A Study to Investigate the Effect of a Nitric Oxide Supplementation on Pre- and Mildly Hypertensive Adults (15NBHN)

A Double Blind, Placebo Controlled Parallel Study to Investigate the Effect of a Nitric Oxide Supplementation Product on Pre- and Mildly Hypertensive Adults.

This study will investigate the effect of a nitric oxide supplementation product, Neo40 Daily®, on blood pressure in pre-hypertensive and mildly hypertensive adults. Subjects will take 2 lozenges per day 12 hours apart for 8 weeks. Half of the subjects will receive Neo40 Daily® and the other half of the subjects will receive placebo.

Study Overview

• Status: Terminated
• Conditions: Pre-hypertension
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Neo40 Daily®

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research - Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:

  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Double-barrier method
  • Non-hormonal intrauterine devices
  • Vasectomy of partner
• BMI 18.5-29.9 kg/m2 (±1 kg/m2)
• Seated resting systolic blood pressures between 130-150 mmHg (inclusive) and diastolic blood pressure ≤ 100 mmHg at screening visit
• Agreement to maintain current level of physical activity and diet throughout the study
• Agrees to comply with study procedures including willingness to fast at least 12 hours before blood samples, abstain from alcohol two days prior to blood sampling and blood pressure measurement, abstain from coffee at least 14 hours before blood pressure measurement and abstain from physical exercise at least 4 hours before and during blood pressure measurement
• Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

• Has given voluntary, written, informed consent to participate in the study
• Use of medication for the treatment of hypertension
• Use of prescription diuretics
• Use of natural health products for the treatment of hypertension within 2 weeks of screening (e.g. garlic supplements, french lavender supplements, cardamom supplements, cinnamon supplements, basil supplements, hawthorn cats claw and celery seed supplements)
• Significant cardiac history defined as a history of myocardial infarction (MI); coronary angioplasty or bypass graft(s); Valvular disease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; coronary artery disease (CAD); or angina (stable or unstable)
• Type I or Type II diabetes
• Diagnosis of hypertensive retinopathy, left ventricular dysfunction or peripheral artery disease
• Abnormal electrolytes, liver or kidney function
• Diagnosis of secondary hypertension
• Diagnosis of anemia
• Unstable medical conditions that in the opinion of the Qualified Investigator preclude the volunteer from participating in the study
• Alcohol or drug abuse within the last 6 months
• Use of medicinal marijuana
• Clinically significant abnormal laboratory results at screening
• Participation in a clinical research trial within 30 days prior to randomization
• Allergy or sensitivity to study supplement ingredients
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Dietary supplement: Placebo
Experimental: Neo40 Daily®	Dietary supplement: Neo40 Daily®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime Systolic BP	Mean ambulatory BP measured from 8am to 8pm	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime Diastolic BP	Mean ambulatory BP measured from 8am to 8pm	8 weeks
24-hour BP	Measured with ambulatory BP	8 weeks
Night-time BP	Mean ambulatory BP measured from 12am to 6am	8 weeks
BP Variability	Measured with ambulatory BP	8 weeks
Seated BP	Seated, resting BP measured in office	8 weeks
Serum Assay: Lipid Profile	Total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides, ApoB, ApoA1, sdLDL, Lp(a)	8 weeks
Serum or Plasma Assay: Inflammatory Markers	MPO, LP-PLA2, hsCRP, ADMA/SDMA, oxLDL	8 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Number of subjects with abnormal haematology	8 weeks
Number of subjects with abnormal clinical chemistry	8 weeks
Number of subjects with abnormal kidney function	8 weeks
Number of subjects with abnormal liver function	8 weeks
Number of subjects with abnormal blood electrolytes	8 weeks
Number of subjects with abnormal blood pressure	8 weeks
Number of subjects with abnormal heart rate	8 weeks
Incidence of Adverse Events	8 weeks

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: Neogenis Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2016
• Primary Completion (Actual): February 3, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Efficacy; Dietary supplement; Nitric oxide; Pre-hypertension; Mild hypertension; Neo40 Daily
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Prehypertension
• Other Study ID Numbers: 15NBHN