<<

US 2017.0065546A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0065546 A1 DUDA et al. (43) Pub. Date: Mar. 9, 2017

(54) COMPOSITIONS CONTAINING AS THE A23D 7700 (2006.01) ACTIVE INGREDIENT COMPONENTS A23D 77005 (2006.01) FROM SALVIA SCLAREA SEED A23D 9/00 (2006.01) A23K2O/58 (2006.01) (71) Applicant: THE STATE OF ISRAEL, A23K 50/75 (2006.01) MINISTRY OF AGRICULTURAL & A23K 50/80 (2006.01) RURAL DEVELOPMENT, A2.3L 7/109 (2006.01) AGRICULTURAL RESEARCH, A2.3L 7/26 (2006.01) Rishon LeZion (IL) A2.3L 7/10 (2006.01) A2.3L 7/30 (2006.01) (72) Inventors: Nativ DUDAI, Kfar Yeheskel (IL); A2.3L 23/00 (2006.01) Zohara YANIV BACHARACH, Tel A2.3L 27/60 (2006.01) Aviv (IL); Eli PUTIEVSKY, Tivon A2.3L 29/206 (2006.01) (IL); Diah SAADI, Bosmat Tivon (IL); A2.3L 33/105 (2006.01) Dan SCHAFFERMAN, Ramat Gan A2.3L 33/15 (2006.01) (IL); David CHAIMOVITSH, Gan Ner A61O 19/08 (2006.01) (IL) (52) U.S. Cl. CPC ...... A6 IK3I/202 (2013.01); A61O 19/08 (21) Appl. No.: 15/353,932 (2013.01); A61O 19/00 (2013.01); A61K 8/361 2013.01); A6 IK 36/537 (2013.01): CIIB I/06 (22) Filed: Nov. 17, 2016 (9-9., CIIB 9/02 SE CIIB 9/025 O O (2013.01); A2ID 2/266 (2013.01); A2ID 2/36 Related U.S. Application Data (2013.01); A23D 7003 (2013.01); A23D (63) Continuation of application No. 13/946,402, filed on 7/0053 (2013.01); A23D 9/00 (2013.01); A23K Jul. 19, 2013, now Pat. No. 9,532,964, which is a 20/158 (2016.05); A23K 50/75 (2016.05); continuation-in-part of application No. 10/570,810, A23K 50/80 (2016.05); A23L 7/109 (2016.08); filed on Aug. 25, 2006, now abandoned, filed as A23L 7/126 (2016.08); A23L 7/198 (2016.08); application No. PCT/IL2004/000804 on Sep. 7, 2004. A23L 1730 (2016.08); A23L 17/35 (2016.08); A23L 23/00 (2016.08); A23L 27/60 (2016.08); (30) Foreign Application Priority Data A23L 29/206 (2016.08); A23L 33/105 (2016.08); A23L 33/115 (2016.08); A61 K Sep. 7, 2003 (IL) ------157785 2236/15 (2013.01); A61 K 2236/30 (2013.01); Publication Classification A23 V 2002/00 (2013.01) (51) Int. Cl. (57) ABSTRACT A6 IK 3L/202 (2006.01) A61O 19/00 (2006.01) The present invention concerns a food Supplement compris A6 IK 8/36 (2006.01) ing Salvia Sclarea seeds, or flour, or pulp or extracts A6 IK 36/537 (2006.01) obtained from the seeds as well as finished food products CLIB I/06 (2006.01) comprising the food Supplement. The present invention CIIB 9/02 (2006.01) further concerns a nutraceutical or cosmetic preparation A2ID 2/26 (2006.01) comprising as an active ingredient Salvia Sclarea seeds, or A2ID 2/36 (2006.01) flour, oil or pulp or extracts obtained from the seeds. US 2017/0065546 A1 Mar. 9, 2017

