Dietary Nitrate and Cardiovascular Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Physiological Effects of Oral Nitrate on Vascular Function

Conditions
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no Medications

Intervention / Treatment
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* Dietary Supplement: Dietary nitrate
* Dietary Supplement: Water


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary nitrate<br>150 ml tab water with 150 umol/kg sodium-nitrate | Dietary Supplement: Dietary nitrate<br>* 150 ml tab water with 150 umol/kg sodium-nitrate<br>* Other names: sodium nitrate;|
| Placebo Comparator: Water<br>150 ml Chapelle mineral water | Dietary Supplement: Water<br>* 150 ml Chapelle mineral water<br>* Other names: H2O;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating angiogenic cells |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines |  | 4 hours | 
| Endothelial function |  | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary nitrate