CA2800438C - Full spectrum fatty acid nutritional supplement - Google Patents

Abstract

The invention provides a unique formulation of short chain, medium chain, long chain and very long chain saturated, unsaturated, non-essential, and essential fatty acids that conform to the full spectrum of fatty acids required for normal cell membrane maintenance and function. The oil composition can lower LDL cholesterol levels while normalizing levels of key biochemical diagnostic metabolites in the human body. The mixture's stability, digestibility and potency are maintained with limonene and menthol. The nutritional fatty acid supplement can be incorporated as a delivery agent of pharmaceuticals and biochemicals or the formulation can be added into salads, infused into gel pill formats and as additives in food products. The formulation can be used topically for alleviating certain skin disorders such as skin rashes (eczema and seborrhea dermatitis). The mixture can be of beneficial use for people with autism, ADHD, mental health related issues and general cardiovascular and metabolic disorders.

Description

Full Spectrum Fatty Acid Nutritional Supplement Specification and Description The invention provides a formulation of short chain, medium chain, long chain and very long chain saturated, unsaturated, non-essential, and essential fatty acids that conform to the full spectrum of fatty acids required for cell membrane maintenance and function. The invention comprises of a full spectrum nutritional oil supplementation with a very broad fatty acid content for individuals, who not only lack a number of essential and non-essential fatty acids, but also the right optimal ratios of these fatty acids in their normal dietary intake. As a result, the invention is geared to those who not only practice good healthy choices but also to those who suffer from a number of acute and chronic medical conditions because of the lack of these non-essential and essential fatty acids (Calder, 2001, Simopoulos, 2008, Tourtas et al, 2012). The invention fills a void that is becoming all too common in North America where more and more natural raw foods are being processed and the nutritional fatty acid contents have become depleted, oxidized (and so not useful to the body) or, in most cases, they have been completely removed. Many biological processes and every cell in the human body (which is made up of cell membranes) is highly dependent on the stability and composition of a number of these different individual fatty acids, hence a full spectrum oil supplementation is crucial.
Background Information The development, growth and maintenance of human cells and body tissues require fatty acids. The membranes of cells, for example, are made of different lipids. These lipids are themselves comprised of fatty acids of various ratios and types. Many biologically important molecules such as sterols (cholesterols), glycerides, triglycerides, and phospholipids make up membranes and hormones. Plasma cholesterol and TG levels for example, are clinically important biomolecules because their abnormal levels are major risk factors for cardiovascular diseases. Fats (lipids) in dietary food intake are digested by lipases to release fatty acids. Because fatty acids are insoluble, they are then mixed with secretions from the bile. This mixture results in the formation of micelles. The fatty acids then diffuse to the brush border of the enterocytes of the small intestine, the long chain fatty acids then bind to the fatty acid binding proteins and transported into the cell. Within the cells, the fatty acids are re-esterified to form triglycerides and then mixed with fat-soluble vitamins, phospholipids and apoproteins to form chylomicrons. The chylomicrons are then released by exocytosis from the erythrocytes into the lymphatic, the thoracic and then into the systemic circulation which then distributes the fatty acids throughout the body for use in as energy or for the incorporation into cell membrane structures or other biological processes.
Fatty acid deficiencies and associated diseases Fatty acids in the human body are either saturated or unsaturated and differ by length.
They are then further classified whether they are short, medium or long chained. Saturated fatty acids are long chain fatty acids. Short chain fatty acids (SCFA) have fewer than 6 carbon atoms, Medium chain Fatty acids have (MCFA) are between 6-12 carbon atoms and are important in forming medium chain triglycerides and are important in optimizing LDL and HDL levels. Long chain fatty acids (LCFA) are longer than 12 carbon atoms and the major components of triglycerides (TG) and are important in cholesterol synthesis and homeostasis and the synthesis of many hormones such as prostaglandins. Very long chain fatty acids (VLCFA) have tails that are longer than 22 carbon atoms and are important in the lipid composition of many brain membranes and synapses (Svennerholm, L, 1968). Many of these fatty acids have been shown to be present in human brain (Svennerholm, 1968, Martinez and Mougan, 1998)), blood plasma ( Saifer, A and Goldman, L, 1961), blood cells (Table 1), and tissues. Tables 2 and 3 show the composition by percentage of different types of fatty acids in the white and grey matter of ethanolamine phosphoglycerides from the brains of different individuals based on sex and age. In general, 18:0 is the major fatty acid present in all ages of humans. In younger brains, polyunsaturated fatty acids of the linoleate series predominate (i.e., 20:4 (n-6) and 22:4 (n-6). As the brain matures there is an increase of fatty acids of the linolenate series from about 25% in the fetal brain to 35% in the older brain.
Note also the changes in the ratio of n-6 to n-3 fatty acids through the different ages in the grey matter i.e., it changes: from 3:1 (fetus), 0.9:1 (26 yr old), 1:1 (52 yr old) to 1:2 (82 yr old). In the white matter the ratio of n-6:n-3 changes from 1.9:1 (fetus), 5:1 (26 yr old), 3:1 (52 yr old) to 2.3:1 (82 yr old). The normal healthy human body can synthesize some of these fatty acids (non-

2 essential fatty acids, NEFA) but a few (essential fatty acids, EFA) have to be obtained solely from diet.
Table 1. Components of fatty acids in plasma and blood cells of seven men.
Dienoic acids (18:2 (n-6), 20:2 (n-6), 22:2 (n-6)); Trienoic acid (16:3 (n-3), 18:3 (n-3), 20:3 (n-3); Tetraenoic acid (18:4 (n-3), 20:4 (n-3), 20:4 (n-6), 22:4 (n-6), 24:4 (n-6); Pentaenoic acid (20:5 (n-3), 21:5 (n-3), 22:5 (n-3), 24:5 (n-3), 22:5 (n-6), 24:5 (n-6) and Hexaenoic acid (22:6 (n-3), 24:6 (n-3) (adapted from Patil and Magar, 1959).
Average values of percentage of total fatty acids, 4- s. 1>., are given.
Component acids Plasma Blood cells Saturated fatty acids 3143 289 50.2 4-144 Oleic acid* 33.3 2-25 21.2 1241 Dienoic acid 22.0 1.49 6.73 0.85 Trienoic acid 2.35+045 -Tetraenoic acid 6-38 + 0..%5 14.3 0.54 Pentaenoic acid 1-19+0.07 3.014-0.17 .Hexacnoic acid 2.46 0.10 4.464-0.64 * Contained small amounts of palmitoleic acid.
Table 2. Fatty acid composition of ethanolamine phosphoglycerides in cerebral gray matter (cortex) (adapted from Svennerholm, 1968). 12 wk fetus (FB 113), 35 wk fetal brain (FB 108), 38 wk fetal brain (FB 112), 1 month female (CB 110), 7 month old male (CB
111), 4 yr old female (CB 113), 16 year old (AB 102), 26 yr old female (AB 112), 52 yr old female (AB 113), 81 yr old male (AB 114) and 82 yr old male (AB 115).
Fecis FB 108 FB 112 CB 110 e11l11 CR 113 12 wk 35 wk 38 wk 1 ultuRb 744aont1 494 1(07 26 Y4 523. 61 Y, 82 yr 16:0 10.6 6.9 7.6 6.4 6.5 5,0 6.0 5.9 5.7 6.3 6.8 161 1.2 0.6 0.6 0.7 0.7 0.4 0.5 0_4 0.4 0_6 1.2 18:0 30.0 29.1 32.8 34.6 27.8 30.1 29.8 30.4 28.4 29.6 27.2 18:1 13.3 9.8 8.5 8.7 10.3 11.11 10.2 8.7 10.3 9.1 9.8 18:2(n-6) 0.2 0.2 0.3 tr. 0.2 0.4 0.4 0.5 0.5 DA 0.3 18:3(4-6) 0.1 G.1 Or. w. ,r. tr. ,,... 0.1 ir.
It. Or..
18:4n.-3) 0.3 0.2 0.2 0.3 0.5 0.4 (I 2 0.2 0.4 0.2 0.2 20:1(n-9)+
183(4-3) Oil 0.5 0.3 0.3 0.6 0,5 0.6 0.5 0.9 0.5 0.6 20:3(s-9) 1.6 0.9 0.8 0.6 0_7 0.5 0.2 0.3 0.5 0.3 0.4 20:5(n-6) 0.5 0.8 1.0 1.2 1.5 1.6 1.1 1.1 1.0 1 1 0.8 20:4(n-6) 17.3 17.8 14.9 16.5 16.4 16.7 13.0 13.2 11.2 9.9 10.3 22:4(n-6) 9.5 10.1 10.6 11 1 11.7 9.9 8.4 8.5 7.7 7.0 6.3 22:5(4-6) 2.8 4.1 4.4 2.7 5.0 2.4 1.7 1.5 1.2 0.8 0.9 22:5(n-3) 0.5 0.6 0.4 O. 0.5 0.6 0.4 0.5 1.1 1.0 1.0 22:6(o-3) 10.8 18.3 17.1 16.1 16.9 22.3 27.0 28.6 30.5 31.4 33.9 24:4(n-6) 0.6 0.2 0.5 0.3 0.5 0.5 0.5 0.1 0.6 0.4 0.2 18-24(44) 31.0 33.3 31.7 31.8 35.3 31.5 25.1 24.8 22.0 19.9 18.8 18-22(n-3) 11.6 19.1 17.7 17.1 17.9 23 1 27 6 29 3 32.0 32 6 35.1 Valuer are weight percentages of methyl ethers.

