COMPOSITION AND METHOD FOR OMEGA-3 AND PLANT FLAVONOIDS FOR INCREASING HDL CHOLESTEROL AND DECREASING LDL CHOLESTEROL AND TRIGLYCERIDE LEVELS

Abstract

The present invention relates to nutritional supplements for the human diet used to manipulate HDL cholesterol, LDL cholesterol, and triglyceride levels in human blood plasma. The invention contains a novel combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) present in Fish Oil, alpha-linolenic acid (ALA) present in Flaxseed Oil, Vitamin E in the form of d-alpha-tocopherol, Allicin present in Garlic, Phosphatidylcholine present in Lecithin, plant phytochemicals present in Parsley herb, citrus flavonoids present in Lemon fruit and Rutin (from Sophora japonica), and Capsaicin present in Cayenne Pepper.

Claims

1. A method of increasing HDL cholesterol and lowering LDL cholesterol and also lowering total triglyceride levels to healthy ranges in the human blood plasma by orally administering a nutritional supplementing amount of a combination of compositions comprising: Fish Oil, Flaxseed Oil, Isoflavones, Allicin, bioflavonoids and combinations thereof.

2. The method of claim 1, wherein the fish oil composition comprises between 500 mg and 3000 mg of Fish Oil containing 100 mg to 1000 mg of EPA and 50 mg to 500 Mg of DHA.

3. The method of claim 1, wherein the Flaxseed Oil composition comprises between 100 to 500 mg of Flaxseed Oil containing 22.5 mg to 112.5 mg of ALA.

4. The method of claim 1, wherein the isoflavones composition comprises between 10 mg to 100 mg of Isoflavones.

5. The method of claim 4, wherein the isoflavones composition is derived from soybeans.

6. The method of claim 4, wherein the allicin composition comprises between 150 mg to 1000 mg of garlic containing the allicin.

7. The method of claim 1, wherein the bioflavonoids composition is further comprised of 200 mg to 100 mg of lemon containing the bioflavonoids.

8. The method of claim 1, further comprising orally administering 4 IU to 30 IU of Vitamin E.

9. The method of claim 8, wherein the vitamin E composition is d-alpha-tocopherol.

10. The method of claim 1, further comprising orally administering a composition selected from the group consisting of phosphatidylcholine, flavonoids, Rutin, capsaicin, polyphenols, Lycopene and combinations thereof.

11. A dietary composition comprising: an encapsulated liquid having a combination of compositions comprising: Fish Oil, Flaxseed Oil, Isoflavones, Garlic containing Allicin, bioflavonoids and combinations thereof.

12. The dietary composition of claim 11 wherein the Fish Oil composition comprises between 500 to 3000 mg of Fish Oil containing 100 mg to 1000 mg of EPA and 50 mg to 500 mg of DHA.

13. The dietary composition of claim 11 wherein the Flaxseed Oil composition is comprised of between 100 to 500 mg of Flaxseed Oil containing 22.5 mg to 112.5 mg of ALA.

14. The dietary composition of claim 11 wherein the isoflavones composition is comprised of between 10 mg to 100 mg of Isoflavones.

15. The dietary composition of claim 12 wherein the isoflavones are derived from soybeans.

16. The dietary composition of claim 11, wherein the garlic composition is between 150 mg and 1000 milligrams.

17. The dietary composition of claim 11 wherein the bioflavonoids composition comprises 20 mg to 100 mg.

18. The dietary composition of claim 17, wherein the bioflavonoids are derived from Lemon.

19. The dietary composition of claim 11, further comprising 4 IU to 30 IU of Vitamin E.

20. The dietary composition of claim 19, wherein the Vitamin E is d-alpha-tocopherol.

21. The dietary composition of claim 11 further a composition selected from the group consisting of comprising 2 mg to 20 mg of Lecithin containing Phosphatidylcholine, 20 mg to 200 mg of Parsley containing flavonoids, 10 mg to 100 mg of Rutin, 10 mg to 100 mg of Cayenne pepper containing capsaicin, 10 mg to 100 mg of Green Tea containing polyphenols, 10 mg to 100 mg of Lycopene.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0007] The first example of the invention is comprised of two parts, (1) a liquid composed of Fish Oil, Flaxseed Oil, Isoflavones, garlic containing Allicin, and Flavonoids, and optionally an additional composition or compositions selected from the group consisting of Vitamin E, Lecithin, Lemon, Parsley, Rutin, Cayenne pepper, Green Tea, and Lycopene (2) a flexible outer layer encapsulating the liquid composed of Gelatin, Glycerin and Water. This combination of a liquid inner portion and flexible outer layer will be referred to as a softgel. The liquid inner portion may contain additional plant ingredients and is not limited to the present ingredients listed.

[0008] (1) The liquid inner portion is comprised of: [0009] 1. 500 mg to 3000 mg of Fish Oil containing 100 mg to 1000 mg of EPA and 50 mg to 500 mg of DHA, including but not limited to a range between 2300 mg to 2500 mg of Fish Oil containing 650 mg to 850 mg of EPA and 450 mg to 650 mg DHA [0010] 2. 100 to 500 mg of Flaxseed Oil containing 22.5 mg to 112.5 mg of ALA, including but not limited to composition containing 200 mg 300 mg of Flaxseed oil containing 45 mg to 67.5 mg of ALA. [0011] 3. 4 IU to 30 IU of Vitamin E, including but not limited to 18 international units to 22 international units of Vitamin D as alpha-tocopherol. [0012] 4. 2 mg to 20 mg of Lecithin containing Phosphatidylcholine, including but not limited to 8 mg to 12 mg of lecithin containing phosphatidylcholine. [0013] 5. 150 mg to 1000 mg of Garlic containing allicin, including but not limited to 650 mg to 850 mg of Garlic containing allicin. [0014] 6. 20 mg to 100 mg of Lemon containing bioflavonoids, including but not limited to 80 mg to 100 mg of Lemon containing bioflavonoids. [0015] 7. 20 mg to 200 mg of Parsley containing flavonoids, including but not limited to 150 mg to 170 mg of Parsley containing flavonoids. [0016] 8. 10 mg to 100 mg of Rutin, preferably from Sophora japonica, including but not limited to 45 mg 65 mg of Rutin from Sophora japonica. [0017] 9. 10 mg to 100 mg of Cayenne pepper containing capsaicin, including but not limited to 50 mg to 70 mg of Cayenne pepper containing capsaicin. [0018] 10. 10 mg to 100 mg of Green Tea containing polyphenols, including but not limited to 75 mg to 95 mg of Green Tea containing polyphenols [0019] 11. 10 mg to 100 mg of Isoflavones including selected compositions of isoflavones extracted from soybeans or extracts from other species so long as the extracted species contain certain isoflavone compositions as follows

[0020] 10 mg to 100 mg of Lycopene, preferably from tomatoes or other plant species including 70 mg to 90 mg of lycopene from tomatoes and selected groups selected individually from the compositions described above and combinations thereof as described below.

[0021] (2) The flexible outer layer of the gel caps is preferably comprised of: [0022] 1. 300 mg to 500 mg of Gelatin. [0023] 2. 100 mg to 300 mg of Glycerin. [0024] 3. 200 mg to 400 mg of Water.

[0025] A single softgel will be taken orally and will contain 1030 mg to 1500 mg of liquid and 600 mg to 1200 mg of the outer layer. The dosage will range from one to six softgels, preferably 4 softgel capsules per day. The overall dimension of the softgel is approximately 25 mm by 10 mm by 10 mm.

[0026] The second example of the invention is comprised of two parts, (1) a liquid composed of Fish Oil, Vitamin E, Lecithin, Garlic, Lemon, Parsley, Rutin and Cayenne pepper, (2) a flexible outer layer encapsulating the liquid composed of Gelatin, Glycerin and Water. This combination of a liquid inner portion and flexible outer layer will be referred to as a softgel. The liquid inner portion may contain additional plant ingredients and is not limited to the present ingredients listed.

