
4 Weeks
Title
Change in cardiac diastolic function,
Description
Change in cardiac diastolic function as determined by echocardiography via measurement of E/A and E/e' aggregated to display diastolic function
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christos Rammos, MD
Phone
020172384808
Email
Christos.Rammos@uk-essen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tienush Rassaf, Prof
Organizational Affiliation
University Hospital, Essen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christos Rammos, MD
Organizational Affiliation
University Hospital, Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fadi Al-Rashid, Dr.med.
Phone
00492017230
Email
fadi.al-rashid@uk-essen.de
First Name & Middle Initial & Last Name & Degree
Christos Rammos, MD, PHD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dietary Nitrate and Erectile Dysfunction

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