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

NCT02679248 | Terminated Phase 2

• 1 other identifier: 15NBHN
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pre-hypertension

Keywords

Pre-hypertension; Mild hypertension; Dietary supplement; Efficacy; Nitric oxide; Neo40 Daily

Outcome Measures

Primary Outcomes (1)

• Daytime Systolic BP

  Mean ambulatory BP measured from 8am to 8pm

  8 weeks

Secondary Outcomes (7)

• Daytime Diastolic BP

  8 weeks

• 24-hour BP

  8 weeks

• Night-time BP

  8 weeks

• BP Variability

  8 weeks

• Seated BP

  8 weeks

Other Outcomes (8)

• 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

Study Arms (2)

Neo40 Daily®

EXPERIMENTAL

Dietary Supplement: Neo40 Daily®

Placebo

EXPERIMENTAL

Dietary Supplement: Placebo

Interventions

Neo40 Daily® DIETARY_SUPPLEMENT

Neo40 Daily®

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KGK Science Inc.: lead
• Neogenis Laboratories: collaborator

Study Sites (2)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Manna Research - Toronto

Toronto, Ontario, M9W 4L6, Canada

Location

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 10, 2016
• Study Start: February 3, 2016
• Primary Completion: February 3, 2017
• Study Completion: March 1, 2017
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

CA (2)