Back to resultsStudy of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults
Primary Purpose
Prehypertension
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nitric Oxide supplement
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Prehypertension focused on measuring Prehypertension, Nitric Oxide, Blood Pressure, Functional Capacity, Quality of Life
Eligibility 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.
Sites / Locations
- California Medical Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nitric Oxide supplement
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01937754
First Posted
August 29, 2013
Last Updated
September 4, 2013
Sponsor
Neogenis Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01937754
Brief Title
Study of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults
Official Title
Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neogenis Laboratories
4. Oversight
5. Study Description
Brief Summary
Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension
Keywords
Prehypertension, Nitric Oxide, Blood Pressure, Functional Capacity, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nitric Oxide supplement
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Nitric Oxide supplement
Other Intervention Name(s)
Neo40 Daily
Intervention Description
Lozenge consisting of beetroot and 75 mg caffeine
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Same form factor and flavor as test lozenge but contains no active ingredients
Primary Outcome Measure Information:
Title
Reduction in Systolic and Diastolic Blood Pressure Readings
Description
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 Outcome Measure Information:
Title
Improvement in Functional Capacity
Description
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
Other Pre-specified Outcome Measures:
Title
Improvement in Quality of Life
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernst Schwarz, MD, PhD
Organizational Affiliation
California Medical Institute, Cedars Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Medical Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults
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