Note: Descriptions are shown in the official language in which they were submitted.
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ADVANCED VITAMIN C-BASED COMPOSITION WITH ENHANCED
BIOTRANSFORMATION AND UTILIZATION OF PROTEIN AND
L-CARNITINE FOR NUTRITIONAL SUPPLEMENTATION OR THE LIKE
By
William Feinstein, Ph.D.
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This Application is based on U.S. Provisional Application Serial No.
60/578,765, filed on June 9, 2004, the disclosure of which is incorporated by
reference herein in its entirety.
FIELD OF THE INVENTION
The present invention relates generally to healthcare products and, more
particularly, to an improved nutritional supplement and method of using the
same.
BACKGROUND OF THE INVENTION
Conventional nutritional supplements usually comprise a mixture of vitamins
and minerals in dosages set according to USDA minimum daily nutritional
requirements. While these supplements may be suitable for some, what is often
necessary for providing adequate nutrition and concomitant energy boost
typically
varies from one person to the next, and depends on their body mass, age,
biochemical
makeup and other considerations. These considerations have, in turn, prompted
the
development of a plethora of vitamin and nutritional concoctions that not only
provide
much needed vitamins and minerals, but also Proteins and other constituents
intended
to enhance health and generally make the user feel "good". Again, however,
while
useful for some, others need more, or in some cases less, of the particular
ingredients,
the ingestion of which, at a minimum, may be unnecessary.
Of particular concern has been the general health and nutritional needs of
patients during hospitalization, after surgery and/or during relatively long
periods of
bed rest, as well as people generally in their later years of life. Patients,
for instance,
have not only been found to experience considerably lower energy levels and
general
fatigue, but are also known to lose considerable muscle tone during bed rest
and to
suffer other health detriments characteristic of long periods of inactivity or
diminished
activity.
Accordingly, a nutritional supplement is desired having key ingredients that
are not only readily available, affordable, and manufacturable, but are also
provided
in concentrations that are highly effective for improving the overall health,
comfort,
vitality, well being, strength and stamina of individuals in need of key
nutritional
supplements. Such supplement would be particularly desirable for
administration to
persons including, but not limited to: (i) older individuals; (ii) individuals
having no
CA 02514687 2005-09-07
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or relatively low levels of activity, such as patients under treatment in
hospitals and/or
other healthcare institutions, or under medical supervision and/or outpatient
care; (iii)
individuals in need of nutritional supplementation, such as athletes and
pregnant
women; and (iv) patients suffering from wounds and/or diseases, including
kidney
failure.
Also desirable is a nutritional supplement that is relatively easy to
administer
and eliminates the ingestion of unnecessary vitamins and minerals as well as
other
substances and additives characteristic of conventional nutritional
supplements.
OB.1ECTS AND SUMMARY OF THE INVENTION
According to one aspect of the present invention, a nutritional supplement is
provided which comprises a selected source of Vitamin C, in mixture, with (i)
a
selected Protein source comprising essential amino acids, or (ii) a selected
source of
L-Carnitine, or (iii) a mixture of (i) and (ii).
According to another aspect of the present invention, a nutritional supplement
is provided which comprises at least a selected source of Vitamin C in mixture
with a
selected source of Protein.
In accordance with a further aspect of the present invention, a nutritional
supplement is provided which comprises at least a selected source of Vitamin C
in
mixture with a selected source of L-Carnitine.
According to yet another aspect of the present invention, a nutritional
supplement is provided which comprises Vitamin C, in mixture, with (i)
Hydrolyzed
Collagen Protein, or (ii) L-Carnitine, or (iii) a mixture of (i) and (ii).
In accordance with another aspect of the present invention, a nutritional
supplement is provided which comprises at least Vitamin C in mixture with
Hydrolyzed Collagen Protein.
According to still another aspect of the present invention, a nutritional
supplement is provided which comprises at least Vitamin C in mixture with L-
Carnitine.
In accordance with a further aspect of the present invention, a nutritional
supplement is provided which comprises Vitamin C generally within a range of
100
milligrams and 5000 milligrams, in mixture, with:
(i) a selected Protein source having essential amino acids generally within a
range of 1 gram and 150 grams; or
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(ii) L-Carnitine generally within a range of 100 milligrams and 5000
milligrams; or
(iii) a mixture of (i) and (ii).
Another aspect of the present invention relates to a nutritional supplement
which comprises Vitamin C, or a source thereof, generally within a range of
250
milligrams and 5000 milligrams, in mixture, with:
(i) a selected Protein source having essential amino acids generally within a
range of 1 gram and 150 grams; or
(ii) L-Carnitine, or a source thereof, generally within a range of 100
milligrams and 5000 milligrams; or
(iii) a mixture of (i) and (ii).
According to still a further aspect of the present invention, a nutritional
supplement is provided which comprises Vitamin C generally within a range of
250
milligrams and 1500 milligrams, in mixture, with:
(i) Hydrolyzed Collagen Protein generally within a range of 7.5 grams and 45
grams; or
(ii) L-Carnitine generally within a range of 500 milligrams and 3000
milligrams; or
(iii) a mixture of (i) and (ii).
In accordance with a yet another aspect of the present invention, a
nutritional
supplement is provided which comprises, in an aqueous-based mixture, a
selected
source of Vitamin C with (i) one or more selected Protein sources having
essential
amino acids, or (ii) a selected source of L-Carnitine, or (iii) a mixture of
(i) and (ii).
According to another aspect of the present invention, a nutritional supplement
is provided which comprises, in a non-aqueous-based mixture, a selected source
of
Vitamin C with (i) one or more selected Protein sources having essential amino
acids,
or (ii) a selected source of L-Carnitine, or (iii) a mixture of (i) and (ii).
In accordance with a further aspect of the present invention, a nutritional
supplement is provided, in tablet form, which comprises a selected source of
Vitamin
C and (i) a selected source of L-Carnitine, and/or (ii) one or more selected
Protein
sources having essential amino acids.
According to still another aspect of the present invention is a nutritional
supplement, in gel capsule form, which comprises a selected source of Vitamin
C and
CA 02514687 2005-09-07
(i) a selected source of L-Carnitine, and/or (ii) one or more selected Protein
sources
having essential amino acids.
In accordance with a yet another aspect of the present invention, a
nutritional
supplement is provided which comprises, in a skin patch, a selected source of
Vitamin
5 C and (i) a selected source of L-Carnitine, and/or (ii) one or more selected
Protein
sources having essential amino acids.
According to a further aspect of the present invention, a nutritional
supplement
is provided which comprises, in a powder for reconstitution, a selected source
of
Vitamin C and (i) a selected source of L-Carnitine, and/or (ii) one or more
selected
Protein sources having essential amino acids.
According to another aspect of the present invention, a nutritional supplement
is provided which comprises, in a nutritional bar or other food, a selected
source of
Vitamin C and (i) a selected source of L-Carnitine, and/or (ii) one or more
selected
Protein sources having essential amino acids.
According to still another aspect of the present invention, a nutritional
supplement is provided which comprises, in mixture, Vitamin C and soy protein
and/or L-Carnitine.
In accordance with yet another aspect of the present invention, a nutritional
supplement is provided which comprises, in mixture, Vitamin C and L-Carnitine
and/or a selected Protein source having essential amino acids.
According to yet a further aspect of the present invention, there is provided
a
method of treatment of a patient through administration of a nutritional
supplement
which comprises at least about 250 milligrams of Vitamin C, in mixture, with
(i) a
selected source of L-Carnitine, and/or (ii) a selected Protein source
comprising
essential amino acids.
According to still a further aspect of the present invention is a method of
treatment using a nutritional supplement. The method comprises the steps of
dispensing to a patient a does, e.g., daily, of between about 15 and about 60
milliliters
of an aqueous-based liquid containing dissolved concentrations of between
about 250
milligrams and about 5000 milligrams of Vitamin C and (i) between about 100
and
about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and
about 150
grams of a Hydrolyzed Collagen Protein.
In accordance with a further aspect of the present invention is a method of
treatment using a nutritional supplement. The method comprises the steps of
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dispensing to a patient a dose, e.g., daily, of between about 15 and about 90
milliliters
of an aqueous-based liquid containing dissolved concentrations of between
about 250
milligrams and about 5000 milligrams of Vitamin C and (i) between about 100
and
about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and
about 150
grams of a Hydrolyzed Collagen Protein.
Yet another aspect of the present invention is a method of treatment using a
nutritional supplement, the method comprising the step of dispensing to a
patient a
dose, e.g., daily, of between about 15 and about 60 milliliters of a non-
aqueous-based
liquid containing dissolved concentrations of between about 250 milligrams and
about
5000 milligrams of Vitamin C and (i) between about 100 and about 5000
milligrams
of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a
Hydrolyzed Collagen Protein.
Still another aspect of the present invention is a method of treatment using a
nutritional supplement, the method comprising the step of dispensing to a
patient a
dose, e.g., daily, of between about 15 and about 90 milliliters of a non-
aqueous-based
liquid containing dissolved concentrations of between about 250 milligrams and
about
5000 milligrams of Vitamin C and (i) between about 100 and about 5000
milligrams
of L-Carnitine, and/or (ii) between about 1 gram and about 150 grams of a
Hydrolyzed Collagen Protein.
