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NCT06777108Completed

Pharmacokinetics of Berkeley Life Oral Nitrate Supplementation

Source: ClinicalTrials.gov · Last updated 17 Jan 2025

Brief summary (registry, in English)

The purpose of the study is to examine the way that a nitric oxide supplement moves through the body. Specifically, the relationship between saliva and blood concentration of the supplement and the elapsed time since taking the supplement. Participants will : * Come to UVA to participate in testing procedures. * Take a nitric oxide supplement up to twice. * Complete a pregnancy test if the participant is a pre-menopausal female. * Produce saliva into a tube to collect a sample. * Undergo several blood draws (less than 6 tablespoons). * Wear a 24-hour non-invasive device that monitors the participant's blood pressure.

Status (registry)
Completed
Study type
Interventional
Enrollment
12 (actual)
First submitted
3 Jan 2025
Start date
7 Feb 2024
Primary completion date
6 Apr 2024
Lead sponsor
University of Virginia
NCT number
NCT06777108

What you commit to

  • Study type: Interventional
  • Participants enrolled: 12
  • From 7 Feb 2024 to the primary completion date, 6 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Medication changes within the previous six months
  • Oral antibiotic use within previous four weeks
  • Currently taking nitroglycerine (or other inorganic nitrates), PDE-5 inhibitors (ex: Cialis, Viagra), or xanthine oxidase inhibitors (ex: Allopurinol)

Other illness

  • Significant cardiac or other medical history
  • Oral cancer/severe oral disease

Other

  • Using an over-the-counter antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use
  • Use of a prescription chlorhexidine or antibacterial mouthwash.
  • Current tobacco users
  • Pregnant or lactating females

Who the study is looking for

  • Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  • Subjects may be of either sex with age ≥ 18 years
  • Blood pressure \>120 systolic and \>80 diastolic at rest

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Virginia Student Health and Wellness Buidling
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.