NCT01937754

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2013

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

8 months

First QC Date

August 29, 2013

Last Update Submit

September 4, 2013

Conditions

Prehypertension

Keywords

PrehypertensionNitric OxideBlood PressureFunctional CapacityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Improvement in Functional Capacity

    30 days

Other Outcomes (1)

  • Improvement in Quality of Life

    30 days

Study Arms (2)

Nitric Oxide supplement

ACTIVE COMPARATOR
Dietary Supplement: Nitric Oxide supplement

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Nitric Oxide supplementDIETARY_SUPPLEMENT

Lozenge consisting of beetroot and 75 mg caffeine

Also known as: Neo40 Daily
Nitric Oxide supplement
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between the ages of 18 to 80 years
  • Two blood pressure readings of \>/=135/80 mmHg at rest, thus representing prehypertension
  • Informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Medical Institute

Beverly Hills, California, 90211, United States

Location

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ernst Schwarz, MD, PhD

    California Medical Institute, Cedars Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Cardiologist, Professor of Medicine

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 10, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2013

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

US(1)