COMPOSITIONS CONTAINING AS THE the cholesterol content in the blood. C-Linolenic acid is a ACTIVE INGREDIENT COMPONENTS found in some plants and can be converted by the FROM SALVIA SCLAREA SEED body to EPA and DHA. Plant sources of C-linolenic acid include walnuts and , flaxseed, rapeseed (used to FIELD OF THE INVENTION make canola oil), soybeans, spinach, mustard greens and purslane. 0001. The present invention relates to food supplements and nutraceutical compositions for raising omega-3 levels in 0010 C-Linolenic acid is produced in high quantities in a Subject. several plants, mainly hemp (up to 23% C-linolenic acid is pressed from hempseed) and (50%). These normally BACKGROUND OF THE INVENTION have an “off” flavor and are seldom used as edible oils due to their bad taste and smell. Conventional food oils, such as 0002 Current research in nutritional medicine indicates rapeseed (canola) and soybean contain only small amounts that the omega-3 fatty acids are essential components of the of linolenic acid (11% and 7% respectively). human diet. According to studies published in the British 0011 Researchers believe that a 1:1 ratio of omega-6 to scientific journal Lancet, the observed low incidence of omega-3 (omega-6 is found primarily in vegetable oils like arteriosclerosis (fatty plaques development on the inner corn, safflower or Sunflower) may be important in preventing walls of the arteries which obstructs the blood flow), includ heart disease. It seems that omega-3s and omega-6’s con ing coronary artery disease, chronic inflammatory disease tinually compete for control of important biochemical reac and diabetes in Greenland Eskimos has been attributed to tions in the body. When the portion of omega-6 is higher their traditional ethnic diet, consisting largely of meat from than that of omega-3, it can lead to an overproduction of whale, seals, sea birds and fish. This diet is rich in and hormone-like Substances called prostaglandins and leukot protein and low in carbohydrates, but it is extremely high in rienes. Large amounts of these hormone-like Substances can omega-3 polyunsaturated fatty acids, and especially rich in disrupt the immune system, initiate the build-up of plaque two omega-3 fatty acids: C22:6 (DHA) and C20:5 (EPA). formations on artery walls, form blood clots and trigger 0003. The most important omega-3 fatty acids are eicosa dangerously irregular heart rhythms. pentaenoic acid (EPA), docosahexaenoic acid (DHA) and O-linolenic acid (ALA). 0012 Currently, the ratio in the American diet is about 10 0004 EPA is a direct source of an important substance omega-6 to 1 omega-3, a ratio, some experts say, which is called prostaglandin E3, which is directly responsible for a dangerous overSupply of omega-6 fatty acids. making blood platelets less sticky, thus leading to an easier 0013 Dietary fish oils containing omega-3 fatty acids are flow of blood. EPA is, therefore, involved in processes that increasingly recommended for their antithrombic and hypo inhibit blood clots whose presence threaten to obstruct the lipidemic (lowering blood lipid) effects (Phillipson, Roth circulation; this mode of action is particularly important in rock, Connor, Harris and Illingworthm, New England J. the small capillaries of the heart. Med., 312:1210-16, 1985). Additional benefits of these oils 0005 DHA (docosahexaenoic acid) is an omega-3 fatty are improvement of immunological function and fighting acid of almost equal importance to EPA. DHA comprises a allergies (Leaf and Weber, New England J. Med, 318:549 significant amount of the tissues that make up the human 557, 1988). brain as well as a large part of the retina of the eye. 0014 Omega-3 fatty acids from vegetable oils could 0006. Some of the most dramatic effects of increased provide all the above health benefits without any of the intake of omega-3 fatty acids are the lowering of high blood disadvantages of oil from animal source. pressure, reduction of serum levels, and an 0015. During ingestion of there is no uptake increase in clotting time, all positive steps in the prevention of cholesterol. Fish oils are a primary source of vitamins A of heart and blood vessel diseases. These beneficial effects and D. Most marine oils may supply potentially toxic of omega-3 fatty acids have been noted in both clinical trials amounts of Vitamins A and D, by Supplying a sufficient and epidemiological studies. Omega-3 fatty acids were amount of EPA and DHA factors. Also, many vegetal found to be extremely useful natural substances powerful omega-3 oils have a clean flavor have a good taste, at least enough to normalize the high cholesterol and triglyceride as compared to bad tasting fish oils. Fish oils are usually levels that are so extensive in modern populations. contained in preservative-free gelatin capsules for conve 0007 Omega-3 fatty acids have also been shown to slow nience due to their bad taste and smell. down or prevent cancerous tumor growth, prevent blood 0016 Aromatic (essential) oil derived from flowers of vessels from closing following vascular Surgery, improve Salvia Sclarea has been used up to date mainly as a perfume; inflammatory diseases Such as rheumatoid arthritis and this usage was known from the time of ancient Rome. Other relieve symptoms of psoriasis. In addition, omega-3 fatty secondary uses for this aromatic oil have been in the tobacco acids are essential for proper vision and brain development industry, and in herbal remedies to fight infection, and to in newborns. regulate the digestive system. The natural habitat of the plant 0008. The average western diet is low in fresh fish and is in Syria, Italy and Southern France; and its growth sea food containing EPA and DHA. On the other hand, it is requirements in terms of soil content are not particular. high in refined carbohydrates and saturated . This kind of Currently, the former Soviet Union, North Africa, and Hun diet can lead to a serious deficiency in the raw materials gary are the largest producers of this oil, and prices range necessary for proper platelet function in the blood stream. from S60-90 per liter of oil. The plant can withstand heat, 0009 Linolenic acid is essential for ensuring healthy skin and is found on mountainous terrain, where rainfall is not condition. Moreover, oils containing large amounts of lower than 400 mm annually. The floral parts alone are used omega-3 fatty acids were shown to be effective in preventing to produce the oil; inclusion of leaves will degrade the oil skin wrinkles. The ingestion of these oils markedly lowers quality. Typically a single harvest of floral parts is per US 2017/0065546 A1 Mar. 9, 2017 formed. If harvest is performed prematurely, the oil will 0021. Furthermore, the discovery of the unique combi contain a large percentage of linoleic acetate, which lowers nation between the fatty acids in the plant (in addition to the quality of the oil. omega-3 fatty acid, the seeds of this plant are especially rich 0017 No previous use has been made of the seeds of in and other ingredients, and the oil produced Salvia Sclarea; previous uses, mainly as a perfume or contains an optimal ratio between omega-3 and omega-6) essential oils, were from plant material derived from the and the absence of toxins, including allergens or harmful flower. Substances, indicated that this plant could be very advanta 0018 WO99/62356 concerns enhanced food for humans geously used for the production of a plant oil that could which has significantly higher omega-3 content by the use of serve as a food Supplement. In addition, it was discovered oil obtained from Salvia hispanica seed. Salvia hispanica that oil produced from the seeds of Salvia Sclarea is, (Chia) is a Summer annual belonging to the Labiate family. Surprisingly, more stable than would have been expected of It originates in mountain regions extending from west cen an oil containing such a large quantity of ALA, and the tral Mexico to northern Guatemala. Due to its endemic advantageousness of this trait for industrial use in the food growth restriction to mountain regions of central and South industry is apparent. ern America and thus its natural habitat is very specific and 0022. The present invention thus embodies numerous growth requirements very particular, making seed grown advantages, inter alia, in that it enables the production of a from the plant not economical, the plants are not widespread nutritional Supplement containing omega-3 fatty acid which and have not acquired wide commercial acceptance as a has a neutral fragrance and taste; is free of toxins, allergens food source. or harmful Substances such as heavy metals; tends to oxidize 0019. It should be emphasized that the presence of ALA less; and producible in an agrotechnically efficient manner. omega-3 fatty acid in oil produced from the seeds of one or Moreover, the chemical composition of a nutritional Supple another plant does not in itself suffice to indicate that the ment according to the invention embodies a unique combi plant will be a good and effective source for that fatty acid. nation offatty acids, minerals and other components, includ The range of different parameters, such as commercial ing oleic acid, calcium, fibers and amino acids, the cultivability, climatic conditions, regulatory provisions, pro composition and quantities of which could not have been file of the fatty acids, percentage of fatty acids, ratio of foreseen, as also the optimal ratio between omega-3 and omega-3 to omega-6, Stability, flavor, fragrance, color, acid omega-6. ity, moisture, toxins, allergens, presence of vitamins and 0023 Seeds of selected lines of Salvia Sclarea (Labiate) antioxidants in the oil, as well as many other parameters, (also known as “clary sage') have an average oil content of determine whether oil from a certain plant will be a good and 25-30%. effective source for ALA omega-3 fatty acid. Sometimes, one parameter alone. Such as aftertaste (e.g. in flax oil or 0024. The inventors now disclose that the seed oil of this Matthiola oil), or overoxidation (in flax or Salvia hispanica plant is a rich source of omega-3 O-linolenic acid (about oil), suffices to prevent use of the oil as an effective and 55%). The other components of this oil are two important stable source for ALA omega-3 fatty acid in a nutritional fatty acids: oleic acid (C18:1), which is present in extremely Supplement. Obviously, such a plant source cannot be des high levels, and (C18:2). Both acids are unsatu ignated as a good and effective source, when a large number rated fatty acids and are essential in the human diet. of drawbacks come together in terms of the parameters listed 0025. The present invention hereby discloses whole above. seeds, or oil, flour/powder, or pulp obtained from Salvia Sclarea seeds, having all the health benefits of fish oil but SUMMARY OF THE INVENTION none of its drawbacks (notably its bad taste, distinctive smell and quick rancidity). The oil or flour/powder has the addi 0020. It has now been discovered, surprisingly, that it is tional above-mentioned benefits over other vegetable oils, possible to produce from the seeds of the plant called clary and can be used for dietary Supplements, as an active sage, whose Latin name is Salvia Sclarea, a plant oil which ingredient in pharmaceutical and cosmetic compositions, is rich in fatty acids of nutritional value, among them omega-3 fatty acids, and at the same time has no unpleasant and for industrial uses. taste or odor, that is free of toxins and does not oxidize easily 0026. Another important application of this vegetable oil upon contact with air. It is Surprising that the oil from the is its use as a drying oil for and lubrication, due to seeds of Salvia Sclarea have no sharp or unpleasant taste or its high content of polyunsaturated fatty acids, namely odor because Salvia Sclarea is known as a plant with a sharp linolenic acid. Up to date, vegetative drying oil has been odor, to the extent that it is used in industry in the prepa obtained from crops such as flaxseeds and Tong trees. These ration of essential oils, i.e., aromatic Volatile oils which do crops do not lend themselves to mechanical harvesting and not contain fatty acids and which are used in the fragrance cleaning. Salvia Sclarea seed oil is useful for industry, and and flavor industry and mainly in the perfume industry. One is relatively easy to obtain. would have expected oil that is produced from seeds of this (0027. The prior art discloses (WO99/62356) oil, rich in plant also to have a sharp taste and odor, and accordingly be omega-3, obtained from Salvia hispanica, which is an unsuitable for incorporation into foods. It is further noted endemic plant restricted in its growth to the high mountain that the genus Salvia includes species that are known to area of Central and South America. The present invention is contain different percentages of toxins (such as thujone), and based on the Surprising finding that seeds obtained from therefore, in general, the health authorities place obstacles in another variant of Salvia, i.e. being Salvia Sclarea, have the way of the approval of food supplements derived from better nutritional value than oil, or crushed seed, obtained Salvia, a fact which was likely to dissuade researchers from from Salvia hispanica as will be shown in the detailed studying Salvia plants for the production of plant-based food description part of the invention and have other significant Supplements. properties that are Superior thereto, including, taste, color US 2017/0065546 A1 Mar. 9, 2017

and oxidative stability (i.e., long shelflife), in addition to the 0035. Thus, the present invention concerns a composition aforementioned ease of cultivation and harvesting. for use as a food Supplement comprising, as an active 0028. The difference between Salvia Sclarea and Salvia ingredient, a composition of matter selected from: hispanica is expressed in additional aspects, such as the fact 0036 a. Salvia Sclarea seed; that the latter does not contain the combination of a high 0037 b. Salvia Sclarea seed oil in an essentially pure concentration of ALA together with a high concentration of form; oleic acid. Oleic acid (omega-9) is a monounsaturated fatty 0038 c. extracts of Salvia Sclarea seed; acid known to help in the prevention of coronary disease. 0039 d. Salvia Sclarea seed crushed or milled to form a Olive oil, for example, contains 55% to 85% of oleic acid, flour or powder; and which is known to reduce the risk of arteriosclerosis, coro nary disease and stroke. The oleic acid content in Salvia 0040 e. Salvia Sclarea seed pulp. Sclarea is almost four times higher than in Salvia hispanica. 0041. The term “composition of matter” refers to several The ratio between omega-3 and omega-6 is greater in Salvia components (fatty acids, proteins, minerals, vitamins, Sclarea, as can be seen in Table 2, below. Furthermore, it is dietary fibers) present as a mixture with specific ratios known that oil produced from Salvia Sclarea contains between the components. Sclareol, which is not found in Salvia hispanica. Likewise, 0042. The term “Salvia Sclarea seed’ refers to the whole the outstanding stability of the oil produced from the sclarea seed, essentially in an unprocessed form as separated from species does not exist in the Salvia hispanica species. the full plant. 0029. Furthermore, the present invention is based on the 0043. The term “Salvia Sclarea seed oil in an essentially realization that not only the oil or crushed flour/powder of pure form' refers to oil obtained from the seed, which is Salvia Sclarea has higher nutritional value than the oil of essentially free from other components. The oil may be Salvia hispanica, but also the growth of the plant of the obtained by various manners known to separate oil from Salvia Sclarea variety, as compared to the Salvia hispanica plant-seeds without damaging their nutritional value. variety is more economical. The Saliva Sclarea plants can 0044 Examples of manners for separating the oil include: grow in any Mediterranean climate such as in the Middle 0.045 1) “cold press' achieved by crushing and press East, in Europe (including Southern European countries ing the seed, centrifugation of the pressed seed for such as Italy, Spain and Southern France as well as Northern collection of the oily fraction present in the Superna and Eastern European countries Such as Finland and Russia), tant, and optionally also purification by various means North Africa, California and Australia; and its growth known in the art such as by using filters, collecting requirements in terms of soil content are not particular. The sediments, etc.; plant can withstand both heat and cold (even Snow), and is 0046 2) By use of volatile hydrophobic found on mountainous terrain, where rainfall is even lower which initially dissolve the oil, and then are evaporated than 400 mm annually. by application of heat and/or vacuum. 0030. Beyond this, the seeds of Salvia Sclarea possess 0047 3) By use of liquid CO or liquid nitrogen in numerous advantages compared to Salvia hispanica. Thus, extremely cold temperature ('super-critical extrac for example: tion'). 0031. The seeds of Salvia hispanica are generally 0048. The term “Salvia Sclarea seed, crushed or milled to likely to be dark, and thus unsuited to the color and form flour or powder refers to crushing or milling of the texture of food products and Supplements, in contrast to seed to fine particles by any mechanical milling means the seeds of Salvia Sclarea, which have a light and known in the art in order to break the seed into smaller uniform color. It has long been known that a dark color fragments such as crumbs of flour or particles of powder, in the field of nutritional supplements is an undesirable and in those flour/powder forms, most of the nutrients are trait. Sometimes, a dark color necessitates adding color more available to the subject than in the whole seed. lightening additives which could affect the traits of the 0049. The term “Salvia Sclarea seed pulp' refers in fact active ingredient in the nutritional Supplement. There also to “defatted Salvia Sclarea seed flour. These two fore, a nutritional Supplement whose original color is alternative terms refer to the seed after the oily fraction has light possesses clear advantages. been extracted there from, which pulp is especially rich in 0032. The size and uniformity of the Salvia Sclarea dietary fibers, minerals, vitamins and proteins and poor in plants and their botanical traits enable more efficient fatty acids and calories. cultivation. 0050. The term “extract of Salvia sclarea seed refers to 0033 Salvia Sclarea is a perennial plant, whereas any compound that is extracted from the seed by using Salvia hispanica is an annual plant. Therefore, Salvia aqueous or alcoholic, or other organic extracts. Typically, Sclarea is more cost efficient (cheaper) to grow than where the extracting liquid is water, mostly to fibers (dietary Salvia hispanica, which suffers from an additional fibers). drawback, noted above, namely, the absence of pheno 0051. By a preferred embodiment of the present inven typic uniformity among individuals from the same tion, the food Supplement consists essentially of species, e.g. variance in the size of the plants or in the time of ripening makes it difficult to harvest them by 0.052 a. Salvia Sclarea seed; industrial means (combine harvesters). 0053 b. Salvia Sclarea seed oil in an essentially pure 0034. The present invention is further based on the sur form; prising finding that from among several species of different 0054 c. extract of Salvia Sclarea seed; Salvia, the specific Salvia Sclarea of the present invention 0055 d. Salvia Sclarea seed crushed or milled to form a was found to have an extremely high nutritional value and flour or powder; and very long shelf life without rancidity. 0056 e. Salvia Sclarea seed pulp. US 2017/0065546 A1 Mar. 9, 2017

