Pre-hypertensionPhase 215NBHNNCT02679248
A Study to Investigate the Effect of a Nitric Oxide Supplementation on Pre- and Mildly Hypertensive Adults
A Phase 2 study testing Neo40 Daily® in people with Pre-hypertension, run by KGK Science Inc. at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-hypertension
- What is being tested?
- Neo40 Daily®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 2 sitesCanada
- Study dates
- 3 Feb 2016to Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
KGK Synergize Inc.
London, Ontario, N6A 5R8
Manna Research - Toronto
Toronto, Ontario, M9W 4L6
About this study
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.
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.
- Conditions
- Pre-hypertension
- Being tested
- Neo40 Daily®, Placebo
- Keywords
- Pre-hypertension, Mild hypertension, Dietary supplement, Efficacy, Nitric oxide, Neo40 Daily
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo40 Daily®Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Neo40 Daily® | Experimental | Not described Receives: Dietary Supplement: Neo40 Daily® |
| Placebo | Experimental | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime Systolic BP
Mean ambulatory BP measured from 8am to 8pm
Measured: 8 weeks
Secondary outcomes (7)
Daytime Diastolic BP
Mean ambulatory BP measured from 8am to 8pm
Measured: 8 weeks
24-hour BP
Measured with ambulatory BP
Measured: 8 weeks
Night-time BP
Mean ambulatory BP measured from 12am to 6am
Measured: 8 weeks
BP Variability
Measured with ambulatory BP
Measured: 8 weeks
Seated BP
Seated, resting BP measured in office
Measured: 8 weeks
Serum Assay: Lipid Profile
Total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides, ApoB, ApoA1, sdLDL, Lp(a)
Measured: 8 weeks
Serum or Plasma Assay: Inflammatory Markers
MPO, LP-PLA2, hsCRP, ADMA/SDMA, oxLDL
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study start3 Feb 2016
- Primary completion3 Feb 2017
- Study completionMar 2017
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-hypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neogenis Laboratories
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679248
- Sponsor's protocol ID
- 15NBHN
- Acronym
- 15NBHN
- Status last verified
- Apr 2018
- First submitted
- 3 Feb 2016
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02679248
- Acronym / sponsor ID
- 15NBHN / 15NBHN
- Conditions
- Pre-hypertension
- Keywords
- Pre-hypertension, Mild hypertension, Dietary supplement, Efficacy, Nitric oxide, Neo40 Daily
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 67 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Neogenis Laboratories
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neo40 Daily® | Experimental | Dietary Supplement: Neo40 Daily® |
| Placebo | Experimental | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neo40 Daily® | Dietary supplement | Neo40 Daily® |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Daytime Systolic BP
Time frame: 8 weeks
Mean ambulatory BP measured from 8am to 8pm
7 secondary outcomes
Daytime Diastolic BP
Time frame: 8 weeks
24-hour BP
Time frame: 8 weeks
Night-time BP
Time frame: 8 weeks
BP Variability
Time frame: 8 weeks
Seated BP
Time frame: 8 weeks
Serum Assay: Lipid Profile
Time frame: 8 weeks
Serum or Plasma Assay: Inflammatory Markers
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetyana Pelipyagina, MD principal investigator
KGK Science Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neo40 Daily® in people with Pre-hypertension, run by KGK Science Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime Systolic BP (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.