Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 29, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date September 10, 2013
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 4, 2013)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults
Official Title  ICMJE Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension
Brief Summary Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Prehypertension
Intervention  ICMJE
  • Dietary Supplement: Nitric Oxide supplement
    Lozenge consisting of beetroot and 75 mg caffeine
    Other Name: Neo40 Daily
  • Dietary Supplement: Placebo
    Same form factor and flavor as test lozenge but contains no active ingredients
Study Arms  ICMJE
  • Active Comparator: Nitric Oxide supplement
    Intervention: Dietary Supplement: Nitric Oxide supplement
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 4, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01937754
Other Study ID Numbers  ICMJE Neo-4085
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Ernst Schwarz, Neogenis Laboratories
Study Sponsor  ICMJE Neogenis Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ernst Schwarz, MD, PhD California Medical Institute, Cedars Sinai Medical Center
PRS Account Neogenis Laboratories
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP