The Effects of a Nitrate Supplementation on Erectile Function

January 16, 2024 updated by: RHA Investments Ltd

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be consented and enrolled in the study. A complete medical history and focused physical examination will be conducted and documented and NO levels will be measured using salivary test strips.

Twenty (20) patients with low NO levels will be enrolled and will be randomly assigned to group 1 or group 2.

Once enrolled, patients will be required to complete a subjective questionnaire (the International Index of Erectile Function (IIEF)), EHS Score questionnaire and a Quality of Life (QOL) survey. Patients will be instructed to take 2 Berkeley Life capsules once daily or the placebo based on randomization. The (IIEF) was developed by Rosen and colleagues in 1997 as a multidimensional, 15-item, self-administered questionnaire with the goal of assessing five domains of male sexual function including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The erectile function domain of the IIEF (IIEF-EF) contains 6 questions which the patient answers on a scale from 1 (never or almost never) to 5 (almost always or always), providing a total score of 6 to 30 points. The questions concern erectile frequency, firmness, penetration ability, maintenance frequency, maintenance ability, and erection confidence. Based on a controlled study of 1,151 men taking sildenafil in order to establish cutoff scores for the IIEF-EF, a score of 26 or greater is defined as normal function, mild ED is a score from 22 to 25, mild to moderate ED 17 to 21, moderate ED 11 to 16, and severe ED 6 to 10.

Patients will be sent home with instructions to take 2 Berkeley Life capsules once daily in combination with their existing treatment protocol and then return on day 60, returning all unused test product.

The subject should be willing to self-administer 2 capsules daily and be willing to, upon waking in the AM, self-test with strip and record on a pre-print sheet the test strip color, followed by self-administration of capsule(s) and then at 2 hours self-test again and record on a pre-print sheet the test strip color.

Upon the return visit, patients will be crossed over after a 4 week wash out and given the other test group combination.

After 60 days of each combination, placebo and active, patients will repeat the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey.

The remaining product will be collected, and patients released from the study. Data will be collected on Case Report Forms.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • 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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitric Oxide

Upon enrollment, patients will complete the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey.

Patients will be sent home with instructions to take 2 Berkeley Life capsules once daily (in this case Active NO), in combination with their existing treatment protocol (Tadalafil) and then return on day 60, returning all unused test product.

After 60 days of taking the active ingredient + tadalafil, patients will repeat the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey.

After a 4 week wash out, patients will be crossed over to the placebo group and given the other combination.

After 60 days of both combinations, placebo and active, patients will repeat the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey
Dietary supplement: Nitric Oxide
Naturally produced and found in many different kinds of cells and organ systems, NO is an integral molecule in regulating blood pressure and maintaining a healthy cardiovascular system. NO produced or generated in the vasculature then diffuses into the underlying smooth muscle causing these muscles to relax. This results in vasodilation, causing a reduction in systemic blood pressure and an increase in blood flow and oxygen delivery to specific vascular beds.
Other Names:
  • Berkeley Life
Drug: Tadalafil
Vasodilator which treats erectile dysfunction and enlarged prostate (benign prostatic hyperplasia). It can also treat high blood pressure in the lungs (pulmonary arterial hypertension).
Placebo Comparator: Placebo

Upon enrollment, patients will complete the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey.

Patients will be sent home with instructions to take 2 Berkeley Life capsules once daily (in this case the placebo), in combination with their existing treatment protocol (Tadalafil) and then return on day 60, returning all unused test product.

After 60 days of taking the placebo + tadalafil, patients will repeat the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey.

After a 4 week wash out, patients will be crossed over to the active group and given the other combination.

After 60 days of each combination, placebo and active, patients will repeat the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey
Drug: Tadalafil
Vasodilator which treats erectile dysfunction and enlarged prostate (benign prostatic hyperplasia). It can also treat high blood pressure in the lungs (pulmonary arterial hypertension).
Other: Placebo
Nitric Oxide Placebo Compound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Index of Erectile Function
Time Frame: Initial, 2 months post first arm, 2 months post second arm
The (IIEF) was developed by Rosen and colleagues in 1997 as a multidimensional, 15-item, self-administered questionnaire with the goal of assessing five domains of male sexual function including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction [17]. The erectile function domain of the IIEF (IIEF-EF) contains 6 questions which the patient answers on a scale from 1 (never or almost never) to 5 (almost always or always), providing a total score of 6 to 30 points. The questions concern erectile frequency, firmness, penetration ability, maintenance frequency, maintenance ability, and erection confidence. Based on a controlled study of 1,151 men taking sildenafil in order to establish cutoff scores for the IIEF-EF, a score of 26 or greater is defined as normal function, mild ED is a score from 22 to 25, mild to moderate ED 17 to 21, moderate ED 11 to 16, and severe ED 6 to 10.
Initial, 2 months post first arm, 2 months post second arm
Erection Hardness Score
Time Frame: Initial, 2 months post first arm, 2 months post second arm
The Erection Hardness Scale (EHS) involves a 1-4 response to a single question to assess firmness of erection, where 3 is sufficient for penetration and 4 is a rigid erection
Initial, 2 months post first arm, 2 months post second arm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 Quality of Life Questionnaire
Time Frame: Initial, 2 months post first arm, 2 months post second arm
The 36-Item Short Form Health Survey (SF-36) in 1992. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.
Initial, 2 months post first arm, 2 months post second arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RHA Investments Ltd

Investigators

  • Principal Investigator: Steven Bauer, OnSite Clinical Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #EDSupp23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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