A further aspect of the present invention concerns a method of treatment using
a nutritional supplement, the method comprising the step of dispensing to a
patient, in
tablet form, a dose, e.g., daily, of the supplement including between about
250
milligrams and about 5000 milligrams of Vitamin C and (i) between about 100
and
about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram and
about 150
grams of a Hydrolyzed Collagen Protein.
In accordance with still another aspect of the present invention is a method
of
treatment using a nutritional supplement, the method comprising the step of
dispensing to a patient, in gel capsule form, a dose, e.g., daily, of the
supplement
including between about 250 milligrams and about 5000 milligrams of Vitamin C
and
(i) between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii)
between
about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
An additional aspect of the present invention relates to a method of treatment
using a nutritional supplement, the method comprising the step of dispensing
to a
patient, in skin patch form, a dose, e.g., daily, of the supplement including
between
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about 250 milligrams and about 5000 milligrams of Vitamin C and (i) between
about
100 and about 5000 milligrams of L-Carnitine, and/or (ii) between about 1 gram
and
about 150 grams of a Hydrolyzed Collagen Protein.
Still a further aspect of the present invention relates to a method of
treatment
using a nutritional supplement, the method comprising the step of dispensing
to a
patient, in a powder for reconstitution, a dose, e.g., daily, of the
supplement including
between about 250 milligrams and about 5000 milligrams of Vitamin C and (i)
between about 100 and about 5000 milligrams of L-Carnitine, and/or (ii)
between
about 1 gram and about 150 grams of a Hydrolyzed Collagen Protein.
A supplemental aspect of the present invention is directed to a method of
treatment using a nutritional supplement, the method comprising the step of
dispensing to a patient, in a nutritional bar or other food, a dose, e.g.,
daily, of the
supplement including between about 250 milligrams and about 5000 milligrams of
Vitamin C and (i) between about 100 and about 5000 milligrams of L-Carnitine,
and/or (ii) between about 1 gram and about 150 grams of a Hydrolyzed Collagen
Protein.
Yet a further aspect of the present invention relates to a nutritional
supplement
and method of treatment using the same, the supplement comprising Vitamin C,
in
mixture, with L-Carnitine and/or one or more selected proteins in selected
proportions
so as to provide a synergistic effect and, thereby, optimize their
biotransformation and
utilization in the body.
Accordingly, it is an object of the present invention to provide a nutritional
supplement that is highly effective for improving the overall health, comfort,
vitality
and well being of patients under treatment in hospitals and others in need of
nutritional aid.
Another object of the present invention is to accommodate the general health
and nutritional needs of patients during hospitalization, after surgery and/or
during
relatively long periods of bed rest.
A further object of the present invention is to provide a nutritional
supplement
particularly well suited for people generally in their later years of life.
Still another object of the present invention is to provide a nutritional
supplement that is not only suitable for health maintenance of athletes, but
is also
appropriate for pregnant women as well as highly active professionals in need
of
additional nutrition.
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g
Yet another object of the present invention is to counteract the considerably
lower energy levels and fatigue suffered by patients during hospitalization.
Still a further object of the present invention is to provide a nutritional
supplement that maintains and improves muscle tone and prevents numerous
health
detriments characteristic of long periods of inactivity or diminished
activity.
Another object of the present invention is to provide a nutritional supplement
having only those ingredients essential for improving overall health, comfort,
vitality,
well being, strength and stamina.
Still another object of the present invention is to provide a nutritional
supplement for general wellness that eliminates unnecessary vitamins and
minerals as
well as other substances and additives characteristic of conventional
supplements.
Yet another object of the present invention is to provide a nutritional
supplement having only ingredients considered necessary for improving overall
health, comfort, vitality, well being, strength and stamina of a patient and
only in
those concentrations suitable for providing such effects over a wide range of
individuals.
Still a further object of the present invention is to provide a novel
nutritional
supplement having a minimal number of ingredients that are not only readily
available
and affordable, but also economical to manufacture in forms that are
convenient to
administer and effective for nutritional absorption.
Another object of the present invention is to provide an enhanced nutritional
supplement and method of treatment using the same that is efficient, effective
and
economical.
A further object of the present invention is to provide a novel nutritional
supplement in liquid form comprising a mixture of Hydrolyzed Collagen Protein
or
other Protein source having essential amino acids, L-Carnitine, and Vitamin C
for
improving the overall health, comfort, vitality, well being, strength and
stamina of a
patient.
Yet a further object of the present invention is to provide a novel
nutritional
supplement in tablet or gel capsule form comprising a mixture of Hydrolyzed
Collagen Protein or other Protein source having essential amino acids, L-
Carnitine,
and Vitamin C for improving the overall health, comfort, vitality, well being,
strength
and stamina of a patient.
