COMPOSITIONS AND METHODS FOR TREATING THYROID DISEASE

Abstract

The present disclosure relates to a compound and method of using such compound, preferably in the form of a dietary supplement that, when administered, is capable of treating thyroid disease and various thyroid-related disorders, such as Hashimoto's thyroiditis. The unique combination of the composition is preferably administered orally via acid resistant or enteric-coated capsule, soft gel or tablet. The composition is preferably comprised of at least Catalase, Reduced Glutathione, Acetylated Glutathione, DPP-IV protease enzyme, Pepsin, Bromelain, Pancreatin, Vitamin D, and Selenium. The composition can further comprise a palliative agent, and can be provided in specific dosages or administered in forms besides those listed above.

Claims

1. A composition for treating a thyroid disorder comprising: selenium; a digestive enzymes DPP-IV; proteolytic enzyme; systemic enzyme; and glutathione.

2. The composition of claim 1, wherein the composition comprises: from about 25 to 200 mcg of selenium; wherein the glutathione is reduced glutathione and acylated glutathione, and comprising: from about 100 to 500 mg the reduced glutathione; and from about 10 to 200 mg of acetylated glutathione; from about 10 to 1,000 mg DPP-IV enzyme; wherein the proteolytic enzyme is bromelain, and wherein the composition comprises from about 50 to 500 mg bromelain; and wherein the systemic enzyme is pancreatin enzyme, and wherein the composition comprises from about 50 to 500 mg pancreatin enzyme.

3. The composition of claim 1, further comprising: from about 25 to 1,000 mg catalase; from about 10 to 50 mg pepsin; and from about 1,000 to 10,000 IU vitamin D.

4. The composition of claim 1, wherein the composition is provided as a dietary supplement.

5. The composition of claim 1, wherein the composition is administered orally in the form of an acid resistant capsule.

6. The composition of claim 1, wherein the composition is administered orally in the form of a tablet.

7. The composition of claim 1, wherein the thyroid disease is Hashimoto's.

8. The composition of claim 1, further comprising a palletability agent.

9. The composition of claim 1, wherein the palletability agent is at least one of a plant oils, plant hydrolysates, yeast, and yeast hydrolysates, and combinations thereof.

10. The composition of claim 1, wherein the composition does not include at least one of gluten, wheat, egg, peanuts, tree nuts, dairy, sugar, corn, soy, artificial colors, preservatives, fish and shellfish.

11. The composition of claim 1, further comprising: about 100 mg of DPP-IV; about 100 mcg of selenium; wherein the proteolytic enzyme is bromelain, and comprising about 250 mg of bromelain; wherein the systemic enzyme is pancreatin enzyme 200 mg of pancreatin enzyme; and wherein the glutathione is reduced glutathione and acylated glutathione, and comprising: about 50 mg of SAG; and about 250 mg of “reduced” glutathione.

12. The composition of claim 2, further comprising: about 250 mg of catalase; 10 to 50 mg of pepsin; and about 4,000 IU vitamin D3.

13. The composition of claim 3, wherein the vitamin D is cholecalciferol.

14. The composition of claim 1, further comprising at least one additional digestive enzyme.

15. A method to manufacture a composition for treating a thyroid disease, comprising: mixing selenium, a digestive enzymes DPP-IV, proteolytic enzyme, systemic enzyme. and glutathione to form a mixture; and compressing the mixture in a capsule.

16. The method of claim 15, wherein the mixture comprises: from about 25 to 200 mcg of selenium; wherein the glutathione is reduced glutathione and acylated glutathione, and comprising: from about 100 to 500 mg the reduced glutathione; and from about 10 to 200 mg of acetylated glutathione; from about 10 to 1,000 mg DPP-IV enzyme; wherein the proteolytic enzyme is bromelain, and wherein the composition comprises from about 50 to 500 mg bromelain; and wherein the systemic enzyme is pancreatin enzyme, and wherein the composition comprises from about 50 to 500 mg pancreatin enzyme.

