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

Prehypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01937754
• Other study ID #: Neo-4085
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: August 29, 2013
• Last updated: September 4, 2013
• Start date: January 2013

Study information

• Verified date: September 2013
• Source: Neogenis Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prehypertension

Intervention

Dietary Supplement:
• Nitric Oxide supplement
Lozenge consisting of beetroot and 75 mg caffeine
• Placebo
Same form factor and flavor as test lozenge but contains no active ingredients

Locations

Country	Name	City	State
United States	California Medical Institute	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Neogenis Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in Quality of Life	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	No
Primary	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.	30 days	No
Secondary	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.	30 days	No