Nitric Oxide Supplement for Prehypertension

Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Neogenis Laboratories

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a nitric oxide supplement can lower blood pressure in individuals with prehypertension (slightly high blood pressure). Participants will receive either the actual supplement or a placebo (a harmless pill with no active ingredient) to determine any differences in blood pressure changes. It suits adults with blood pressure readings at or above 135/80 mmHg who are not on any blood pressure medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

If you are currently taking any medication to lower blood pressure, you cannot participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nitric oxide supplements can lower blood pressure and improve blood vessel function. People taking these supplements have experienced reduced blood pressure and enhanced blood flow. In one study, a nitric oxide supplement improved blood pressure and blood vessel health in just 30 minutes. Another study found that these supplements helped individuals with slightly high blood pressure walk longer distances.

However, nitric oxide supplements might cause side effects, particularly for those with certain health issues like liver disease. These side effects are uncommon in healthy individuals. Overall, studies suggest that most people tolerate nitric oxide supplements well.12345

Why do researchers think this study treatment might be promising?

Most treatments for prehypertension, like ACE inhibitors and beta-blockers, work by controlling blood pressure through different biological pathways. But the Nitric Oxide supplement works differently, targeting the improvement of blood vessel function directly. Nitric Oxide is a natural molecule in the body that helps relax and widen blood vessels, potentially offering a novel way to manage blood pressure. Researchers are excited because this supplement could provide a more natural and possibly safer alternative to traditional medications, with fewer side effects.

What evidence suggests that this trial's treatments could be effective for prehypertension?

Research has shown that nitric oxide supplements, which participants in this trial may receive, can help lower blood pressure. In one study, participants experienced a noticeable drop in blood pressure after taking these supplements. Another study found that nitric oxide, a natural substance in the body, helps relax blood vessels, which can also lower blood pressure. Early findings suggest that these supplements can improve blood flow and heart health. These results are promising for using nitric oxide supplements to manage slightly elevated blood pressure, known as prehypertension.13678

Who Is on the Research Team?

ES

Ernst Schwarz, MD, PhD

Principal Investigator

California Medical Institute, Cedars Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with prehypertension, which means their blood pressure readings are at or above 135/80 mmHg. Participants must be able to give informed consent and follow the study's procedures. Those with serious internal or heart diseases, using blood pressure meds, or unable to consent are excluded.

Inclusion Criteria

Your blood pressure is consistently at or above 135/80 mmHg when you are resting.
Informed consent

Exclusion Criteria

I have a serious heart or internal disease.
I am currently taking medication for high blood pressure.
I am able to give informed consent and follow up on my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral supplementation of Neo40(TM), a nitrate lozenge, to reduce blood pressure

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure readings and functional capacity tests

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nitric Oxide supplement
  • Placebo
Trial Overview The study tests if Neo40(TM), a nitric oxide supplement taken orally as a lozenge, can lower blood pressure in prehypertensive adults compared to a placebo (a dummy pill).
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Nitric Oxide supplementActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neogenis Laboratories

Lead Sponsor

Trials
6
Recruited
190+

Published Research Related to This Trial

Elevated blood pressure is a significant risk factor for stroke and coronary heart disease, particularly when systolic/diastolic levels exceed 140/90 mmHg, highlighting the importance of managing hypertension.
Recent studies suggest that nutraceuticals and functional foods, such as the DASH diet, garlic, and fish oil, may serve as effective alternative therapies for prehypertensive patients, offering a natural approach to lowering blood pressure.
Anti-hypertensive nutraceuticals and functional foods.Chen, ZY., Peng, C., Jiao, R., et al.[2009]

Citations

Acute Effects of an Oral Nitric Oxide Supplement on Blood ...A single administration of an oral active NO supplement appears to acutely lower BP, improve vascular compliance, and restore endothelial function in patients ...
A Large Blood Pressure–Raising Effect of Nitric Oxide ...First, l-NAME produced robust increases in blood pressure that were more than 2 times larger than those previously reported in humans with l-NMMA and ...
Nitric oxide deficiency is a primary driver of hypertensionNitric oxide is a naturally produced vasodilator that controls and regulates vascular tone and therefore controls and regulates blood pressure. Research over ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/24942311/
Effects of an oral nitric oxide supplement on functional ...Nitric oxide supplementation resulted in a significant decrease in resting blood pressure (138 ± 12 mm Hg in systole and 84 ± 5 mm Hg in diastole at baseline vs ...
A Study to Investigate the Effect of a Nitric Oxide ...Study Overview. This study will investigate the effect of a nitric oxide supplementation product, Neo40 Daily®, on blood pressure in pre-hypertensive and ...
Effects of an Oral Nitric Oxide Supplement on Functional ...Nitric oxide supplementation significantly decreased resting blood pressure and increased walking distance in adults with prehypertension.
Effect of a Nitric Oxide Supplementation Product on ...This study investigates the effect of Neo40 Daily, a nitric oxide supplement, on blood pressure and endothelial dysfunction in pre- and mildly ...
Dietary supplements for improving nitric-oxide synthesisNitric oxide supplementation could have a higher risk of side-effects in persons with certain health conditions. Such health conditions include cirrhosis, ...
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