COMPOSITIONS AND METHODS FOR TREATING THYROID DISEASE

Abstract

The present disclosure relates to methods of administering a compound for treating a patient suffering from thyroid disease and various thyroid-related disorders, including hyperthyroid and hypothyroid. The composition is preferably comprised of at least selenium, zinc, iodine, manganese, molybdenum, ashwaganda root powder, polygonum root extract, a digestive enzyme such as DPP-IV, L-tyrosine and mullein leaf, in pre-determined amounts. The composition can further comprise a palliative agent, and can be provided in the form of a capsule or tablet.

Claims

1. A method for treating a thyroid disease comprising: administering an effective amount of a composition to a patient suffering from the thyroid disease, wherein the composition comprises: 1.5 to 3.5 mg of B6; 50 to 100 mcg of B12; 500 to 700 mcg of iodine; 50 to 150 mcg of selenium; 4 to 12 mg of zinc; 0.5 to 2 mg of manganese; 25 to 125 mcg to molybdenum; 450 to 600 mg of ashwaganda root powder; 102 to 170 mg of an extract selected from the group consisting of polygonum root extract, a grape seed extract, or combinations thereof; and 100 to 300 mg of at least one digestive enzyme.

2. The method of claim 1, wherein the thyroid disease is selected from the group consisting of hyperthyroid, and hypothyroid.

3. The method of claim 1, wherein the composition is administered orally in the form of a capsule.

4. The method of claim 3, wherein the method further comprises administering between 2 and 3 capsules of the composition to the patient per day.

5. The method of claim 1, wherein the composition administered to the patient further comprises 40 to 110 mg of L-Tyrosine.

6. The method of claim 5, wherein the composition administered to the patient further comprises 20 to 80 mg of mullein leaf

7. The method of claim 6, wherein the digestive enzyme is DPP-IV.

8. A method for treating a thyroid disease by administering to a patient in need thereof a composition, wherein the composition comprises: 2 mg of B6; 90 mcg of B12; 500 mcg of iodine; 150 mcg of selenium; 10 mg of zinc; 2 mg of manganese; 75 mcg of molybdenum; 450 mg of ashwagandha root powder; 102 mg of polygonum root extract; 200 mg of DPP-IV; 75 mg of L-Tyrosine; 50 mg of mullein leaf; and wherein the composition is administered in the form of a single capsule.

9. The method of claim 8, wherein the B12 administered to the patient is in the form of methylcobalamin.

10. The method of claim 8, wherein the composition administered to the patient further comprises calcium phosphate.

11. The method of claim 8, wherein the composition administered to the patient further comprises copper gluconate.

12. The method of claim 8, wherein the composition administered to the patient further comprises hydroxypropyl methylcellulose.

13. The method of claim 8, wherein the composition administered to the patient does not comprise additives selected from the group consisting of gluten, wheat, egg, peanuts, tree nuts, dairy, sugar, com, soy, artificial colors, preservatives, fish and shellfish.

14. The method of claim 8, wherein the composition administered to the patient further comprises at least one palatability agent.

15. The method of claim 14, wherein the palatability agent is selected from the group consisting of plant oils, plant hydrolysates, yeast, and yeast hydrolysates.

16. The method of claim 15, wherein the thyroid disease is selected from the group consisting of hyperthyroid, and hypothyroid.

17. The method of claim 15, wherein the composition is administered to the patient as a dietary supplement.

Description

DETAILED DESCRIPTION

[0028] 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.

Composition

[0029] An aspect of the present invention is directed to a composition. The composition can be used in treating thyroid disease, various thyroid-related disorders, or alcoholics or consumers of alcohol with difficulty retaining zinc, which is another aspect of the invention. The composition includes vitamin B6, vitamin B12, iodine, zinc, selenium, manganese, molybdenum, ashwagandha root powder, an extract, a digestive enzyme, L-thyrosine, and mullein leaf. The composition can include other materials.

Digestive Enzyme

[0030] In a preferred embodiment, the composition is comprised of at least one digestive enzyme. In a most preferred embodiment, the compound is comprised of 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, proteins found in wheat and dairy, respectively. As gluten and casein are known to attack and damage the thyroid glands of certain individuals, it is desirable to include a pre-determined amount of DPP-IV with the composition. In addition, certain individuals have a deficiency in this enzyme, and therefore have trouble breaking down the gluten protein. Partial digestion of the gluten protein can exasperate the gastrointestinal tract, inflame the small intestine, and provoke an immune response, which in turn attacks the human thyroid gland.

[0031] In a preferred embodiment, the composition comprises from about 700 to 1300 mg of a digestive enzyme, preferably DPP-IV. Other suitable enzymes include, but are not limited to, amylase, lipase, protease, proteolytic enzymes or other digestive enzymes, or combinations thereof. In a most preferred embodiment, the composition comprises about 1000 mg of DPP-IV. In alternate embodiments, one or more additional digestive enzymes are included. The DPP-IV can be in the form of protease DPP-IV.

Ashwagandha Root Powder

[0032] In a preferred embodiment, the composition is comprised of a pre-determined amount of the Ayurvedic botanical “ashwagandha,” which has been found through experimentation to improve T4 concentrations. Ashwagandha is also known as an adrenal adaptogen. When the adrenals go into a state of ‘overdrive’ they produce high amounts of cortisol. High cortisol levels can interfere with thyroid function, resulting in low T4 or poor conversion of T4 to the active form, T3. Ashwagandha has been found through experimentation to support normal levels of cortisol. In a preferred embodiment, the composition comprises from about 300 to 600 mg of ashwagandha root powder. In a most preferred embodiment, the composition comprises about 450 mg of ashwagandha root powder.

Selenium

[0033] In a preferred embodiment, the composition is comprised of a pre-determined amount of selenium. Selenium helps with thyroid hormone production and usage. More specifically, this antioxidant mineral is essential for the D (deiodinase) enzyme, which converts T4 to T3. Deficiency of selenium equates to lower T3 levels. In essence, deficiency in selenium could cause a person to be clinically hypothyroid, even though circulating levels of T3 and T4 appear to be normal. Selenium is also needed to balance excess thyroid activity that may be caused by external or internal stressors, and protects the thyroid gland from damage from excessive iodine exposure. In a preferred embodiment, the composition comprises from about 50 to 250 mcg of selenium. In a most preferred embodiment, the composition comprises about 150 mcg of selenium. The selenium can be provided as sodium selenite.

Iodine

[0034] In a preferred embodiment, the composition further comprises a pre-determined amount of iodine. Iodine has been found through experimentation to assist in the formation of T4, which in turn promotes healthy thyroid function. In a preferred embodiment, the composition comprises from about 300 to 700 mcg of iodine. In a most preferred embodiment, the composition comprises about 500 mcg of iodine. The iodine can be provided as potassium iodide.

L-Tyrosine

[0035] In a preferred embodiment, the composition further comprises a pre-determined amount of L-tyrosine. The amino acid L-tyrosine has been discovered through experimentation to be a desirable component of both T4 and T3 formation. In a preferred embodiment, the composition comprises from about 40 to 110 mg of L-Tyrosine. In a most preferred embodiment, the composition comprises about 75 mg of L-Tyrosine.

Polygonum Root Extract

[0036] In a preferred embodiment, the composition further comprises a pre-determined amount of polygonum root extract and/or grape seed extract. Through experimentation it has been discovered that conversion of T4 to T3 may be inhibited by heavy metal toxicity and lipid peroxidation. It is believed that dosages of supplements containing polygonum root extract and/or grape seed extract, such as with the antioxidant blend “Oxyphyte,” can counterbalance this inhibition. Polygonum root has also been found to activate SIRT1 (silent information regulator 1), dubbed the “skinny gene.” With respect to thyroid function, polygonum root may help prevent or slow growth of both papillary and follicular thyroid cancer, and further enhances iodine utilization, metabolism and thyroid function by affecting SIRT1 gene and other genes. Thus, in a preferred embodiment, the composition comprises from about 50 to 170 mg of polygonum root extract and/or from about 150 to 300 mg of grape seed extract. In a most preferred embodiment, the composition comprises about 110 mg of polygonum root extract and/or about 200 mg of grape seed extract.

B6

[0037] In a preferred embodiment, the composition further comprises a pre-determined amount of B6. Pyridoxal 5′ Phosphate (P5P) is an active form of vitamin B6. It has been discovered through experimentation that a deficiency of this B vitamin can make an immune system more likely to attack the thyroid. In addition, P5P is required to work with the mineral zinc, which is necessary to make the human thyroid hormone function, and some individuals cannot readily convert B6 to its biologically active (usable) form. Low levels of B6 are also associated with premenstrual difficulties, and a deficiency of P5P can lead to hypothyroidism and autoimmune thyroid disease. In a preferred embodiment, the composition comprises from about 0.5 to 3.5 mg of B6. In a most preferred embodiment, the composition comprises about 2 mg of B6.

B12

[0038] In a preferred embodiment, the composition further comprises a pre-determined amount of the vitamin B12, because through experimentation it has been determined that insufficiency of B12 interferes with the activity of thyroid hormones. Methylcobalamin is one of the active forms of vitamin B12. Methylcobalamin and B12 have been found to play a key role in cell metabolism of the human body, increasing energy, improving mental sharpness, and promoting healthy nervous system function. Research indicates that nearly 40% of hypothyroid patients suffer B12 deficiency. In a preferred embodiment, the composition comprises from about 10 to 90 mcg of B12. In a most preferred embodiment, the composition comprises about 50 mcg of B12.