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Another object of the present invention is to provide a novel nutritional
supplement in a skin patch, a powder for reconstitution, nutritional bar or
other food
comprising a mixture of Hydrolyzed Collagen Protein or other Protein source
having
essential amino acids, L-Carnitine, and Vitamin C for improving the overall
health,
comfort, vitality, well being, strength and stamina of a patient.
Yet another object of the present invention is to provide a nutritional
supplement for preventing and/or countering the effects of Alzheimer's
Disease,
Chronic Fatigue Syndrome (CFS), Chronic Kidney Disease, Chronic Muscle
Myopathy, Connective Tissue Diseases, Diabetes Mellitus, Dialysis, Dieting,
Epilepsy, Heart Diseases, Immune Deficiency, Muscle Atrophy, Old Age, Renal
Insufficiency and Stroke.
Another object of the present invention is to lower healthcare costs by
improving patient care, decreasing the length of stay of patients in the
hospital,
allocation of nursing hours as well as the rate of re-hospitalization,
decreasing the
duration of ventilator dependence and the need for physical therapy, lessening
the use
of curative medications, such as antibiotics, and the use of dressing and skin
care
products for wound healing, and, thereby, lowering healthcare costs.
Still other objects and advantages of the present invention will become
apparent from the following description of the preferred embodiments.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
One of the most important nutrients for maintaining good health and vitality
is
Protein. Proteins are a primary requirement for growth and development of all
body
tissues. They are also essential for healthy brain tissue, hair, skin and
nails. Although
critical, Proteins are not normally consumed for energy by the human body when
adequate levels of fats and carbohydrates are present.
Proteins are relatively large complex molecules that must be broken down into
individual components, commonly known as peptides and amino acids, before they
can be absorbed and utilized by the body. This process typically occurs in the
digestive tract and is the result of a certain enzyme action referred to as
hydrolysis.
Put another way, Proteins are "hydrolyzed" during digestion into their
components,
namely, peptides and amino acids.
Notably, when the body breaks down Protein, waste products are produced
that build up in the blood and become harmful. Healthy kidneys or an
artificial
CA 02514687 2005-09-07
kidney, as in kidney dialysis, draw these wastes out of the body to prevent
serious
medical complications.
However, without adequate dietary Proteins, the human body cannot produce
sufficient antibodies to defend itself against disease organisms, thereby
lowering the
5 body's overall resistance to disease and increasing chances for infection.
In addition,
absent sufficient Proteins, the liver cannot manufacture enough plasma
Proteins to
maintain a requisite fluid balance in the blood and tissues. Muscle breakdown
and
weakness are also known to occur. Proper Protein intake and nutrition are,
therefore,
important both to the quality and length of life.
10 In addition, it has been found, there are long-term consequences of Protein
deficiency on patient care, including: increased duration of hospitalization,
especially
in intensive care units, as well as increased rate of re-hospitalization;
increased length
of ventilator dependence, need for physical therapy and allocation of nursing
hours;
and increased consumption of curative medications, such as antibiotics, and
use of
dressing and skin care products for wound healing. The net result has been
increased
healthcare costs.
As for sources of Protein, while the nature of the Protein source may not be
critical, it is considered important that essential amino acids be provided.
Such amino
acids include, but are not limited to, L-arginine, L-histidine, L-isoleucine,
L-leucine,
L-lysine, L-methionine, L-phenylalanine, L-threonine, L-valine and mixtures
thereof.
Such Protein source may comprise, for example, soy protein.
Of particular interest as a Protein source is Hydrolyzed Collagen Protein.
Hydrolyzed Collagen Protein is a type of Protein found in virtually all organs
of the
body, it being the most prevalent Protein in the human body. Predominantly, it
is
found in the skin, nails, ligaments and bones. Hydrolyzed Collagen Protein is
essentially a connective tissue substance. In other words, it is the "cement"
that holds
everything together. Hydrolyzed Collagen Protein, along with Elastin, are
considered
the key structural components of bones, cartilage, tendons, skin, lung tissue
and blood
vessels. Specifically, Hydrolyzed Collagen Protein provides the structure and
firmness to body tissues, whereas Elastin is largely responsible for their
flexibility.
Hydrolyzed Collagen Protein has many known benefits such as aiding the
formation and maintenance of bones, skin and cartilage, and maintenance of
healthy
joints and tendons. Another advantage is that it assists in tissue repair
following
CA 02514687 2005-09-07
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injury and facilitates healing wounds. It is also useful for muscle spasticity
problems
and is considered extremely important in brain metabolism.
Another important nutrient is L-Carnitine. While found naturally in the body
in relatively small quantities, L-Carnitine is a vitamin-like nutrient which
maintains
normal life functions including energy production and the metabolism of fat.
It is also
known for supporting healing of many health disorders and generally improving
the
quality of life.
