Effects of Dietary Nitrate on Age-related Vascular Function

December 6, 2013 updated by: Heinrich-Heine University, Duesseldorf

Effects of Dietary Nitrate Supplementation on Age-related Vascular Dysfunction

Purpose of the study is to characterize the chronic effect of dietary nitrate on vascular function in healthy volunteers with particular emphasis on age-related alterations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nrw,
      • Duesseldorf,, Nrw,, Germany, 40225
        • Heinrich-Heine-University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

>55 Years Healthy

Exclusion Criteria:

known cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nitrate
150µmol /Kg bodyweight /day
Dietary supplement: Nitrate
Dietary Supplement
PLACEBO_COMPARATOR: PLacebo
150µmol /Kg bodyweight /day
Dietary supplement: Placebo
Dietary Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial function measured by flow-mediated dilation (FMD)
Time Frame: 30 days
The effect of dietary nitrate on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (ESTIMATE)

November 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 6, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Nitrate for vascular age

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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