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

September 4, 2013 updated by: Dr. Ernst Schwarz, Neogenis Laboratories

Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • California Medical Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo
Same form factor and flavor as test lozenge but contains no active ingredients
ACTIVE_COMPARATOR: Nitric Oxide supplement
Dietary supplement: Nitric Oxide supplement
Lozenge consisting of beetroot and 75 mg caffeine
Other Names:
  • Neo40 Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Systolic and Diastolic Blood Pressure Readings
Time Frame: 30 days
Two blood pressure readings at rest will be taken at baseline and again after thirty days during the follow-up appointment.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Functional Capacity
Time Frame: 30 days
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.
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Quality of Life
Time Frame: 30 days
Participants will fill out a standardized quality of life questionnaire at baseline and again after thirty days during the follow-up appointment. Summary component scores will be recorded and compared.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neogenis Laboratories

Investigators

  • Principal Investigator: Ernst Schwarz, MD, PhD, California Medical Institute, Cedars Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (ESTIMATE)

September 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neo-4085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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