Phase 1
Completed N=11
Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults
Focus of Study of Healthy Adults
Source: ClinicalTrials.gov NCT01681836 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Peak Plasma Nitrate Concentration Over 24 Hour Study Period — 769; 41 microMolar (microM)
Summary
This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and nitrite capsules for cardiovascular disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plasma Nitrate Concentration Over 24 Hour Study Period |
769; 41 | — |
| PRIMARY Peak Plasma Nitrite Concentration Over 24 Hour Study Period |
0.51; 5.5 | — |
| PRIMARY Peak Red Blood Cell (RBC) Iron-nitrosyl Hemoglobin (NO-Hb) Concentrations Over 24 Hour Study Period |
NA; 1.04 | — |
| SECONDARY Peak Percentage Level of Methemoglobin Over 24 Hour Study Period |
1.24; 1.59 | — |
| SECONDARY Peak Change in Mean Arterial Pressure Over 24 Hour Study Period |
-2.9; -10.4 | — |
| SECONDARY Peak Change in Systolic Blood Pressure Over 24 Hour Study Period |
-0.8; -12.1 | — |
| SECONDARY Peak Change in Diastolic Blood Pressure Over 24 Hour Study Period |
-6.3; -8.1 | — |
| SECONDARY Peak 15Nitrogen Nitro-conjugated Linoleic Acid (cLA) Concentrations Over 24 Hour Study Period |
0.14; NA | — |
| SECONDARY Percent Platelet Activation at 6 Hours |
9.0; 8.3 | — |
| SECONDARY Peak Change in Heart Rate Over 24 Hour Study Period |
-6; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-60 years
- Systolic blood pressure ≤130 and diastolic blood pressure ≤85 mm Hg
Exclusion Criteria
- Positive urine pregnancy test or breastfeeding
- Concurrent use of medications affecting glucose or lipid metabolism
- Recent addition or change in dosing of hormonal contraceptive medications (oral contraceptive pill, intrauterine device, DepoProvera)
- Current use of ≥2 anti-hypertensive agents regardless of blood pressure control or normotensive on a single agent
- Current use of phosphodiesterase 5 inhibitors or organic nitrates
- Not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc
- Known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes
- Smoker
Data sourced from ClinicalTrials.gov (NCT01681836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.