Frequently Asked Questions
Q: What is specialty supplement?
A: A specialty supplement is a formula that has been specially designed to support a specific structure/function application in the body – such as joint health and immune support. Some are single-ingredient products. Others are combination formulas, providing unique blends of complementary ingredients that scientific research has shown work synergistically in the body to illicit similar pharmacological effects. Included are: glucosamine, melatonin, probiotics, DHEA, fish oils/shark cartilage, bee products, CoQ10, 5HTP, amino acids, homeopathic remedies, SAMe, chondroitin, probiotics, prebiotics, colostrum, other oils, other enzymes, other hormones, etc.
Q. How is Glutrasol different than vitamin, mineral and herbal supplements?
A. Glutrasol products are science-based specialty supplements or nutraceuticals formulated specifically to support a specific striation/function application in the body. As nutraceuticals, Glutrasol products are regulated as dietary supplements by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act. Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. A nutraceutical is a category of specialty supplement that contains active constituents from foods, herbs, natural compounds and other botanicals.
Q. Can people buy the Glutrasol products off the shelf?
Q. Is a prescription required to purchase a medical food?
Q. Does FDA evaluate and certify Specialty Supplements?
A. Specialty supplements are regulated as dietary supplements by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.
Q. Can animal studies be used for FDA certification?
A. FDA does not accept animal data as conclusive of human data. Animal data can (and should) be referenced. But it won’t carry the day.
Q. What chemical marker is most pertinent to Glutrasol?
A. Cortisol. Cortisol is the major stress hormone. Chronically high levels are the problem. Persistently high cortisol correlates with human fertility issues,diabetes, heart disease, sleep disorders, depression and breast cancer (among others). Glutrasol supports cortisol control as relates to these health issues.
Q. Have you tested Glutrasol?
A. Yes, but only in animal studies. Many of the same compounds that make up Glutrasol have been prescribed by veterinarians to treat many diseases in animals. The success of animal treatments has been well documented, and we are confident that human results will be the same.
Q. What are examples of successful Glutrasol animal interventions?
A. Cattle fertility increased dramatically. Horses with Cushings Syndrome (diagnosed by high cortisol) improved. Livestock morbidity dropped. Livestock weight increased without using antibiotics. This was a small sampling.
The range of animal testing includes birds, sheep, horses, cattle, goats, dogs, cats and pigs.
Q. Why are you confident that animal and human results will be the same?
A. All mammals have the same cortisol production mechanism. Monkeys, cows, pigs, goats, sheep, dogs, cats, and humans are the same from the cortisol perspective.
Specifically, the hypothalamus releases corticotropin releasing hormone, which causes the anterior pituitary gland to secrete adrenocorticotropic hormone (ACTH). Adrenocorticotropic hormone travels to the adrenal cortex, which responds by producing cortisol. Levels of cortisol are controlled by negative hormone feedback loops.
Q: How do you plan to sell the Glutrasol products?
A: This is a rather different model than a standard start-up company because CortControl is a product development and intellectual property company. First, we develop formulations based on our existing dominant patents and patent applications. Second, we secure method-of-use patents to further provide a “picket fence” of IP protection. Third, we develop the brand, establish trademarks, and perform testing for human application. At this point, we have a complete package to sell because all the dietary supplement fundamentals are in place. The exit step is to sell our brand to manufacturers/distributors, which can enter a highly profitable market without delay.
Q. Does the manufacturer/distributor have to undergo FDA drug audits?
A. No. FDA oversight will be limited to food audits.
Q. What is CortControl’s revenue stream?
A. Our revenue comes from the initial sale of each compound license, plus a royalty from every unit sold by the distributor.
CortControl’s licensee will make the product, create the packaging and perform the sales and distribution to the licensed medical groups that prescribe it to the patient for treatment.
Q: What is the expected time for human studies?
A: We plan to complete human beta studies for Glutrasol FE and human clinical studies for Glutrasol IE in early 2018.
Q: Why try to control Cortisol?
A: Cortisol is called a “Stress” hormone and affects the immune system. Cortisol can diminish the effectiveness of our body’s ability to fight disease. If we control the Cortisol levels in patients that have diseases with indications for high Cortisol, we can help their immune system fight their disease.
Research studies have demonstrated a connection between high cortisol and each of our six initial target areas. Some correlations are dramatic. For example, one cardiovascular study concluded that high cortisol is a better predictor of heart attacks than either high cholesterol or high blood pressure.
Recently, there has been quite a bit of press correlating stress to fertility issues.
Q: How do you know that the taste will be acceptable to humans?
A: We have developed the Glutrasol compounds in powder form so they can be blended into smoothies, juice blends, soups etc. We have worked with a taste testing lab to develop flavor that will be attractive to human taste. We also have capsules that can be taken orally.
Q. Has CortControl chosen the initial market focus area?
A: Yes. two. Fertility enhancement and immune-enhancement. U.S. Patents for both applications were granted in 2017. U.S. Patent Application No. 14/640,457; Our Ref: 128247-219292 (P003) Fertility . . . US Patent 9,463,218 B2 and Response for Immunodeficiency or high cortisol . . . US Patent 9,610,347.