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Dietary Nitrate and Cardiovascular Health

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ClinicalTrials.gov Identifier: NCT01262521
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : November 8, 2013
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Study Description
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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.


Condition or disease Intervention/treatment Phase
no Medications Dietary Supplement: Dietary nitrate Dietary Supplement: Water Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Physiological Effects of Oral Nitrate on Vascular Function
Study Start Date : November 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dietary nitrate
150 ml tab water with 150 umol/kg sodium-nitrate
 Dietary Supplement: Dietary nitrate
150 ml tab water with 150 umol/kg sodium-nitrate
Other Name: sodium nitrate
Placebo Comparator: Water
150 ml Chapelle mineral water
 Dietary Supplement: Water
150 ml Chapelle mineral water
Other Name: H2O


Outcome Measures
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Primary Outcome Measures :
  1. Circulating angiogenic cells [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. Cytokines [ Time Frame: 4 hours ]
  2. Endothelial function [ Time Frame: 4 hours ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 36 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262521


Locations
Germany
Heinrich-Heine-University
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Study Chair: Tienush Rassaf, MD, PhD University of Duesseldorf
Principal Investigator: Christian Meyer, MD University of Duesseldorf
Principal Investigator: Christian Heiss, MD University of Duesseldorf
Study Director: Malte Kelm, MD, PhD University of Duesseldorf
More Information
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Additional Information:
Link to the homepage of the Division of Cardiology, Pneumology, and Angiology at the University of Duesseldorf  This link exits the ClinicalTrials.gov site

Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Christian Meyer, MD, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01262521     History of Changes
Other Study ID Numbers: Protective dietary nitrate
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
Dietary nitrate