3 Table 3. Fatty acid composition of ethanolamine phosphoglycerides in cerebral white matter).
12 wk fetus (FB 113), 35 wk fetal brain (FB 108), 38 wk fetal brain (FB 112), 1 month female (CB 110), 7 month old male (CB 111), 4 yr old female (CB 113), 16 year old (AB
102), 26 yr old female (AB 112), 52 yr old female (AB 113), 81 yr old male (AB 114) and 82 yr old male (AB 115) (adapted from Svennerholm,1968).

Al3 113 AB 114 AB 115 38 wk 1 month 7 month 4 yr 16 yr 26 yr 52 yr 81 yr 82 yr 16:0 7.8 5.9 5.0 4.8 4.9 6.2 3.4 4.7 5.4 16:1 0.6 0.5 0.9 0.5 1.0 1.1 0.5 tr.
0.8 18:0 28.9 28,7 13.8 10.2 9.6 13.8 9.3 17.6 10.7 18:1 7.6 13.0 23.6 35.2 38.3 43.2 38.9 39.7 40.4 18:2(n-6) 0.2 0.1 0.4 0.7 0.5 0.5 0.5 tr.
0.3 1813(n-6) It. It. it. 0.1 tr. 0.1 0.1 it.
it, 18!4(n-3) 0.2 0.7 1 9 1 9 1.5 1.3 1 5 0 71 1.2 20:1(n-9)-1-18:3(n-3) 0.3 1.6 3.6 6.4 5.6 6.0 8.5 6,1 6.2 20:3(n-9) 0.7 0.7 (.3 0.7 0.5 0.4 0.9 0.4 0.8 203(n-6) 1,1 1.4 1,7 1.9 1:2 1.0 1.0 1.2 0.9 20:4(n-6) 16.2 15.1 13.4 9.5 8.4 7.9 8.3 7.7 9.2 22:4(n-6) 13.3 13.3 19.6 18.0 18.6 13.4 16.5 10.6 12.8 22:5(n-6) 4.8 2.3 3.5 1.4 1.2 0.5 0.7 0.7 0.6 2.25(ft-3) 0.5 0.9 0.8 0.7 0.6 0.3 1.0 0.9 1.1 22:6(n-3) 17.7 15.2 8,7 5.7 5 7 3.0 7.5 8.6 24:4(n-6) 0.2 0.5 1.6 2.2 2.7 1.5 1.4 1.1 1.1 18-24n-6) 35.8 32.7 40.2 33 8 32 6 24.9 28.5 21.3 24.9 18-22(n-3) 18.4 16.8 11.4 8.3 7.8 4.6 9.8 10.2 10.6 Values are weight pereentaget of methyl esters.
In individuals whose digestive capabilities for proper extraction of fatty acids from dietary foods is inadequate because of lack of enzymes like lipases for the release of fatty acids from triglycerides in food, the need for fatty acids becomes important.
In addition, for individuals who lack enzymes for the proper synthesis of medium, long chain and very long chain fatty acids as well as the catabolism of these fatty acids then supplementations with a broad spectrum nutritional fatty acid supplement formulation is imperative. It is generally well accepted that identifying the stages in deficiencies in fatty acid synthesis or degradation is difficult. More importantly, the determination of the blood levels of an individual lacking an essential or non-essential fatty acid is complex and considerably expensive.
It has been shown, however, that there was a noticeable difference in the levels essential fatty acids like arachidonic acid and docosahexaenoic acid, in red blood cell membranes from schizophrenic patients relative to healthy control subjects (Peet et al, 1995, 1996, Khan et al, 2002). It was also shown that a supplementation of n-3 fatty acid supplementation relieved a number of schizophrenic symptoms and tardive dyskinesia over a 6 week period (Peet et al, 1996). A
number of research groups have also studied the effects of dietary fatty acids on atopic