[0027] (1) The liquid inner portion is comprised of: [0028] 1. 500 mg to 3000 mg of Fish Oil containing 100 mg to 1000 mg of EPA and 50 mg to 500 mg of DHA. [0029] 2. 4 IU to 30 IU of Vitamin E as d-alpha-tocopherol. [0030] 3. 2 mg to 20 mg of Lecithin containing Phosphatidylcholine. [0031] 4. 150 mg to 1000 mg of Garlic containing allicin. [0032] 5. 20 mg to 100 mg of Lemon containing bioflavonoids [0033] 6. 20 mg to 200 mg of Parsley containing flavonoids. [0034] 7. 10 mg to 100 mg of Rutin from Sophora japonica. [0035] 8. 10 mg to 100 mg of Cayenne pepper containing capsaicin.

[0036] (2) The flexible outer layer is comprised of: [0037] 1. 300 mg to 500 mg of Gelatin. [0038] 2. 100 mg to 300 mg of Glycerin. [0039] 3. 200 mg to 400 mg of Water.

[0040] A single softgel will be taken orally and will contain 1000 mg to 1200 mg of liquid and 600 mg to 1200 mg of the outer layer. The dosage will range from one to six softgels, preferably 4 softgel capsules per day. The overall dimension of the softgel is approximately 25 mm by 10 mm by 10 mm. The manufacturing of the invention is performed as follows: The liquid inner portion of the mixture is combined in a mixing vessel in the order listed. Once the mixture is thoroughly mixed and homogenous, the mixture is set aside for the encapsulation step. The outer layer is produced as follows: water is added to a heated mixing vessel and brought to a temperature between 50° C. to 60° C., glycerin then be added to the mixing vessel. The temperature is maintained between 50° C. to 60° C., gelatin is than added and then mixed until the mixture is homogenous. The outer layer mixture, also referred to as the gel mass, is added to the encapsulation machine. The inner composition, also referred to as the “fill,” is then be added to the encapsulation machine. The next step is the encapsulation process wherein the gel mass is wrapped around the core composition combination comprising the fill to create a softgel. Once the softgel is produced, the assembly is dried until the outer layer does not contain more than 5% water content. The softgel are then be sorted, inspected and cleaned. Once the softgel is cleaned, a suitable plurality of the softgels consistent with a specified number of oral dosages are than packaged and ready for human consumption. The encapsulation machine is commercially available and many companies provide services to produce softgels. One such company is CAP PLUS TECHNOLOGIES (CAP PLUS TECHNOLOGIES). A visual representation of how a softgel is produced can be found here www.capplustech.com/how to softgel.htm

[0041] Each of these ingredients listed in the two examples are commercially available from many suppliers. Fish oil containing EPA and DHA can be sourced from fishes such as mackerel (Scomber scombrus), sardines (Sardina pilchardus), and menhaden (Brevoortia tyrannus). The process in which fish oil is produced from these fishes involve the steam rendering of the fresh fish, sludge decanter to separate the oil and water from the dry matter, vacuum drying, deacidification, vacuum drying a second time. This dried mass is then filtered of high melting components, producing crude fish oil, which is then deodorized to remove odors. Natural absorbents are used to remove polychlorinated biphenyl and pesticides, and an analysis is performed. The mass then goes through a crystallization process, homogenizing and blending of the fish oil, and an analysis is performed., then through filtration and packaging. Flaxseed oil containing ALA can be sourced from Flax (Linum usitatissimum). Flaxseed oil is produced as follows: mechanically cleaning of flax, pressing of flax, collection of oily fraction, analysis performed , then filtration and packaging. Vitamin E is produced from soybean (Glycine max). It is produced by starting with soybean oil, esterification with methanol and sulfuric acid, producing a crystal liquid, which is then refrigerated. The liquid is then filtered and distilled, producing crude mixed tocopherols. Column chromatography is performed separating the mixed tocopherols, solvents are then removed, the crude alpha tocopherols are produced, and then distillation of the crude alpha tocopherols refines the d-alpha-tocopherol. Lecithin is produced from soybeans (Glycine max) by first starting with crude soybean oil, degumming is performed to produce crude soybean lecithin, de-oiling the crude soybean lecithin produces oil-free lecithin, then concentrating the lecithin, drying and packaging. Garlic (Allium sativum) used in this invention is produced by first extracting with water into concentrated garlic extract. The garlic extract is then spray-dried and ground to a powder. An analysis of allicin is performed and then the garlic powder is packaged. Lemon (Citrus limon) fruit containing bioflavonoids is produced by removing the juice and oil, then the lemon is milled to the ideal extraction size. Bioflavonoids are extracted and concentrated with water.