0057 Preferably, in accordance with a preferred embodi egg yolks is an increase of 2- to 10-fold, preferably an ment of the invention, the composition of matter is Salvia increase of more than 4-fold, more preferably an increase of Sclarea oil or Salvia Sclarea flour or powder. more than 6-fold. 0058. By a more preferred embodiment of the invention 0077. By another aspect, the present invention concerns the food Supplement consists of: a method for increasing the level of at least one omega-3 0059 a. Salvia sclarea seed; fatty acid in egg yolks or in the meat of hens, the method 0060 b. Salvia Sclarea seed oil in an essentially pure comprising: administering to the hens an effective amount form; the food supplement of the present invention. 0061 c. extract of Salvia Sclarea seed; 0078. The term “effective amount' is as defined above. 0062 d. Salvia Sclarea seed crushed or milled to form a 007.9 The present invention further concerns a nutraceu flour or powder; and tical composition comprising a nutraceutically acceptable 0063 e. Salvia Sclarea seed pulp. carrier and, as an active ingredient, a composition of matter 0064. By one embodiment, the food supplement further selected from: comprises a “carrier suitable for consumption in food 0080 a. Salvia Sclarea seed; products. The carrier is chosen as a carrier known in the art I0081 b. Salvia Sclarea seed oil in an essentially pure for the specific type of composition of matter of the inven form; tion. For example, where the composition of matter of the 0082 c. extracts of Salvia Sclarea seed; invention is oil, the carrier may be other types of vegetable 0083 d. Salvia Sclarea seed crushed or milled to form a oils such as olive oil, rapeseed (canola) oil, corn oil, soy oil, flour or powder; and wheat germ oil, coconut oil, peanut oil, Sesame oil, palm oil, almond oil, nut. Such as walnut, oil, etc. Where the compo I0084 e. Salvia Sclarea seed pulp Salvia Sclarea seed oil sition of matter of the invention is powder or flour the in an essentially pure form. “carrier may be other types of flour/powder such as wheat, Preferably, the Salvia seed oil is prepared by as disclosed barley, corn, Soy flour, oat flour, rice flour, tapioca, or rye above. More preferably, the nutraceutical composition con flour. sists essentially of a composition of matter selected from: 0065. By another possibility, the food supplement con 0085 a. Salvia Sclarea seed; tains only one of the ingredients (a-e) above without any I0086 b. Salvia Sclarea seed oil in an essentially pure “carrier. form; 0066. The present invention further concerns the use of 0087 c. extracts of Salvia Sclarea seed; an agent selected from 0088 d. Salvia Sclarea seed crushed or milled to form a 0067 a. Salvia Sclarea seed; flour or powder; and 0068 b. Salvia Sclarea seed oil in an essentially pure I0089 e. Salvia Sclarea seed pulp Salvia Sclarea seed oil form; in an essentially pure form. 0069 c. extracts of Salvia Sclarea seed; 0090 The term “nutraceutical composition” refers to any 0070 d. Salvia Sclarea seed crushed or milled to form a Substance that is a food or a part of a food and provides flour or powder; and medical or health benefits, including the prevention and 0071 e. Salvia Sclarea seed pulp for the preparation of a treatment of disease or disorder. food Supplement. 0091. The present invention further concerns a nutraceu 0072 The food supplement above may be used for tical composition as defined above for the treatment of a human or non-human consumption, preferably in order to disease or a disorder wherein a therapeutically beneficial increase the level of at least one omega-3 fatty acid in the effect may be evident by increasing the level of at least one Subject. The non-human animal may be a farm animal. Such omega-3 fatty acid. as cattle (cow, goat, and sheep) or poultry (hens, ducks, 0092. The term “treatment . . . therapeutically beneficial turkeys), as well as fish grown in fish ponds, such as carp, effect” may refer to at least one of the following: decrease bass, tilapia, trout, and pond-raised salmon. in at least one undesirable effect of the disease; slowing the 0073. The food supplement of the present invention is deterioration caused by the disease; increase in the disease expected to raise the level of at least one omega-3 fatty acid free time period; or prevention of the disease altogether. in the meat of the non-human animal (cow, sheep, hens, 0093. Typically, the disease or disorder is selected from: fish), as well as to raise the level of at least one omega-3 fatty arthrosclerosis, coronary artery disease, chronic inflamma acid in the products of the animals, such as milk and eggs. tory disease such as rheumatoid arthritis and IBD, diabetes, 0074 Thus, the present invention concerns a method for cancer, prevention of blood vessels from closing after vas increasing at least one omega-3 fatty acid level in a subject, cular Surgery, relieving symptoms of psoriasis, skin wrinkles the method comprising administering to the Subject an and depression and mood disorders. The disease may be any effective amount of the food supplement of the present disease or condition which is known Scientifically, or is invention. The subject may be as defined above and may be discovered empirically, to benefit from the increase in the a human or non-human animal. level of at least one omega-3 fatty acid in the Subject. 0075. The term “effective amount is an amount that 0094. The nutraceutical composition is typically taken increases the level of at least one omega-3 fatty acid in a orally, for example in the form of gel-capsules containing statistically significant manner as compared to a control the oil, liquid formulation containing the oil, tablets con subject not fed with the food supplement of the present taining the flour/powder as known in the art for preparing invention. Such compositions, but for several indications. Such as 0076. The increase in the level of omega-3 fatty acid in psoriasis, and other dermal conditions (wrinkles, dry skin), the animal may be adjusted in accordance with the type of the oil containing formulations (gel-caps, oil) may also be subject and the desired level, but typically, for example, in topically applied. US 2017/0065546 A1 Mar. 9, 2017

0095. The present invention further concerns a cosmetic 01.06 Comparative analysis Salvia Sclarea and Salvia composition comprising a cosmetically acceptable carrier hispanica and, as an active ingredient, Salvia Sclarea seed oil in an essentially pure form. Typically the cosmetic composition is TABLE 1. for prevention of wrinkles of the skin and/or ensuring skin health. General contents 0096. The term “at least one omega-3 fatty acid refers to Test per 100 g Saivia Sciarea Salvia hispanica any unsaturated fatty acid with its first double bond at the % moisture (g/100 gr) 7.40 7.8 third carbon atom from the methyl-end. These fatty acids % protein (g/100 gr) 23.38 21.1 may be such as essential fatty acid, C.-linoleic acid (ALA) as % Fat (g/100 gr) 26.20 32.3 well as non essential fatty acids Such as docosahexaenoic % Ash (g/100 gr) 5.77 4.8 acid (DHA) and eicosapentaenoic acid (EPA). % Crude Fiber (g/100 gr) 20.60 27.7 mg/100 g Calcium O.82-O.928 O.O68O 0097. The present invention further concerns a food mg/100 g Phosphorus O.70-0682 O.78O product comprising the food Supplement of the present mg/100 Potassium 1.02-129 O.809 invention. Examples of food products are as follows: g/100 g Dietary fibers 17.8O NA 0.098 1. Food product comprising whole seeds of from total gr, fat 2.50 3.35 Salvia Sclarea: granola-like cereals, granola-like Snake bars, foodstuff for hens, cows, etc. After soaking in 0.107 As can be seen the Salvia Sclarea seeds have a water the whole seeds may be used in whole breads, higher protein and dietary fiber contents than Salvia his rolls, crackers, biscuits, etc. panica seeds. 0099 2. For Salvia Sclarea seeds, ground or milled to produce flour/powder: granola-like cereals, granola TABLE 2 like Snake bars, and foodstuff for hens, cows, etc., whole breads, rolls, crackers, biscuits, pasta and other Fatty acids contents baked goods. The flour/powder may be used as thick Range ener in gravy, Soup, dips pressings and other prepared Fatty Acid Range (Saivia (Salvia food that typically contains flour of Some sort as a Profile hispanica) Sclarea) thickener. Myristic Acid C14:0 0.1-0. O 0100 3. For Salvia Sclarea oil-formulated into oily Palmitic Acid C16:O 6.6-6.7 6.8-8.0 Palmitoleic Acid C16:1 0.1-0. pastes or dips (tehini, humus) and in oils and paste Such Heptadecanoic Acid C17:0 O.2-0.2 as sesame oil or sesame paste, formulated into other Heptadecenoic Acid C17:1 0.1-0. vegetable oils or margarine and margarine-like spreads, Stearic Acid C18:0 2.8-3. 1.9-26 Salad dressings, fish oil, caviar-like products, etc. Oleic Acid C18:1 6.6-7.0 24.7-25.2 Linoleic Acid C18:2 186-18.9 12.1-14.8 0101 4. The pulp (defatted seed flour), due to its high Linolenic Acid C18:3 (a) - 3) 582-59.1 49.9-5 6.O fiber content, is extremely suitable for the preparation Linolenic Acid C18:3 (a) - 6) O.O-O. O-O.2 of low calorie (diet) baked products (breads, rolls) and Arachidic Acid C2O:O O3-03 Gadoleic Acid C2O:1 0.1-0. O6 also for the preparation of diet drinks and shakes with Eicosadienoic Acid C2O:2 O. 1-0 high fiber, protein and mineral contents. Eicosatrienoic Acid C20:3 (a) - 3) 0.1-0. Behemic Acid C22:O 0.1.0. O.1 DETAILED DESCRIPTION OF THE Docosatetraenoic Acid C22:4 0.1-0. INVENTION Lignoceric Acid C24 O.2-0.2 O.1 Total Fat 32.25%. 26.2% 0102 Salvia Sclarea has an average oil content of omega 3 25-30% in the seeds, with maximum levels of 60% omega Ratio: = 3.12 3.95 3-linolenic acid of the total fatty acids in the oil. Salvia omega 6 Sclarea lines were tested and evaluated as a potential new oil crop for dietary Supplement for humans and animals, for use 0108. As can be seen, the omega 3:omega 6 ratio in as an active ingredient in pharmaceutical and cosmetic Salvia Sclarea seeds is higher than in Salvia hispanica seeds. compositions and mixtures and for industrial uses. Furthermore the oleic acid contents in Salvia Sclarea seeds 0103 Omega-3 fatty acids from vegetable oils could is significantly higher than in Salvia hispanica seeds. provide all the above health and cosmetic benefits without any of the disadvantages of oil from animal sources. TABLE 3 0104. Another important aspect of this vegetable oil is its quality as drying oil, for painting and lubrication, due to the mineral profile high content of polyunsaturated fatty acids, namely linolenic In () the Saivia Sciarea acid. Up to date, vegetative drying oil is obtained from crops recommended USRDA mg in 100 g seeds Salvia hispanica Such as flax seeds and Tong trees. These crops do not lend (mg) mg/kg mg in 100 g seeds themselves to mechanical harvesting and cleaning, as does Ag

0105. The Salvia Sclarea oil of the present invention has B 1.4 NA many advantages as compared to the previously know Salvia Bal 2.3 NA hispanica oil, as can be seen, for example, by the following Be <0.01 NA comparative analyses in Tables 1-4: US 2017/0065546 A1 Mar. 9, 2017

TABLE 3-continued 0110. As can been seen, the amino acid contents in 100 g Salvia Sclarea supplies 50-160% of the USRDA essential mineral profile amino acid contents. In ( ) the Saivia Sciareaf recommended USRDA mg in 100 g seeds Salvia hispanica Example 1 (mg) mg/kg mg in 100 g seeds Effect of Salvia Sclarea Seed-Products on Hens Ca (1000) 928 679.8 Cd <0.01 O.O18 0111. An experiment was conducted to measure the tox Co

