Effect of Neo40 on PAD
Peripheral Artery Disease
About this trial
This is an interventional treatment trial for Peripheral Artery Disease focused on measuring nitric oxide, Neo40 supplement,, exercise tolerance
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Neo40 Supplement
Placebo
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.
A placebo product has been manufactured that looks, tastes and feels like the Neo40 active lozenge without the active ingredients