Manganese

[0039] In a preferred embodiment, the composition further comprises a pre-determined amount of manganese. Manganese is believed to promote healthy mitochondria, which convert glucose into energy by spawning ATP. It has been found that the thyroid hormone does not work unless mitochondria are alive and functioning. As it pertains to thyroid health, this enzyme (which is dependent on manganese) is the primary antioxidant and protector of thyroid hormone in the human liver. Furthermore, most T4 and T3 conversion occurs in cells from the liver. Additionally, manganese helps people who are “pear-shaped” improve metabolism, and reduce fat accumulation in the liver, which can cause lipid peroxides. In a preferred embodiment, the composition comprises from about 0.5 to 3.5 mg of manganese. In a most preferred embodiment, the composition comprises about 2 mg of manganese. The manganese can be provided as manganese gluconate.

Molybdenum

[0040] In a preferred embodiment, the composition further comprises a pre-determined amount of molybdenum. The human body requires molybdenum to convert sulfites in meats, dried fruit, wine and sulfur-containing foods (for example, broccoli, garlic, or onions) into sulfate. Certain individuals have a genetic mutation or single nucleotide polymorphism (“snp”—pronounced snip), which causes difficulty in making this conversion. The enzyme that makes this conversion is called “sulfite oxidase.” Individuals who suffer from poor mental focus or lack of concentration may have molybdenum deficiencies. Therefore, in a preferred embodiment, the composition comprises from about 25 to 125 mcg of molybdenum. In a most preferred embodiment, the composition comprises about 75 mcg of molybdenum. The molybdenum can be provided as sodium molybdate in some embodiments.

Zinc

[0041] Zinc aids in the conversion of T4 to T3. In a preferred embodiment, the composition comprises from about 5 mg to about 50 mg of zinc. In a most preferred embodiment, the composition comprises about 10 mg of zinc. The zinc can be provided as zinc M nomethionine.

Mullein Leaf

[0042] Mullein leaf is an herb is known botanically as “Berbascum Thapsus” and has strong medicinal benefits and antibiotic actions against tuberculosis, leprosy and many other pathogens. Furthermore, mullein possesses strong anti-inflammatory, anti-tumor, antifungal, antibacterial and anti-viral actions. It also has analgesic properties from its healing polysaccharides and flavonoids, which reduce inflammatory cytokines (by blocking NF-kB, a pathway in the body that churns pain-causing compounds). Because of its ability to reduce superoxide free radicals, mullein leaf may also reduce glandular inflammation associated with Graves' disease or Hashimoto's. In a preferred embodiment, the composition comprises from about 20 to 80 mg of mullein leaf. In a most preferred embodiment, the composition comprises about 50 mg of mullein leaf.

Optional Components

[0043] In varying embodiments, the composition can further comprise one or more of calcium phosphate, hydroxypropyl methylcellulose, and copper gluconate. In addition, the composition of a preferred embodiment is substantially free of gluten, wheat, egg, peanuts, tree nuts, dairy, sugar, corn, soy, artificial colors, preservatives, fish and shellfish.

[0044] In addition to the benefits described herein, several of the botanicals and nutrients described in varying embodiments of the present invention have been found to exhibit antifungal and antibacterial activity against a wide variety of organisms, which in turn provides an additional layer of protection to the human thyroid gland.

[0045] 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. 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.

[0046] An aspect of the invention is a method to treat a thyroid disease with a composition comprising vitamin B6, vitamin B12, iodine, zinc, selenium, manganese, molybdenum, ashwagandha root powder, an extract, and a digestive enzyme. The composition can include other components such as L-thyrosine, and mullein leaf, calcium phosphate, hydroxypropyl methylcellulose, copper gluconate, and combinations thereof. The patient is treated by providing an effective amount of the composition to affect the thyroid. By way of example, between 1 and 3 capsules of the composition can be provided to a patient per day, in some embodiments 2 capsules per day. The capsules can be taken by the patient daily, preferably in the morning before any other food is ingested by the patient. In some embodiments, the dosage can be adjusted to result in an adequate thyroid level in the patient.

[0047] An aspect of the invention is a method to treat a patient with a zinc deficiency. The method includes administering a dose of a composition comprising vitamin B6, vitamin B12, iodine, zinc, selenium, manganese, molybdenum, ashwagandha root powder, an extract, and a digestive enzyme to the patient suffering from the zinc deficiency. The composition can include other components such as L-thyrosine, and mullein leaf, calcium phosphate, hydroxypropyl methylcellulose, copper gluconate, and combinations thereof. The dose can be daily, every other day, every week, or as necessary to provide affect the zinc deficiency in the patent. By way of example, between 1 and 3 capsules of the composition can be provided to a patient per day, in some embodiments 2 capsules per day. The capsules can be taken by the patient daily, preferably in the morning before any other food is ingested by the patient. In some embodiments, the dosage can be adjusted to result in an adequate zinc level in the patient.

[0048] While various embodiments 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, Lose Weight, Look Beautiful and Live the Life You Imagine” 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.

[0049] 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.