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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01937754

Enrollment

Registered

2013-09-10

Start date

2013-01-31

Completion date

Unknown

Last updated

2013-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prehypertension

Keywords

Prehypertension, Nitric Oxide, Blood Pressure, Functional Capacity, Quality of Life

Brief summary

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

Interventions

DIETARY_SUPPLEMENTNitric Oxide supplement

Lozenge consisting of beetroot and 75 mg caffeine

DIETARY_SUPPLEMENTPlacebo

Same form factor and flavor as test lozenge but contains no active ingredients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Improvement in Quality of Life	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026