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

NCT ID: NCT01937754

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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

Detailed Description

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Conditions

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Prehypertension

Keywords

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Prehypertension Nitric Oxide Blood Pressure Functional Capacity Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nitric Oxide supplement

Group Type ACTIVE_COMPARATOR

Nitric Oxide supplement

Intervention Type DIETARY_SUPPLEMENT

Lozenge consisting of beetroot and 75 mg caffeine

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Nitric Oxide supplement

Lozenge consisting of beetroot and 75 mg caffeine

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Neo40 Daily

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neogenis Laboratories

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ernst Schwarz

Attending Cardiologist, Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ernst Schwarz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

California Medical Institute, Cedars Sinai Medical Center

Locations

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California Medical Institute

Beverly Hills, California, United States

Site Status

Countries

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United States

Other Identifiers

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Neo-4085

Identifier Type: -

Identifier Source: org_study_id