Effect of Neo40 on PAD

Peripheral Artery Disease Clinical Trial

Official title:

The Effects of an Oral Nitric Oxide Lozenge on Peripheral Artery Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02934438
• Other study ID #: R41AT009171-01A1
• Status: Not yet recruiting
• Phase: N/A
• First received: October 12, 2016
• Last updated: October 14, 2016
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2016
• Source: HumanN
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• Persons of at least 45 years of age

• Persons with unilateral or bilateral PAD confirmed by a resting ankle-brachial index (ABI) <0.9

• Persons with stable intermittent claudication for the previous 3 months

• Persons with the ability to walk 1 to 12 minutes on a treadmill. The pre-randomization treadmill test is limited by exercise-induced leg pain, which is relieved by cessation of the test. Variability of maximum walking distances between 2 consecutive screening treadmill tests will be <10%.

Exclusion Criteria:

• Persons with ischemic rest pain, ulceration or gangrene

• Persons with history in the previous 3 months of acute coronary syndrome or revascularization involving the peripheral or coronary arteries

• Persons with major amputation

• Persons with malignancy within the previous 5 years (except for treated non-melanoma skin cancer)

• Persons with proliferative retinopathy

• Persons with uncontrolled hypertension

• Persons with active inflammatory, infectious, or autoimmune diseases.

• Persons taking taking phosphodiesterase inhibitors, organic nitrates and/or hydralazine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Dietary Supplement:
• Neo40

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
HumanN	The Methodist Hospital System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skinner-Gardner treadmill protocol.	The primary end point is the change at 3 months in the absolute claudication distance. Distance will be measured in meters walked on treadmill	3 months	No
Secondary	Endothelial function	Secondary objectives are to evaluate endothelial function. EndoPAT score of 1.67 and below correlates to endothelial dysfunction.	3 months	No