NCT01729234

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

November 14, 2012

Last Update Submit

December 6, 2013

Conditions

Keywords

age related Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Endothelial function measured by flow-mediated dilation (FMD)

    The effect of dietary nitrate on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.

    30 days

Study Arms (2)

Nitrate

EXPERIMENTAL

150µmol /Kg bodyweight /day

Dietary Supplement: Nitrate

PLacebo

PLACEBO COMPARATOR

150µmol /Kg bodyweight /day

Dietary Supplement: Placebo

Interventions

NitrateDIETARY_SUPPLEMENT

Dietary Supplement

Nitrate
PlaceboDIETARY_SUPPLEMENT

Dietary Supplement

PLacebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>55 Years Healthy

You may not qualify if:

  • known cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Interventions

Nitrates

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsNitric AcidNitrogen CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 20, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations