Pre-hypertension
Conditions
Keywords
Pre-hypertension, Mild hypertension, Dietary supplement, Efficacy, Nitric oxide, Neo40 Daily
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.
Interventions
DIETARY_SUPPLEMENTNeo40 Daily®
DIETARY_SUPPLEMENTPlacebo
Sponsors
Neogenis Laboratories
KGK Science Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daytime Systolic BP | 8 weeks | Mean ambulatory BP measured from 8am to 8pm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daytime Diastolic BP | 8 weeks | Mean ambulatory BP measured from 8am to 8pm |
| 24-hour BP | 8 weeks | Measured with ambulatory BP |
| Night-time BP | 8 weeks | Mean ambulatory BP measured from 12am to 6am |
| BP Variability | 8 weeks | Measured with ambulatory BP |
| Seated BP | 8 weeks | Seated, resting BP measured in office |
| Serum Assay: Lipid Profile | 8 weeks | Total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides, ApoB, ApoA1, sdLDL, Lp(a) |
| Serum or Plasma Assay: Inflammatory Markers | 8 weeks | MPO, LP-PLA2, hsCRP, ADMA/SDMA, oxLDL |
Other
| 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 |
Countries
Canada
Outcome results
None listed