Endothelial DysfunctionPhase 1/2NCT01729234
Effects of Dietary Nitrate on Age-related Vascular Function
A Phase 1/2 study testing Nitrate in people with Endothelial Dysfunction, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Purpose of the study is to characterize the chronic effect of dietary nitrate on vascular function in healthy volunteers with particular emphasis on age-related alterations. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to May 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >55 Years Healthy
Who cannot join
- known cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Effects of Dietary Nitrate Supplementation on Age-related Vascular Dysfunction
Purpose of the study is to characterize the chronic effect of dietary nitrate on vascular function in healthy volunteers with particular emphasis on age-related alterations.
- Conditions
- Endothelial Dysfunction
- Being tested
- Nitrate, Placebo
- Keywords
- age related Endothelial Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitrateDietary supplement
Dietary Supplement
PlaceboDietary supplement
Dietary Supplement
| Study group | Role | What they receive |
|---|---|---|
| Nitrate | Experimental | 150µmol /Kg bodyweight /day Receives: Dietary Supplement: Nitrate |
| PLacebo | Placebo comparator | 150µmol /Kg bodyweight /day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function measured by flow-mediated dilation (FMD)
The effect of dietary nitrate on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729234
- Sponsor's protocol ID
- Nitrate for vascular age
- Status last verified
- Dec 2013
- First submitted
- 14 Nov 2012
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Nitrate Supplementation on Age-related Vascular Dysfunction
- ClinicalTrials.gov ID
- NCT01729234
- Acronym / sponsor ID
- Nitrate for vascular age
- Conditions
- Endothelial Dysfunction
- Keywords
- age related Endothelial Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study is to characterize the chronic effect of dietary nitrate on vascular function in healthy volunteers with particular emphasis on age-related alterations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate | Experimental | Dietary Supplement: Nitrate150µmol /Kg bodyweight /day |
| PLacebo | Placebo comparator | Dietary Supplement: Placebo150µmol /Kg bodyweight /day |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >55 Years Healthy
Key exclusion criteria (1 listed)
- known cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitrateDietary Supplement | Dietary supplement | Nitrate |
| PlaceboDietary Supplement | Dietary supplement | PLacebo |
Primary outcome
Endothelial function measured by flow-mediated dilation (FMD)
Time frame: 30 days
The effect of dietary nitrate on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitrate in people with Endothelial Dysfunction, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function measured by flow-mediated dilation (FMD) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.