St Petersburg FL , March 29, 2018 (GLOBE NEWSWIRE) -- Leone Asset Management announced that their subsidiary Go Epic Health is starting clinical studies for their product Prostade™
James Price, CEO of Go Epic Health stated, “we are happy to announce the new clinical study for Prostade™. Prostade™ is an exclusive formulation designed to support urinary and cardiovascular function. Having proven clinical data to support the product will place Prostade™ light years ahead of the other products in the market place.”
The clinical research study will be designed to validate the use of Prostade™ in improving Prostate health in human subjects greater than age 50.
The measure of Prostate Health will be done under the following criteria – Sexual function (Erectile dysfunction symptom changes), Benign Prostatic Hyperplasia symptoms using the IPSS (International Prostate Symptom Scale), which is a validated score for BPH symptoms, Prostate Cancer risk (using PSA levels and PSA doubling time) and change in symptoms of Prostatitis.
The research study will involve the use of human subjects and thus will need to be done in a clinical setting. It will also need an IRB approval before the study gets started. We intend to use Western IRB for study protocol approval. The study will be conducted in several clinic locations in the Memphis, Tennessee area.
The genesis of this study is based on the potential Prostate health benefits shown in various clinical trials in human subjects using the ingredients of Prostade™ namely - Citrus Pectin, Saw Palmetto, Flower Pollen, Beta-Sitosterol, Pumpkin Seed Extract, Cranberry, Lycopene, Selenium, Stinging Nettle, Vitamin C, Vitamin E, Magnesium, Zinc, B6, CoQ10, and Patent-Pending Go-Some delivery and absorption technology.
We want to build on the results of those ingredient studies and further explore the medium and long-term effects of Prostade™ on Prostate health as a whole.
This new proposed study will involve human subjects who will have baseline labs and scores calculated on the first visit before being put on Prostade™ or the placebo. The subjects will be tested for baseline Sexual function (Erectile dysfunction symptom changes), baseline IPSS scale for Benign Prostatic Hyperplasia symptoms using the IPSS, PSA levels for Prostate Cancer risk and baseline symptoms of Prostatitis. In addition, the subject’s full lipid panel will be tested for total Cholesterol, LDL, HDL, TG and advanced Lipids. These advanced Lipids and Arterial Inflammatory markers have been shown to be elevated in subjects vulnerable to an impending cardiovascular adverse event
These labs will be drawn at baseline before the start of the study period. After signing a consent form to be a part of the study protocol, these subjects will then be randomized into the Prostade™ or the Placebo group for a period of 12 weeks and followed longitudinally with the same set of labs and scores to be calculated every 4 weeks.
These subjects will undergo 4-week, 8-week and 12-week follow up clinic visits and have the same labs and scores drawn on each visit. We will longitudinally follow these patients and look for afore-mentioned outcomes.
We will try to propensity match the placebo and treatment groups. We will look to minimize confounding. The change in lab values and scores will be statistically evaluated.
We will also look at adverse reactions and side effect profile of the Prostade™ product during this research study.
The results will be published in a peer-reviewed journal and be available on PubMed for review and viewing. We expect robust positive clinical outcome results for the Prostade™ product, which will help increase its market share.
About Leone Asset Management
Leone Asset Management, Inc., is a multi-national, multi-industry conglomerate with subsidiary companies that operate in Health and Wellness, Infrastructure development and agriculture management. For additional information, visit: www.leoneasset.com.
About Go Epic Health
Go Epic Health, a Leone Asset Management subsidiary, is a nutritional product holding company which owns the intellectual property and worldwide manufacturing and distribution rights to Cholesterade®, a natural cholesterol reducing product created by the late Dr. Robert Cade, creator of Gatorade®. Go Epic Health markets and distributes Cholesterade® as well as other new and innovative consumer goods through the nation's largest retail pharmacy chain stores, drug and health food stores and product specific catalogs. For further information, please visit www.goepichealth.com , www.cholesterade.com, www.prostade.com.
Forward-Looking Statements Disclosure:
This press release may contain "forward-looking statements" within the meaning of the federal securities laws. In this context, forward-looking statements may address the Company's expected future business and financial performance, and often contain words such as "anticipates," "beliefs," "estimates," "expects," "intends," " plans," "seeks," "will," and other terms with similar meaning. These forward-looking statements by their nature address matter that are, to different degrees, uncertain. Although the Company believes that the assumptions upon which its forward-looking statements based are reasonable, it can provide no assurances that these assumptions will prove to be correct. All forward-looking statements in this press release are expressly qualified by such cautionary statements, risk, and uncertainties, and by reference to the underlying assumptions.