METHODS AND COMPOSITIONS FOR TREATING JOINT DISEASE

Abstract

The present disclosure relates to a compound, method of making and method of using such compound preferably in the form of a dietary supplement. The composition, when administered, is capable of treating arthritis and various joint-related pain syndromes. The unique combination of the composition is preferably administered orally. A preferred composition is comprised of at least 10 to 200 mcg of selenium, from about 200 to 1200 mg of MSM, from about 100 to 900 mg of boswellia, from about 1 to 5 mg of type II collagen, from about 25 to 200 mg of hyaluronic acid, and from about 50 to 500 mg of ginger.

Claims

1. A method to improve joint function in a patient, comprising: administering to the patient a composition comprising: about 30 mcg of selenium; about 10 mg of type II collagen; about 100 mg of boswellia; about 500 mg of MSM; about 100 mg hyaluronic acid; and about 180 mg of ginger; wherein the composition is provided in the form of the capsule or the tablet; and wherein between one and four of the capsule or the tablet is provided to the patient on a daily basis.

2. The method of claim 1, wherein the composition is provided to the patient in the form of a capsule, a tablet, a suspension, a sublingual spray, a powder, or a lozenge.

3. The method of claim 1, wherein the joint function is improved by regenerating connective tissue.

4. The method of claim 1, wherein a diminished joint function in the patient is caused by arthritis.

5. The method of claim 1, wherein the composition provided to the patient does not include at least one of a fish, a shellfish, a gluten, a wheat, an egg, a peanut, a tree nut, dairy, a sugar, a corn, soy, an artificial color, or a preservative.

6. A method for treating one or more joints in a patient, comprising: administering an effective amount of a composition to a patient suffering from arthritis, wherein the composition comprises: 30 mcg of selenium; 10 mg of type II collagen; 100 mg of boswellia; 500 mg of MSM; 100 mg hyaluronic acid; and 180 mg of ginger.

7. The method of claim 6, wherein the composition is provided to the patient in the form of a capsule, a tablet, a suspension, a sublingual spray, a powder, or a lozenge.

8. The method of claim 6, wherein the composition is administered in the form of the capsule or the tablet, and wherein between one and four of the capsule or the tablet is administered to the patient on a daily basis.

9. The method of claim 6, wherein the one or more joints are improved by regenerating connective tissue in the one or more joints.

10. The method of claim 6, wherein the composition administered to the patient does not include at least one of a fish, a shellfish, a gluten, a wheat, an egg, a peanut, a tree nut, dairy, a sugar, a corn, soy, an artificial color, or a preservative.

Description

DETAILED DESCRIPTION

[0031] 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:

[0032] Selenium

[0033] In a preferred embodiment, the composition includes a pre-determined amount of selenium. Consumption of Selenium promotes glutathione production, a major natural detoxificant and potent liver antioxidant. However, it can be depleted easily due in part to dietary consumption, for example, by drinking wine or taking medications, or eating poorly. Replenishment of glutathione is useful for optimal health.

[0034] Glutathione cannot be made without sufficient amounts of selenium. Selenium is a mineral antioxidant. More specifically, this antioxidant is essential for people with autoimmune arthritis (termed rheumatoid). Rheumatoid arthritis sufferers often have a selenium deficiency. It has been discovered through experimentation that selenium can help relieve arthritis symptoms by regulating free radical production and preventing damage to healthy tissues.

[0035] In addition, selenium can regulate immune function, which can account for selenium's beneficial effect in rheumatoid arthritis. Selenium intake has been found to eliminate joint pain, reduce joint stiffness, improve mobility, decrease joint inflammation, support healthy joints and lower the risk of developing arthritis, due in part to its ability to neutralize inflammatory free- radicals which lodge in joints. It has further been found that deficiency of selenium equates to a higher risk of joint pain and immobility.

[0036] In a preferred embodiment, the composition includes from about 10 mcg to 200 mcg of selenium. In a most preferred embodiment, the composition includes about 30 mcg of selenium.

[0037] Collagen Type II

[0038] In a preferred embodiment, the composition further includes a pre-determined amount of type II collagen. Commonly referred to as collagen, it can be undenatured or denatured. Collagen is the principal structural protein in cartilage. Cartilage is a primary connective tissue in the body, providing flexibility and support to bones and joints, and confers tensile strength and toughness.

[0039] Collagen has been discovered through experimentation to be a desirable component of cartilage. The collagen can be derived from chicken sternum cartilage, collagen can be undenatured, which works with the immune system to support healthy joints and promote more mobility and flexibility. Collagen's composition has demonstrated its efficacy in human clinical studies. In a preferred embodiment, the composition includes a pre-determined amount of collagen. In an embodiment, the composition further includes a synergistic blend of anti-inflammatories, antioxidants and lubricating compounds.

