Clinical Trials Directory

Trials / Completed

CompletedNCT01262521

Dietary Nitrate and Cardiovascular Health

Physiological Effects of Oral Nitrate on Vascular Function

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Heinrich-Heine University, Duesseldorf · Academic / Other
Sex
All
Age
21 Years – 36 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTDietary nitrate150 ml tab water with 150 umol/kg sodium-nitrate
DIETARY_SUPPLEMENTWater150 ml Chapelle mineral water

Timeline

Start date
2010-11-01
Primary completion
2012-10-01
Completion
2012-12-01
First posted
2010-12-17
Last updated
2013-11-08

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01262521. Inclusion in this directory is not an endorsement.