17. The method of claim 15, wherein the capsule is an acid resistant, an enteric-coated capsule, a soft gel or a tablet.

18. The method of claim 15, further comprising: catalase, pepsin; and vitamin D.

19. A method to treat a patient with an autoimmune disease, comprising: providing the patient with a capsule, wherein the capsule comprises: from about 25 to 200 mcg of selenium; from about 100 to 500 mg the reduced glutathione; and from about 10 to 200 mg of acetylated glutathione; from about 10 to 1,000 mg DPP-IV enzyme; from about 50 to 500 mg bromelain; and from about 50 to 500 mg Pancreatin enzyme.

20. The method of claim 19, wherein the autoimmune disease is Hashimoto's.

Description

DETAILED DESCRIPTION

[0057] Although the following text sets forth a detailed description of numerous different embodiments, it should be understood that the legal scope of the description is defined by the words of the claims set forth at the end of this disclosure. The Detailed Description is to be construed as exemplary only and does not describe every possible embodiment since describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims.

[0058] Composition

[0059] An aspect of the invention is directed to a composition. The composition comprises selenium, digestive enzymes DPP-IV, proteolytic enzyme, systemic enzyme, selenium, and antioxidants glutathione. Other components can be included in the composition.

Catalase

[0060] Certain individuals have a genetic mutation or a single nucleotide polymorphism (SNP—pronounced snip), which causes difficulty in converting hydrogen peroxide to its harmless byproducts. The enzyme that makes this conversion is called “catalase” and in supplemental form can break down peroxide. People with Hashimoto's have elevated levels of peroxide that must be quelled.

[0061] Catalase reduces oxidative stress by breaking down a potent free radical toxin called hydrogen peroxide which cells naturally produce each day. In patients with Hashimoto's thyroidits, there is an enormous amount of “lipid peroxidation,” which is a scientific term describing the destruction (or peroxidation) of cell membranes.

[0062] Lipid preoccupation is the oxidative breakdown of lipids (fats). It is the process in which free radicals take electrons from the fats in cell membranes, resulting in cell damage. This process is proceeded by a free radical chain reaction mechanism. It spawns a lot of harmful cytokines, namely hydrogen peroxide. Catalase directly breaks down hydrogen peroxide, rendering it harmless by turning it into water and oxygen.

[0063] In some embodiments, the composition further comprises a pre-determined amount of catalase. The human body requires catalase to convert the free radical “hydrogen peroxide” into harmless water and oxygen. Without enough catalase, the body will begin to “rust” and the hair may turn grey and the build-up of peroxides will increase damage to the cells, in particular the cell membranes of the thyrocytes (thyroid cells).

[0064] People who are deficient in iron or niacin (due to drinking coffee, or taking ibuprofen or aspirin) may have insufficient levels of catalase enzyme activity. People with genetic SNPs may also be deficient in catalase.

[0065] In some embodiments, the composition can comprise from about 25 to 1,000 mg of catalase. In a preferred embodiment, the composition can comprise about 250 mg of catalase.

DPP-IV Digestive Enzyme

[0066] People with Hashimoto's have a difficult time digesting food, especially proteins. In some embodiments, the composition can include at least one digestive enzyme. The compound can include a pre-determined amount of “Dipeptidyl peptidase 4” or DPP-IV. It has been found from experimentation that DPP-IV reduces absorption of gluten and casein, two proteins found in wheat and dairy, respectively. As gluten and casein are known to attack and damage the thyroid glands of certain individuals, and set forth autoimmune attacks within the human body, it is desirable to include a pre-determined amount of DPP-IV within the composition. In addition, certain individuals have a deficiency in this enzyme, and therefore have trouble breaking down gluten and casein protein. Partial digestion of these food proteins will leak through the highly permeable intestinal lining, and travel through the bloodstream ultimately provoking an immune response. When these molecules land in or near the thyroid gland, there is an autoimmune thyroid assault.

[0067] The composition can include from about 10 to 1,000 mg of DPP-IV. In some embodiments, the composition can include about 100 mg of DPP-IV. In some embodiments, one or more additional digestive enzymes are included or substituted for DPP-IV. Suitable digestive items, for examples of DPP-IVs include, but are not limited to, amylase, cellulose, phytase, lactase, sucrose, lipase, and combinations thereof.