[0042] The bioflavonoid concentrate is dried, ground to a powder , and an analysis of bioflavonoids is performed, then packaged. Parsley (Petroselinum crispum) herb powder is produced by first cleaning the parsley, then dehydrating and milling to a powder. A microbial analysis is performed and then the parsley powder is packaged. Rutin is produced from Sophora japonica flower buds. The flower buds are milled to a powder , and then soaked in 100° C. water for extraction. The soaked flower buds powder are filtered, the liquid is then crystallized using hydrochloric acid, and the crystallized material is then filtered and dried, then milled into a powder. An analysis of rutin content is performed and then the rutin is packaged. Cayenne Pepper (Capsicum frutescens) powder is produced by first cleaning the peppers, then dehydrating the peppers. Once the peppers are dried they are milled into a powder , then the powdered cayenne pepper is analyzed for capsaicin content, and then packaged. Green Tea (Camellia sinensis) is produced by first separating the leaves from the stems. The green tea leaves are then soaked in water to remove the polyphenols from the tea leaves. The tea leaves are filtered leaving behind the polyphenols. The polyphenols are concentrated then spray dried. The concentrated green tea polyphenols are then blended, deionized and packaged.

[0043] Soy Isoflavones are produced by first washing the soybeans (Glycine max), then extracting the isoflavones by soaking the soybeans with water and ethanol. The soybeans are filtered leaving behind the isoflavones. The isoflavones are further concentrated by removing additional liquid then it is spray dried. The concentrated isoflavones are then grinded, sifted and then packaged. Lycopene is produced by separating the tomato (Lycopersicum esculentum) peel from the fruit. The lycopene is extracted from the peel producing a lycopene oleoresin. The lycopene oleoresin is filter, crystallized and then dried. The lycopene crystal is then grinded, sifted and packaged.

[0044] Those of ordinary skill in the art will readily recognize, in light of this description, the many variations of suitable formulation and manufacturing procedures are suitable to fabricate the nutraceutical compositions described herein.

[0045] As used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.

[0046] Where a range of values is provided, each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure and can be claimed as a sole value or as a smaller range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0047] Where a discrete value or range of values is provided, that value or range of values may be claimed more broadly than as a discrete number or range of numbers, unless indicated otherwise. For example, each value or range of values provided herein may be claimed as an approximation and this paragraph serves as antecedent basis and written support for the introduction of claims, at any time, that recite each such value or range of values as “approximately” that value, “approximately” that range of values, “about” that value, and/or “about” that range of values. Conversely, if a value or range of values is stated as an approximation or generalization, e.g., approximately X or about X, then that value or range of values can be claimed discretely without using such a broadening term.

[0048] However, in no way should this specification be interpreted as implying that the subject matter disclosed herein is limited to a particular value or range of values absent explicit recitation of that value or range of values in the claims. Values and ranges of values are provided herein merely as examples.

[0049] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described with respect to only one embodiment, then it should be understood that that feature, element, component, function, or step can be used with every other embodiment described herein unless explicitly stated otherwise. This paragraph therefore serves as antecedent basis and written support for the introduction of claims, at any time, that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps from one embodiment with those of another, even if the following description does not explicitly state, in a particular instance, that such combinations or substitutions are possible. It is explicitly acknowledged that express recitation of every possible combination and substitution is overly burdensome, especially given that the permissibility of each and every such combination and substitution will be readily recognized by those of ordinary skill in the art.

[0050] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof and are herein described in detail. It should be understood, however, that these embodiments are not to be limited to the particular form disclosed, but to the contrary, these embodiments are to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, as well as negative limitations that define the inventive scope of the claims by features, functions, steps, or elements that are not within that scope.