Clinical trial NCT01262521: Dietary Nitrate and Cardiovascular Health
Official title: Physiological Effects of Oral Nitrate on Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: no Medications
Keywords: Dietary nitrate
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Circulating angiogenic cells
timeFrame: 4 hours
Secondary outcomes:
measure: Cytokines
timeFrame: 4 hours
measure: Endothelial function
timeFrame: 4 hours
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Heinrich-Heine-University
state: NRW
Study officials:
affiliation: University of Duesseldorf
name: Tienush Rassaf, MD, PhD
role: STUDY_CHAIR
affiliation: University of Duesseldorf
name: Christian Meyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Duesseldorf
name: Christian Heiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Duesseldorf
name: Malte Kelm, MD, PhD
role: STUDY_DIRECTOR
References: