HypertensionNCT03895749
Effect of a Nitric Oxide Supplementation Product on Endothelial Dysfunction and Prehypertensive Adults
A study testing NEO40 Daily in people with Hypertension, run by Hypertension Institute, Nashville at 1 site in United States.
Trial summary
The nitric oxide supplementation product, Neo40 Daily®, provides a dietary source of No2-. The product also allows for robust No2-reduction to NO from the extremely potent nitrite-reducing capacity of the polyphenols found in Hawthorne berry.(Bartsch et al., 1993) Neo40 Daily® is a unique product since it provides the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- NEO40 Daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2017to 18 Apr 2018
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with seated resting systolic blood pressures between 130-160 mmHg and diastolic between 85 and 100 mm Hg (inclusive) at screening visit
- Subjects with an elevated ADMA
- 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
Who cannot join
- Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study.
- Seated office systolic blood pressure ou side of the target range (systolic BP<130 mm Hg or >160 mmHg) or diastolic BP< 85 or 100 mm Hg at screening visit
- The use of natural health products for th treatment of hypertension within 2 weeks of screening
- Significant cardiac history defined as a h story of myocardial infarction (Ml); coronary angioplasty or bypass graft(s); Valvular isease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD)
- Type I diabetes
- Unstable medical conditions that in the opinion of the Principle Investigator preclude the subject from participating in the study
Show all 12Show fewer
- Alcohol or drug abuse within the last 6 months
- Clinically significant abnormal laboratory results at screening
- Participation in a clinical research trial wi hin 30 days prior to randomization
- Allergy or sensitivity to study supplemen ingredients
- Individuals who are cognitively impaired nd/or who are unable to give informed consent
- Any other condition which in the lnvestig tor's opinion may adversely affect the subject's ability to complete the study or its meas res or which may pose significant risk to the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Parallel Study to Investigate the Effect of a Nitric Oxide Supplementation Product on Endothelial Dysfunction and Prehypertensive Adults
The nitric oxide supplementation product, Neo40 Daily®, provides a dietary source of No2-. The product also allows for robust No2-reduction to NO from the extremely potent nitrite-reducing capacity of the polyphenols found in Hawthorne berry.(Bartsch et al., 1993) Neo40 Daily® is a unique product since it provides the dietary source of No2-, as well as the rate limiting No2- reduction activity.
Read the detailed description
Neo40 Daily® facilitates both endothelial dependent and independent NO production. The acute effects of Neo40 Daily® have been demonstrated in hypertensive patients.(Zand et al., 2011) Within 30 minutes following a single dose of the Neo40 Daily®, a significant reduction in systolic/diastolic BP and vascular compliance was observed, as well as, 4 hours following treatment, a significant improvement in endothelial function was seen. Furthermore, it has been used in longer term clinical trials to show elevated plasma levels of No3• and No2·, indicating an increase in systemically available NO, and lower levels of triglycerides in an older population with cardiovascular risk factors.(Zand et al., 2011) This pilot study also demonstrated a trend towards reduced BP and improved quality of life among its prehypertensive participates (Biswas et al., 2015). This current clinical trial aims to expand on this pilot study and examine the effect of NO supplementation on a pre- and mildly hypertensive populations with endothelial dysfunction as measured by EndoPAr® and asymmetric dimethyl L-arginine (ADMA). In a double blinded placebo controlled parallel arm study, we will further investigate the effect of Neo40 Daily® on 40 pre- and mildly hypertensive subjects with regards to changes in blood pressure, endothelial dysfunction and other markers of NO availability and CVD risk.
- Conditions
- Hypertension
- Being tested
- NEO40 Daily
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEO40 DailyDietary supplement
Per Capsule: N5-carbamoylornithine 100 mg, crataegus laevigata 100 mg, L-ascorbic acid 50 mg, vitamin B-12 0.05 mg, vitamin C 50 mg.
| Study group | Role | What they receive |
|---|---|---|
| Neo40 Daily | Active comparator | Per Capsule: N5-carbamoylornithine 100 mg, crataegus laevigata 100 mg, L-ascorbic acid 50 mg, vitamin B-12 0.05 mg, vitamin C 50 mg. Receives: Dietary Supplement: NEO40 Daily |
| Placebo | Placebo comparator | Per Capsule: Beet Juice concentrate, Carmine, Croscarmellose Sodium, D-Mannitol, Magnesium Stearate, Orange flavour, Silicon dioxide, Stevia rebaudiana leaf, Xylitol. Receives: Dietary Supplement: NEO40 Daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome is the between-group changes from baseline (Day 0) to end of study (Day 30) in daytime mean systolic and diastolic BP.
The primary efficacy outcome to be analyzed is the between-group changes from baseline (Day 0) to end of study (Day 30) in daytime mean systolic and diastolic BP readings using AHA guidelines.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start5 Apr 2017
- Primary completion1 Feb 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II, randomized,double-blind, placebo-controlled 2 arm parallel
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hypertension Institute, Nashville
- Sponsor type
- University, hospital or other
- Collaborators
- Neogenis Laboratories
- Responsible party
- Sponsor
- Investigators
- Mark Houston, MD, Principal investigator, Hypertension Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895749
- Sponsor's protocol ID
- Neo40 ADMA
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. 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 Endothelial Dysfunction and Prehypertensive Adults
- ClinicalTrials.gov ID
- NCT03895749
- Acronym / sponsor ID
- Neo40 ADMA
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hypertension Institute, NashvilleUniversity, hospital or other
- Collaborators
- Neogenis Laboratories
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 29 Mar 2019 (actual)
- 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.
The nitric oxide supplementation product, Neo40 Daily®, provides a dietary source of No2-. The product also allows for robust No2-reduction to NO from the extremely potent nitrite-reducing capacity of the polyphenols found in Hawthorne berry.(Bartsch et al., 1993) Neo40 Daily® is a unique product since it provides the dietary source of No2-, as well as the rate limiting No2- reduction activity.
Detailed description
Neo40 Daily® facilitates both endothelial dependent and independent NO production. The acute effects of Neo40 Daily® have been demonstrated in hypertensive patients.(Zand et al., 2011) Within 30 minutes following a single dose of the Neo40 Daily®, a significant reduction in systolic/diastolic BP and vascular compliance was observed, as well as, 4 hours following treatment, a significant improvement in endothelial function was seen. Furthermore, it has been used in longer term clinical trials to show elevated plasma levels of No3• and No2·, indicating an increase in systemically available NO, and lower levels of triglycerides in an older population with cardiovascular risk factors.(Zand et al., 2011) This pilot study also demonstrated a trend towards reduced BP and improved quality of life among its prehypertensive participates (Biswas et al., 2015). This current clinical trial aims to expand on this pilot study and examine the effect of NO supplementation on a pre- and mildly hypertensive populations with endothelial dysfunction as measured by EndoPAr® and asymmetric dimethyl L-arginine (ADMA). In a double blinded placebo controlled parallel arm study, we will further investigate the effect of Neo40 Daily® on 40 pre- and mildly hypertensive subjects with regards to changes in blood pressure, endothelial dysfunction and other markers of NO availability and CVD risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase II, randomized,double-blind, placebo-controlled 2 arm parallel
| Arm | Type | Receives |
|---|---|---|
| Neo40 Daily | Active comparator | Dietary Supplement: NEO40 DailyPer Capsule: N5-carbamoylornithine 100 mg, crataegus laevigata 100 mg, L-ascorbic acid 50 mg, vitamin B-12 0.05 mg, vitamin C 50 mg. |
| Placebo | Placebo comparator | Dietary Supplement: NEO40 DailyPer Capsule: Beet Juice concentrate, Carmine, Croscarmellose Sodium, D-Mannitol, Magnesium Stearate, Orange flavour, Silicon dioxide, Stevia rebaudiana leaf, Xylitol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with seated resting systolic blood pressures between 130-160 mmHg and diastolic between 85 and 100 mm Hg (inclusive) at screening visit
- Subjects with an elevated ADMA
- 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
Key exclusion criteria (12 listed)
- Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study.
- Seated office systolic blood pressure ou side of the target range (systolic BP<130 mm Hg or >160 mmHg) or diastolic BP< 85 or 100 mm Hg at screening visit
- The use of natural health products for th treatment of hypertension within 2 weeks of screening
- Significant cardiac history defined as a h story of myocardial infarction (Ml); coronary angioplasty or bypass graft(s); Valvular isease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD)
- Type I diabetes
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 DailyPer Capsule: N5-carbamoylornithine 100 mg, crataegus laevigata 100 mg, L-ascorbic acid 50 mg, vitamin B-12 0.05 mg, vitamin C 50 mg. | Dietary supplement | Neo40 Daily, Placebo |
Primary outcome
The primary efficacy outcome is the between-group changes from baseline (Day 0) to end of study (Day 30) in daytime mean systolic and diastolic BP.
Time frame: 30 days
The primary efficacy outcome to be analyzed is the between-group changes from baseline (Day 0) to end of study (Day 30) in daytime mean systolic and diastolic BP readings using AHA guidelines.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Recruiting
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Heart Failure, Heart Diseases
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
Mark Houston, MD principal investigator
Hypertension Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEO40 Daily in people with Hypertension, run by Hypertension Institute, Nashville at 1 site in United States.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary efficacy outcome is the between-group changes from baseline (Day 0) to end of study (Day 30) in daytime mean systolic and diastolic BP. (time frame: 30 days). 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 30 Oct 2019.