4 diseases (i.e., allergies) and have reported the importance of dietary supplementation in affected individuals (Kankaanpaa et al, 1999, Sala et al, 2008)). Kankaanpaa, 1999, concluded that careful manipulation of dietary PUFAs can be helpful the proper management of immunological responses such as inflammation associated with any atopic diseases. Sala et al, 2008 noted that in their research that it is recommended that the amount and type of PUFAs must be adjusted in patients' diets for the more efficacious treatment of these atopic diseases.
Abnormal levels of many fatty acids in diet has also been linked to metabolic syndrome diseases that are associated with the increased risk of type 2 diabetes mellitus and cardiovascular diseases (Roche et al, 2005, Phillips et al, 2006). In addition, dietary lipid intake has a number of effects on gene expression and hence modulation of many gene products in the human body (Roche, 2004, Burns et al, 2012). Saturated fatty acids from cold press extraction of Palm oil for example, also has been shown to lower blood cholesterol level, raise HDL levels and reduce platelet aggregability (i.e., it does not promote atherosclerosis and arterial thrombosis) (Chong and Ng, 1991, Elson, 1992, Edem, 2002, Oguntibeju et al, 2009, Nevin and Rajamohan, 2004). Important also was that virgin coconut oil was able to increase bone density and prevent bone loss Hayatullina et al, 2012).
Other diseases that have been implicated in abnormal values of non-essential and essential fatty acids are Alzheimer (Conquer et al, 2000, Cunnane et al,.
2012), Autism (Tamiji and Crawford, 2010, El-Ansary et al, 2011, Yui et al, 2012) and ADHD
(Sorgi et al, 2007, Milte et al, 2012, Richardson et al, 2012). A very good review on the role of unsaturated fatty acids and diseases in the brain at various ages can be found by the article written by Bourre, 2004.
The problem with previous oils and fatty acid supplementations Oil supplementation and modified nutritional oil dietary supplements have focused mainly on the omega 3,6 and 9 fatty acids (Canadian patents: 02413109, 2634139 and 2766799). These fatty acids though are important are only a minor part of the necessary fatty acids requirements of the human body. Scientific results on the appropriate optimum ratios of these oils and their stability in a dietary oil formulation is at best controversial (Ravnskov U., 1998, Simopoulos AP, 2002). Other commonly known issues, by medical practitioners well verse in the field of omega supplementation, involve the level of therapeutic adsorption and availability of fatty acids throughout the body.
Description of Invention The present invention provides a number of fatty acids and other important biochemicals that are important to the human body at concentrations that are easily digestible and incorporated into the human body. This invention fills the gap that other formulations failed to recognize, that is, having saturated and unsaturated fatty acids in one optimum formulation.
The whole formulation is able to stay in liquid form at room temperatures (21 C) and as well, above and below room temperature. The whole final formulation is created as a five step process as described below: The first step involves creating a mixture by adding the following saturated individual fatty acids (Table 4) together. The mixture is kept at 25 C.
Table 4. Mixture of saturated fatty acids.
Saturated Fatty Acids Percentage in Final Composition (v/v A) Capric acid 1.27 Lauric Acid 9.92 Myristic Acid 4.42 Palmitic Add 9.84 Stearic Acid 3.84 The second step involves the addition of the following unsaturated fatty acids together at 16 C (Table 5).
Table 5. Mixture of unsaturated fatty acids.
Unsaturated Fatty Acids Percentage in Final Composition (v/v %) Oleic acid 26.02 Linoleic Acid 12.11 a-Linolenic Acid 9.54 Y-Linolenic Acid 4.47 Gadoleic Acid 1.81 The third step involves the addition of the following unsaturated fatty acids (Table 6) at 16 C.
Table 6. Mixture of unsaturated fatty acids.
Unsaturated Fatty Acids Percentage in Final Composition (v/v %) Eicosapentaenoic Acid 2.04 Erucic Acid 0.39 Docosahexaenoic Acid 5.69 Nervonic Acid 0.39 The fourth step involves the addition of Limonene and menthol to an amount of 1.80%
and 1.0% respectively in the final formulation. In step 5, the ingredients I3-pinene and camphor are incorporated into the mixture and they add up to 2.0% (v/v) of the final composition. To improve digestibility and reduced fish odour, cocoa butter was added at a final concentration of 3.45%. All mixtures are pooled according to the steps outline above and then added together in the order they were prepared to obtain maximum mixing and maintenance of the solution in liquid form at 16 C and at a density of 0.8 g/mL (25 C). The final formulation is then stored under nitrogen to prevent oxidation. The formulation is stored at 4 C and/or -20 C. All individual ingredients are derived from natural organic sources of vegetable and fish oils extracted from cold pressed sources by manufacturers well known in the art of lipid and fatty acid extraction. Some ingredients are obtained together as an oil mixture from their extracted sources and so are used in their correct ratios, proportions and percentage concentration in a manner that is appropriate (i.e. volume or mass) to create the final supplement formulation.
Examples of Uses Example 1. Normalization and lowering of Cholesterol, blood pressure levels and other biochemical markers.
The fatty acid supplement is added to a protein shake and taken at morning and evening. User A102 is a 43 year old male who had approached his physician for his annual physical examination. The physician recommended regular routine blood work analysis and blood pressure monitoring. Initially, a number of biochemical markers had abnormal readings.
The user, however, after taking the fatty acid supplement for about six months and no additional changes to the regular daily diet requested a follow up blood work from his physician. The 6 month follow-up revealed that the previous biochemical marker levels and blood pressure levels had all normalized as shown in Table 7 and Table 8 respectively. All blood biochemical marker analysis was performed by BC Provincial Medical Association approved labs. Biochemical markers in the reference ranges are interpreted by medical professionals as indicators of good health and a healthy lifestyle.
Table 7. Biochemical markers for user A102 before and after 6 months of fatty acid supplementation.
BIOCHEMICAL Initial 6 months REFERENCE RANGE
PERCENT CHANGE
MARKER
(normal values) Platelet Count 141 176 150-400 25% increase (normalized) Cholesterol 5.4 4.8 2-5.2 11% decrease (normalized) LDL Cholesterol 3.8 3.4 1.5-3.4 11% decrease (normalized) HDL Cholesterol 1.1 1.0 >0.9 9% decrease Cho/HDL (Risk Ratio) 4.9 4.8 <5.0 2%
decrease ' Trig lycerides 1.2 0.9 <2.3 25% decrease Table 8. Average blood pressure readings of user A102 taken at 7:00 am each Monday of the week.
Blood Pressure Systolic Diastolic Week 1 145 94 Week 2 140 90 Week 3 138 83 Week 4 120 79 Week 5 110 82 Example 2. Glucose and Hemoglobin Alc decrease levels.
User A103 is a 65 year old male who is a type 2 diabetic with issues of high blood pressure, high glucose, Alc and urine ACR levels. The user also suffered from high cholesterol levels. User A103 took one tablespoon (5mL) in the morning and one tablespoon (5 mL) in the evening. Table 9 shows the reduction in the biochemical markers (glucose, Alc and urine ACR) after 6 months of supplementation. All blood tests were recommended by User Al 03's practicing physician as routine check-up. In addition, all blood biochemical marker analysis was performed by BC Provincial Medical Association approved labs.
Decreases in these diabetic markers are interpreted by medical professionals as indicative of better control of type 2 diabetes and hence better prognosis outcomes.
Table 9.
BIOCHEMICAL Initial 6 months REFERENCE RANGE PERCENT CHANGE
MARKER
(normal values) Glucose 19.3 12.6 3.6-5.5 35% decrease Urine ACR 30.3 7.2 <2.0 mg/mmol 76% decrease (Albumin/Creatinine) Hemoglobin Alc 11.3 9 4.8-6.2% 20.3%
decrease Cholesterol 4.8 2-5.2 normal Cho/HDL (Risk Ratio) 4.1 <5.0 normal Example 3. Unicameral Bone Cyst and increased bone density and growth.
User C111 is a child who has been diagnosed with a unicameral bone cyst on the upper femur of the left leg at age 7 (Figure la). Two hormonal treatments followed by bone grafting surgery showed no improvement in bone growth and bone density (Figure 1 b-c).
C111 was given the supplement at age 9 for 1 year. At the most recent visit and routine examination, x-ray results (as interpreted by the practicing physician) revealed 20% more bone growth and 50% more bone density in the affected region, Figures id and le.

F A44141 ' *4 i ' a. b.NI\ ..õ-:
- ) { , c.L1, - ,-, , d. 1 e.*
, t Figure 1. Unicameral bone cyst of user C111 . X-ray images of upper left femur (a) diagnosis in 2009, (b) One year later, 2010, (c) 2011, (d) 2012 and (e) 2012.
There were no visible changes in the growth of the bone or its density from 2009-2011 (a-c).
In 2012 (d and e), one year after treatment with the fatty acid formulation there is more bone growth and bone density.

Example 4. Lowering of fluid build-up in eye User A104, is a 46 year type 2 diabetic male who was diagnosed with 90% fluid in the right eye and surgery was suggested to drain the fluid. He decided to take supplementation for two months and follow up with his regular physician routine checkup. It was revealed that in his subsequent visit, 90% of the fluid was removed from his eye and surgery was cancelled.
Example 5. Improved blood circulation User A105 is a 77 year old type 2 diabetic male who had complain of black spots on the lower extremities of his shin of both legs. The spots were diagnosed as being due to lack of blood circulation. The user stated after using the supplementation for two months, the black spots have all disappeared.
Example 6. Improved cognitive, behavioural and social interactions in Autism User C113 is a male child of 10 years who was diagnosed with very severe low functioning autism at age 4. At the time of diagnosis, he showed: poor of eye contact and lack of speech, severe fine and gross motor skills issues, inability to process pain, severe behavioral problems including temper tantrums, compulsive behaviour, anxiety, a phobia for crowds and large noisy spaces (such as gyms, skating arenas, malls, churches, etc.), hypersensitivity to sound, light, and textures, repetitive body movements and abnormal posture, inability to focus or have proper social interactions with others. A
few months after the autism diagnosis he was also diagnosed with craniosynostosis, with premature closure of the sagittal and the metopic sutures. Reconstructive skull surgery was performed at age 4.5, which alleviated significantly the motor skills issues and restored the ability to process pain to normal levels. However, the other behavioural and social issues traditionally associated with autism remained well after the surgery.

At age 5, the child was initially placed in a modified kindergarten elementary school program with a full-time special education assistant (SEA) and remained in the modified program for grades 1 and 2. The child has been on the fatty acid formulation since age 7 years. After a year of taking the supplement, the child was placed in a more challenging adapted program at a similar level as his peers at school at age 8. His ability to focus and remain calm, language and social awareness and interaction skills have improved, as well as his capacity to handle change. His anxiety, compulsive behaviours, and panic of large noisy spaces have been significantly reduced. The constant repetitive body movements have disappeared. He continues to mature and increase cognitive learning as reported by independent testing at the School and from The UBC Autism Research Unit. The child is now years old and in grade 5 at the time of submission of this patent application.
He is performing school and extracurricular activities, such as ice skating and choir, with minimum or no supervision. Such independent studies have also shown that his focus and behavior at school has improved as determined by the tests carried out by the above mentioned third parties.
Example 7. Recovery of arm movement following paralysis from stroke User F105, is a young female age 35 who suffered a severe stroke and was paralysed on the right half side of her body. The user had no movement in the right arm or fingers for 3 months prior to using the fatty acid supplementation. After using the fatty acid formulation for two weeks, the user was able to regain partial movement of the arm and fingers.
Example 8. Improved memory and speech from Alzheimer's User F106 is a 77 year old woman with Alzheimer's and speech clarity problems.