Since the cardiac muscle derives its energy primarily through oxidation of
fatty acids, L-Carnitine is particularly important for nourishment of the
heart. In fact,
L-Carnitine supplements have been shown to strengthen the heart and increase
cardiac
output. In addition, L-Carnitine has been shown to increase muscle tissue
strength
and endurance. It is also well regarded not only for enhancing liver function
including improvement of the liver's fat burning process, but also for
increasing
Protein synthesis. L-Carnitine has even been shown to slow the aging process
and to
improve cognitive abilities such as concentration, memory and the ability to
learn.
Consequences of L-Carnitine deficiency include hepatic enzyme derangement
and increased risk of fatty liver, severe hypoglycemia, weakness, and risk of
electrolyte imbalances, and hypertriglyceridemia including a risk of severe
acute
pancreatitis.
Turning now to perhaps the best known nutritional supplement, Vitamin C is
uniquely important to the health and well-being of humans. It plays a key role
as a
component of enzymes involved in the natural synthesis of collagen and L-
Carnitine
in the body. Possibly the most important role of Vitamin C is in the
maintenance of a
healthy immune system. Specifically, Vitamin C stimulates the immune system
and
protects against damage by free radicals released by the body in its fight
against infec-
tion. Medical research has shown that people who suffer from asthma,
arthritis,
cancer, diabetes, and heart disease have much lower levels of Vitamin C in
their blood
than do healthy people. It has also been determined that Vitamin C supplements
significantly lower the risk of cataracts and glaucoma.
Vitamin C deficiency, in turn, results in increased risk of skin breakdown,
prolonged wound healing time, decreased response to and, hence, prolonged
duration
of infection, iron-deficiency anemia, bleeding gums and other dental problems.
It has been found that Vitamin C also plays a key role as a component of
enzymes involved in the biosynthesis and utilization of both collagen and L-
Carnitine
CA 02514687 2005-09-07
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in the body. When small amounts of carnitine and/or Protein are ingested, some
utilization of these materials takes place in the body. However, when large
amounts
of carnitine and/or Protein are ingested without Vitamin C or in the presence
of low
levels of Vitamin C, much of the carnitine and/or Protein are not utilized by
the body
and are wasted. For example, it is known that in the absence of Vitamin C
supplementation, there are instances wherein proper collagen fibers are not
formed in
the body. This may account for the varying clinical results in human clinical
trials for
these materials as reported in the literature. However, it has surprisingly
been found
that when relatively large amounts of carnitine and/or Protein are ingested in
the
presence of sufficient amounts of Vitamin C, the body is able to efficiently
convert
the carnitine and/or Protein through its collagen and/or carntine building
enzyme
systems into many compounds/compositions useful in the body. Furthermore, in
addition to its role in potentiating the biotransformation of Protein and/or
carnitine,
Vitamin C potentiates the bioabsorption of Protein and/or carnitine.
The foregoing description is provided for purposes of illustration and not to
limit the intended content or application of the present invention. The
remaining
aspects of the structure, function and chemistry of the foregoing are
considered
known by those skilled in the art and further description is considered
unnecessary for
illustration of the present invention.
Referring now to the present invention with greater particularity including,
but
not limited to, its constituents, dosages, manner of use and/or treatment, a
nutritional
supplement is provided having, according to one embodiment of the present
invention, enhanced Vitamin C fortified with Hydrolyzed Collagen Protein (or
Protein
Hydrolysate) and/or L-Carnitine for nutritional supplementation. At the kernel
of the
present invention is a relatively high concentration of Vitamin C formulated
with
essential amino acids and/or L-Carnitine so as to optimize the uptake of
Vitamin C, L-
Carnitine and Protein by the body. Generally speaking, Vitamin C is considered
to be
an essential constituent of the present invention.
In one embodiment, a nutritional supplement is provided which comprises,
preferably in an aqueous-based mixture, Vitamin C or a selected source of
Vitamin C
generally within a range of 250 milligrams and 1500 milligrams and (i) a
selected
source of L-Carnitine generally within a range of 500 milligrams and 3000
milligrams, and/or (ii) a selected source of Proteins) having essential amino
acids,
such source containing Proteins generally within a range of 7.5 grams and 45.0
grams.
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13
Suitable sources of Vitamin C that have been found acceptable include, but are
not limited to, Ascorbic Acid, Sodium Ascorbate, Calcium Ascorbate, as well as
any
salt or ester of Ascorbic Acid. Sources of L-Carnitine, for example, include,
but are
not limited to, L- Acetyl L-Carnitine, L-Carnitine Fumarate, L-Carnitine L-
Tartrate,
L-Carnitine HCL, and/or any salt or ester of L-Carnitine and mixtures thereof.
Of
particular interest and preferred, according to various aspects of the present
invention,
is the use of Hydrolyzed Collagen Protein.
In general, the composition preferably contains Vitamin C, for example, in
bulk powder form as sold by Royal DSM N.V., in sufficient quantities such that
a
daily dose of the composition contains at least about 250 milligrams of
Vitamin C.
Alternatively or concurrently, the composition contains between about 250 and
about
5000 milligrams of Vitamin C. According to another embodiment, the composition
of
the present invention contains Vitamin C in quantities generally within a
range of 250
and 3000 milligrams. It has been found that a daily dose containing between
about
250 and about 1500 milligrams of Vitamin C is optimal.
In accordance with various aspects of the present invention, namely, when the
composition contains L- Carnitine, or a source thereof, e.g., sold by Lonza
Group Ltd.
under the trade name Carnipure, in sufficient quantities such that a daily
dose of the
composition contains between about 100 and about 5000 milligrams of L-
Carnitine.
According to another embodiment, the composition of the present invention
contains
L-Carnitine or a source thereof in quantities generally within a range of 250
and 4000
milligrams. It is believed especially desirable that the daily dose contain
between
about 500 and about 3000 milligrams of L-Carnitine.
Alternatively or concurrently, when a Protein source is present, for instance,
Hydrolyzed Collagen Protein distributed by P.B. Leiner under the Polypro
label, it is
preferred that such source be in sufficient quantities that a daily dose of
the
composition, according to the present invention, will contain between about 1
gram
and about 150 grams of Protein. In another embodiment of the present
invention, the
composition contains a Protein source in sufficient quantities such that a
daily dose of
the composition contains between about 5 and about 100 grams of Protein. It is
considered particularly desirable that such daily dose contain generally
within a range
of 7.5 and 45 grams of Protein.
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14
It is preferred that compositions, in accordance with the present invention,
be
consumed by a patient in sufficient quantities and at such concentration that
the
patient's intake of the operative constituents are as follows:
Vitamin C: about 250 to about 5000 milligrams,
L-Carnitine: about 100 to about 5000 milligrams, and
Protein: about 1 to about 150 grams;
or
Vitamin C: about 250 to about 5000 milligrams, and
L-Carnitine: about 100 to about 5000 milligrams;
or
Vitamin C: about 250 to about 5000 milligrams, and
Protein: about 1 to about 150 grams.
In liquid form, desirable concentrations of the composition are such that
daily dosages
could be administered through ingestion of between about 1 and about 6
tablespoons
of such composition daily. While the present invention is described with
reference to
such selected dosages in tablespoons, it is understood that any number of
tablespoon
dosages may be utilized, giving consideration to the purpose for which the
present
invention is intended.
The present invention may be dispensed, as is, in conventional tablet or gel
capsule form, in food or a nutritional bar, or may be readily mixed with water
or other
aqueous-based liquids (e.g., orange juice, grape fruit juice, grape juice,
etc.). For
instance, in the case of a nutritional bar, a specific, illustrative
disclosure of food of
this type is provided in U.S. Patent No. 6,143,335, entitled SOLID NUTRITIONAL
FOODS AND METHODS OF MAKING THE SAME, which issued on November 7,
2000 to Russell G. McKenzie. Alternatively, the composition according to the
present invention may be mixed with non-aqueous-based liquids or dispensed in
a
conventional skin patch form in generally lower concentrations, as will be
appreciated
by those skilled in the art of skin patches. A nutritional type skin patch of
this general
description may be found, for example, in U.S. Patent No. 6,893,656, entitled
ATHLETIC PATCH, which issued on May 15, 2005 to Andrew Blitzer and Terry
Pretorius, the disclosure of which is incorporated by reference herein it its
entirety.
Further in the alternative or concurrently therewith, the composition of the
present
CA 02514687 2005-09-07
invention is distributed, for instance, in an eight (8) fluid ounce container
(236.5
milliliters), containing approximately 16 tablespoonful doses of premixed
liquid.
A further benefit of the present invention is its relatively mild taste. This
makes it readily usable with conventional flavorings such as a pleasant
tasting orange
5 flavor or the like. Its mild taste also makes it highly versatile for
addition to non-
citrus beverages, soups, gravies, sauces and other regular menu items to
increase
Protein intake when such foods can be consumed. Similarly, it is considered
suitable
for use in electrolyte restricted diets and does not contain sugar, fats,
carbohydrates,
lactose, gluten, yeast, corn, wheat starch, eggs, fish or dairy.
