Clinical trial NCT02934438: Effect of Neo40 on PAD
Official title: The Effects of an Oral Nitric Oxide Lozenge on Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: nitric oxide
Neo40 supplement,
exercise tolerance
Lead sponsor: HumanN
Sponsor class: INDUSTRY
Collaborators: name: The Methodist Hospital Research Institute
First posted: 2016-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Skinner-Gardner treadmill protocol.
timeFrame: 3 months
Secondary outcomes:
measure: Endothelial function
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: