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

Phase 1

• Conditions: Prehypertension
• Interventions: Dietary Supplement: Nitric Oxide supplement; Dietary Supplement: Placebo

• Registration Number: NCT01937754
• Lead Sponsor: Neogenis Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-08-29
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study First Submitted QC: 2013-09-04
• Last Update Submitted: 2013-09-04
• Study First Posted: 2013-09-10
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitric Oxide supplement	Nitric Oxide supplement	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Reduction in Systolic and Diastolic Blood Pressure Readings	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

Name	Time	Method
Improvement in Functional Capacity	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.

Trial Locations

Locations (1)

California Medical Institute; 🇺🇸 Beverly Hills, California, United States