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

Phase 2

Terminated

• Conditions: Pre-hypertension
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Neo40 Daily®

• Registration Number: NCT02679248
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-03
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Primary Completion: 2017-02-03
• Study Completion: 2017-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Neo40 Daily®	Neo40 Daily®	-

Primary Outcome Measures

Name	Time	Method
Daytime Systolic BP	8 weeks	Mean ambulatory BP measured from 8am to 8pm

Secondary Outcome Measures

Name	Time	Method
24-hour BP	8 weeks	Measured with ambulatory BP
Seated BP	8 weeks	Seated, resting BP measured in office
Daytime Diastolic BP	8 weeks	Mean ambulatory BP measured from 8am to 8pm
Night-time BP	8 weeks	Mean ambulatory BP measured from 12am to 6am
BP Variability	8 weeks	Measured with ambulatory BP
Serum or Plasma Assay: Inflammatory Markers	8 weeks	MPO, LP-PLA2, hsCRP, ADMA/SDMA, oxLDL
Serum Assay: Lipid Profile	8 weeks	Total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides, ApoB, ApoA1, sdLDL, Lp(a)

Trial Locations

Locations (2)

KGK Synergize Inc.; 🇨🇦 London, Ontario, Canada

Manna Research - Toronto; 🇨🇦 Toronto, Ontario, Canada