Dietary Nitrate and Cardiovascular Health

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

ClinicalTrials.gov Identifier:

NCT01262521

First received: December 16, 2010

Last updated: November 7, 2013

Last verified: November 2013

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

Drug Information available for: Sodium nitrate

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
Study Completion Date:	December 2012
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

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Please refer to this study by its ClinicalTrials.gov identifier: 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

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

This link exits the ClinicalTrials.gov site

No publications provided


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
Study First Received:	December 16, 2010
Last Updated:	November 7, 2013
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 March 01, 2015

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