Note: Descriptions are shown in the official language in which they were submitted.
CA 02800438 2016-10-18
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
1
CA 02800438 2016-10-18
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
CA 02800438 2016-10-18
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
A8102 AB 112 AR 113 A8114 A11115
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
CA 02800438 2016-10-18
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).
FB 112 CB 110 CB 111 CB 113 AB 102 A3112
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
8 3
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
CA 02800438 2016-10-18
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
CA 02800438 2016-10-18
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
6
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
7
CA 2800438 2018-03-12
CA 02800438 2016-10-18
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
8
CA 02800438 2016-10-18
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.
9
CA 02800438 2016-10-18
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.
CA 02800438 2016-10-18
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.
11
CA 02800438 2016-10-18
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.
F106
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.
12
CA 02800438 2016-10-18
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.
13
CA 02800438 2016-10-18
References
Bourre JM. 2004. Roles of unsaturated fatty acids (especially omega-3 fatty
acids) in the
brain at various ages and during ageing. J. Nutr. Health Aging. 8(3):163-74.
Burns TA, Duckett SK, Pratt SL, Jenkins TC. 2012. Supplemental palmitoleic
(C16:1 cis-
9) acid reduces lipogenesis and desaturation in bovine adipocyte cultures. J.
Anim. Sci.
90(10):3433-41.
Calder PC. 2001. Polyunsaturated fatty acids, inflammation, and immunity.
Lipids.
36(9):1007-24.
Chong YH and Ng TK. 1991. Effects of palm oil on cardiovascular risk. Med. J.
Malaysia. 46(1):41-50.
Conquer JA, Tierney MC, Zecevic J, Bettger WJ, Fisher RH. 2000. Fatty acid
analysis of
blood plasma of patients with Alzheimer's disease, other types of dementia,
and
cognitive impairment. Lipids. 35(12):1305-12.
Cunnane SC, Schneider JA, Tangney C, Tremblay-Mercier J, Fortier M, Bennett
DA,
Morris MC. 2012. Plasma and brain fatty acid profiles in mild cognitive
impairment and
Alzheimer's disease. J. Alzheimers Dis. 29(3):691-7.
Edem DO. 2002. Palm oil: biochemical, physiological, nutritional,
hematological, and
toxicological aspects: a review. Plant Foods Hum. Nutr. 57(3-4):319-41.
El-Ansary AK, Bacha AG, Al-Ayahdi LY. 2011. Plasma fatty acids as diagnostic
markers
in autistic patients from Saudi Arabia. Lipids Health Dis. 21(10):62.
Elson CE. 1992. Tropical oils: nutritional and scientific issues. Grit. Rev.
Food Sci. Nutr.
31(1-2):79-102.
Hayatullina Z, Muhammad N, Mohamed N, Soelaiman IN. 2012. Virgin coconut oil
supplementation prevents bone loss in osteoporosis rat model. Evid. Based
Complement Alternat . Med. 2012:237236.
14
CA 02800438 2016-10-18
Kankaanpaa P, SUtas Y, Salminen S, Lichtenstein A, lsolauri E. 1999. Dietary
fatty
acids and allergy. Ann. Med. 31(4):282-7.
Khan MM, Evans DR, Gunna V, Scheffer RE, Parikh W, Mahadik SP. 2002. Reduced
erythrocyte membrane essential fatty acids and increased lipid peroxides in
schizophrenia at the never-medicated first-episode of psychosis and after
years of
treatment with antipsychotics. Schizophr. Res. 58(1):1-10.
Martinez M. and Mougan I. 1998. Fatty acid composition Acid Composition of
Human
Brain Phospholipids during normal development. J. of Neurochem. 71(6):2528-
2533.
Milte CM, Parletta N, Buckley JD, Coates AM, Young RM, Howe PR. 2012.
Eicosapentaenoic and docosahexaenoic acids, cognition, and behavior in
children with
attention-deficit/hyperactivity disorder: a randomized controlled trial.
Nutrition. 28(6):670-
7.
Nevin KG, Rajamohan T. 2004. Beneficial effects of virgin coconut oil on lipid
parameters and in vitro LDL oxidation. Olin. Biochem. 37(9):830-5.
Oguntibeju, 00, Esterhuyse, AJ, Truter, EJ. 2009. Red palm oil: nutritional,
physiological and therapeutic roles in improving human wellbeing and quality
of life. Br.
J. Biomed. Sci. 66(4):216-22.
Patil V.S. and Magar NG. 1960. Fatty Acids of Human Blood. 74:427-429
Patterson E, Wall R, Fitzgerald GE, Ross RP, Stanton C. 2012. Health
implications of
high dietary omega-6 polyunsaturated Fatty acids. J. Nutr. Metab. 2012:539426.
Peet M, Laugharne J, Rangarajan N, Horrobin D, Reynolds G. 1995. Depleted red
cell
membrane essential fatty acids in drug-treated schizophrenic patients. J.
Psychiatr. Res.
29(3):227-32.
Peet M, Laugharne JD, Mellor J, Ramchand ON. 1996. Essential fatty acid
deficiency in
erythrocyte membranes from chronic schizophrenic patients, and the clinical
effects of
dietary supplementation. Prostaglandins Leukot Essent Fatty Acids. 55(1-2):71-
5.
CA 02800438 2016-10-18
Phillips C, Lopez-Miranda J, Perez-Jimenez F, McManus R, Roche HM. 2006.
Genetic
and nutrient determinants of the metabolic syndrome. Curr. Opin. Cardiol.
21(3):185-93.
Ravnskov U. 1998. The questionable role of saturated and polyunsaturated fatty
acids in
cardiovascular disease. J. Clin. Epidemiol. 51(6):443-60.
Richardson AJ, Burton JR, Sewell RP, Spreckelsen TF, Montgomery P. 2012.
Docosahexaenoic Acid for Reading, Cognition and Behavior in Children Aged 7-9
Years: A Randomized, Controlled Trial (The DOLAB Study). PLoS One.
7(9):e43909.
Roche HM. 2004. Dietary lipids and gene expression. Biochem. Soc.Trans.
32(6):999-
1002.
Roche HM, Phillips C, Gibney MJ. 2005. The metabolic syndrome: the crossroads
of
diet and genetics. Proc. Nutr. Soc. 64(3):371-7.
Simopoulos AP. 2008. The importance of the omega-6/omega-3 fatty acid ratio in
cardiovascular disease and other chronic diseases. Exp. Biol. Med. 233(6):674-
88.
Simopoulos AP. 2002. The importance of the ratio of omega-6/omega-3 essential
fatty
acids. Biomed. Pharmacother. 56(8):365-79.
Saifer A and Ldman L.1961.The free fatty acids bound to human serum albumin.
J.
Lipid Research. Volume 2: 3.
Sala-Vila A, Miles EA, Calder PC. 2008. Fatty acid composition abnormalities
in atopic
disease: evidence explored and role in the disease process examined. Clin.
Exp.
Allergy. 38(9):1432-50.
Sorgi PJ, Hallowell EM, Hutchins HL, Sears B. 2007. Effects of an open-label
pilot study
with high-dose EPA/DHA concentrates on plasma phospholipids and behavior in
children with attention deficit hyperactivity disorder. Nutr. J. 13(6):16.
Svennerholm, L. 1998. Distribution and fatty acid composition of
phosphoglycerides in
normal human brain. J. Lipid Research. 9:570-579.
Tamiji J, Crawford DA. 2010. The neurobiology of lipid metabolism in autism
spectrum
16
CA 02800438 2016-10-18
disorders. Neu rosig nals. 18(2):98-112.
Tourtas T, Birke MT, Kruse FE, Welge-Lussen UC, Birke K. 2012. Preventive
effects of
omega-3 and omega-6 Fatty acids on peroxide mediated oxidative stress
responses in
primary human trabecular meshwork cells. PLoS One. 7(2):e31340.
Yui K, Koshiba M, Nakamura S, Kobayashi Y. 2012. Effects of large doses of
arachidonic acid added to docosahexaenoic acid on social impairment in
individuals with
autism spectrum disorders: a double-blind, placebo-controlled, randomized
trial. J. Clin.
Psychopharmacol. 32(2):200-6.
17
