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Clinical Author:
Larry Zuccolotto, PhD, is the founder and CEO of Giovane Medical. For the past thirty-five years he has been a veteran and industry expert in implementing healthcare benefits and programs. He has a national reputation in the medical and fitness sectors and is recognized as an experienced lecturer and presenter. He is certified in anti-aging and hormone replacement therapy. Thru Giovane medical, He has developed, manufactured, and distributed a number of products for medical professionals and has developed Giovane’s educational arm providing certification programs for medical doctors, and chiropractors.
Introduction
Men who take oral 5-Alpha Reductase Inhibitors (5-ARIs), such as Finasteride, experience hormonal shifts, notably increased estrogen levels and reduced free testosterone. These hormonal changes underlie common side effects, including sexual dysfunction, mood disturbances, and physical changes such as gynecomastia. Giovane Medical has consistently observed elevated Estradiol (E2) and reduced Free Testosterone levels in these individuals.
Objective
This clinical trial aims to evaluate whether supplementation with “Alpha Balance” effectively mitigates hormonal imbalances—specifically, elevated estrogen and reduced free testosterone levels—in men aged 30 to 55 who have taken 5-ARIs for at least one year.
Methodology
- Participant Recruitment: Minimum of 50 men, aged between 30 and 55, currently taking 5-ARI for a duration of at least one year.
- Exclusion Criteria: No concurrent use of Testosterone Replacement Therapy (TRT) or testosterone-boosting supplements.
- Protocol Compliance: Participants will sign informed consent forms agreeing to adhere strictly to trial protocols.
- Treatment Regimen: Participants will take a standardized dosage of Alpha Balance supplements daily for the duration of the trial.
- Data Collection: Participants will complete a medical questionnaire assessing symptoms related to hormonal imbalance.
- Privacy Assurance: All participant information will be securely managed and stored in Giovane Medical’s HIPAA-compliant Electronic Health Record (EHR) system.
Evaluation Criteria
Hormone levels will be assessed via blood tests both pre- and post-trial, evaluating Free Testosterone (pg/mL), Total Testosterone (ng/dL), and Estradiol (pg/mL). Success will be determined by statistically significant improvements from baseline measurements.
Secondary Outcomes
Participants will also be assessed on the following secondary outcomes:
- Changes in libido and sexual function, measured by standardized questionnaires.
- Mood and cognitive improvements, evaluated by validated psychological assessment tools.
- Incidence and severity of any side effects reported during supplementation.
- Overall satisfaction and willingness of participants to continue supplementation.
These outcomes will provide additional insights into the overall quality of life and well-being improvements from the Alpha Balance supplementation.
Hypothesis
It is anticipated that Alpha Balance supplementation will effectively mitigate the hormonal side effects of 5-ARI medications, balancing Estrogen and Free Testosterone levels without compromising the therapeutic effectiveness of the original medication in preventing advanced hair loss.
Supporting Research and Clinical Justification
Clinical and meta-analytical evidence indicates significant hormonal disruptions due to 5-ARI use. Specifically, finasteride usage leads to a pronounced decrease in DHT, an increase in circulating estrogen, and a corresponding reduction in free testosterone, resulting in well-documented adverse effects including sexual dysfunction, mood disturbances, and gynecomastia (Traish et al.; Irwig, 2020; Di Loreto et al.). The Alpha Balance supplement is formulated specifically to target these hormonal imbalances, providing a clear rationale for its anticipated efficacy in this trial.
Conclusion
Should Alpha Balance demonstrate effectiveness in normalizing hormone levels, it will support its use as an adjunctive therapy to alleviate hormonal side effects associated with 5-ARI medications, thereby enhancing patient outcomes and treatment adherence.
If successful, this trial will support Alpha Balance as a recommended adjunctive therapy for patients prescribed 5-Alpha Reductase Inhibitors.