The Effects of a Nitrate Supplementation on Erectile Function

Description

Twenty (20) individuals to be recruited from Ballantyne Medical Associates in Charlotte, NC, without any significant chronic medical history. These patients are general patients for primary care that meet inclusion criteria. Patients will be screened and enrolled by Dr. Bauer and his delegated research staff upon patient consult. Patients will be informed of the purpose of the study including risks, benefits, and alternative treatments to the study. After the potential participants have been given the opportunity to ask questions and have their questions answered, they will be asked to sign an informed consent prior to any study-specific procedures being performed. Blinded test product will be randomly assigned to study subjects. Test group 1 will be dosed with a placebo capsule taken two capsules once daily Test group 2 will be dosed with Berkeley Life capsules taken two capsules once daily. At baseline, prior to crossover to the other treatment, and at the study's conclusion, NO levels will be monitored using salivary nitric oxide test strips. Both test groups will remain on their existing treatment protocol throughout the study.

Conditions

Erectile Dysfunction

Study Overview

Study Details

Study overview

Twenty (20) individuals to be recruited from Ballantyne Medical Associates in Charlotte, NC, without any significant chronic medical history. These patients are general patients for primary care that meet inclusion criteria. Patients will be screened and enrolled by Dr. Bauer and his delegated research staff upon patient consult. Patients will be informed of the purpose of the study including risks, benefits, and alternative treatments to the study. After the potential participants have been given the opportunity to ask questions and have their questions answered, they will be asked to sign an informed consent prior to any study-specific procedures being performed. Blinded test product will be randomly assigned to study subjects. Test group 1 will be dosed with a placebo capsule taken two capsules once daily Test group 2 will be dosed with Berkeley Life capsules taken two capsules once daily. At baseline, prior to crossover to the other treatment, and at the study's conclusion, NO levels will be monitored using salivary nitric oxide test strips. Both test groups will remain on their existing treatment protocol throughout the study.

To Determine the Potentiating Effects of Berkeley Life Foundation Nitric Oxide Capsules in Supporting Healthy Sexual Function in Men on an Existing Treatment Plan But Who Are Experiencing Occasional Unsatisfactory Erections.

The Effects of a Nitrate Supplementation on Erectile Function

Condition
Erectile Dysfunction
Intervention / Treatment

-

Contacts and Locations

Charlotte

OnSite Clinical Solutions, Charlotte, North Carolina, United States, 28277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subjects Male between the ages of 40 and 65
  • * Subjects looking to support healthy sexual function who have been undergoing treatment to support healthy erections for at least 90 days with unsatisfactory results and whose nitric oxide levels are suboptimal based on an easy-to-use, self-check saliva strip that provides immediate, real-time, actionable feedback.
  • * Patients who are able to sign informed consent.
  • * Patients who are not considered medically stable (history of drug or alcohol dependency or having experienced health issues which could prevent experiencing a healthy erection).
  • * Patients with any known allergy to ingredients of capsule.
  • * Patients currently taking organic nitrates for acute angina
  • * Patients who do not or cannot tolerate PDE5 inhibitors
  • * Patients are unwilling or unable to provide informed consent.

Ages Eligible for Study

40 Years to 65 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

RHA Investments Ltd,

Steven Bauer, PRINCIPAL_INVESTIGATOR, Onsite Clinical Solutions

Study Record Dates

2024-05-30