EXAMPLE I
A nutritional supplement formulation is provided in an aqueous-based
mixture, the supplement comprising up to about 7.S grams of Hydrolyzed
Collagen
Protein (Polypro), about S00 milligrams of L-Carnitine (Carnipure) and about
250
milligrams of Vitamin C (in bulk powder form) in a total volume of about 1S
milliliters. The supplement is dispensed in liquid form, in a dosage of one
(1) or more
tablespoons (or about a 1S milliliter equivalent or more) per day. Each liquid
tablespoon provides the following essential amino acids in the approximate
amounts
expressed in milligrams available:
L-Arginine 61
S
L-Histidine 77
L-Isoleucine 112
L-Leucine 233
L-Lysine 31
S
L-Methionine 122
L-Phenylalanine 148
L-Threonine 151
L-Valine 17S
EXAMPLE II
A nutritional supplement formulation is provided in an aqueous-based
mixture, the supplement comprising about 1S grams of Hydrolyzed Collagen
Protein,
about 1000 milligrams of L-Carnitine and about S00 milligrams of Vitamin C.
The
supplement is dispensed in liquid form, two (2) tablespoons (or about a 30
milliliter
equivalent) per day. Each liquid tablespoon provides the following essential
amino
acids (approximately in milligrams):
L-Arginine 1230
CA 02514687 2005-09-07
16
L-Histidine 155
L-Isoleucine 224
L-Leucine 466
L-Lysine 630
L-Methionine 244
L-Phenylalanine 296
L-Threonine 302
L-Valine 350
EXAMPLE III
A nutritional supplement formulation is provided in an aqueous-based
mixture. The supplement comprises about 30 grams of Hydrolyzed Collagen
Protein,
about 2000 milligrams of L-Carnitine and about 1000 milligrams of Vitamin C.
The
supplement is dispensed in liquid form, four (4) tablespoons (or about a 60
milliliter
equivalent) per day. Each liquid tablespoon provides the following amino acids
(approximately in milligrams):
L-Arginine 2460
L-Histidine 310
L-Isoleucine 448
ZO L-Leucine 932
L-Lysine 1260
L-Methionine 488
L-Phenylalanine 592
L-Threonme 604
L-V aline 700
EXAMPLE IV
A nutritional supplement formulation comprising, in an aqueous-based
mixture, about 45 grams of Hydrolyzed Collagen Protein, about 3000 milligrams
of
L-Carnitine and about 1500 milligrams of Vitamin C. The supplement is
dispensed to
a patient in liquid form, six (6) tablespoons (or about a 90 milliliter
equivalent) per
day. Each liquid tablespoon provides the following amino acids:
L-Arginine 3700
L-Histidine 470
L-Isoleucine 670
L-Leucine 1400
L-Lysine 1890
L-Methionine 730
L-Phenylalanine 890
L-Threonine 910
L-Valine 1050
CA 02514687 2005-09-07
17
Although the present invention has been shown and described in connection
with a particular Garner for treatment, i.e., in an aqueous-based mixture, it
is
understood that the composition may be in other forms, whether in a non-
aqueous-
based mixture, in tablet form, in gel capsule form, in a fluid, or other
conventional
and non-conventional method of administration, as is practicable, giving
consideration to the purpose for which the present invention is intended.
In addition, while the present invention is disclosed with reference to
particular ranges of constituents, it will be appreciated that other suitable
ranges of
ingredients may be utilized, giving consideration to the purpose for which the
present
invention is intended. For example, although the invention is described as
containing
constituents in relatively high potency levels such as Vitamin C generally
within a
range of 250 milligrams and 5000 milligrams, other suitable ranges, e.g.,
between
about 100 milligrams and about 1000 milligrams of Vitamin C, may also be used,
within the spirit and scope of the present invention.
By one embodiment, the present invention is provided as a powder for
reconstitution prior to administration. For instance, the three active
ingredients, i.e.,
Protein, L-Carnitine and Vitamin C, are prepared in powder form and blended
generally uniformly with selected natural or synthetic conventional
flavorings) and a
conventional sweetener, e.g., non-caloric, also in powder form. The resulting
uniform
powder mix is then packaged in a canister or conventional foil or foil
laminate packet
and sealed. The packet preferably contains product information, batch number
information, and the expiration date of the powder.
In use, a patient or healthcare professional simply tears the packet open,
adds
the powder contents to an appropriate liquid (e.g., water, juice, milk or the
like), stirs
the same to a uniform blend, and then drinks (or otherwise administers) the
liquid.
Alternatively, such as in the case when the patient is unable to feed himself
or herself,
an appropriate conventional liquid carrier containing the active ingredients
of the
present invention is used as a transfer medium to be dispensed to the patient
through a
suitable feeding tube.
According to one aspect of the present invention, the nutritional supplement
described is particularly useful for providing extra Protein to persons having
increased
Protein needs or for patients who are unable to meet their daily Protein needs
with a
normal diet. Such patients include those requiring pre- or post-operative
Protein
CA 02514687 2005-09-07
18
supplementation or nutritional support during cancer therapy; those suffering
from
chronic kidney disease, in severe burn conditions, and those patients
requiring
increased Protein due to excessive Protein loss such as in stress and trauma
conditions.