0123 No toxicity was observed for Salvia Sclarea seed oils (based on 2000 calories per day diet) with an excellent flour. fatty acid profile that contains approximately 50% omega-3 0124. These results demonstrate Salvia Sclarea seeds are ALA, 25% oleic acid, and 3.4 to 1 ratio of omega-3 to a viable source of omega-3 fatty acids and that consumption omega-6. of Salvia Sclarea seed flour results in a direct positive effect I0127 100 grams per day of Salvia Sclarea seeds will also on the level of omega-3 fatty acids in the consumer. Dietary supply 75% of the recommended USA daily values for Supplements containing Salvia Sclarea seed flour or oil are dietary fiber based on a 2000 calories diet (or 100% accord thus nutritionally recommended and could aid in preventing ing the UK recommendations), 100% of the USRDA for or ameliorating arteriosclerosis and other conditions where most of the minerals (Ca, Mg, Cu, Se, Mn), 50% of the high levels of omega-3 fatty acids have been found to be USRDA for Potassium (K) and Iron (Fe), 33% o for Zinc beneficial. (Zn) and Boron (B) 1.4 mg/100 g. I0128. The Salvia Sclarea seeds are also free of trans-fatty TABLE 5 acids and gluten, and absorb approximately 8 times their weight in water, making them ideal for diet-low calorie Content of Eggs Produced by Hens after Consumption of Salvia Sclarea Seed Flour foods, as fat replacement products and water binders. 90 Fatty Acids In Oil Example 3 Fatty acid Name Control Treated % change Production of Salvia Sclarea Flour/Powder C14:0 Myristic 0.37 O3S C16:O Palmitic 24.64 23.36 -6 I0129. The Salvia sclarea seeds are ground into meal, C16:1 Palmitolic 3.18 3.55 +5 blended with natural antioxidants to prevent oil oxidation C18:0 Stearic 9.23 7.68 -17 (rancidity) and to prolong the shelf life of the product and C18:1 Oleic 42.28 43.26 +2 then formulated as an ingredient into weight reducing, C18:2 Linoleic 15.78 15.51 -2 C18:3 Linolenic 0.57 4.09 +617 nutritionally balanced powdered drink mixes, bars and low C20:5 EPA cal/low carbohydrate baked goods. As will be shown below, C22:6 DHA 0.57 O.69 +21 however, antioxidants are not absolutely necessary in light Total fat in the 20.9 23.0 +10 of the natural shelflife for the oil in the Salvia Sclarea seeds, egg (%) PS ratio O.47 O.69 +21 Example 4 Production of Cereals Snacks and Pasta TABLE 6 0.130. The Salvia sclarea seeds are ground into meal, Content of Hen Body Fat after Consumption of Salvia Sciarea partially blended with whole seeds, formulated with other Seed Flour grain flours such as wheat, barley, soy or corn, together with natural binders and fibers, and then extruded by cooking 90 Fatty Acids in Oil extruders into flakes for breakfast cereals, and other shapes Fatty acid Name Control Treated % change for Snacks, then flavored, spiced, oil coated and baked (or fried) in oils blended with Salvia Sclarea omega-3 enriched C14:0 Myristic O.S2 O.S4 +4 C16:O Palmitic 18.84 19.55 +4 vegetable oils. C16:1 Palmitolic 3.71 4.70 +27 I0131 For production by “cooking extruders,” a dry blend C18:0 Stearic 5.89 5.51 -6 of Salvia Sclarea meal and other ingredients are cooked C18:1 Oleic 37.95 40.88 +8 together under high pressure, using a single or twin co C18:2 Linoleic 29.75 23.57 -21 C18:3 Linolenic 1.44 3.85 --167 rotating screws inside a barrel with injection ports. Water Total hen's fat 55.3 37.6 -32 and/or other liquids are injected into the barrel during the (%) cooking and blending process. The extruded product is PS ratio 1.23 1.07 -7 baked or air-dried, fried, and then flavored. % S in 14.5 9.93 -32 I0132) Formulations for cold extruded pasta products include usage of special natural colorings, dough improvers, spices, flavorings, fibers, etc., that render natural, omega-3 0.125 Based on the nutritional-chemical spectra of analy enriched pastas of various shapes and colors. sis, the general conclusions are that Salvia Sclarea seeds can I0133. The extruded products can be used as such (without be regarded as nearly a nutritionally complete foodstuff. further processing) or mixed with other ingredients for production of health oriented dry or cooked meals, breakfast Example 2 cereals, granola mixes, etc. Using state-of-the art formula tions for cold-extrusion systems omega-3 enriched pasta is Calculations Concerning Salvia Sclarea as a Food obtained in various shapes and colors (using natural colors Supplement for Human Consumption also with antioxidant activities). 0126. According to the analysis shown in tables 1-4 Example 5 above, it is calculated that 100 grams of Salvia Sclarea seeds per day will supply approximately 40% to 50% of the required proteins, including all the USRDA for essential Production of Low-Calorie Baked Goods Amino Acids (except a too low quantity of Methionine), 0.134 Salvia Sclarea whole seeds are pretreated by soak approximately 40% of the daily recommendations for fats/ ing in water or other Suitable liquids or marinades, and then US 2017/0065546 A1 Mar. 9, 2017

