Effect of Neo40 on PAD

NCT ID: NCT02934438

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-10-31

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Neo40 Supplement

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.

Group Type: ACTIVE_COMPARATOR

Neo40

Intervention Type: DIETARY_SUPPLEMENT

Placebo

A placebo product has been manufactured that looks, tastes and feels like the Neo40 active lozenge without the active ingredients

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Neo40

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: collaborator

HumanN

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

R41AT009171-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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