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OpenTrials
Completed

NCT Number: NCT01262521

Dietary Nitrate and Cardiovascular Health

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.

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Key information

Conditions

no Medications

Age range

21 year–36 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dietary nitrate

Dietary Supplement

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

Other names: sodium nitrate

Water

Dietary Supplement

150 ml Chapelle mineral water

Other names: H2O

Primary outcomes

  1. Circulating angiogenic cells

    Time frame: 4 hours

Secondary outcomes

  1. Cytokines

    Time frame: 4 hours

  2. Endothelial function

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

Physiological Effects of Oral Nitrate on Vascular Function

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 17, 2010
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.