Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2010-11-30
2012-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Dietary nitrate
150 ml tab water with 150 umol/kg sodium-nitrate
Dietary nitrate
150 ml tab water with 150 umol/kg sodium-nitrate
Water
150 ml Chapelle mineral water
Water
150 ml Chapelle mineral water
Interventions
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Dietary nitrate
150 ml tab water with 150 umol/kg sodium-nitrate
Water
150 ml Chapelle mineral water
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* refrain from nitrate containing food ingestion during trial
Exclusion Criteria
* 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)
21 Years
36 Years
ALL
Yes
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Klinik für Kardiologie, Pneumologie und Angiologie
Christian Meyer, MD
Principal Investigators
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Tienush Rassaf, MD, PhD
Role: STUDY_CHAIR
University of Duesseldorf
Christian Meyer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Duesseldorf
Christian Heiss, MD
Role: PRINCIPAL_INVESTIGATOR
University of Duesseldorf
Malte Kelm, MD, PhD
Role: STUDY_DIRECTOR
University of Duesseldorf
Locations
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Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, Germany
Countries
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Related Links
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Link to the homepage of the Division of Cardiology, Pneumology, and Angiology at the University of Duesseldorf
Other Identifiers
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Protective dietary nitrate
Identifier Type: -
Identifier Source: org_study_id