The Effects of a Nitrate Supplementation on Erectile Function

NCT06213077 | Unknown

• 1 other identifier: #EDSupp23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Erectile Dysfunction; Nitric Oxide

Outcome Measures

Primary Outcomes (2)

• International Index of Erectile Function

  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

  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 Outcomes (1)

• SF-36 Quality of Life Questionnaire

  Initial, 2 months post first arm, 2 months post second arm

Study Arms (2)

Nitric Oxide

ACTIVE COMPARATOR

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; Drug: Tadalafil

Placebo

PLACEBO COMPARATOR

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; Other: Placebo

Interventions

Nitric Oxide DIETARY_SUPPLEMENT

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.

Also known as: Berkeley Life

Nitric Oxide

Tadalafil DRUG

Vasodilator which treats erectile dysfunction and enlarged prostate (benign prostatic hyperplasia). It can also treat high blood pressure in the lungs (pulmonary arterial hypertension).

Nitric Oxide; Placebo

Placebo OTHER

Nitric Oxide Placebo Compound

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• RHA Investments Ltd: lead

Study Sites (1)

OnSite Clinical Solutions

Charlotte, North Carolina, 28277, United States

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Nitric Oxide; Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Steven Bauer

  Onsite Clinical Solutions

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Holland, MD

CONTACT

3476326963; rebecca@berkeleylife.com

Trish Lally

CONTACT

00353 86 8735603; trish.lally@lifes2good.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: IRB approved, double blind placebo-controlled crossover study. Control product (Tadalafil) open label. Nitric Oxide and placebo products labelled Sample 1 and Sample 2.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: IRB approved, double blind placebo-controlled crossover study

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 19, 2024
• Study Start: December 12, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)