Pepsin

[0068] The human body forms antibodies to the various proteins which are also the same exact antibodies that could target the thyroid gland during Hashimoto's disease. When a person eats food, and the undigested food proteins and particles lodge in or around the thyroid gland, then the immune system launches an attack. These poorly digested protein/food particles become fuel for opportunistic bacteria and yeast that live in the gut microbiome. An overgrowth of these opportunistic infections leads to more gastrointestinal symptoms. Studies have shown that overgrowth of opportunistic bacteria are tied to autoimmune dysfunction of the thyroid gland. Hashimoto's symptoms increase due to the unregulated influx of pro-inflammatory (pain-causing) chemicals that leave the gut and travel throughout the bloodstream, potentially lodging in the thyroid gland.

[0069] In some embodiments, the composition further can comprise a pre-determined amount of pepsin, which can be animal or vegetable derived. Pepsin is a protein-digesting enzyme known as “proteases,” whose function is to break down large proteins into their smaller particles called peptides. Pepsin has been found through experimentation to assist in the reduction of auto-antibodies aimed at the thyroid gland, so indirectly, enzymes promote a healthy thyroid function.

[0070] The composition can comprise from about 10 to 50 mg of pepsin. In some embodiments, the composition can include about 20 mg of pepsin.

Bromelain

[0071] Thyroid disorders are characterized by increased inflammation in the body and in the case of Hashimoto's thyroiditis, there is a tremendous amount of inflammation around the thyroid tissue itself. Bromelian helps reduce inflammation.

[0072] Bromelain is not a single substance, but rather a collection of protein-digesting enzymes and other compounds. It is a proteolytic enzyme that works to modulate (or coordinate) the activity of inflammatory immune complexes. Proteolytic enzymes have an affinity for immune complexes that would otherwise travel through the blood stream and increase inflammatory chemical (called cytokines) such as Tumor Necrosis Factor (TNF) and C Reactive Protein (CRP). Bromelian can reduce the reactivity of the immune complexes, which come from undigested food particles, and simultaneously reduced production of pro-inflammatory cytokines.

[0073] The composition can comprise a pre-determined amount of bromelain. The enzyme can be derived from pineapples and has been discovered through experimentation to be a desirable method of reducing inflammation. In some embodiments, the composition comprises from about 50 to 500 mg of bromelain. In some embodiments, the composition can comprise about 250 mg of bromelain.

Pancreatin

[0074] Clearly, with Hashimoto's disease, there is a need for additional support in food metabolism and breakdown. Increased intestinal permeability (commonly termed “leaky gut syndrome”) is associated with autoimmune disease. In fact, reversing symptoms of autoimmune disease, including Hashimoto's depends on healing the lining of the gastrointestinal tract. Drug treatment only seeks to suppress symptoms, not heal the gut or reduce the problem of undigested food particles, which leave the gut and travel throughout the bloodstream. With Hashimoto's, the body makes antibodies to the thyroid gland. Pancreatin is a pancreatic enzyme that reduces the burden that the body has to face from partially digested food particles that leaves the “leaky gut.” Pancreatin is a digestive enzyme that supports food metabolism.

[0075] The composition can include a pre-determined amount of pancreatin enzymes. Through experimentation it has been discovered that undigested food proteins which lead to thyroid autoimmunity are minimized or eliminated by pancreatin, a digestive enzyme that is naturally produced in the body by the exocrine cells of the human pancreas. Pancreatin might help to lessen the antigenic load or toxic molecules being presented on the intestinal lining and bloodstream. Pancreatin is not a single enzyme but rather it is composed of amylase, lipase and protease, which breaks down carbohydrates, fats and proteins, respectively. Studies show that supplementation of pancreatin can help with autoimmune dysfunction. Pancreatin can also be useful for flatulence, cystic fibrosis or chronic pancreatitis.

[0076] With respect to thyroid function and Hashimoto's, pancreatin may help suppress antigenic load from undigested food particles that have migrated through the leaky gut into the bloodstream and/or thyroid tissue.

[0077] The composition can include from about 50 to 500 mg of pancreatin. In some embodiments, the composition comprises about 200 mg of pancreatin enzyme.

Vitamin D

[0078] Studies show a tight correlation with vitamin D deficiency and autoimmune diseases of many sorts including Hashimoto's. Researchers in South Korea, in 2013 looked at vitamin D levels and how they correlated with the presence of the antibody TPO-Ab (antibodies to TPO, a biomarker for Hashimoto's). The presence of TPO-Ab signals that the body has or has had an attack on the thyroid.