formulated into low-calorie, nutritionally enhanced baked Example 8 goods. For example, in one embodiment a 250 calorie per 100 gram standard bread has its energy reduced by 40% to Production of Omega-3 Enriched Oil Preparations a 150 calorie per 100 gram diet bread. Similarly, a substan 0.143 Salvia Sclarea whole seeds are washed and soaked tial reduction in calories applies to buns and rolls, biscuits, in a water solution of salts, acid regulators, natural antioxi bagels, etc. These low-calorie baked goods, which are also dants, natural flavors and natural colors. Soaking times vary omega 3 enriched, are Suitable also for fast food chains according to the desired formulations. The soaked seeds are (buns for hotdogs or hamburgers), Sandwiches, etc. thoroughly drained of excess solution. 0135 The Salvia Sclarea seeds are marinated in buffered, 0144. The treated and drained seeds are blended with fish flavored and naturally colored solutions for varying lengths oils, and natural marine flavors omega-3 EPA and DHA fatty of time as desired. Temperature and pH are controlled. acids in desired ratios according to product recipe. 0136. The marinated seeds and also Salvia Sclarea flourf 0145 The finished product is packed in glass, plastic or powder are mixed into bread dough and other bakery metal packaging and processed to render shelf stable or products and baked accordingly. The marinated seeds will chilled products with long shelf lives. These products are render products containing them low calorie products and actually described as Vegetarian caviar (fish roe) like prod also low-carbohydrates (low-carb.) since the bound water ucts with high nutritional values that include all the nutri marinade will react with the Salvia Sclarea fibers to form a tional factors of Salvia Sclarea seeds, and in addition the full Soft jelly-type mixture. group of omega-3 fatty acids (ALA, DHA and EPA) from vegetable and marine sources. 0146 In this embodiment, the Salvia Sclarea whole seeds Example 6 are treated by soaking using a multi-stage battery of variable speed mixers. The differential soaking solutions contain Production of Oil osmotic and acid regulations, and natural antioxidants, fla Vors and colors. Time and temperatures are controlled and 0137 Salvia Sclarea seed oil is extracted from seeds, the solutions treated seeds are dewatered by low-speed blended with other oils, vegetable proteins, water, and centrifuges. The seeds are blended as described, and then natural emulsifying and Stabilizing ingredients and then processed by pasteurization/sterilization (according to pH of homogenized by a homogenizer and formed into a butter/ product) to yield shelf stable products. margarine-like flavored spread, free of trans fatty acids, very low in Saturated fats, and high in omega-3 and oleic fatty Example 9 acids. 0138 Salvia Sclarea seed oil is extracted from Salvia Production of Fish Feed Formulations seeds by a multi-stage press-extractor. Prior to extraction the 0147 Salvia Sclarea seeds are milled and blended at seeds are lightly heated and wetted for maximum yields. various ratios into fish feed formulations. 0.139. The excess water is then removed by a decanting 0.148. This embodiment provides sweet water or salty centrifuge. The omega-3 rich and oleic acid rich oil is water fish with the entire range of nutritional benefits of collected, blended with natural oxidants, if desired, and Salvia Sclarea special oil rich in omega-3 alpha linolenic bottled as such or blended with other oils (see also Example acid, omega-6 linoleic acid and oleic acid. 8), bottled or blended with other ingredients (emulsifiers, 0.149 The fish formulations are then extruded into float stabilizers, water, etc.) and then homogenized under vacuum ing or sinking pellets according to the type of fish to be fed. to produce high omega-3 and oleic acid butter-like spreads, 0150. The raised fish will contain in their fillets a rela Vegetarian mayonnaise, etc. tively higher concentration of omega-3 fatty acids, which in turn can be controlled by the concentration of ALA (C18:3) Example 7 which is also a precursor for natural synthesis of DHA (C22:6) in animal, poultry and fish flesh. 0151. These feed formulae contain all typical ingredients Production of Paste and added Salvia(X) meal containing high value proteins, 0140 Salvia Sclarea seeds, rich in proteins, omega-3 oil minerals and omega-3 oils. and soluble fibers are roasted and ground into a very fine paste by proprietary equipment. The paste may be packed as Example 10 is, as a high nutritional base that can be used for thickening Production of Packaged or Encapsulated Oil gravies, Soups and preparation of many oriental and Indian type dishes Such as meat or vegetarian Satay, curries, hum 0152 Salvia Sclarea seed oil rich in omega-3 ALA is mus etc. extracted from seeds. The oil is blended with olive and other vegetable oils, rich in mono-unsaturated and omega-6 fatty 0141 Additional usage can be to prepare dips such as acids and fortified with natural proprietary antioxidants that tehini dip, prepared in conjunction with sesame paste or oil, will further prevent the oil mixture from oxidation and also water, garlic, lemon juice, spices and herbs. The tehini dip will provide beneficial antioxidants (such as Vitamin E, can be used as is or made into Salad dressings, etc. Vitamin C and others) to the user. When the Salvia Sclarea 0142. A sesame/coffee type roaster is used for roasting seed oil is used alone, without mixing with other oils, the and controlled temperature heating of the Salvia Sclarea need for antioxidants is substantially eliminated because of seeds, which are then ground and homogenized into an the natural properties of this oil that make it very slow to omega-3 rich tehini-type paste. rancidify. See Example 11. US 2017/0065546 A1 Mar. 9, 2017

0153. The ratio of monounsaturated fatty acids to Minatelli, which attests to the very poor oxidative stability omega-3 fatty acid and omega-6 fatty acid is calculated to be of Chia oil when not extracted under inert gases and with 1 to 1/2 to 1/2, in order to maintain the recommended ratio antioxidants. of 1/3 monousaturated fatty acid, 1/3 polyunsaturated a fatty 0160 To test the stability of Salvia sclarea seed oil acid (with a ratio of 1 to 1 between omega-3 fatty acid and against oxidation, the standard Rancimat test was conducted omega-6 fatty acid) and 1/3 saturated fatty acids of veg at various temperatures. This test is detailed in Sullivan and etable or animal origin (such as palm oil, coconut oil, butter, Carpenter, Methods of Analysis for nutrition labeling, etc.). All fats and oils should be trans-free. AOAC International, Chapter 1, 1993. The results were as 0154 The total fats/oil per daily use is calculated to be 60 follows: gr. or 75 gr. (i.e., 27% of diets with 2000 calorie?day or 2500 calorie?day respectively). Oil stability (105° C.), hir 6.6 0155. About 2-3 grams a day of fish oils containing 1000 Oil stability (120° C.), hir 2.4 mg. omega-3 DHA and EPA PUFA, are enclosed separately Oil stability (130° C.), hir O.85 to the package, in order to Supply daily the whole range of omega-3 PUFA: ALA, EPA and DHA. 0.161 This may be compared to the stability reported for 0156 The entire fatty acids/oils daily portion is packed in Chia oil, such as that reported in Ixtaina et al., “Oxidative a 3 compartment package which will include in compart Stability of Chia (Salvia hispanica L.) Seed Oil: Effect of ment 1 the fluid oils blend (to be used in salads, cooking, Antioxidants and Storage Conditions.' J Am Oil Chem Soc etc.), in compartment 2 a spreadable Saturated fatty acids 89:1077-1090 (2012). That article reports the induction time mix (to be used by spreading on crackers, bread slices, etc.) in hours as a result of the same Rancimattest used above for and in compartment 3, the omega-3 PUFA rich, fish oils (to analyzing S. Sclarea oil, but conducted at 98° C., as being be used with fish salads, dishes, etc., or any other food with 2.3+0.3. Thus, even at a much lower temperature (98 C.), a compatible flavor). the Chia oil became rancid faster than S. Sclarea oil tested 0157. The fish oil may also be encapsulated. at 120° C. As the higher the temperature, the more rapid the 0158 Special oil blends including natural herbal and oxidation, it is clear that S. Sclarea oil is much more stable other antioxidants, and rich in omega-3 and oleic acids may than is Chia oil. This significantly enhanced stability over be compounded to yield nutritionally recommended ratios of Chia oil is surprising and unexpected. omega-6:omega-3, mono-unsaturated poly unsaturated and Example 12 saturated fatty acids. Assessment of Oxidative Deterioration of Salvia Example 11 Sclarea Seed Oil at Ambient and Sunlight Storage 0162 This study was carried out in order to probe the ComparativeSility of Salvia Sclarea Oil extent of oxidative alterations in Salvia Sclarea (Sage) seed oil, Subjected to ambient and Sunlight storage, over a period 0159. It has been discovered that the Salvia Sclarea seed of different times and storage conditions. The results are oil has a remarkable stability that far exceeds that of other shown in Tables 7-14. known vegetable oils that are rich in omega-3 fatty acids, 0163 The magnitude of oxidative changes was moni Such as Chia (Salvia hispanica), flaxseed, hemp, and others. tored by the periodic measurement of peroxide value (PV) It is well known that Chia oil has a substantial drawback as (analysis Method-AOCS Cd 8b-90) and free fatty acid a commercial product because of its low oxidative stability. (FFA) content, (analysis Method-AOCS Ca 5a-40). A twelve See, for example, US 2011/0183033 to Gillot, which dis month oil of cold press Salvia Sclarea seeds was used from closes a method of microencapsulation of the Chia oil in two different batches, with no addition of industrial or order to overcome the problems caused by Chia oils lack of natural stabilizers to the oil. The protein in oil was <0.1%, good oxidative stability. See also US 2011/0306666 to moisture 0.04% max with an average 50% of ALA in the oil. TABLE 7

