no MedicationsNCT01262521
Dietary Nitrate and Cardiovascular Health
A study testing Dietary nitrate and Water in people with no Medications, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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 (IR) injury and hypertension. Read more about this study
- Who is it for?
- Ages 21 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- no Medications
- What is being tested?
- Dietary nitrate and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Dec 2012
- Phase
- Interventional
- 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 21 to 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age > 20 years
- refrain from nitrate containing food ingestion during trial
Who cannot join
- > 36 years
- poor endothelial function
- acute infection
- any chronic heart or pulmonary disease
- arrhythmias
- acute or chronic renal failure
- cardio-vascular risk factors: diabetes mellitus, hypertension, hyperlipidemia
- intake of nutrition supplements (l-arginine, creatinine)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Physiological Effects of Oral Nitrate on Vascular Function
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 (IR) injury and hypertension. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate and nitrite are abundant in our everyday diet.
Whether increasing the circulating pool of nitric oxide and nitrite by dietary nitrate offers a novel mechanistic approach to regulate mobilization of circulating angiogenic cells and thus regenerative processes in cardiovascular medicine is not known. Thus, in the present study, we tested whether oral application of nitrate leads to an enhanced number of circulating angiogenic cells and whether this is associated with an improvement in endothelial function.
Read the detailed description
Administration of a single dose of nitrate intervention or water alone to healthy volunteers. Before and up to 4 hours (short-term)/6 days (long-term) after ingestion, marker of vascular function are measured in plasma and by using high-resolution ultrasound.
Measurements are taken before and up to 4 h after double blind cross-over per os administration of a single dose of nitrate intervention (150 ml tab water with 150 umol/kg sodium-nitrate) or water control (100 ml Chapelle mineral water) to healthy volunteers. Circulating angiogenic cells are measured as CD34+/KDR+ and CD133+/KDR+ mononuclear cells in blood by flow cytometry and plasma is analyzed for nitrate and nitrite, as well as mobilization markers and cytokines including stromal cell derived factor, vascular endothelial growth factor and stem cell factor. All measurements are performed after >12h overnight fasting.
- Conditions
- no Medications
- Being tested
- Dietary nitrate, Water
- Keywords
- Dietary nitrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary nitrateDietary supplement
Also called sodium nitrate
150 ml tab water with 150 umol/kg sodium-nitrate
WaterDietary supplement
Also called H2O
150 ml Chapelle mineral water
| Study group | Role | What they receive |
|---|---|---|
| Dietary nitrate | Experimental | 150 ml tab water with 150 umol/kg sodium-nitrate Receives: Dietary Supplement: Dietary nitrate |
| Water | Placebo comparator | 150 ml Chapelle mineral water Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating angiogenic cells
Measured: 4 hours
Secondary outcomes (2)
Cytokines
Measured: 4 hours
Endothelial function
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no MedicationsStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Tienush Rassaf, MD, PhD, Study chair, University of DuesseldorfChristian Meyer, MD, Principal investigator, University of DuesseldorfChristian Heiss, MD, Principal investigator, University of DuesseldorfMalte Kelm, MD, PhD, Study director, University of Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262521
- Sponsor's protocol ID
- Protective dietary nitrate
- Status last verified
- Nov 2013
- First submitted
- 16 Dec 2010
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Oral Nitrate on Vascular Function
- ClinicalTrials.gov ID
- NCT01262521
- Acronym / sponsor ID
- Protective dietary nitrate
- Conditions
- no Medications
- Keywords
- Dietary nitrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Dec 2010 (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.
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 (IR) injury and hypertension. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate and nitrite are abundant in our everyday diet.
Whether increasing the circulating pool of nitric oxide and nitrite by dietary nitrate offers a novel mechanistic approach to regulate mobilization of circulating angiogenic cells and thus regenerative processes in cardiovascular medicine is not known. Thus, in the present study, we tested whether oral application of nitrate leads to an enhanced number of circulating angiogenic cells and whether this is associated with an improvement in endothelial function.
Detailed description
Administration of a single dose of nitrate intervention or water alone to healthy volunteers. Before and up to 4 hours (short-term)/6 days (long-term) after ingestion, marker of vascular function are measured in plasma and by using high-resolution ultrasound.
Measurements are taken before and up to 4 h after double blind cross-over per os administration of a single dose of nitrate intervention (150 ml tab water with 150 umol/kg sodium-nitrate) or water control (100 ml Chapelle mineral water) to healthy volunteers. Circulating angiogenic cells are measured as CD34+/KDR+ and CD133+/KDR+ mononuclear cells in blood by flow cytometry and plasma is analyzed for nitrate and nitrite, as well as mobilization markers and cytokines including stromal cell derived factor, vascular endothelial growth factor and stem cell factor. All measurements are performed after >12h overnight fasting.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary nitrate | Experimental | Dietary Supplement: Dietary nitrate150 ml tab water with 150 umol/kg sodium-nitrate |
| Water | Placebo comparator | Dietary Supplement: Water150 ml Chapelle mineral water |
Who may qualify
- Ages
- 21 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age > 20 years
- refrain from nitrate containing food ingestion during trial
Key exclusion criteria (8 listed)
- > 36 years
- poor endothelial function
- acute infection
- any chronic heart or pulmonary disease
- arrhythmias
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 |
|---|---|---|
| Dietary nitrateAlso: sodium nitrate150 ml tab water with 150 umol/kg sodium-nitrate | Dietary supplement | Dietary nitrate |
| WaterAlso: H2O150 ml Chapelle mineral water | Dietary supplement | Water |
Primary outcome
Circulating angiogenic cells
Time frame: 4 hours
2 secondary outcomes
Cytokines
Time frame: 4 hours
Endothelial function
Time frame: 4 hours
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 8 Nov 2013.
- Link to the homepage of the Division of Cardiology, Pneumology, and Angiology at the University of DuesseldorfLink provided by the sponsor.
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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.
Tienush Rassaf, MD, PhD study chair
University of Duesseldorf
Christian Meyer, MD principal investigator
University of Duesseldorf
Christian Heiss, MD principal investigator
University of Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary nitrate and Water in people with no Medications, 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 2 inclusion and 8 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 8 Nov 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.
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?
Circulating angiogenic cells (time frame: 4 hours). 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 8 Nov 2013.