[0079] The researchers looked at 6,685 patients between 2008 and 2012. All participants had their blood drawn, so the researchers could measure both TPO-Ab and vitamin D levels. The researchers divided patients into three different categories, those who were severely deficient in vitamin D (had levels less than 10 ng/ml), deficient in vitamin D (levels between 10-30 ng/ml) and those who were sufficient in vitamin D (over 30 ng/ml). Those who were deficient in vitamin D were much more likely to have TPO-Ab positive tests (a biomarker confirming Hashimoto's thyroiditis). The prevalence of TPO-Ab positive tests was 21.2% in the severely vitamin D deficient group, 15.5% in the deficient group, and just 12.6% in the sufficient group. Participants who lacked vitamin D more than normal, had the highest autoantibody levels against the thyroid gland. Simply put, those with the lowest levels of vitamin D had the most destruction of their thyroid gland occurring.

[0080] In a preferred embodiment, the composition further comprises a pre-determined amount of vitamin D, a natural fat-soluble antioxidant produced in the human body from ultraviolet ray (sun) exposure. Vitamin D is known to promote a healthy immune system, and is particularly useful for autoimmune conditions.

[0081] As it pertains to thyroid health and autoimmune thyroid conditions, vitamin D is the primary antioxidant to protect the thyroid gland. The composition can include from about 1,000 to 10,000 IU of vitamin D3 (cholecalciferol). In some embodiments, the composition can include about 4,000 IU vitamin D3 (cholecalciferol).

Glutathione (Reduced and Acetylated)

[0082] Glutathione is one of the human body's most powerful antioxidant and is produced naturally in the liver, and released to be used throughout the entire system. As one function, glutathione protects DNA from damage and is critical for proper mitochondrial function and energy production. If the mitochondria are damaged, you will feel more fatigue and you can't detoxify poisons from your cells. Glutathione can be taken in supplementation form.

[0083] There are a lot of benefits to taking Glutathione orally, however, taken alone in a regular form will cause it to be of little use. Glutathione rapidly degrades once it enters the stomach where the gastric (hydrochloric acid) dissolves the glutathione molecule before it can be absorbed. Acetyl Glutathione is used to help overcome the problems with absorption. Increasing the amount of Glutathione that reaches the cells, this acetylated form permeates the barriers that once held back the benefits of supplementing Glutathione orally.

[0084] The “acetylated” form can bypass stomach acid, thus improving bioavailability. S-Acetyl Glutathione can be included in the composition to ensure optimum absorption. “Reduced” glutathione is the natural form produced by the body, and can also be included in the composition.

[0085] Aside from detoxifying poison from the cell, glutathione has been shown through experimentation to break down (metabolize) hydrogen peroxide which is high in people with Hashimoto's disease. By neutralizing peroxide in the body, free radical damage is reduced.

[0086] Glutathione is a potent “heavy metal” chelator and can help clear the body of mercury, cadmium, lead and other heavy metals. People with Hashimoto's may have elevated levels of heavy metals as part of their disease, so the enhanced clearance of heavy metals is desired. Glutathione supports immune function. It also has natural antiviral activity.

[0087] A poor diet or poor intestinal permeability, as well as chronic illness will deplete human stores of glutathione and inhibit its production. The body's ability to make glutathione declines naturally with age. Individuals over the age of 45 are especially likely to be deficient. Acetyl Glutathione benefits every system in the body, and truly earns the title of our body's “Master Antioxidant” as many people refer to it.

[0088] Therefore, the composition can include from about 10 to 200 mg of S-acetylglutathoine (SAG). In some embodiments, the composition can include about 50 mg of SAG. In some embodiments, SAG can be in a reduced form. Reduced SAG can get into the blood-brain barrier.

[0089] In some embodiments, the composition can include a predetermined amount of “reduced” glutathione, which means it is in the form that is recognized and absorbed by the cells of the body. The combination of both forms of glutathione provides optimal absorption, and synergetic effects. Reduced L-glutathione is a natural compound made in the body from the amino acids glutamic acid, cysteine and glycine. Reduced glutathione is an antioxidant that protects cells and tissues by scavenging free radicals. In this process, reduced glutathione is transformed into the oxidized form. However, reduced glutathione can quickly be depleted under heavy bouts of free radical stress or exposure to compounds that require detoxification. A shift in the ratio towards the oxidized state leaves cells and tissues vulnerable to free radical damage and inflammation. The “L” designation indicates the natural molecular structure. The composition can include from about 100 to 500 mg of “reduced” glutathione. In some embodiments, the composition can include comprises about 250 mg of “reduced” glutathione.

