Dietary Nitrate and Cardiovascular Health
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ClinicalTrials.gov Identifier: NCT01262521 |
Recruitment Status
:
Completed
First Posted
: December 17, 2010
Last Update Posted
: November 8, 2013
|
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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 (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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
no Medications | Dietary Supplement: Dietary nitrate Dietary Supplement: Water | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Physiological Effects of Oral Nitrate on Vascular Function |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Dietary nitrate
150 ml tab water with 150 umol/kg sodium-nitrate
|
Dietary Supplement: Dietary nitrate
150 ml tab water with 150 umol/kg sodium-nitrate
Other Name: sodium nitrate
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Placebo Comparator: Water
150 ml Chapelle mineral water
|
Dietary Supplement: Water
150 ml Chapelle mineral water
Other Name: H2O
|
- Circulating angiogenic cells [ Time Frame: 4 hours ]
- Cytokines [ Time Frame: 4 hours ]
- Endothelial function [ Time Frame: 4 hours ]

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Ages Eligible for Study: | 21 Years to 36 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- age > 20 years
- refrain from nitrate containing food ingestion during trial
Exclusion Criteria:
- > 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262521
Germany | |
Heinrich-Heine-University | |
Duesseldorf, NRW, Germany, 40225 |
Study Chair: | Tienush Rassaf, MD, PhD | University of Duesseldorf | |
Principal Investigator: | Christian Meyer, MD | University of Duesseldorf | |
Principal Investigator: | Christian Heiss, MD | University of Duesseldorf | |
Study Director: | Malte Kelm, MD, PhD | University of Duesseldorf |
Additional Information:
Responsible Party: | Klinik für Kardiologie, Pneumologie und Angiologie, Christian Meyer, MD, Heinrich-Heine University, Duesseldorf |
ClinicalTrials.gov Identifier: | NCT01262521 History of Changes |
Other Study ID Numbers: |
Protective dietary nitrate |
First Posted: | December 17, 2010 Key Record Dates |
Last Update Posted: | November 8, 2013 |
Last Verified: | November 2013 |
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
Dietary nitrate |