Tier 2 — strong

Effect of a Proprietary Nitric Oxide Supplement (Nitralis) on Salivary Nitric Oxide Levels: A Randomized, Placebo-Controlled Trial

Paige Baily
Biomedical Journal of Scientific & Technical Research 2025 Volume 63, Issue 4; DOI:10.26717/BJSTR.2025.63.009914

Bibliography

DOI
10.26717/BJSTR.2025.63.009914
Funding
Funded by DoNotAge.org.
Competing interests
Report states all authors are affiliated with DoNotAge.org, developer of Nitralis.

Study snapshot

DesignSponsor-funded randomized placebo-controlled 30-day pilot trial
ModelAdults aged 30–70 screened to exclude major cardiovascular disease, uncontrolled hypertension and pregnancy
Sample85 participants reported as assigned/completing (43 Nitralis; 42 placebo)
Intervention30 days of one daily 400 mg capsule containing a proprietary fermented beet, magnesium ascorbate and epimedium blend compared with placebo, as described by the trial report. The current standalone retail recommendation is two 400 mg capsules (800 mg/day); independent confirmation of formula and dose equivalence is pending.
Duration30 days
EndpointsSemi-quantitative salivary test-strip change at day 30; Prespecified threshold responder proportion; Adverse event reporting

What the study showed, in plain terms

The manufacturer-funded Nitralis pilot reported greater 30-day changes on salivary test strips versus placebo. It did not measure blood pressure, vascular function, exercise capacity or clinical outcomes.

Key findings

Median day-30 strip change +90 units in the Nitralis group versus 0 with placebo; reported threshold responder rates 60.5% versus 11.9%. These are strip-based outcomes, not proven improvements in blood or tissue nitric oxide.

What this study can and cannot tell us

Manufacturer-funded, manufacturer-affiliated 85-person pilot with semi-quantitative salivary test strips, not calibrated measures of circulating nitric oxide. The original publication did not measure clinical blood pressure, endothelial function, exercise performance, or disease outcomes. Its single daily 400 mg study intervention differs from the current retail recommendation of two 400 mg capsules (800 mg/day); formulation and dose equivalence require manufacturer documentation. Short follow-up and lack of verified independent replication limit clinical inference.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology