Clinical trial NCT02679248: A Study to Investigate the Effect of a Nitric Oxide Supplementation on Pre- and Mildly Hypertensive Adults
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pre-hypertension
Keywords: Pre-hypertension
Mild hypertension
Dietary supplement
Efficacy
Nitric oxide
Neo40 Daily
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Neogenis Laboratories
First posted: 2016-02-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Daytime Systolic BP
timeFrame: 8 weeks
Secondary outcomes:
measure: Daytime Diastolic BP
timeFrame: 8 weeks
measure: 24-hour BP
timeFrame: 8 weeks
measure: Night-time BP
timeFrame: 8 weeks
measure: BP Variability
timeFrame: 8 weeks
measure: Seated BP
timeFrame: 8 weeks
measure: Serum Assay: Lipid Profile
timeFrame: 8 weeks
measure: Serum or Plasma Assay: Inflammatory Markers
timeFrame: 8 weeks
Other outcomes:
measure: Number of subjects with abnormal haematology
timeFrame: 8 weeks
measure: Number of subjects with abnormal clinical chemistry
timeFrame: 8 weeks
measure: Number of subjects with abnormal kidney function
timeFrame: 8 weeks
measure: Number of subjects with abnormal liver function
timeFrame: 8 weeks
measure: Number of subjects with abnormal blood electrolytes
timeFrame: 8 weeks
measure: Number of subjects with abnormal blood pressure
timeFrame: 8 weeks
measure: Number of subjects with abnormal heart rate
timeFrame: 8 weeks
measure: Incidence of Adverse Events
timeFrame: 8 weeks
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
city: Toronto
country: Canada
facility: Manna Research - Toronto
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Tetyana Pelipyagina, MD
role: PRINCIPAL_INVESTIGATOR
References: