Study of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults

Neogenis Laboratories

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Prehypertension

Treatments: Dietary Supplement: Nitric Oxide supplement; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01937754

Neo-4085

Details and patient eligibility

About

Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults between the ages of 18 to 80 years
• Two blood pressure readings of >/=135/80 mmHg at rest, thus representing prehypertension
• Informed consent

Exclusion criteria

• Existence of any significant internal or cardiovascular disease;
• Current use of any antihypertensive medication.
• Inability to give informed consent, or fill out standard questionnaires or inability to follow up clinically.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Nitric Oxide supplement

Active Comparator group

Treatment:

Dietary Supplement: Nitric Oxide supplement

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo