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

Phase 2UnknownNCT01937754

Neogenis Laboratories30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Prehypertension

Interventions

Nitric Oxide supplementDIETARY_SUPPLEMENT

Lozenge consisting of beetroot and 75 mg caffeine

PlaceboDIETARY_SUPPLEMENT

Same form factor and flavor as test lozenge but contains no active ingredients

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

California Medical Institute

Beverly Hills, California, United States

Outcomes

Primary Outcomes

Reduction in Systolic and Diastolic Blood Pressure Readings

Two blood pressure readings at rest will be taken at baseline and again after thirty days during the follow-up appointment.

Time frame: 30 days

Secondary Outcomes

Improvement in Functional Capacity

Participant will take a six minute walk test at baseline and again after thirty days during the follow-up appointment. Achieved distances will be measured and recorded.

Time frame: 30 days

Data from ClinicalTrials.gov

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