Effects of nitrate supplementation on erectile function
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.
This study is testing if taking nitrate supplements can improve erectile function in men aged 40 to 65 who have low nitric oxide levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Male |
| Sponsor | RHA Investments Ltd Industry-sponsored |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT06213077 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of nitrate supplementation on erectile function in men aged 40 to 65 with low nitric oxide (NO) levels. Twenty participants will be recruited from Ballantyne Medical Associates in Charlotte, NC, and will undergo screening and informed consent processes. Participants will be randomly assigned to receive either a placebo or Berkeley Life nitrate capsules, and their erectile function will be assessed using the International Index of Erectile Function (IIEF) questionnaire and other measures at baseline, during crossover, and at the conclusion of the study.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 to 65 who have been undergoing treatment for erectile dysfunction for at least 90 days with unsatisfactory results and have low nitric oxide levels.
Not a fit: Patients with a history of drug or alcohol dependency, those with known allergies to the capsule ingredients, or those currently taking organic nitrates for acute angina may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for men experiencing erectile dysfunction due to low nitric oxide levels.
How similar studies have performed: While the approach of using nitrate supplementation for erectile dysfunction is not widely tested, similar studies have shown promising results in improving erectile function through nitric oxide modulation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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 this trial is running
Charlotte, North Carolina
- OnSite Clinical Solutions — Charlotte, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Steven Bauer — Onsite Clinical Solutions
- Study coordinator: Rebecca Holland, MD
- Email: rebecca@berkeleylife.com
- Phone: 3476326963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.