Nitric Oxide Supplement for Prehypertension

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Neogenis Laboratories

Must not be taking: Antihypertensives

Disqualifiers: Cardiovascular disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a lozenge called Neo40(TM) that contains nitrates. It aims to help healthy adults who have slightly high blood pressure. The lozenge works by widening blood vessels, which can lower blood pressure. Neo40(TM) lozenge contains nitrates, which have been shown to reduce blood pressure by converting to nitric oxide, a vasodilator.

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 the Nitric Oxide supplement safe for humans?

The research articles provided do not contain specific safety data for Nitric Oxide supplements in humans. ^{1 2 3 4 5}

How does the nitric oxide supplement treatment for prehypertension differ from other treatments?

The nitric oxide supplement is unique because it is an orally disintegrating lozenge that generates nitric oxide in the mouth, which helps lower blood pressure in people with prehypertension. Unlike other treatments that focus on diet and lifestyle changes, this supplement directly targets blood pressure regulation through nitric oxide, a molecule important for cardiovascular health. ^{6 7 8 9 10}

What data supports the effectiveness of the nitric oxide supplement treatment for prehypertension?

A study showed that taking a nitric oxide supplement significantly lowered blood pressure in people with prehypertension, reducing systolic pressure from 138 to 126 mm Hg and diastolic pressure from 84 to 78 mm Hg over 30 days. ^{8 11 12 13 14}

Who Is on the Research Team?

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?

Group I: Nitric Oxide supplement Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-hypertensive nutraceuticals and functional foods. Chen, ZY., Peng, C., Jiao, R., et al.[2009]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effects of an oral nitric oxide supplement on functional capacity and blood pressure in adults with prehypertension. [2014]

2. Croatia pubmed.ncbi.nlm.nih.gov

Decreased nitric oxide in women with essential hypertension in prehypertensive phase. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Endothelial nitric oxide synthase gene polymorphisms are associated with cardiovascular risks in prehypertensives. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Inhibition of nitric oxide synthesis increases blood pressure in healthy humans. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Prehypertension is associated with impaired nitric oxide-mediated endothelium-dependent vasodilation in sedentary adults. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Randomised, double-blind, placebo-controlled, assessment of the efficacy and safety of dietary supplements in prehypertension. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Anti-hypertensive nutraceuticals and functional foods. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Effect of supplementation of water-soluble vitamins on oxidative stress and blood pressure in prehypertensives. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Prehypertension in Mexico and Its Association With Hypomagnesemia. [2015]

10. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of mindfulness-based stress reduction for arterial hypertension. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

A Slow- Compared with a Fast-Release Form of Oral Arginine Increases Its Utilization for Nitric Oxide Synthesis in Overweight Adults with Cardiometabolic Risk Factors in a Randomized Controlled Study. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Acute Ingestion of A Novel Nitrate-Rich Dietary Supplement Significantly Increases Plasma Nitrate/Nitrite in Physically Active Men and Women. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Dietary nitrate improves muscle microvascular reactivity and lowers blood pressure at rest and during isometric exercise in untreated hypertensives. [2019]