was placed on the fatty acid formulation for 2 weeks with supplementation beginning in the morning (1 tablespoon, 15 mL) and ending at night time (1 tablespoon, 15 mL).
At the end of the two weeks, her M.D. noted the improved clarity of speech and her improved awareness and recognition of family members and friends.

Example 9. Topical Application User F107 and M108 had issues with inflamed skin rashes (eczema and seborreah dermatitis respectively) and had applied the fatty acid formulation onto their skin for a period of 2 weeks. The topical application of the fatty acid formulation aided in the general healing of most of the inflammation and contributed to improving the general skin health in that affected region.
From the documented results (examples 1-9) from the above users of the supplement it is evident that the product can be used for the general maintenance of cell membrane and cell tissues of the human body. The product is meant to be used solely as an important nutritional fatty acid supplement that nourishes the body for individuals who lack these fatty acids in their regular diet. Because of the importance of essential fatty acids in brain development, the product will have many uses for people with brain diseases and nerve cell signaling disruptions. Therefore, the product would be useful for people with Autism Spectrum Disorders, ADHD and other mental health problems such as dementia and Alzheimer's.
Important as well is that the product helps in lowering cholesterol and bring the values of a number of biochemical markers to within normal range. The product also helps regulate bowel movements and have been shown to be useful to people who have constipation issues.
Examples of limits of usage of the fatty acid formulation The final fatty acid formulation as described earlier (see section on Description) should not be heated on the stove at temperatures > 25 C, or microwaved in its liquid form. The product should be used directly out of the bottle undiluted and not left for long periods in an open container. These inappropriate usages of the product will decrease the effectiveness of the product as fatty acids may be more susceptible to oxidation and lead to eventual decomposition of the product mixture. The formulation should not be placed on open bleeding skin wounds.

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Claims (10)

Claims The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A full spectrum fatty acid oil formulation that contains the following composition of ingredients: capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, alpha linolenic acid, gamma linolenic acid, gadoleic acid, eicosapentaenoic acid, erucic acid, docosahexaenoic acid, nervonic acid, limonene, menthol, beta pinene, camphor and cocoa butter.

2. A process of mixing and combining the ingredients into the formulation of claim 1 wherein:
a) the first step involves creating a mixture by adding: capric acid, lauric acid, myristic acid, palmitic acid and stearic acid, b) the mixing of oleic acid, linoleic acid, alpha linolenic acid, gamma linolenic acid and gadoleic acid as the second step, c) a third step that involves the addition of eicosapentaenoic acid, erucic acid, docosahexaenoic acid and nervonic acid, d) a fourth step that involves the addition of limonene and menthol and, e) the addition of .beta.-pinene, camphor and cocoa butter as the fifth step in said process.

3. The use of the fatty acid formulation in claim 1 in gel or liquid capsules, fruit jellies or as part of other edible food mixtures.

4. The use of the formulation in claim 1 in daily dosage of 5 mL for the first 7 days and then thereafter a daily dosage of 10 mL.

5. The use of the fatty acid formulation in claim 1 as an additive to dairy and non-dairy products, salads, shakes and fruit and non-fruity drinks.

6. The use of the fatty acid formulation in claim 1 as a nutritional food supplement for patients of Alzheimer's, ADHD, Autism, Asperger's, Stroke, and cardiovascular diseases.

7. The use of the formulation in claim 6 in daily dosage of 10 mL for the first 7 days and then thereafter a daily dosage of 20 mL.

8. The use of the formulation of claim 1 for treating high cholesterol levels and/or high blood pressure in humans.

9. The use of the formulation in claim 8 in daily dosage of 10 mL for the first 7 days and then thereafter a daily dosage of 20 mL.

10. The use of the formulation of claim 1 as a topical application on people with skin inflammation and/or rashes in humans.