A Dietary Composition Comprising Plant-Based Sources of Fatty Acids

Abstract

A dietary composition including saw palmetto and coconut oil in a proportion whereby the daily dose provides a controlled amount of fatty acids, having a minimum of 37.5 mg lauric acid and 16.44 mg myristic acid.

Claims

1. A dietary composition including saw palmetto and coconut oil in a proportion whereby the daily dosage provides a minimum of 37.5 mg lauric acid and 16.44 mg myristic acid, and wherein the daily dosage of the total composition provides a minimum of 80 mg total fatty acids.

2-56. (canceled)

Description

DETAILED DESCRIPTION OF AT LEAST ONE EMBODIMENT OF THE INVENTION

[0027] Example embodiments will now be described in detail.

[0028] These are provided for illustrative purposes only, they are not intended to be limiting in any way to the scope of the invention. Since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly all suitable modifications and equivalents may be resorted to, falling within the scope of the invention. For example, the relative quantities of the ingredients may be varied to optimize the desired effects and/or additional ingredients may be added.

[0029] Within this specification, the terms standardised minimum quantities and standardised minimum amounts mean to guarantee a minimum amount of lauric and myristic acid in the composition and in this context, ensure the daily dose of the composition contains a lauric acid content of equal to or greater than 37.5 mg and a myristic acid content of equal to or greater than 16.44 mg.

[0030] Within this specification, sunflower oil and sunflower oil powder may include any of the following varieties: virgin, extra-virgin, organic, high oleic, high linoleic, mid-oleic or regular, water dispersible, cold water dispersible, or a combination thereof.

[0031] Within this specification, coconut oil and coconut oil powder may include any of the following varieties: organic, virgin, extra-virgin, cold water dispersible, and water dispersible.

[0032] Within this specification, the term about means plus or minus 10%.

[0033] Within this specification, the terms 50% oil powders, coconut oil powder 50% and sunflower oil powder 50% refer to oil-powders which contain about 50% total fat, and/or about 50% of the original oil within the powder.

[0034] Within this specification, the terms 70% oil powders, coconut oil powder 70% and sunflower oil powder 70% refer to oil-powders which contain about 70% total fat, and/or about 70% of the original oil within the powder.

[0035] Within this specification, the term 50% load refers to oil-powders which have been converted from oil to powder and retain 50% of the original oil within the powder.

[0036] Within this specification, the term 70% load refers to oil-powders which have been converted from oil to powder and retain 70% of the original oil within the powder.

[0037] Within this specification, 85% extract refers to a commercial saw palmetto oil extract which has been standardised to contain 85-95% total fatty acids.

[0038] Within this specification, 45% extract refers to a commercial saw palmetto powder extract which has been standardised to contain 45-50% total fatty acids.

[0039] Within this specification, 25% extract refers to a commercial saw palmetto powder extract which has been standardised to contain 25% total fatty acids.

[0040] Within this specification, the term hair loss also includes the following: alopecia, balding, thinning hair and pattern hair loss.

[0041] Within this specification, the term hirsutism refers to abnormal or unwanted hair growth on a woman's face or body.

[0042] Within this specification, the term prostate conditions or prostate issues includes the following conditions and symptoms: frequent urination, urgency of urination, urinary hesitancy, weak urination, urinary blockage, urinary leakage, urinary dribbling, night urination, prostatitis, elevated prostate specific antigen levels, tumor cells, enlarged prostate, benign prostate hyperplasia, prostate cancer, and combinations thereof.

[0043] Within this specification, the term PCOS refers to Polycystic Ovary Syndrome.

[0044] Within this specification, the terms treat and treating refer to the reduction, slowing, stopping, limiting, prevention, and/or elimination of hair loss, acne, hirsutism, prostate conditions, hormone imbalance, and/or the effects of PCOS. The treatment may also improve skin and/or hair quality and texture as to minimize effects of acne or hair loss on appearance.

[0045] Within this specification, the terms food supplement and dietary supplement refer to concentrated sources of nutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet. In other terms, food supplement means any food the purpose of which is to supplement the normal diet and which is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination. A food supplement is preferably sold in dose form. The definition of to supplement can be interpreted as taken in addition to the diet.

[0046] Within this specification, the singular form a, an, and the includes plural references unless indicated otherwise.

[0047] Within this specification, Orgen-Zn and Orgen-Bio refer to products which can be purchased from Orgenetics.

[0048] The composition and the examples below may be mixed together by conventional mixing equipment known in the art of pharmaceuticals and food supplements, and inserted, in dosage-sized quantities, into capsules or tablets for oral use. The capsules may be soft-gel capsules, vegetarian soft-gel capsules, hard 2-piece gelatin capsules or hard 2-piece vegetarian capsules made from hydroxypropyl methyl cellulose.

[0049] The composition may be in oil form. Preferably the saw palmetto oil will be an 85% extract.

[0050] Preferably, the composition will be in powder form. If encapsulating the composition in powder form, it is preferable to use microencapsulated oil powders.

[0051] The composition may include at least one other plant-based source of fatty acids. This other plant-based source of fatty acids may be at least one of the following, which may be in oil form or may be in powder form: sunflower seed oil, sunflower oil, olive oil, flax seed oil, evening primrose oil, pumpkin seed oil, sea buckthorn oil, blackcurrant seed oil, chia seed oil, borage oil, grape seed oil, hemp seed oil, perilla seed oil, safflower seed oil, sesame seed oil, cranberry seed oil, wheat germ oil, echium seed oil.

[0052] All powder-based example compositions below use 50% oil powders or 50% load oil powders; however, they may be replaced with 70% oil powders or 70% load oil powders, if so desired.

[0053] The composition and examples below may be mixed with acceptable carriers, additives, colours and excipients. Any suitable excipient may be used, including for example inert diluents, disintegrating agents, binding agents, flowing/anti-caking agent, lubricating agents, wetting agents, stabilizers, emulsifiers, buffers, sweetening agents, flavouring agents, bulking agents, preservatives and the like. Examples of bulking agents which may be used are rice flour or rice powder. Examples of flowing/anti-caking agents which may be used are magnesium stearate and/or silicon dioxide. The material used for the capsule shell in the following examples may be substituted with another suitable material.

[0054] The amount of lauric and myristic acid in the composition can be controlled and contained in standardised minimum amounts by, but not limited to, the following processes:

[0055] Process when Using Powders [0056] Source a saw palmetto powder. A 45% extract is preferred; [0057] Source a coconut oil powder (preferably 50%), which has a guaranteed minimum quantity of lauric and myristic acid, for example, minimums of 20% and 8%, respectively. [0058] Send a 100 g sample of the saw palmetto powder to a fatty acid testing laboratory, such as Eurofins; [0059] Based on the results showing the quantity of lauric and myristic acid in the saw palmetto powder, decide how much coconut oil powder and saw palmetto powder are required in order to provide minimums of 37.5 mg and 16.44 mg in the composition, respectively; [0060] Include enough coconut oil powder and saw palmetto powder in the composition so that the minimum quantities of lauric and myristic acid in the composition are 37.5 mg and 16.44 mg respectively. The amount of coconut oil and/or saw palmetto in the composition can be varied to achieve higher quantities of lauric and myristic acid if required. If repeating this process more than once for the same final product, it is preferable to keep the amount of saw palmetto the same each time.

[0061] Process when Using Oils [0062] Source a saw palmetto oil. An 85% extract is preferred; [0063] Source a coconut oil (preferably virgin), which has a guaranteed minimum quantity of lauric and myristic acid, for example, minimums of 44% and 13%, respectively; [0064] Send a 100 g sample of the saw palmetto oil to a fatty acid testing laboratory, such as Eurofins; [0065] Based on the results showing the quantity of lauric and myristic acid in the saw palmetto oil, decide how much coconut oil and saw palmetto oil are required in order to provide minimums of 37.5 mg and 16.44 mg in the composition, respectively; [0066] Include enough coconut oil and saw palmetto oil in the composition so that the minimum quantities of lauric and myristic acid in the composition are 37.5 mg and 16.44 mg respectively. The amount of coconut oil and/or saw palmetto in the composition can be varied to achieve higher quantities of lauric and myristic acid if required. If repeating this process more than once for the same final product, it is preferable to keep the amount of saw palmetto the same each time.

[0067] Another Alternative Process which can be Used for Both Oils and Powders: [0068] Source a saw palmetto oil or powder. [0069] Source a coconut oil or powder which has a guaranteed minimum quantity of lauric and myristic acid. [0070] Send 100 g samples of both products to a fatty acid testing laboratory, such as Eurofins; [0071] Based on the results showing the exact quantities of lauric and myristic acid in both the saw palmetto and coconut oil, decide how much additional lauric and myristic acid is required in order to provide minimums of 37.5 mg and 16.44 mg in the composition, respectively; [0072] Include enough coconut oil/powder and saw palmetto oil/powder in the composition so that the minimum quantities of lauric and myristic acid in the composition are 37.5 mg and 16.44 mg respectively. The amount of coconut oil and/or saw palmetto in the composition can be varied to achieve higher quantities of lauric and myristic acid if required. If repeating this process more than once for the same final product, it is preferable to keep the amount of saw palmetto the same each time.

[0073] All example compositions below have the following 3 features in common: including saw palmetto and coconut oil, in a proportion whereby the daily dose provides a minimum of 37.5 mg lauric acid and 16.44 mg myristic acid, and wherein the daily dose of the total composition provides a minimum daily dosage of 80 mg total fatty acids.

[0074] Composition 1

[0075] In Composition 1, the ingredients are combined such that one capsule of the composition provides each ingredient in the quantities shown below in Table 1. The composition is formulated as 2-piece vegetarian size 00 capsules. Table 1 also demonstrates Composition 1 providing above 80 mg total fatty acids. Table 1 also shows how Composition 1 is able to control and standardise the amount of lauric and myristic acid to above 37.5 mg and 16.44 mg respectively.

TABLE-US-00001 TABLE 1 Amount of Amount of Amount of Amount fatty acids lauric acid myristic acid per capsule per capsule per capsule per capsule Ingredient Saw Palmetto Powder (45% Extract) 160 mg 80.88 mg 25.95 mg 11.33 mg Sunflower Oil Powder 50% (High 101.5 mg 52.78 mg n/a n/a Oleic, Microencapsulated) Coconut Oil Powder 50% 158 mg 82.32 mg 37.98 mg 15.23 mg (Microencapsulated) Acerola Cherry Powder (25% Vitamin C) 50 mg n/a n/a n/a 10% Natural Beta-Carotene/Mixed 11 mg n/a n/a n/a Carotenoids (D. Salina Algae) Other Ingredients: Gluten free Rice Flour 145 mg n/a n/a Hyproxypropylmethyl Cellulose 96 mg n/a n/a n/a (capsule shell) Total fatty Total lauric Total myristic acids per capsule: acid per capsule: acid per capsule: 215.98 mg 63.93 mg 26.56 mg

[0076] Example Method of Administering Composition 1 to a Specific Population

[0077] Composition 1 in weights shown in Table 1 above can be administered to women as a treatment with a view to maintaining normal/improving skin or treating acne.

[0078] The serving size is two capsules per day, taken with food. The composition can be taken as long as needed. This composition is not recommended for pregnant, lactating or breastfeeding women. This composition can be taken as a food supplement or a medicine.

[0079] Composition 2

[0080] In Composition 2, the ingredients are combined such that one capsule of the composition provides each ingredient in the quantities shown below in Table 2. The composition is formulated as 2-piece vegetarian size 1 capsules. Table 2 also demonstrates Composition 2 providing above 80 mg total fatty acids. TABLE 2 also shows how Composition 2 is able to control and standardise the amount of lauric and myristic acid to above 37.5 mg and 16.44 mg respectively.

TABLE-US-00002 TABLE 2 Amount of Amount of Amount of Amount fatty acids lauric acid myristic acid per capsule per capsule per capsule per capsule Ingredient Saw Palmetto Powder (45% extract) 160 mg 81 mg 25.95 mg 11.33 mg Coconut Oil Powder (50% load) 175 mg 72 mg 35 mg 14 mg Organic Sesbania (Agati) Extract 5 mg n/a n/a (Orgen-Bio) Other Ingredients: Gluten free Rice Flour (bulking agent) 60 mg n/a n/a Hyproxypropylmethyl Cellulose n/a n/a (capsule shell) Total fatty Total lauric Total myristic acids per capsule: acid per capsule: acid per capsule: 153 mg 60.95 mg 25.33 mg

[0081] Example Method of Administering Composition 2 to a Specific Population

[0082] Composition 2 can be administered to men and women as a treatment with a view to maintaining normal/improving hair or treating hair loss. The serving size is two capsules per day, taken with food. It can be taken as long as needed. The composition is not recommended for pregnant, lactating or breastfeeding women. This composition can be taken as a food supplement or a medicine.

[0083] Composition 3

[0084] In Composition 3, the ingredients are combined such that one capsule of the composition provides each ingredient in the quantities shown below in Table 3. The composition is formulated as 2-piece vegetarian size 0 capsules. Composition 3 provides a daily dose of above 80 mg total fatty acids. Table 3 also shows how Composition 3 is able to control and standardise the amount of lauric and myristic acid to above 37.5 mg and 16.44 mg respectively.

TABLE-US-00003 TABLE 3 Amount of Amount of Amount of Amount fatty acids lauric acid myristic acid per capsule per capsule per capsule per capsule Ingredient Saw Palmetto Whole Berry Powder 200 mg 26 mg 7 mg 4.7 mg Coconut Oil Powder (50%, 160 mg 83.36 mg 38.46 mg 15.42 mg Microencapsulated) Pumpkin Seed Oil Powder (50% load) 75 mg 27 mg n/a n/a Organic Sesbania (Agati) Extract 4 mg n/a n/a (Orgen-Bio) Organic Guava Extract (Orgen-Zn) 40 mg n/a n/a n/a Other Ingredients: Gluten free Rice Flour (bulking agent) 21 mg n/a n/a Hyproxypropylmethyl Cellulose 96 mg n/a n/a (capsule shell) Total fatty Total lauric Total myristic acids per capsule: acid per capsule: acid per capsule: 136.36 mg 45.46 mg 20.12 mg

[0085] Example Method of Administering Composition 3 to a Specific Population

[0086] Composition 3 can be administered to men and women as a cosmetic treatment with a view to maintaining normal hair growth or treating hair loss.

[0087] Alternatively, Composition 3 can be administered to men with a view to supporting prostate function, maintaining a normal prostate or treating prostate conditions.

[0088] Alternatively, Composition 3 can be administered to men and women as a cosmetic treatment with a view to improving or maintaining normal skin, hair and nails.

[0089] In all populations, the serving size is 2-3 capsules per day, taken with food. It can be taken as long as needed. The composition is not recommended for pregnant, lactating or breastfeeding women. This composition can be taken as a food supplement or a medicine.

[0090] Composition 4

[0091] In Composition 4, the ingredients are combined such that one capsule of the composition provides each ingredient in the quantities shown below in Table 4. The composition is formulated as 2-piece vegetarian size 1 capsules. Table 4 also demonstrates Composition 4 providing above 80 mg total fatty acids.

[0092] TABLE 4 also shows how Composition 4 is able to control and standardise the amount of lauric and myristic acid to above 37.5 mg and 16.44 mg respectively.

TABLE-US-00004 TABLE 4 Amount of Amount of Amount of Amount fatty acids lauric acid myristic acid per capsule per capsule per capsule per capsule Ingredient Saw Palmetto (45% extract) 160 mg 84.8 mg 26.74 mg 10.6 mg Coconut Oil Powder (50% load) 175 mg 72 mg 35 mg 14 mg Sunflower Oil Powder (50% load, 60 mg 27 mg n/a High Oleic) Other Ingredients: Gluten free Rice Flour (bulking agent) 5 mg n/a n/a Hyproxypropylmethyl Cellulose n/a n/a (capsule shell) Total fatty Total lauric Total myristic acids per capsule: acid per capsule: acid per capsule: 183.8 mg 61.74 mg 24.6 mg

[0093] Example Method of Administering Composition 4 to a Specific Population

[0094] Composition 4 can be administered to men with a view to maintaining normal prostate, supporting prostate function or treating prostate conditions.

[0095] Composition 4 can alternatively be administered to men or women as a cosmetic treatment with a view to maintaining normal hair/hair growth, improving hair or treating hair loss.

[0096] Composition 4 can alternatively be administered to women as a cosmetic treatment with a view to maintaining normal skin/improving skin or treating acne.

[0097] Composition 4 can alternatively be administered to women as a cosmetic treatment with a view to treating hirsutism or normal facial and bodily hair growth.

[0098] Composition 4 can alternatively be administered to women with a view to treating one or more of the symptoms of Polycystic Ovary Syndrome.

[0099] Alternatively, Composition 4 can be administered to the general population, without giving details of a function, as a food supplement.

[0100] In all populations, the serving size is two capsules per day, taken with food. It can be taken as long as needed. This composition can be taken as a food supplement or a medicine. The composition is not recommended for use by pregnant or breastfeeding women.

[0101] Composition 5

[0102] In Composition 5, the ingredients are combined such that one capsule of the composition provides each ingredient in the quantities shown below in Table 5. The composition is formulated as soft-gelatine capsules. Table 5 also demonstrates Composition 5 providing above 80 mg total fatty acids. TABLE 5 also shows how Composition 5 is able to control and standardise the amount of lauric and myristic acid to above 37.5 mg and 16.44 mg respectively.

TABLE-US-00005 TABLE 5 Amount of Amount of Amount of Amount fatty acids lauric acid myristic acid Ingredient per capsule per capsule per capsule per capsule Saw Palmetto Oil (85-95% fatty 117 mg 105 mg 37 mg 17.56 mg acids) Coconut Oil (Organic, Virgin) 50 mg 49.7 mg 25 mg 8 mg Total fatty Total lauric Total myristic acids per capsule: acid per capsule: acid per capsule: 154.7 mg 62 mg 25.56 mg

[0103] Example Method of Administering Composition 5 to a Specific Population

[0104] Composition 5 can be administered to men with a view to maintaining a normal prostate or treating prostate conditions.

[0105] Composition 5 can alternatively be administered to men or women as a cosmetic treatment with a view to maintaining normal hair or treating hair loss.

[0106] Composition 5 can alternatively be administered to women as a cosmetic treatment with a view to treating hirsutism or normal facial and bodily hair growth.

[0107] Alternatively, Composition 5 can be administered to the general population, without giving details of a function, as a food supplement.

[0108] In all populations, the serving size is two capsules per day, taken with food. It can be taken as long as needed. This composition can be taken as a food supplement or a medicine. The composition is not recommended for use by pregnant or breastfeeding women.

[0109] Composition 6

[0110] In Composition 6, the ingredients are combined such that one capsule of the composition provides each ingredient in the quantities shown below in Table 6. The composition is formulated as 2-piece vegetarian size 0 capsules. The Acerola cherry can be replaced by 30 mg of Orgen-Zn (Organic Guava Extract). Table 6 also demonstrates Composition 6 providing above 80 mg total fatty acids. TABLE 6 also shows how Composition 6 is able to control and standardise the amount of lauric and myristic acid to above 37.5 mg and 16.44 mg respectively.

TABLE-US-00006 TABLE 6 Amount of Amount of Amount of Amount fatty acids lauric acid myristic acid per capsule per capsule per capsule per capsule Ingredient Saw Palmetto Powder (45% extract) 95 mg 49 mg 22 mg 9.8 mg Coconut Oil Powder (50% Load) 95 mg 39 mg 19 mg 7.6 mg Blackcurrant Seed Oil Powder (50% Load) 280 mg 118 n/a n/a Acerola Cherry Powder (25% vitamin c) 30 mg n/a n/a Other Ingredients: Hyproxypropylmethyl Cellulose 96 mg n/a n/a (capsule shell) Total fatty Total lauric Total myristic acids per capsule: acid per capsule: acid per capsule: 206 mg 41 mg 17.4 mg

[0111] Example Method of Administering Composition 6 to a Specific Population

[0112] Composition 6 can be administered to men or women as a cosmetic treatment to maintain normal skin/improving skin or treating acne.

[0113] Composition 6 can alternatively be administered to men with a view to maintaining normal prostate or treating prostate conditions.

[0114] Composition 6 can alternatively be administered to men or women with a view to maintaining normal hair or treating hair loss.

[0115] Composition 6 can alternatively be administered to women as a cosmetic treatment of hirsutism or normal facial and bodily hair growth.

[0116] Alternatively, Composition 6 can be administered as a cosmetic treatment as a skin and hair supplement; or a skin, hair and nails supplement.

[0117] Composition 6 can alternatively be administered to women with a view to treating one or more of the symptoms of Polycystic Ovary Syndrome.

[0118] In all populations, the serving size of Composition 6 is two capsules per day, taken with food. It can be taken as long as needed. This composition can be taken as a food supplement or a medicine. The composition is not recommended for use by pregnant or breastfeeding women.

[0119] In Composition 7, the ingredients are combined such that one capsule of the composition provides each ingredient in the quantities shown below in Table 7. The composition is formulated as vegetarian soft-gel capsules. Table 7 also demonstrates Composition 7 providing above 80 mg total fatty acids. TABLE 7 also shows how Composition 7 is able to control and standardise the amount of lauric and myristic acid to above 37.5 mg and 16.44 mg respectively.

TABLE-US-00007 TABLE 7 Amount of Amount of Amount of Amount fatty acids lauric acid myristic acid Ingredient per capsule per capsule per capsule per capsule Saw Palmetto Oil (85-95% fatty 80 mg 71.8 mg 25.3 mg 12 mg acids) Sunflower Oil (Mid-Oleic) 20 mg 20 mg n/a n/a Coconut Oil (Virgin) 50 mg 49.7 mg 25 mg 8 mg Acerola Juice Concentrate 70 mg n/a n/a n/a Carrot Juice Concentrate 50 mg n/a n/a n/a Total fatty Total lauric Total myristic acids per capsule: acid per capsule: acid per capsule: 141.5 mg 50.3 mg 20 mg

[0120] Example Method of Administering Composition 7 to a Specific Population

[0121] Composition 7 in weights shown in Table 7 above can be administered to as a cosmetic treatment women with a view to maintaining normal skin or treating acne. The serving size is two capsules per day, taken with food. The composition can be taken as long as needed. This composition is not recommended for pregnant, lactating or breastfeeding women. This composition can be taken as a food supplement or a medicine.

[0122] Any of example compositions 1-7 can be administered with a view to inhibiting 5-alpha reductase and/or reducing DHT.

[0123] Any of example compositions 1-7 can be administered with a view to balancing hormones and/or treating hormonal imbalances.

[0124] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art.