Shelf life test 1: Glass bottle 250 cc of Sage Oil

Batch number:

11AE1S 11 AE1S 11AE1S 11AE1S 11 AE1S 11AE1S 11AE15

Days at 40° C. O 30 60 90 120 150 18O acceleration Free fatty acid O.92 1.03 1.02 1.08 1.13 O.96 O.92 content% as oleic acid (FFA) peroxide 7.4 5 3.7 6.5 3.3 3 7.6 value (PV) (meg/kg) US 2017/0065546 A1 Mar. 9, 2017 10

TABLE 8 Shelf life test 2: Glass bottle 250 cc of Sage Oil Batch number:

12AE16 12AE16 12AE16 12AE16 12AE16 12AE16 12AE16 Days at 40° C. O 30 60 90 120 150 18O acceleration Free fatty acid 1.11 1.18 1.21 1.3 1.35 1.37 1.08 content% as oleic acid (FFA) peroxide 6.4 4.6 3.6 6.2 2.7 2.1 6.5 value (PV) (meg/kg)

TABLE 9 TABLE 12 Shelf life test 6: PET bottle 250 cc of Sage Oil Shelf life test 3: Glass bottle 250 cc of Sage Oil Batch number:

Batch number: 12AE16 12AE16 12AE16 12AE16 12AE16 Days at -22 C. O 90 123 270 365 11AE1S 11 AE1S 11 AE1S 11 AE1S 11 AE15 Free fatty acid O.92 1.16 1.09 O.88 1.03 content% as oleic acid (FFA) Days at 25° C. O 90 123 270 365 peroxide 7.4 6.7 6.6 11.7 5.4 Free fatty acid O.92 O.96 O.96 1.01 1.03 value(meg/kg) (PV) content% as oleic acid (FFA) peroxide 7.4 6 4.9 3.3 3.6 TABLE 13 value (PV) (meg/kg) Shelf life test 7: Glass bottle 250 cc of Sage Oil Batch number:

11AE15 11AE15 11AE15 TABLE 10 Days at 4° C. O 18O 365 Shelf life test 4: Glass bottle 250 cc of Sage Oil Free fatty acid O.92 O.94 O.96 content % as oleic acid (FFA) Batch number: peroxide 7.4 7.6 5.3 value (PV) 12AE16 12AE16 12AE16 12AE16 12AE16 (meg/kg) Days at 25° C. O 90 123 270 365 Free fatty acid 1.11 1.2 1.13 1.25 122 content% as oleic acid (FFA) TABLE 1.4 peroxide 6.4 5.5 4.3 3 2.9 value (PV) Shelf life test 8: Glass bottle 250 cc of Sage Oil (meg/kg) Batch number:

12AE16 12AE16 12AE16 TABLE 11 Days at 4° C. O 18O 365 Shelf life test 5: PET bottle 250 cc of Sage Oil Free fatty acid 1.11 1.08 1.13 content % as oleic acid (FFA) Batch number: peroxide 6.4 6.5 4.7 value (PV) 11AE1S 11 AE1S 11 AE1S 11 AE1S 11 AE15 (meg/kg) Days at -22 C. O 90 123 270 365 Free fatty acid O.92 O.94 O.9S O.91 0.97 content% as oleic 0164. These results may be contrasted to the PV values acid EA) 7.4 8.1 7.2 S.6 5.7 for flax seed oil, such as those reported in Hamed and peroxide Abo-Elwafa, “Enhancement of oxidation stability of flax value(meg/kg) (PV) seed oil by blending with stable vegetable oils.'1 99 J App Sci Res 8:5039-5048 (2012). This publication reports that rela tively short shelf-life of most commercially available veg US 2017/0065546 A1 Mar. 9, 2017

etable oils limits their usefulness in various applications. It 23. A therapeutic method of increasing the level of further states that flaxseed oil, with the high levels of PUFA, omega-3 fatty acid in a Subject, comprising: is more readily oxidized if stored or handled improperly. administering to the subject a therapeutically effective While accelerated at 62°C., the PV values for pure flaxseed amount of a product selected from the group consisting oil (FO) in FIG. 4, are extremely high as compared to the of Salvia Sclarea seed, Salvia Sclarea seed oil, and results above for S. Sclarea seed oil. Salvia Sclarea seed crushed or milled to form a flour or powder. (0165. See also the peroxide value (PV) for Chia oil as 24. A therapeutic method of treating a Subject Suffering reported in FIG. 4 of Ixtaina (2012), supra. It shows that from a disease or condition which is known Scientifically, or fresh Chia oil at 20° C. after 195 days has a PV of 20. This is discovered empirically, to benefit from an increase in the may be compared with one year Salvia Sclarea oil at 25°C. level of omega-3 fatty acid, comprising: after 270 days, which has a PV of only 3.3 and one year orally administering to the Subject an effective amount of Salvia Sclarea oil at 40° C. after 365 days, which has a PV a product selected from the group consisting of Salvia of only 3.6. Sclarea seed, Salvia Sclarea seed oil, and Salvia Sclarea 0166 The extremely high stability of S. Sclarea seed oil, seed crushed or milled to form a flour or powder. as compared to other oils high in omega-3, is surprising and 25. In a method for relieving the symptoms of psoriasis in unexpected. a subject, comprising topically administering to the affected 1-21. (canceled) area of the Subject an effective amount of a composition 22. A method of preventing wrinkling of skin or ensuring comprising omega-3 fatty acids, the improvement wherein skin health in a subject, comprising: said composition comprises Salvia Sclarea seed oil. topically applying to the Subject a therapeutically effec 26. A method in accordance with claim 24, wherein said tive amount of a cosmetic composition comprising disease or condition is coronary artery disease. Salvia Sclarea seed oil. k k k k k