Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
2000-07-13
2002-05-21
Gitomer, Ralph (Department: 1623)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C514S783000, C514S026000, C514S025000, C514S027000, C514S568000, C514S717000, C514S726000, C514S874000, C514S899000, C514S923000
Reexamination Certificate
active
06391309
ABSTRACT:
This invention relates to compositions extracted from vegetable matter and more particularly to phytochemicals including saponogenins and saponins, catechins, lignans, phenolic acids, and isoflavones, and especially those extracted from a family of plants including soy, flax, tea and cocoa and methods of sing these compositions as nutritional supplements or food additives.
BACKGROUND
As used herein, the term “isoflavone” includes malonyl, acetyl, glucoside, and aglycone forms of the isoflavones.
Currently, western women suffer symptoms, especially in mid-life, which Asian women do not suffer. It is thought that diet accounts for these differences. It is further thought that may of these symptoms are either preventable or treatable by a use of phytochemicals, especially isoflavones, as a source of supplemental hormones, and particularly if such use begins before a woman's puberty. Men also benefit from such phytochemical treatments which address prostate cancer; however, the benefits do not appear to be so dependent upon when the use of isoflavones begins.
However, it is also thought that there are superior results when a plurality of such phytochemicals are consumed in combinations which are selected for particular symptoms. While a proper diet should contain the desired phytochemicals, a trouble is that many people do not have or do not like the proper kind of diet which provides the desirable effects. This is particularly true of the pre-pubescent years when the consumption of isoflavones is thought to have the most beneficial effect upon reducing the symptoms that females encounter later in life. Hence, the problem is to furnish the necessary food values in some other form which is more acceptable to the personal taste of people in the western world. Therefore, there is a need for a refining process which will enable a selection of specific isoflavones in the proper combinations.
Plant materials are known to contain a number of classes of organic low molecular weight compounds which exert bioactivity in various animals. Historically, these compounds have been considered to be somewhat non-nutritive however, recent scientific evidence now suggests these compounds may play an important role in the maintenance of health, in chemoprevention, and in the mitigation of certain conditions or diseases associated with the circulation of sex hormones, including sleep disorders and vaginal dryness.
Edible plants normally contained in the diet, or materials used as herbal remedies/dietary supplements, may contain collections of structurally related compounds. These related substances are often unique in their amounts and distribution when compared among various plant sources. The most notable groups of compounds exhibiting bioactivity are known as flavonoids, isoflavones, saponins, lignans, alkaloids, catechins and phenolic acids.
Epidemiology studies relating diet to disease suggest that dietary components may, predispose populations to reduced risk of certain diseases. Far eastern populations consuming soy have reduced rates of breast, prostate and colon cancers and coronary heart disease, while populations in Finland have reduced rates of prostate cancer. Researchers are just now studying the specific compounds in the diet to understand the basis for the epidemiological observations.
Among the various plants consumed in the diet, several are rich sources of phytochemicals. Soy products contain high amounts of isoflavones and saponins. Unrefined diet grains include plants such as wheat, psyllium, rice, flax and oats that contain lignans. Cocoa contains catechins and phenolic acids. Certain non-dietary plants are also sources of the same chemical molecules, such as lignans and isoflavones in kudzu root or red clovers. Isoflavones and lignans act as weak estrogenic substances. Tea plants are also a rich source of phytochemicals, including catechins and phenolic acids.
Isoflavones can be used alone to treat or prevent breast cancer, prostate cancer, skin cancer, and colon cancer or as mechanism inhibitors. Isoflavones alone may also reduce or prevent various symptoms related to the onset and duration of menopause. including hot flashes and osteoporosis. Isoflavones alone may also be effective in certain cardiovascular applications, including heart disease, reducing cholesterol-lipid levels, modulating angiogenesis, and other vascular effects. Moreover, isoflavones alone have been implicated in reducing headaches dementia, inflammation, and alcohol abuse, as well as immunomodulation.
Lignans alone have been implicated in preventing or treating breast cancer, prostate cancer and colon cancer as well as reducing hot flashes, preventing osteoporosis and showing antiviral potential. Lignans also have antimitotic and fungicidal activity. A plant lignan the catecholic nordihydro-guaiaretic acid, was a potent antioxidant once used by the food industry.
Saponins alone have been implicated in preventing or treating skin cancer, colon cancer, reducing serum cholesterol, and in immunomodulation and antiviral activity. Saponins also exhibit antioxidant effects and act as free radical scavengers.
Phenolic acids have shown antioxidant activity.
People who eat a high soy diet show reduction of many of these above-discussed symptoms. This suggests that ingesting a combination of these phytochemicals in a ratio such as that found in soy may result in an additive or synergistic effect. However, a high soy diet has some undesirable effects, including flatulence, undesirable taste, and hesitancy among Western consumers to change their lifestyle to incorporate soy in their diets, even for such benefits.
Isoflavones, which are heterocyclic phenols, are understood to include the soy compounds genistin, daidzin and glycitein, as well as biochanin A, equol, formononetin, and o-desmethylangolensin and natural derivatives thereof. These compounds and their aglycone or de-methylated aglycone forms, such as genistein and daidzein, are believed to have similar activities once they are ingested. They are sometimes referred to as phyto-estrogens.
Lignans are defined to be compounds possessing a 2,3-dibenzylbutane structure. They include matairesinol, secoisolariciresinol, lariciresinol, isolariciresinol, nordihydroguaiaretic acid, pinoresinol, olivil, other compounds which may be precursors of enterolactone and enterodiol and modifications thereof, including diglucosides.
Phenolic acids include p-hydrobenzoic acid, protocatechuic acid and vanillic acid. Other phenolic acids are chlorogenic acid, caffeic acid, ferulic acid, gallic acid, sinapic acid, syringic acid, coumaric acid, cinnamic acid, gentisic acid, salicylic acid, hydroxy benzoic acid and hydroxy phenyl acetic acids and derivatives. This list of phenolic acids should be understood to include the various isomers and derivatives found in the natural vegetable source.
Catechins, or flavan-3-ols, include epigallocatechin catechin, epicatechin and gallocatechin.
Saponogenins are C-27 sterols in which the side chain has undergone metabolic changes to produce a spiroketal. Saponogenins occur naturally as saponins, which are
3
-O-glycosides of the parent steroid or triterpenes. Digitonin from Digitalis is a saponin. Saponins include glucosides of sapogenin such as triterpenoids or steroids and saccharides such as glucose, arabinose, galactose or glucuronic acid. Typical examples of leguminous saponins are glycyrrhizin (glycyrrhetinic acid+glucuronic acid) contained in Glycyrrhiza glabra, soysaponin contained in soybean and alfalfasaponin contained in Medicago sativa. Saponins also include chemical entities identified as triterpene phenols such as tomatine, soyasapogenols A, B, C, D, E and F, ginsengoside fraction 3 and 4, medicagenic acid, hederagenin, glycyrrhizin digitonin, quillaja saponin, lucernic acid and zahnic acid. The natural modifications of these compounds found in the vegetable source are also included in this identification.
A need exists for an improved composition consisting substantially of isoflavones, lignans, saponogenins, saponins, and
Empie Mark
Gugger Eric
Archer Daniesl Midland Company
Gitomer Ralph
Khare Devesh
Michael Best & Friedrich LLC
Whitesel J. Warren
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