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

KGK Science

Status and phase

Terminated

Phase 2

Conditions

Pre-hypertension

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Neo40 Daily®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02679248

15NBHN

Details and patient eligibility

About

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.

Enrollment

67 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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