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.

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
United States
North Carolina
OnSite Clinical Solutions
RECRUITING
Charlotte
Contact Information
Primary
Rebecca Holland, MD
rebecca@berkeleylife.com
3476326963
Backup
Trish Lally
trish.lally@lifes2good.com
00353 86 8735603
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2024-05-30
Participants
Target number of participants: 20
Treatments
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
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
Sponsors
Leads: RHA Investments Ltd

This content was sourced from clinicaltrials.gov