Selenium

[0090] The composition can include a pre-determined amount of selenium. Ideally, selenium should be supplemented in a form in which it occurs naturally in foods. Although there are various forms of the mineral selenium, such as sodium selenite, which can be used for selenoprotein biosynthesis, only “Selenomethionine” is incorporated into body proteins. Selenomethionine is a natural form of selenium. Because the L-isomer of selenomethionine (termed in the literature as Se-met) is a major natural food-form of selenium, it is used in the composition, though one skilled in the art would understand that equivalent forms can be used without deviating from the invention. This form of selenium can be stored in the human and reversibly released by normal metabolic processes, thus offering an advantage over other selenium salts. Ingested selenomethionine is absorbed in the small intestine and helps with thyroid hormone production, conversion and utilization.

[0091] Selenium is a popular compound used in thyroid support formulas since it is an antioxidant mineral and is essential for the Deiodinase enzymatic system. The deiodinase enzyme converts T4 (inactive) to T3 (active) thyroid hormone. Certain selenium-dependent deiodinase enzymes therefore activate human thyroid hormone. Deficiency of selenium would result in reduced active T3 levels. Deficiency in selenium could result in clinical hypothyroidism. The composition can include from about 10 to 400 mcg of selenium. In some embodiments, the composition comprises about 100 mcg of selenium.

Other Components

[0092] In varying embodiments, the composition can be substantially free of gluten, wheat, egg, peanuts, tree nuts, dairy, sugar, corn, soy, artificial colors, preservatives, fish and shellfish, and combinations thereof.

Palatability

[0093] According to certain embodiments, the compositions described herein can further be provided with one or more palatability agents. These palatability agents serve to add flavor to the composition so that an effective dosage is easier to be ingested by a patient. It is within the scope of the present invention that any safe, flavor enhancing palatability agent can be used in a composition of the present invention. Particularly suitable palatability agents for use in the composition of the present invention include, but are not limited to, plant oils, plant hydrolysates, yeast, and yeast hydrolysates, and combinations thereof.

Method to Treat a Patient

[0094] An aspect of the invention is a method to treat a thyroid disease with a composition comprising selenium, digestive enzymes DPP-IV, proteolytic enzyme, systemic enzyme, and glutathione. The composition can include other components such as catalase, antioxidants, and pepsin, along with palatability components. The patient is treated by providing an effective amount of the composition to affect the thyroid. The capsules can be taken by the patient daily, preferably in the morning before any other food is ingested by the patient. The capsule can be acid resistant or enteric-coated capsule, soft gel or tablet. In some embodiments, the dosage can be adjusted to result in an adequate thyroid level in the patient. In some embodiments, the disease can be Hashimoto's.

Method for Making the Composition

[0095] An aspect of the invention is a method to prepare a composition. The method comprises providing proportional amounts of each component such that the resulting composition results containing from about 100 to 500 mg Reduced Glutathione, from about 10 to 200 mg of Acetylated Glutathione, from about 10 to 1,000 mg DPP-IV enzyme, from about 50 to 500 mg Bromelain, from about 50 to 500 mg Pancreatin enzyme, and from about 25 to 200 mcg of Selenium. In some embodiments, the composition can further include from about 25 to 1,000 mg Catalase, from about 10 to 50 mg Pepsin, from about 1,000 to 10,000 IU Vitamin D. The components are mixed, then can be provided to a delivery device (for example capsule or a powder). The capsule can be acid resistant or enteric-coated capsule, soft gel or tablet.

[0096] Ranges have been discussed and used within the forgoing description. One skilled in the art would understand that any sub-range within the stated range would be suitable, as would any number within the broad range, without deviating from the invention.

[0097] While various embodiment of the present disclosure have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present disclosure, as set forth in the following claims. For further illustration, the book “Thyroid Healthy” authored by the named inventor of the present invention is expressly made a part of this disclosure and incorporated by reference herein in their entirety.

[0098] The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.