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Dietary Nitrate and Cardiovascular Health

Physiological Effects of Oral Nitrate on Vascular Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01262521
Enrollment
20
Registered
2010-12-17
Start date
2010-11-30
Completion date
2012-12-31
Last updated
2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

no Medications

Keywords

Dietary nitrate

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 (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.

Interventions

DIETARY_SUPPLEMENTDietary nitrate

150 ml tab water with 150 umol/kg sodium-nitrate

DIETARY_SUPPLEMENTWater

150 ml Chapelle mineral water

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 36 Years
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)

Design outcomes

Primary

MeasureTime frame
Circulating angiogenic cells4 hours

Secondary

MeasureTime frame
Cytokines4 hours
Endothelial function4 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026