Effect of Neo40 on PAD

Not Applicable

• Conditions: Peripheral Artery Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Neo40

• Registration Number: NCT02934438
• Lead Sponsor: HumanN

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

Not available

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-14
• Last Update Submitted: 2016-10-14
• Study First Posted: 2016-10-17
• Last Update Posted: 2016-10-17
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	A placebo product has been manufactured that looks, tastes and feels like the Neo40 active lozenge without the active ingredients
Neo40 Supplement	Neo40	Utilizing intellectual property developed out of the University of Texas Health Science Center in Houston, Neo40 is a GMP certified, over the counter, all natural formulation that provides a system for generating NO in an endothelium-dependent and independent manner. The NEO40™ Daily™ product ingredients list and packaging was submitted to FDA Office of Compliance by Neogenis Labs, Inc. for use as a dietary supplement. It is made up of Beet root extract, hawthorne berry, Vitamin C, L-citrulline and sodium nitrite. The lozenges utilize natural product chemistry activated by the saliva to generate authentic NO gas in the oral cavity through the one-electron reduction of nitrite. This product's formulation was designed to be a quick dissolve that melts in the mouth within four to five minutes.

Primary Outcome Measures

Name	Time	Method
Skinner-Gardner treadmill protocol.	3 months	The primary end point is the change at 3 months in the absolute claudication distance. Distance will be measured in meters walked on treadmill

Secondary Outcome Measures

Name	Time	Method
Endothelial function	3 months	Secondary objectives are to evaluate endothelial function. EndoPAT score of 1.67 and below correlates to endothelial dysfunction.