The Effects of a Nitrate Supplementation on Erectile Function

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT06213077

Run by

RHA Investments Ltd

People needed

20

Starts

2023-12-12

Expected to finish

2024-05-30

Last updated by the study team

2024-01-19

Who can join

Age: 40 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• OnSite Clinical Solutions — Charlotte, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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