Ignite Creation Date:
2024-05-06 @ 9:13 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02934438
Status:
UNKNOWN
Last Update Posted:
2016-10-17
First Post:
2016-10-12
Brief Title:
Effect of Neo40 on PAD
Sponsor:
HumanN
Organization:
HumanN
Study Overview
Official Title:
The Effects of an Oral Nitric Oxide Lozenge on Peripheral Artery Disease
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Reduced nitric oxide NO availability is a hallmark of a number of cardiovascular diseases CVD including peripheral artery disease PAD The investigators will test the hypothesis that sub-chronic NEO40 supplementation will improve vascular NO function and improve intermittent claudication in patients with PAD Using a prospective double blind placebo controlled experimental design in 30 patients graded treadmill tests will be performed at baseline and after 3 months after randomization according to the Skinner-Gardner protocol Initial claudication distance ICD and absolute claudication distance ACD will be recorded Two consecutive treadmill tests will be performed within 1 week at baseline before administration of study drug and 2 test will be performed at 3 months Functional status will also be assessed by the Walking Impairment Questionnaire and the Health Status Survey SF-36 questionnaire SF-36 Vascular function will be assessed with the use of a Vendys vascular reactivity endothelial function test Endothelix Inc Digital pulse amplitude will be assessed using sensor probes on the index finger during reactive hyperemia Blood will be collected for measurement by Neogenis of plasma levels of nitrite and nitrate at baseline and at the completion of the study Based on previously published trials using this NO technology the investigators predict that the group receiving the active supplement will exhibit an improvement in claudication distance and all measures of vascular function after 3 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None