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

Pre-hypertension Clinical Trial

— 15NBHN  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02679248
• Other study ID #: 15NBHN
• Status: Terminated
• Phase: Phase 2
• First received: February 3, 2016
• Last updated: April 10, 2018
• Start date: February 3, 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2018
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: March 2017
• Est. primary completion date: February 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pre-hypertension
• Prehypertension

Intervention

Dietary Supplement:
• Neo40 Daily®

• Placebo

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario
Canada	Manna Research - Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	Neogenis Laboratories

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects with abnormal haematology		8 weeks
Other	Number of subjects with abnormal clinical chemistry		8 weeks
Other	Number of subjects with abnormal kidney function		8 weeks
Other	Number of subjects with abnormal liver function		8 weeks
Other	Number of subjects with abnormal blood electrolytes		8 weeks
Other	Number of subjects with abnormal blood pressure		8 weeks
Other	Number of subjects with abnormal heart rate		8 weeks
Other	Incidence of Adverse Events		8 weeks
Primary	Daytime Systolic BP	Mean ambulatory BP measured from 8am to 8pm	8 weeks
Secondary	Daytime Diastolic BP	Mean ambulatory BP measured from 8am to 8pm	8 weeks
Secondary	24-hour BP	Measured with ambulatory BP	8 weeks
Secondary	Night-time BP	Mean ambulatory BP measured from 12am to 6am	8 weeks
Secondary	BP Variability	Measured with ambulatory BP	8 weeks
Secondary	Seated BP	Seated, resting BP measured in office	8 weeks
Secondary	Serum Assay: Lipid Profile	Total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides, ApoB, ApoA1, sdLDL, Lp(a)	8 weeks
Secondary	Serum or Plasma Assay: Inflammatory Markers	MPO, LP-PLA2, hsCRP, ADMA/SDMA, oxLDL	8 weeks