Pharmacokinetics of Berkeley Life Oral Nitrate Supplementation

NCT06777108 | Completed

• 1 other identifier: HSR230481
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Nitric Oxide; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in plasma nitrite

  Change in plasma nitrite over a 24-hour period. Measured at the following timepoints: baseline (before single-dose supplementation), 2 hours, 4 hours, 8 hours, and 24 hours following single-dose supplementation.

  24-hours following supplementation (data collected at baseline (before supplementation), 2 hours, 4 hours, 8 hours, and 24 hours following supplementation.

Secondary Outcomes (1)

• Change in plasma nitrate

  24-hours following supplementation (data collected at baseline (before supplementation), 2 hours, 4 hours, 8 hours, and 24 hours following supplementation.

Other Outcomes (7)

• Change in saliva nitrite

  24-hours following supplementation (data collected at baseline (before supplementation), 2 hours, 4 hours, 8 hours, and 24 hours following supplementation.

• Change in saliva nitrate

  24-hours following supplementation (data collected at baseline (before supplementation), 2 hours, 4 hours, 8 hours, and 24 hours following supplementation.

• Changes in 24-hour blood pressure

  24-hour period following supplementation (data collected every 30 minutes)

Study Arms (2)

Single Dose - Two Capsules

EXPERIMENTAL

Participants will take a single-dose (two capsules) of the Berkeley Life Pro supplement. Saliva and blood will be assessed at multiple timepoints: baseline, 2 hours, 4 hours, 8 hours, and 24 hours following supplementation.

Dietary Supplement: Inorganic Nitrate

1/2 Dose - Single Capsule

EXPERIMENTAL

Participants will have the option to participate in a second supplementation protocol following at least a one-week washout period where they will take a ½ dose (one capsule) of the Berkeley Life Pro supplement. Saliva and blood will be assessed at multiple timepoints: baseline, 2 hours, 4 hours, 8 hours, and 24 hours following supplementation.

Dietary Supplement: Inorganic Nitrate

Interventions

Inorganic Nitrate DIETARY_SUPPLEMENT

The intervention evaluates the single and 1/2-dose pharmacokinetics of a plant-based bioequivalent inorganic nitrate (NO3-) complex with vitamins, antioxidantsand phytophenol rich food extracts.

Also known as: Berkeley Life Pro Capsules

1/2 Dose - Single Capsule; Single Dose - Two Capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant cardiac or other medical history
• Medication changes within the previous six months
• Oral antibiotic use within previous four weeks
• Oral cancer/severe oral disease
• 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
• Currently taking nitroglycerine (or other inorganic nitrates), PDE-5 inhibitors (ex: Cialis, Viagra), or xanthine oxidase inhibitors (ex: Allopurinol)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Student Health and Wellness Buidling

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology

Model Details: Participants will take a single-dose (two capsules) of the Berkeley Life Pro supplement. Saliva and blood will be assessed at multiple timepoints: baseline, 2 hours, 4 hours, 8 hours, and 24 hours following supplementation. Participants will then have the option to participate in a second crossover supplementation protocol following at least a one-week washout period where they will take a ½ dose (one capsule) of the Berkeley Life Pro supplement. Saliva and blood will be assessed at multiple timepoints: baseline, 2 hours, 4 hours, 8 hours, and 24 hours following supplementation.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 15, 2025
• Study Start: February 7, 2024
• Primary Completion: April 6, 2024
• Study Completion: April 6, 2024
• Last Updated: January 17, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)