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Dietary Nitrate and Cardiovascular Health

This study is currently recruiting participants.
Verified June 2012 by Heinrich-Heine University, Duesseldorf
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01262521
First received: December 16, 2010
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
no Medications
 Dietary Supplement: Dietary nitrate
Dietary Supplement: Water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Physiological Effects of Oral Nitrate on Vascular Function

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Circulating angiogenic cells [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cytokines [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years to 36 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262521

Contacts
Contact: Christian Meyer, MD +49-211-8118800 Christian.Meyer@med.uni-duesseldorf.de

Locations
Germany
Heinrich-Heine-University Recruiting
Duesseldorf, NRW, Germany, 40225
Contact: Christian Meyer, MD     +49 211 8118800     Christian.Meyer@med.uni-duesseldorf.de    
Principal Investigator: Malte Kelm, MD, PhD            
Principal Investigator: Christian Meyer, MD            
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

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

No publications provided

Responsible Party: Klinik für Kardiologie, Christian Meyer, MD, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01262521     History of Changes
Other Study ID Numbers: Protective dietary nitrate
Study First Received: December 16, 2010
Last Updated: June 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:
Dietary nitrate

ClinicalTrials.gov processed this record on May 23, 2013