Dietary Nitrate and Cardiovascular Health

NCT01262521 | Completed

• 1 other identifier: Protective dietary nitrate
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

no Medications

Keywords

Dietary nitrate

Outcome Measures

Primary Outcomes (1)

• Circulating angiogenic cells

  4 hours

Secondary Outcomes (2)

• Cytokines

  4 hours

• Endothelial function

  4 hours

Study Arms (2)

Dietary nitrate

EXPERIMENTAL

150 ml tab water with 150 umol/kg sodium-nitrate

Dietary Supplement: Dietary nitrate

Water

PLACEBO COMPARATOR

150 ml Chapelle mineral water

Dietary Supplement: Water

Interventions

Dietary nitrate DIETARY_SUPPLEMENT

150 ml tab water with 150 umol/kg sodium-nitrate

Also known as: sodium nitrate

Dietary nitrate

Water DIETARY_SUPPLEMENT

150 ml Chapelle mineral water

Also known as: H2O

Water

Eligibility Criteria

• Age: 21 Years - 36 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age \> 20 years
• refrain from nitrate containing food ingestion during trial

You may not qualify if:

• \> 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)

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Links

• Link to the homepage of the Division of Cardiology, Pneumology, and Angiology at the University of Duesseldorf

MeSH Terms

Interventions

sodium nitrate; Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Tienush Rassaf, MD, PhD

  University of Duesseldorf

  STUDY CHAIR

• Christian Meyer, MD

  University of Duesseldorf

  PRINCIPAL INVESTIGATOR

• Christian Heiss, MD

  University of Duesseldorf

  PRINCIPAL INVESTIGATOR

• Malte Kelm, MD, PhD

  University of Duesseldorf

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christian Meyer, MD

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

DE (1)