[0040] In an October 2013 study in the Journal of The International Society of Sports Nutrition, it was found that a patented form of undenatured type II collagen could also reduce knee pain and improve mobility. See Lugo et al., Undenatured type II collagen (UC-II) for joint support: A randomized, double-blind placebo-controlled study in healthy volunteers (incorporated by reference in its entirety). This research was based upon randomized, double-blind, placebo-controlled study in healthy volunteers, and concluded that daily supplementation of UC-II was well tolerated and led to improved knee joint extension in the subjects. Adverse events related to the product were not observed during the study.

[0041] Accordingly, dietary supplements containing collagen have been proven to assist in reestablishing normal joint function. Collagen is also effective in supporting joint elasticity and reducing stiffness. A study in the International Journal of Clinical Pharmacology Research stated, UC II has demonstrated the ability to induce tolerance, effectively reducing joint pain and swelling in [rheumatoid arthritis] subjects. Bagchi et al., Effects of Orally Administered Undenatured Type II chicken Collagen Against Arthritic Inflammatory Pathologies: A Mechanistic Exploration, 22(3-4):101-10 (2002) (incorporated by reference in its entirety). The authors of this study concluded, UC-II [collagen] may serve as a novel therapeutic tool in joint inflammatory conditions and symptoms of [osteoarthritis] and [rheumatoid arthritis]. Id.

[0042] In a preferred embodiment, the composition includes from about 1 mg to 5 mg of type II collagen. In a most preferred embodiment, the composition includes about 2 mg of type II collagen.

[0043] Boswellia

[0044] In a preferred embodiment, the composition further includes a pre-determined amount of boswellia extract. Boswellia extract is sometimes called Frankincense. It comes from the sap of the Boswellia serrata tree. Boswellia has been found to support joint health and reduce pain and inflammation by suppressing 5 lipoxygenase (5-lox). There are prescription medications on the market today that suppress this same pathway, and are termed 5-LOX inhibitors. These medications, however, come with a variety of side effects.

[0045] Through experimentation it has been discovered that compounds including a pre-determined amount of Boswellia may help reduce pain or slow the production of inflammation chemicals. Thus, in a preferred embodiment, the composition includes from about 100 mg to 900 mg of boswellia. In a most preferred embodiment, the composition includes about 250 mg of boswellia.

[0046] MSM (Methylsulfonylmethane)

[0047] In a preferred embodiment, the composition further includes a pre-determined amount of MSM. MSM is a sulfur containing compound that occurs naturally in certain plants and foods. It is included to provide sulfur to the joints and aid detoxification.

[0048] Sulfur has also been found to be beneficial to treating joint disease. Recent experimentation has shown that MSM (methylsulfonylmethane) supplementation may improve joint function, relieve symptoms associated with joint degeneration and improve mobility and quality of life among older individuals. Therefore, providing a composition that also includes appropriate levels of MSM can be beneficial.

[0049] Through experimentation, applicant has found that MSM shows positive effects in improving joint function, relieving symptoms associated with joint degeneration and improving the quality of life in aging populations. Several studies have shown significant benefit in arthritis, especially of the knee. In the publication, International Journal of Biomedical Science (available at http://www.ijbs.org/user/ContentFullText.aspx?VolumeNO=11& StartPage=54#ABS, last viewed Dec. 14, 2016 (incorporated in its entirety by reference)), a total of 100 male and female participants over 50 years old who had at least one of the related symptoms of joint degeneration (joint pain, joint stiffness, joint swelling, difficulty walking, difficulty getting up from bed and difficulty going down stairs) were recruited for a study. The participants were given MSM and monitored for symptoms of joint degeneration before and after the intervention, and the results were recorded. MSM was shown to improve joint function, relieve symptoms of joint degeneration and improve activities of daily living in the participants. Furthermore, MSM is required to provide a sulfur component which improves both joint structure and function. The clinical use of sulfur in the diet has been shown to be useful in optimizing health. Sulfur is needed to product the natural antioxidant glutathione, which neutralizes toxins in the body.

[0050] In a preferred embodiment, the composition includes from about 200 mg to 1200 mg of MSM. In a most preferred embodiment, the composition includes about 400 mg of MSM.

[0051] Hyaluronic Acid

[0052] In a preferred embodiment, the composition further includes a pre-determined amount of the hyaluronic acid. Through experimentation, it has been determined that insufficiency of hyaluronic acid leads to greater pain. Hyaluronic acid can further be injected into knee joints as a temporary treatment for osteoarthritis.

[0053] Hyaluronic acid acts as a lubricant and helps arthritis sufferers feel better even if they must be supported on analgesic drugs, physical therapy or topical anesthetics. A recent 5-year study in Arthritis Research and Therapy (Sasaki et al., Serum hyaluronic acid concentration predicts the progression of joint space narrowing in normal knees and established knee osteoarthritisa five-year prospective cohort study, 17:283 (2015) (incorporated by reference in its entirety)), concluded that there is a correlation in serum hyaluronic acid levels and the progression of knee joint deterioration. The less hyaluronic acid, the faster the decline, meaning the individual will likely be more apt to suffer pain, inflammation and inflexibility. With respect to joint function, hyaluronic acid help lubricate the joints, improving mobility and reducing pain.

[0054] In a preferred embodiment, the composition includes from about 25 mg to 200 mg of hyaluronic acid. In a most preferred embodiment, the composition includes about 50 mg hyaluronic acid.

[0055] Ginger

[0056] Ginger is an herb known botanically as Zingiber officinale, and has strong medicinal benefits as an anti-inflammatory. Ginger is also thought to reduce nausea and vomiting. However the inclusion of this herb in this embodiment, and more particularly in the form of a ginger root extract, is for the reduction of pain-causing compounds that are released by the human body, specifically in connection with chronic pain syndrome. For example, the compound 5-LOX is known to be released within the body and can cause tremendous pain and inflammation. Ginger root extract has been shown to reduce this pain-causing compound. Other compounds such as tumor necrosis factor alpha (TNF) and cyclooxygenase 2 (COX 2) are two other pain-causing compounds that rise in the human body during arthritic pain flares and chronic joint-related syndromes.

[0057] Ginger also has analgesic properties from its healing polysaccharides and flavonoids, which reduce inflammatory cytokines (by blocking NF-kB, a pathway in the body that secretes pain-causing compounds). Because of its ability to quell free radicals, ginger can also reduce the damage to joints by superoxides.

[0058] Reducing any of the above-mentioned pain-causing biomarkers (termed cytokines) in turn reduces pain and inflammation. As an added benefit, ginger root has been found to target and kill a harmful bacterium called H. pylori, (commonly referred to as the ulcer bug because it is frequently found in people with ulcers). Regretfully, this same pathogen, H. pylori has been implicated in the pathogenesis of joint inflammation. Eradicating H. pylori seems to be especially advantageous in infected rheumatoid arthritis patients. Ginger root reduces pro-inflammatory cytokines and helps to eradicate a destructive pathogen which may contribute to autoimmune arthritis (such as rheumatoid).

[0059] In a preferred embodiment, the composition includes from about 50 mg to 500 mg of ginger. In a most preferred embodiment, the composition includes about 180 mg of ginger.

[0060] 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 joints, cartilage and connective tissue, and may further reduce pain and inflammation.

Additional Embodiments

[0061] In addition, the composition of a preferred embodiment can be substantially free of fish, shellfish, gluten, wheat, egg, peanuts, tree nuts, dairy, sugar, corn, soy, artificial colors and preservatives, or combinations thereof.

[0062] The composition can be in the form of a capsule, a tablet, a suspension, a sublingual spray, a powder for a drink or a dissolvable lozenge. The capsule can be vegetarian.

Method of Treating a Patient

[0063] An aspect of the invention is a method to improve the function of joints and connective tissue. The method includes providing the patient with a composition, where the composition includes from about 10 to 200 mcg of selenium, from about 1 to 5 mg of collagen, from about 100 to 900 mg of boswellia, from about 200 to 1200 mg of MSM, from about 25 to 200 mg of hyaluronic acid, and from about 50 to 500 mg of ginger. Other components such as a palatability agent can also be added to the composition. Between about 386 mg and about 3005 mg of the composition can be provided to the patient. The composition can be provided in the form of a capsule, a tablet, a suspension, a sublingual spray, a powder, or a lozenge. Between one to four capsules can be provided to a patient per day. The capsule can be size 0, which corresponds to an overall closed length of between about 20.7-21.7 mm, and an average weight of between 98-106.4 mg +/6%. The number of capsules can be sized to provide the patient with between about 386 mg and about 3005 mg per day. As the number of capsules vary, the size of the capsule can vary as well.

[0064] An aspect of the invention is a treatment for a patient to improve function of the joints and connective tissue by administering the composition of the present invention. Another aspect of the invention is a method to regenerate connective tissue in a patient by administering the composition of the present invention.

Method of Making the Composition

[0065] An aspect of the invention is a method to prepare a composition. The method comprises providing proportional amounts of each material such that the resulting composition results containing from about 10 to 200 mcg of selenium, from about 1 to 5 mg of collagen, from about 100 to 900 mg of boswellia, from about 200 to 1200 mg of MSM, from about 25 to 200 mg of hyaluronic acid, and from about 50 to 500 mg of ginger. Other components such as a palatability agent can also be added to the composition. The components are mixed, then can be provided to a delivery device (for example capsule, tablet, suspension, sublingual spray, powder for a drink or dissolvable lozenge).

[0066] 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.

[0067] 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.

[0068] 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.