More particularly, patients suffering from chronic kidney disease with renal
insufficiency have higher needs for increased Protein, L-Carnitine and Vitamin
C
intake. Unfortunately, when there are increased requirements for Proteins, L-
Carnitine and Vitamin C, their customary supply through normal dietary intake,
it has
been found, is not necessarily sufficient in such extreme conditions. In
addition,
during altered state conditions, the human body's synthesis process for
Proteins and
L-Carnitine often does not deliver the requisite synthesized amounts to
guarantee the
levels required for maintaining vitality.
The ingredients of the present invention have been proven clinically to
rejuvenate muscles using the synergy from nutrients known to enhance cell
function.
Each nutrient enhances a different aspect of cell function and, together, they
support
muscle, not fat. In this manner, the patient's body receives the "energy" edge
it needs
without side effects. It also provides the nutritional building blocks a
patient needs to
fight muscle loss and build a more muscular body.
Accordingly, the present invention is an ideal nutritional supplement to oral
and tube-fed enteral administered products for patients that require Protein
supple
mentation for a particular clinical condition. It is also useful generally as
a highly
effective first line of defense or as a support to other therapies as a first
step in
wellness.
Overall, the present invention advantageously provides concentrated Protein
supplementation in a unique formula including L-Carnitine along with other
essential
amino acid nutrients, and Vitamin C. It is formulated so as to be easily
digestible and,
therefore, rapidly absorbed to enhance delivery of its nutritionally balanced
contents.
In this manner, Amino Acids, L-Carnitine and Vitamin C, which are all
important for
good nutritional health and well-being, are now available in a unique,
concentrated
dose that is easy to administer, safe and non-toxic.
In this manner, relatively high levels of therapeutic ingredients are provided
in
a synergistic formulation at concentrations which optimize the body's function
and
utilization of each of these ingredients.
CA 02514687 2005-09-07
19
In addition, the present invention provides numerous additional beneficial
features including, but not limited to, a composition that is rapidly absorbed
by the
body in solution, easily digestible such that the amino acid constituents are
readily
available for absorption, and is well-tolerated by the body with no known side
effects,
such as diarrhea. Moreover, the composition according to the present invention
is
formulated such that it is ready to use with no premixing required by the
user, with a
relatively small dosage, concentrated solution being provided (e.g., 2
tablespoons =
grams of Protein), that also contains an active form of L-Carnitine.
Furthermore, in solution, the present invention prepared for non-oral
10 administration will not clog patient feeding tubes, has zero carbohydrates,
contains no
fats, sugar, or phosphorus, and is both lactose free and gluten free.
Beneficially, the
solution is also pleasant tasting and can be formulated in a wide range of
concentrations.
Medical conditions and user groups believed to derive particular benefit from
1S use of the above-described compositions, in accordance with the present
invention,
include, but are not limited to: muscle atrophy, weakness, disease including
muscular
dystrophy and ALS, general fatigue and poor endurance; diabetes mellitus;
kidney
disease and nutritional deficiencies resulting from dialysis; nutritional
deficiencies
resulting from dieting; lipid abnormalities such as elevated cholesterol
and/or
triglyceride levels; liver disease; atherosclerosis/heart disease, namely,
ischemic heart
disease, angina pectoris, and cardiac arrhythmias; immune diseases, suppressed
immune system; obesity; burn injuries; Crohn's disease; decubitus ulcers;
connective
tissue/joint-related diseases including arthritis and sports injuries;
individuals on total
parenteral nutrition; anemia (by enhancing absorption of ferrous sulfate, and
when
used in conjunction with Epoetin Alfa therapy, can lead to higher levels of
hemoglobin and hematocrit); pancreatic; peri-operative patients; and
developmentally
delayed babies and children. The present invention may also be used to aid in
the
healing of wounds and to provide a nutritional supplement for preventing
and/or
countering the effects of Alzheimer's Disease, Chronic Fatigue Syndrome (CFS),
Chronic Muscle Myopathy, Connective Tissue Diseases, Epilepsy and Stroke.
Additionally, use of the present invention will further lower healthcare costs
by improving patient care, decreasing the length of stay of patients in the
hospital,
allocation of nursing hours as well as the rate of re-hospitalization,
decreasing the
duration of ventilator dependence and the need for physical therapy, lessening
the use
CA 02514687 2005-09-07
of curative medications, such as antibiotics, and the use of dressing and skin
care
products for wound healing and, thereby, lower healthcare costs.
Various modifications and alterations to the present invention may be
appreciated based on a review of this disclosure. These changes and additions
are
5 intended to be within the scope and spirit of this invention as defined by
the following
claims.
