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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679248
Recruitment Status : Terminated (Slow recruitment)
First Posted : February 10, 2016
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Neogenis Laboratories
Information provided by (Responsible Party):
KGK Science Inc.

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.

Condition or disease Intervention/treatment Phase
Pre-hypertension Dietary Supplement: Neo40 Daily® Dietary Supplement: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Double Blind, Placebo Controlled Parallel Study to Investigate the Effect of a Nitric Oxide Supplementation Product on Pre- and Mildly Hypertensive Adults.
Actual Study Start Date : February 3, 2016
Actual Primary Completion Date : February 3, 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neo40 Daily® Dietary Supplement: Neo40 Daily®
Experimental: Placebo Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Daytime Systolic BP [ Time Frame: 8 weeks ]
    Mean ambulatory BP measured from 8am to 8pm


Secondary Outcome Measures :
  1. Daytime Diastolic BP [ Time Frame: 8 weeks ]
    Mean ambulatory BP measured from 8am to 8pm

  2. 24-hour BP [ Time Frame: 8 weeks ]
    Measured with ambulatory BP

  3. Night-time BP [ Time Frame: 8 weeks ]
    Mean ambulatory BP measured from 12am to 6am

  4. BP Variability [ Time Frame: 8 weeks ]
    Measured with ambulatory BP

  5. Seated BP [ Time Frame: 8 weeks ]
    Seated, resting BP measured in office

  6. Serum Assay: Lipid Profile [ Time Frame: 8 weeks ]
    Total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides, ApoB, ApoA1, sdLDL, Lp(a)

  7. Serum or Plasma Assay: Inflammatory Markers [ Time Frame: 8 weeks ]
    MPO, LP-PLA2, hsCRP, ADMA/SDMA, oxLDL


Other Outcome Measures:
  1. Number of subjects with abnormal haematology [ Time Frame: 8 weeks ]
  2. Number of subjects with abnormal clinical chemistry [ Time Frame: 8 weeks ]
  3. Number of subjects with abnormal kidney function [ Time Frame: 8 weeks ]
  4. Number of subjects with abnormal liver function [ Time Frame: 8 weeks ]
  5. Number of subjects with abnormal blood electrolytes [ Time Frame: 8 weeks ]
  6. Number of subjects with abnormal blood pressure [ Time Frame: 8 weeks ]
  7. Number of subjects with abnormal heart rate [ Time Frame: 8 weeks ]
  8. Incidence of Adverse Events [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679248


Locations
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Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Manna Research - Toronto
Toronto, Ontario, Canada, M9W 4L6
Sponsors and Collaborators
KGK Science Inc.
Neogenis Laboratories
Investigators
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Principal Investigator: Tetyana Pelipyagina, MD KGK Science Inc.
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Responsible Party: KGK Science Inc.
ClinicalTrials.gov Identifier: NCT02679248    
Other Study ID Numbers: 15NBHN
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Keywords provided by KGK Science Inc.:
Pre-hypertension
Mild hypertension
Dietary supplement
Efficacy
Nitric oxide
Neo40 Daily
Additional relevant MeSH terms:
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Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases