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

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ClinicalTrials.gov Identifier: NCT01937754
Recruitment Status : Unknown
Verified September 2013 by Dr. Ernst Schwarz, Neogenis Laboratories.
Recruitment status was:  Active, not recruiting
First Posted : September 10, 2013
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Ernst Schwarz, Neogenis Laboratories

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

Condition or disease Intervention/treatment Phase
Prehypertension Dietary Supplement: Nitric Oxide supplement Dietary Supplement: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension
Study Start Date : January 2013
Estimated Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitric Oxide supplement Dietary Supplement: Nitric Oxide supplement
Lozenge consisting of beetroot and 75 mg caffeine
Other Name: Neo40 Daily

Placebo Comparator: Placebo Dietary Supplement: Placebo
Same form factor and flavor as test lozenge but contains no active ingredients




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937754


Locations
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United States, California
California Medical Institute
Beverly Hills, California, United States, 90211
Sponsors and Collaborators
Neogenis Laboratories
Investigators
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Principal Investigator: Ernst Schwarz, MD, PhD California Medical Institute, Cedars Sinai Medical Center

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Responsible Party: Dr. Ernst Schwarz, Attending Cardiologist, Professor of Medicine, Neogenis Laboratories
ClinicalTrials.gov Identifier: NCT01937754     History of Changes
Other Study ID Numbers: Neo-4085
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Keywords provided by Dr. Ernst Schwarz, Neogenis Laboratories:
Prehypertension
Nitric Oxide
Blood Pressure
Functional Capacity
Quality of Life

Additional relevant MeSH terms:
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Prehypertension
Vascular Diseases
Cardiovascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents