U.S. patent application number 12/917237 was filed with the patent office on 2011-02-24 for dietary supplement and method for the treatment of digestive tract ulcers in equines.
Invention is credited to Peter M. J. Bedding, Franklin L. Pellegrini.
Application Number | 20110045107 12/917237 |
Document ID | / |
Family ID | 33416936 |
Filed Date | 2011-02-24 |
United States Patent
Application |
20110045107 |
Kind Code |
A1 |
Bedding; Peter M. J. ; et
al. |
February 24, 2011 |
Dietary Supplement and Method for the Treatment of Digestive Tract
Ulcers in Equines
Abstract
A novel dietary supplement and nutritional aid and methods for
the manufacture and administration of the same are disclosed for
the efficacious treatment and/or prevention of digestive tract
ulcers in horses and other animals. The dietary supplement of the
present invention is effective in treating and/or preventing
gastric ulcers, and in treating colonic ulcers as well. The dietary
supplement of the present invention consists of safe and natural
ingredients rather than drugs, and is orally administrable. The
ingredients of the dietary supplement of the present invention when
combined provide a synergistic efficacy which greatly exceeds the
sum of the efficacies of the individual ingredients, making the
dietary supplement highly effective in the treatment of digestive
tract ulcers.
Inventors: |
Bedding; Peter M. J.;
(Crediton, GB) ; Pellegrini; Franklin L.;
(Streetsboro, OH) |
Correspondence
Address: |
REINHART BOERNER VAN DEUREN S.C.;ATTN: LINDA KASULKE, DOCKET COORDINATOR
1000 NORTH WATER STREET, SUITE 2100
MILWAUKEE
WI
53202
US
|
Family ID: |
33416936 |
Appl. No.: |
12/917237 |
Filed: |
November 1, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10435367 |
May 9, 2003 |
7824706 |
|
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12917237 |
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Current U.S.
Class: |
424/727 ;
424/750; 424/755; 424/757; 514/54 |
Current CPC
Class: |
A23K 20/142 20160501;
A61K 36/31 20130101; A23K 20/10 20160501; A61K 36/31 20130101; A61K
36/63 20130101; A61K 31/353 20130101; A61K 45/06 20130101; A61P
39/06 20180101; A61K 36/899 20130101; A61K 36/8998 20130101; A23K
50/20 20160501; A61K 36/8998 20130101; A61K 47/183 20130101; A61P
1/00 20180101; A23K 20/158 20160501; A61K 36/48 20130101; A61K
47/44 20130101; A61P 31/00 20180101; A61K 36/55 20130101; Y10S
426/807 20130101; A61K 36/889 20130101; A61K 36/63 20130101; A61K
36/28 20130101; A23K 20/163 20160501; A61K 36/48 20130101; A61K
36/28 20130101; A61K 2300/00 20130101; A61P 1/04 20180101; A61K
36/899 20130101; A61P 39/00 20180101; A61K 31/353 20130101; A61K
36/889 20130101; A61K 36/55 20130101; A61K 2300/00 20130101; A61K
2300/00 20130101; A61K 2300/00 20130101; A61K 2300/00 20130101;
A61K 2300/00 20130101; A61K 2300/00 20130101; A61K 2300/00
20130101; A61K 2300/00 20130101 |
Class at
Publication: |
424/727 ;
424/750; 424/757; 424/755; 514/54 |
International
Class: |
A61K 31/716 20060101
A61K031/716; A61K 36/899 20060101 A61K036/899; A61K 36/8998
20060101 A61K036/8998; A61K 36/48 20060101 A61K036/48; A61P 1/04
20060101 A61P001/04; A61P 39/06 20060101 A61P039/06; A61K 36/889
20060101 A61K036/889; A61K 36/31 20060101 A61K036/31; A61P 39/00
20060101 A61P039/00; A61P 31/00 20060101 A61P031/00 |
Claims
1. A dietary supplement for use in treating digestive tract ulcers,
comprising: a polar lipid that has been isolated from its natural
source which polar lipid strengthens the mucous gut membrane lining
the inside wall of the stomach; a soluble fiber source that has
been fractionated from its natural origin which soluble fiber
source is present in an amount that is effective to slow the
passage of foodstuffs ingested together with the dietary supplement
through the stomach, wherein said soluble fiber source is derived
from at least one ingredient selected from the group consisting of
oats, barley, and soybeans; and a nutricine which increases the
integrity of digestive tract membranes consisting of amino acids,
wherein said amino acids include at least one of L-threonine or
L-glutamine; wherein said polar lipid, said soluble fiber source,
and said nutricine are present in said dietary supplement in
respective amounts sufficient to treat digestive tract ulcers in
horses.
2. A dietary supplement as defined in claim 1, wherein said polar
lipid contains antioxidants.
3. A dietary supplement as defined in claim 1, wherein said polar
lipid contains lipids of oats.
4. A dietary supplement as defined in claim 1, wherein said polar
lipid comprises at least one oil selected from the group consisting
of oat oil, soybean oil, olive oil, palm oil, sunflower oil, corn
oil, rape seed oil, and linseed oil.
5. A dietary supplement as defined in claim 1, wherein said polar
lipid comprises: oat oil.
6. A dietary supplement as defined in claim 1, wherein said polar
lipid comprises between approximately twenty-nine percent and
eighty percent of said dietary supplement by weight.
7. A dietary supplement as defined in claim 6, wherein said polar
lipid comprises between approximately forty percent and sixty-five
percent of said dietary supplement by weight.
8. A dietary supplement as defined in claim 7, wherein said polar
lipid comprises approximately fifty-two and one-half percent of
said dietary supplement by weight.
9. A dietary supplement as defined in claim 1, wherein said soluble
fiber source is derived from oats.
10. A dietary supplement as defined in claim 1, wherein said
soluble fiber source comprises: .beta.-glucan (beta-glucan).
11. A dietary supplement as defined in claim 10, wherein said
wherein said .beta.-glucan is derived from oats.
12. A dietary supplement as defined in claim 1, wherein said
soluble fiber source comprises between approximately ten and fifty
percent of said dietary supplement by weight.
13. A dietary supplement as defined in claim 11, wherein said
soluble fiber source comprises between approximately fifteen and
forty percent of said dietary supplement by weight.
14. A dietary supplement as defined in claim 13, wherein said
soluble fiber source comprises approximately thirty-six percent of
said dietary supplement by weight.
15. A dietary supplement as defined in claim 1, wherein said amino
acids comprise: L-threonine.
16. A dietary supplement as defined in claim 15, wherein said
L-threonine comprises between approximately one percent and eight
percent of said dietary supplement by weight.
17. A dietary supplement as defined in claim 16, wherein said
L-threonine comprises approximately two and one-half percent of
said dietary supplement by weight.
18. A dietary supplement as defined in claim 1, wherein said amino
acids comprise: L-glutamine.
19. A dietary supplement as defined in claim 18, wherein said
L-glutamine comprises between approximately one percent and five
percent of said dietary supplement by weight.
20. A dietary supplement as defined in claim 19, wherein said
L-glutamine comprises approximately two percent of said dietary
supplement by weight.
21. A dietary supplement as defined in claim 1, additionally
comprising: a second nutricine which absorbs and eliminates
mycotoxins and/or pathogens in the digestive tract.
22. A dietary supplement as defined in claim 21, wherein said
second nutricine that absorbs and eliminates mycotoxins and/or
pathogens in the digestive tract comprises: a pathogenic bacteria
absorbant.
23. A dietary supplement as defined in claim 22, wherein said
pathogenic bacteria absorbant comprises between approximately two
percent to five percent of said dietary supplement by weight.
24. A dietary supplement as defined in claim 23, wherein said
pathogenic bacteria absorbant comprises approximately two and
one-half percent of said dietary supplement by weight.
25. A dietary supplement as defined in claim 21, wherein said
second nutricine that absorbs and eliminates mycotoxins and/or
pathogens in the digestive tract comprises: a mycotoxin
absorbant.
26. A dietary supplement as defined in claim 25, wherein said
mycotoxin absorbant comprises between approximately two percent to
five percent of said dietary supplement by weight.
27. A dietary supplement as defined in claim 26, wherein said
mycotoxin absorbant comprises approximately two and one-half
percent of said dietary supplement by weight.
28. A dietary supplement as defined in claim 1, additionally
comprising: a pH balancer.
29. A dietary supplement as defined in claim 28, wherein said pH
balancer comprises: sodium bicarbonate.
30. A dietary supplement as defined in claim 28, wherein said pH
balancer comprises a sufficient percentage of said dietary
supplement to bring said dietary supplement to a neutral pH.
31. A dietary supplement as defined in claim 28, wherein said pH
balancer comprises a sufficient percentage of said dietary
supplement to bring said dietary supplement to a pH of
approximately seven.
32. A dietary supplement as defined in claim 28, wherein said pH
balancer comprises approximately two percent of said dietary
supplement by weight.
33. A dietary supplement as defined in claim 1, additionally
comprising: a medication that is carried with the other ingredients
of said dietary supplement, wherein at least one of the absorption
or the therapeutic value of said medication is maximized by being
taken in conjunction with said dietary supplement.
34. A feed supplement for use in treating digestive tract ulcers in
horses, comprising: an oil-based polar lipid that has been isolated
from its natural source; a .beta.-glucan (beta-glucan) soluble
fiber source that has been fractionated from its natural origin
which .beta.-glucan soluble fiber source is present in an amount
that is effective to slow the passage of foodstuffs ingested
together with the dietary supplement through the stomach, wherein
said .beta.-glucan soluble fiber source is derived from at least
one ingredient selected from the group consisting of oats, barley,
and soybeans, wherein said .beta. glucan soluble fiber source is
derived from at least one ingredient selected from the group
consisting of oats, barley, and soybeans; a nutricine which
increases the integrity of digestive tract membranes consisting of
amino acids, wherein said amino acids include at least one of
L-threonine or L-glutamine; and a second nutricine which absorbs
mycotoxins and/or pathogens in the digestive tract; wherein said
polar lipid, said soluble fiber source, said nutricine, and said
second nutricine are present in said dietary supplement in
respective amounts sufficient to treat digestive tract ulcers in
horses.
35. A dietary supplement for use in treating and/or inhibiting
digestive tract ulcers, comprising: a polar lipid that has been
isolated from its natural source for strengthening the mucous gut
membrane lining the inside wall of the stomach, to help the mucous
gut membrane retain its ability to protect the inside wall of the
stomach; a soluble fiber source that has been fractionated from its
natural origin for slowing the passage of foodstuffs ingested
together with the dietary supplement through the stomach; and a
nutricine for increasing the integrity of the mucous gut membrane
lining the inside wall of the stomach which nutricine comprises
amino acids.
36. A method of making a feed supplement for horses, said method
comprising: providing a polar lipid that has been isolated from its
natural source; providing a soluble fiber source that has been
fractionated from its natural origin which soluble fiber source is
present in an amount that is effective to slow the passage of
foodstuffs ingested together with the dietary supplement through
the stomach, wherein said soluble fiber source is derived from at
least one ingredient selected from the group consisting of oats,
barley, and soybeans; providing a nutricine which increases the
integrity of digestive tract membranes consisting of amino acids,
wherein said amino acids include at least one of L-threonine or
L-glutamine; and mixing said polar lipid, said soluble fiber
source, and said nutricine which increases the integrity of
digestive tract membranes together; wherein said polar lipid, said
soluble fiber source, and said nutricine are present in said
dietary supplement in respective amounts sufficient to treat
digestive tract ulcers in horses.
37. A method of making a feed supplement for horses, said method
comprising: providing a polar lipid that has been isolated from its
natural source; providing a soluble fiber source that has been
fractionated from its natural origin which soluble fiber source is
present in an amount that is effective to slow the passage of
foodstuffs ingested together with the dietary supplement through
the stomach, wherein said soluble fiber source is derived from at
least one ingredient selected from the group consisting of oats,
barley, and soybeans; providing a nutricine that increases the
integrity of digestive tract membranes consisting of amino acids,
wherein said amino acids include at least one of L-threonine or
L-glutamine; providing a second nutricine that absorbs mycotoxins
and/or pathogens in the digestive tract; and mixing said polar
lipid, said soluble fiber source, said nutricine that increases the
integrity of digestive tract membranes, and said nutricine that
absorbs mycotoxins and/or pathogens together; wherein said polar
lipid, said soluble fiber source, said nutricine, said second
nutricine, and said pH balancer are present in said dietary
supplement in respective amounts sufficient to treat digestive
tract ulcers in horses.
38. A method for feeding a dietary supplement for use in treating
digestive tract ulcers in horses, said method comprising: preparing
an appropriately sized dose of dietary supplement comprising: a
polar lipid that has been isolated from its natural source; a
soluble fiber source that has been fractionated from its natural
origin which soluble fiber source is present in an amount that is
effective to slow the passage of foodstuffs ingested together with
the dietary supplement through the stomach, wherein said soluble
fiber source is derived from at least one ingredient selected from
the group consisting of oats, barley, and soybeans; and a nutricine
that increases the integrity of digestive tract membranes
consisting of amino acids, wherein said amino acids include at
least one of L-threonine or L-glutamine; administering said dietary
supplement to a horse on a regular basis; and repeating said
preparing and administering steps at least once daily; wherein said
polar lipid, said soluble fiber source, and said nutricine are
present in said dietary supplement in respective amounts sufficient
to treat digestive tract ulcers in horses.
39. A method for administering a medication in horses utilizing a
dietary supplement for use in treating digestive tract ulcers in
horses, said method comprising: preparing an appropriately sized
dose of dietary supplement comprising: a polar lipid that has been
isolated from its natural source which polar lipid acts as a
spreading agent to effectively coat the digestive tract with said
dietary supplement; a soluble fiber source that has been
fractionated from its natural origin which soluble fiber source is
present in an amount that is effective to slow the passage of
ingested items through the stomach, wherein said soluble fiber
source is derived from at least one ingredient selected from the
group consisting of oats, barley, and soybeans; and a nutricine
which increases the integrity of digestive tract membranes
consisting of amino acids, wherein said amino acids include at
least one of L-threonine or L-glutamine; a second nutricine for
absorbing and eliminating mycotoxins and/or pathogens in the
digestive tract; wherein said polar lipid, said soluble fiber
source, said nutricine, and said second nutricine are present in
said dietary supplement in respective amounts sufficient to treat
digestive tract ulcers in horses; mixing an appropriately sized
dose of a medication into said dietary supplement; administering
said dietary supplement to a horse.
40. A method of treating digestive tract ulcers in horses,
comprising: preparing an appropriately sized dose of dietary
supplement comprising: a polar lipid that has been isolated from
its natural source which polar lipid acts as a spreading agent to
effectively coat the digestive tract with said dietary supplement;
a soluble fiber source that has been fractionated from its natural
origin which soluble fiber source is present in an amount that is
effective to slow the passage of ingested items through the
stomach, wherein said soluble fiber source is derived from at least
one ingredient selected from the group consisting of oats, barley,
and soybeans; a nutricine that increases the integrity of digestive
tract membranes consisting of amino acids, wherein said amino acids
include at least one of L-threonine or L-glutamine; and a second
nutricine for absorbing and eliminating mycotoxins and/or pathogens
in the digestive tract; wherein said polar lipid, said soluble
fiber source, said nutricine, and said second nutricine are present
in said dietary supplement in respective amounts sufficient to
treat digestive tract ulcers in horses; and administering said
appropriately sized dose of dietary supplement to a horse.
Description
IDENTIFICATION OF RELATED APPLICATIONS
[0001] This patent application is a continuation of U.S. patent
application Ser. No. 10/435,367, filed on May 9, 2003, now U.S.
Pat. No. 7,824,706, granted on Nov. 2, 2010, entitled "Dietary
Supplement and Method for the Treatment of Digestive Tract Ulcers
in Equines," which is assigned to the assignee of the present
patent application, and which is hereby incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] Field of the Invention--The present invention relates
generally to feed supplements and to the treatment of ulcers in
horses and other animals, and more particularly to a novel feed
supplement and nutritional aid for the efficacious treatment and/or
inhibition of digestive tract ulcers in horses and other
animals.
[0003] The incidence of digestive tract ulcers in performance
horses has risen most sharply, from approximately twenty percent in
1920 to approximately ninety percent or better in the last decade.
In racehorses, for example, as much as ninety-seven percent of the
racehorse population has been reported to have digestive tract
ulcers, with the percentage of show horses having digestive tract
ulcers lagging only slightly behind. Even performance horse foals
have been inflicted with this condition, with approximately sixty
percent of performance horse foals having digestive tract ulcers.
While pleasure horses have a lower incidence of digestive tract
ulcers than show horses, the increasing incidence of digestive
tract ulcers in the last two decades has been significant for all
segments of the horse population, including pleasure horses.
[0004] A recent scientific study of a random cross-section of
horses indicated that approximately fifty-five percent of them had
gastric ulcers and forty percent of them had colonic ulcers. The
incidences of gastric and colonic ulcers were not identical,
meaning that some horses had only gastric ulcers and other horses
had only colonic ulcers. However, a large percentage of the horses
that had colonic ulcers also had gastric ulcers, with less than
thirty percent of the horse population as a whole not having either
gastric or colonic ulcers. As mentioned above, the incidence of
digestive tract ulcers for show horses and racehorses is even
higher than these statistics for the general horse population.
[0005] The direct cause of digestive tract ulcers in horses appears
to be excess stomach acid, as is the case with humans and other
animals. Excess stomach acid can "eat" through the protective
lining of the stomach and damage the interior surface of the
stomach, causing gastric ulcers. In humans, it is believed that the
prevalent factor in the development of stomach ulcers is the
helicobacter pylori bacteria. However, the helicobacter pylori
bacteria has not been isolated from horse stomachs, and thus is not
believed to be a factor in the development of digestive tract
ulcers in horses.
[0006] One factor contributing to the high incidence of digestive
tract ulcers in horses is the somewhat unique digestive tract
anatomy of horses. While horses are monogastric (one stomach)
animals, they are also hindgut fermenters, which means that they
have relatively small stomachs and small intestines (collectively
referred to as the foregut), and relatively large colons
(collectively referred to as the hindgut). The relative volume of
the foregut in horses is approximately thirty-five to forty percent
of the total volume of the digestive tract. By comparison, the
relative volume of the foregut in pigs is sixty to sixty-five
percent of the total volume of the digestive tract, and the
relative volume of the foregut in ruminant animals such as cows is
eighty-five to ninety percent of the total volume of the digestive
tract.
[0007] While the foregut of horses is relatively small, their
stomachs are even smaller, representing only approximately
one-quarter of the volume of the foregut, and thus approximately
nine percent of the total volume of the digestive tract. In view of
the small percentage of the digestive tract represented by the
stomach, one might refer to a horse's stomach as a preparatory
chamber. The principal consequence of this relatively small stomach
size is that the rate of passage of feed through horses' stomachs
is relatively fast, leaving relatively little time for the
digestion process to occur. In addition, smaller feed particles
pass through horses' foreguts even more quickly, with the time of
passage of such smaller particles through the horses' stomachs
potentially not allowing for proper digestion to occur.
[0008] In the case of humans and most other animals, gastric acid
is secreted in the stomach in response to eating. In contrast,
horses have developed over millennia as trickle feeders (eating
slowly but more or less continuously over most of the day), and
their digestive systems are geared for such a diet, with a
continuous production of gastric juices and bile secretion into the
foregut from the liver. Thus, the stomach of a horse may be thought
of as an acid pump that produces gastric acid more or less
continuously through the day, whether or not the horse is being
fed.
[0009] The inside wall of the stomach is protected by a mucous gut
membrane lining which is a fatty layer containing polar lipids.
When there is no food contained in the horse's stomach, the gastric
acid will act on the mucous gut membrane lining the inside wall of
the stomach, oxidizing the cells of the gut lining and burning them
up. These burned-up gut lining cells are sloughed off, and pass
through the digestive system, exposing the gut wall to the gastric
acid and allowing gastric ulcers to form. This condition is known
as equine gastric ulcer syndrome ("EGUS").
[0010] In addition, there is a continuous peroxidation and
oxidation of proteins and lipids which results in the formation of
free radicals. As the fatty cells containing polar lipids in the
mucous gut membrane are oxidized and burned off, free radicals are
created. These free radicals can break down muscle tissue, and have
been shown to have an adverse affect on the performance of horses.
Thus, it is readily apparent to those skilled in the art that
digestive tract ulcers have a substantial adverse effect on
performance horses, and can prevent performance horses from
achieving their true potential.
[0011] In the case of humans, the production of saliva and its
mixing with ingested foodstuffs initiates the digestion process
since human saliva includes the enzyme amylase, which breaks down
starch into sugar. Horse saliva does not contain amylase or any
other enzyme that can initiate the digestion process. However,
horse saliva does contain a buffering agent that can help to
neutralize gastric acid contained in the horse's stomach.
[0012] Another unique feature of horses' digestive tracts is the
presence of a large microbial population in the hindgut. These
microorganisms are responsible for the fermentation of the residues
of the digestive process and absorption of digested feed, and have
the ability to utilize the cellulose that is present in forages.
The anatomy of the hindgut, which has a number of folds contained
therein, causes the passage of ingested feed to pass through
relatively slowly as compared to the rate of passage of ingested
feed through the foregut. While this is advantageous when digesting
roughages such as forage, it can also predispose a horse to
digestive upsets when insufficient roughage is contained in the
ingested feed.
[0013] In addition to the unique anatomy of horses' digestive
tracts, there are several other factors which also appear to
increase the incidence of digestive tract ulcers in horses. These
factors include feeding practices, physical stress (including the
stress from being in a stable as much as twenty-three hours of the
day), and medications being given to the horses. In the case of
performance horses, two additional factors which can also increase
the incidence of digestive tract ulcers are the intensity of
training and the initiation of training of foals at a young age,
the latter of which is particularly prevalent with racehorses.
However, it has been determined by the inventors that while all of
these factors are significant, the primary factors are the unique
physiology of the horse digestive tract and modern feeding
practices, with the other factors acting to further exacerbate a
condition which is essentially caused by two aforesaid primary
factors.
[0014] Thus, other than the unique physiology of horses' digestive
tracts, the primary factor leading to the high incidence of
digestive tract ulcers in horses is diet-related, and is a
consequence of a drastic change in the diet of most horses. Until
the relatively recent past, horses for the most part had been
allowed to be free-range grazers, with a diet that consisted
primarily of forage. However, beginning in the 1920's, fewer and
fewer horses have had the opportunity to free range graze, or even
to have the freedom to eat hay or other forage during much of the
day. Instead, most horses are fed diets that are high in grains,
with forage either being reduced to minimal levels or eliminated
entirely from the horses' diets. Typical feeding schedules for
horses are twice or three times daily, generally with feedings in
the morning and the evening, and a third feeding at midday,
mimicking a human diet. With this change in diet, the incidence of
digestive tract ulcers in horses has increased tremendously,
especially in performance horses (including both racehorses and
show horses), which also have additional stresses that exacerbate
the problem caused by the consequences of a low forage diet and the
nature of the digestive tract of horses.
[0015] When horses are allowed to eat forage (which is essentially
high fiber, low nutrition material), as they have evolved to do,
they typically eat for approximately sixteen hours a day. If
allowed to graze, they will begin feeding in the early morning, and
will continue to feed until well after dark, nibbling, chewing,
swallowing, and digesting slowly to keep their small stomachs from
becoming empty. Given free choice, horses will search out and find
a balanced diet typically consisting of grasses, berries, and
leaves, which provide a balance of essential microminerals in
addition to basic volume and energy requirements. The constant
chewing produces saliva that neutralizes the gastric acid. (Saliva
contains positive ions ("cations") which counteract the negative
ions ("anions") of gastric acid.)
[0016] Most horses today are neither kept in pastures where they
can eat forage all day long, nor fed forage in a stable. Instead,
stabled horses are typically fed a concentrated, low volume diet of
grain products with relatively small quantities of hay or forage
being available to them, and then only intermittently. With regard
to racehorses and other performance horses, the diet bears even
less resemblance to a forage diet. Racehorses are fed a high-energy
diet to maximize muscle growth and activity levels; this diet
typically consists of a mixture of grains, molasses, nutrients, and
feed additives, usually with minimal hay in the form of one or two
flakes with each meal.
[0017] The concentrated, low volume diet of grain products is
generally fed to the horses three times (or in some cases only
twice) a day, and the horses generally eat it rapidly. When fed to
horses, such a low volume diet of grain products passes through
their stomachs relatively quickly. Since this type of diet is
concentrated and of high quality, horses fed such a diet are not
nutritionally underfed; rather, they are "behaviorally" underfed.
Diets that are low in fiber and high in starch increase the
potential that starches which are not digested in the foregut will
enter the hindgut, where they will rapidly ferment, causing a rapid
reduction in the pH level in the hindgut and a volatile fatty acid
imbalance. The acidic environment created in this manner has a
direct effect on the balance of microflora (the huge community of
microorganisms which forms a complex and dynamic ecosystem within
the hindgut) within the hindgut.
[0018] One consequence of such a diet is that relatively little of
the buffering saliva reaches the horses' stomachs. This is due to
the fact that the buffering capacity is determined mainly by the
volume of saliva that is produced while horses are eating. For a
given weight of concentrated food such as grain products, the
volume of saliva produced is less than half the volume of saliva
that would be produced by the same weight of forage. Thus, it will
at once be appreciated by those skilled in the art that, except for
the relatively brief time when horses are eating and shortly
thereafter, their stomachs will be empty, with no buffering saliva.
Since horses' stomachs are not adapted to such intermittent
feeding, they will constantly be bathed with gastric acid, causing
gastric ulcers.
[0019] Since the gastric acid from the stomach can flow into the
hindgut, it is also possible for horses to have colonic ulcers,
particularly ulcers in the large intestine, typically in the right
ventral colon. The consequences of colonic ulcers in horses are
caused or exacerbated due to the presence of pathogens and
mycotoxins in the hindgut. These pathogens and mycotoxins can
fasten themselves onto the lesions and cause infections in the
walls of the hindgut. The pathogens and mycotoxins are ingested by
horses in their feed, and are metabolites of funguses growing on
the feed. Generally, the pathogens and mycotoxins will pass through
horses' digestive tracts unless there are colonic ulcers that are
susceptible to the pathogens and mycotoxins. Pathogens and
mycotoxins can cause severe problems including digestive,
reproductive, neurological, and athletic problems, as well as
chronic obstructive pulmonary disease ("COPD") in horses. For
example, colonization on sites of colonic ulcers caused by pH
changes and attack by acids can cause transit of mycotoxins into
the blood, and eventually may result in damage to the liver and
even renal dysfunctions.
[0020] There are three solutions to the problem of digestive tract
ulcers in horses that have been utilized in the art, none of which
have been satisfactory. The first known solution is the use of
antacids, also referred to euphemistically as "gastric ulcer
transnutrients." Antacids (typically mixtures of magnesium and
aluminum hydroxide) are administered to temporarily neutralize acid
in the stomach. However, antacids are treating the symptom rather
than the problem, and are relatively ineffective due to the fact
that they pass rapidly through horses' stomachs, and thus an
increase in pH in the stomach that is achieved with antacids is
typically of short duration. In addition, since gastric acid is
constantly produced by horses, it will at once be appreciated by
those skilled in the art that antacids are substantially
ineffective in treating digestive tract ulcers in horses.
[0021] The second known solution is the use of drugs, which are
administered to inhibit the production of gastric acid. These are
presently three classes of drugs which are used for this purpose:
histamine type-2 antagonists such as cimetidine (available from
GlaxoSmithKline under its registered trademark Tagamet) and
ranitidine (available from Pfizer under its registered trademark
Zantac or from Ranvet under its registered trademark Ulcerguard),
or proton pump inhibitors such as omeprazole (available from Astra
AB under its registered trademark Gastrogard). These drugs claim to
be effective in curing gastric ulcers in three to four weeks, but
are very expensive. It is apparent to those skilled in the art that
the temporary change in the stomach environment is highly unlikely
to result in complete restoration of health during treatment.
[0022] They do have several disadvantages in addition to their
expense, the most problematic of which is that once they are
discontinued the digestive tract ulcers will usually recur quickly,
requiring another round of treatment. In some instances,
veterinarians may find it necessary to prescribe continuing
treatment with one of these medications, which becomes extremely
expensive. In addition, some of these drugs must be withheld prior
to racing in the case of racehorses. Another profound disadvantage
is that these drugs interfere with proper digestion by changing the
natural pH balance, which results in the treated horses being in
less than optimum condition.
[0023] The third, and most effective, known solution is the only
natural solution known at present--rest and a diet of forage. This
means allowing horses to return to pasture, and a diet of hay and
other forage. It is the only real solution that has been known in
the art, and it is the universal prescription to provide a complete
return to health. For performance horses, it may inhibit the
ability of the horses to compete; for owners of other horses it
represents an ideal solution that is simply not possible.
Accordingly, rest and diet does not represent an optimal solution
for many horses and their owners.
[0024] It is accordingly the primary objective of the dietary
supplement of the present invention that it efficaciously treat
digestive tract ulcers in horses and, potentially, in other animals
and even humans as well. In addition to having the effect of
efficaciously treating digestive tract ulcers, it is a related
objective of the dietary supplement of the present invention that
it demonstrate efficacy in the prevention of such digestive tract
ulcers as well. It is a further objective of the dietary supplement
of the present invention that it be effective in treating and/or
preventing gastric ulcers, and it is a related objective of the
preferred embodiment of the dietary supplement of the present
invention that it also be effective in treating colonic ulcers as
well.
[0025] It is another objective of the dietary supplement of the
present invention that it not interfere with the proper digestion
of foodstuffs while it is treating and/or preventing digestive
tract ulcers. It is an additional objective of the dietary
supplement of the present invention that it consist entirely of
safe and natural ingredients rather than drugs. It is a still
further objective of the dietary supplement of the present
invention that it be orally administrable, thereby making its
dispensation a simple matter. It is a related objective of the
dietary supplement of the present invention that it be packaged in
single doses to make its administration as convenient as is
possible.
[0026] The dietary supplement of the present invention must also be
both stable and have a commercially acceptable shelf life, and it
should also require no special care to be provided by the user
throughout its shelf life prior to usage. In order to enhance the
market appeal of the dietary supplement of the present invention,
it should also be relatively inexpensive when compared to
previously known methods of digestive tract ulcer treatment to
thereby afford it the broadest possible market. Finally, it is also
an objective that all of the aforesaid advantages and objectives of
the dietary supplement of the present invention and its method of
administration be achieved without incurring any substantial
relative disadvantage.
SUMMARY OF THE INVENTION
[0027] The disadvantages and limitations of the background art
discussed above are overcome by the present invention. With this
invention, a novel dietary supplement that is specifically
formulated to treat and/or prevent digestive tract ulcers is
provided. Through the periodic administration of this dietary
supplement to horses or other animals in accordance with methods
taught by the present invention, digestive tract ulcers are
effectively treated and/or prevented in such horses or other
animals. As will rapidly become apparent to those skilled in the
art, the dietary supplement of the present invention is much more
than the sum of its ingredients, with the combination of
ingredients yielding a synergistic result substantially more
efficacious than the results which would be produced if each of the
ingredients acting by itself were provided to horses or other
animals.
[0028] In its basic form, the dietary supplement of the present
invention is targeted to accomplish three goals, each of which is
facilitated by the inclusion of a particular ingredient or a
mixture of ingredients in the dietary supplement. The first goal is
to strengthen the mucous gut membrane lining the inside wall of the
stomach, to help the mucous gut membrane retain its ability to
protect the inside wall of the stomach. This involves enhancing the
cationic efficiency of the mucous gut membrane, by producing
additional cations, or positive ions, to counteract the anions, or
negative ions, in the gastric acid.
[0029] The ingredient of the dietary supplement of the present
invention which strengthens the mucous gut membrane lining the
inside wall of the stomach is a polar lipid supplement. In the
preferred embodiment, the polar lipid supplement is oat oil, which
contains a high concentration of polar lipids and antioxidants.
Optionally, different phases of oat oils may be used in order to
vary the viscosity of the oat oil, which may be advantageous
depending upon the intended method of administration of the dietary
supplement of the present invention. For example, if the dietary
supplement is to be administered orally by syringe, a more viscous
oat oil mixture would be used than if the dietary supplement were
to be administered by pouring it onto feed that is then
ingested.
[0030] The second goal of the dietary supplement of the present
invention is to slow the passage of feed ingested together with or
in close proximity to administration of the dietary supplement
through the stomach, which in and of itself will be highly
beneficial. In conjunction with this second goal, it is also the
most readily apparent benefit of slower transit of feed through the
stomach is that during the increased time that feed spends in the
stomach, gastric acid will not be attacking the mucous gut lining
the inside wall of the stomach. In addition, by causing feed to
spend a greater amount of time in the stomach, the digestion of the
feed will be improved, also benefiting the health of horses.
[0031] The ingredient of the dietary supplement of the present
invention which slows the transit of feed through the stomach is a
soluble fiber. In the preferred embodiment, .beta.-glucan
(beta-glucan), which is the soluble fiber in oats, is used as this
ingredient. .beta.-glucan is an oligosaccharide that is found in
the kernel of oats, and is a powder when dried. It is a jelling
agent that has an increased jelling effect when exposed to water,
and also has a beneficial spreading effect that spreads the dietary
supplement on the inner surface of the stomach.
[0032] The third goal of the dietary supplement of the present
invention is to increase the integrity of the mucous gut membrane
lining the inside wall of the stomach. The way in which the dietary
supplement accomplishes this goal is by increasing the rate of cell
growth in the mucous gut membrane. By increasing the rate of cell
growth in the mucous gut membrane lining the inside wall of the
stomach, the dietary supplement of the present invention can
effectively strengthen the mucous gut membrane and thereby enable
it to continue to protect the inside wall of the stomach.
[0033] The ingredient of the dietary supplement of the present
invention which increases the integrity of the mucous gut membrane
lining the inside wall of the stomach is one or more nutricines
such as surfactant amino acids. In the preferred embodiment,
L-threonine and/or L-glutamine are used as this ingredient. Both
L-threonine and L-glutamine are naturally produced amino acids that
are produced by breaking down a protein.
[0034] It will be appreciated by those skilled in the art that
these three ingredients of the dietary supplement of the present
invention represent a balanced, multifaceted solution to the
problem posed by gastric ulcers in horses. With this solution, the
dietary supplement protects the stomach wall from gastric acid in
three ways: by providing polar lipids to strengthen the mucous gut
membrane and increase the cationic efficiency of the mucous gut
membrane; by increasing the amount of time feed is in the stomach,
thereby reducing the amount of time that the stomach is empty and
exposed to gastric acid; and by increasing the integrity of the
mucous gut membrane. It is believed that the dietary supplement of
the present invention would also have efficacious application to
other animals, including humans.
[0035] In the preferred embodiment, the dietary supplement of the
present invention also includes one or more ingredients to absorb
and eliminate mycotoxins and/or pathogens (i.e., bacteria) in the
hindgut (the intestines and the colon), thereby treating and/or
preventing colonic ulcers. One such ingredient that can be used is
a mycotoxin absorbant material that absorbs or soaks up mycotoxins
in the hindgut. Another such ingredient that can be used is a
pathogenic bacteria absorbant material that attracts bacteria and
passes through the digestive system in the feces.
[0036] The ingredients of the dietary supplement of the present
invention which absorb or soak up mycotoxins and/or attract and
eliminate pathogens are nutricines which may be made from
saccharomyces cerevisiae (brewer's yeast). In the preferred
embodiment, a mycotoxin absorbant such as the material marketed
under the registered trademark MYCOSORB by Alltech, Inc., may be
used to absorb or soak up mycotoxins in the colon. Additionally, in
the preferred embodiment, a pathogenic bacteria absorbant such as
the material marketed under the trademark BIOMOS by Alltech, Inc.,
may be used to attract and eliminate pathogens.
[0037] Finally, in the preferred embodiment, the dietary supplement
of the present invention also includes an ingredient to keep the
dietary supplement at a neutral pH. Typically, when the
above-described ingredients are mixed together to make the dietary
supplement of the present invention, the mixture will have an
acidic pH. Accordingly, a material that can be used to keep the
dietary supplement at a neutral pH is sodium bicarbonate.
[0038] The dietary supplement of the present invention can be
administered in any of a number of ways, and may either be added to
feed or fed directly as a dietary supplement. It is desirable that
the animal is given a regular dose of the dietary supplement, which
in the preferred embodiment is daily in order to maintain an
optimal level of the ingredients in the animal's digestive tract.
The dietary supplement of the present invention may be manufactured
as a liquid, in which case it can be added to feed which is then
fed to a horse. Alternately, it may be manufactured as a liquid or
paste and stored in a gelatin capsule (as gelcaps), which makes for
a consistent dosage of the dietary supplement. Finally, it can be
manufactured as a paste for oral administration using a dose
syringe. In practice, even when giving horses the dietary
supplement at times other that their normal feeding, they see it as
a treat since they like its taste.
[0039] Upon disclosure of the dietary supplement of the present
invention to those skilled in the art, they will immediately
appreciate that the dietary supplement is much more than merely the
sum of its ingredients. The combination of polar lipid supplement,
soluble fiber, and nutricines yield a synergistic result
substantially more efficacious than a sum of the results which
would be produced if each ingredient by itself was used. In
addition to the utility of the polar lipid supplement to strengthen
the mucous gut membrane lining the inside wall of the stomach, the
polar lipid supplement also acts as a spreading agent which
enhances the efficacy of the soluble fiber and the nutricines by
spreading them to cover the entire digestive tract. The soluble
fiber slows down the passage of the polar lipid supplement and the
nutricines, giving them more time to provide their beneficial
effects on the digestive tract. The nutricines also increase the
integrity of the gut membrane, but are much more effective with the
polar lipid supplement than they would be without it.
[0040] It may therefore be seen that the present invention teaches
a dietary supplement which efficaciously treats digestive tract
ulcers in horses and, potentially, in other animals and even humans
as well. The dietary supplement of the present invention can be fed
to any animal including, but not limited to, avian, bovine,
porcine, equine, ovine, caprine, canine, and feline species. In
addition to having the effect of efficaciously treating digestive
tract ulcers, the dietary supplement of the present invention
demonstrates efficacy in the prevention of such digestive tract
ulcers as well. The dietary supplement of the present invention is
effective in treating and/or preventing gastric ulcers, and in
treating colonic ulcers as well.
[0041] The dietary supplement of the present invention does not
interfere with the proper digestion of foodstuffs while it is
treating and/or preventing digestive tract ulcers. It consists
entirely of safe and natural ingredients rather than drugs. The
dietary supplement of the present invention is orally
administrable, thereby making its dispensation a simple matter. It
can also be packaged in single doses to make its administration as
convenient as is possible.
[0042] The dietary supplement of the present invention is stable
and has a long shelf life, and requires no special care to be
provided by the user throughout its shelf life prior to usage. The
dietary supplement of the present invention is also inexpensive
relative to previously known dietary tract ulcer treatments,
thereby enhancing its market appeal and affording it the broadest
possible market. Finally, all of the aforesaid advantages and
objectives of the dietary supplement of the present invention and
its method of administration are achieved without incurring any
substantial relative disadvantage.
DESCRIPTION OF THE DRAWINGS
[0043] These and other advantages of the present invention are best
understood with reference to the drawings, in which:
[0044] FIG. 1 is a somewhat schematic drawing of a horse showing
the anatomy of the horse's digestive tract.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0045] Prior to a discussion of the dietary supplement of the
present invention and methods of making and administering it, it is
helpful to briefly discuss the anatomy of the digestive system of a
horse. Referring to the FIGURE, a side view of a horse 20 is
illustrated, schematically illustrating the digestive tract of the
horse. The digestive tract of the horse 20 may be separated into a
foregut, which is indicated generally by the reference numeral 22,
and a hindgut, which is indicated generally by the reference
numeral 24.
[0046] The digestive tract of the horse 20 begins at its mouth 26,
and sequentially extends through an esophagus 28 into a stomach 30
and then into a small intestine 32, which together constitute the
foregut 22 of the horse 20. The foregut 22 of the horse 20
constitutes approximately thirty-five to forty percent of the
relative capacity of the digestive tract of the horse 20.
[0047] From the small intestine 32, the digestive tract extends
through a cecum 34, a large colon 36, and a small colon 38 which
terminates in a rectum 40. These elements of the digestive tract of
the horse 20 together constitute the hindgut 24 of the horse 20.
The hindgut 24 constitutes approximately sixty to sixty-five
percent of the relative capacity of the digestive tract of the
horse 20.
[0048] In its simplest implementation, the preferred embodiment of
the dietary supplement of the present invention includes three
primary ingredients which are mixed together to manufacture the
dietary supplement. These ingredients are a polar lipid supplement
to strengthen the mucous gut membrane lining the inside wall of the
stomach, a soluble fiber to slow the transit of feed through the
stomach, and one or more nutricines such as surfactant amino acids
which increase the integrity of the mucous gut membrane. Each of
these ingredients will be discussed separately below, together with
a description of its preferred composition, alternative
compositions, the preferred amount of the composition used in the
dietary supplement, and the range of the amount of the composition
which may be used in the dietary supplement. During the following
discussion of the ingredients of the dietary supplement of the
present invention, it will rapidly become apparent to those skilled
in the art that the benefits achieved by the dietary supplement of
the present invention are substantially greater than the sum of the
individual benefits of each of the dietary supplement's
ingredients.
[0049] The first primary ingredient of the dietary supplement of
the present invention is a polar lipid supplement to strengthen the
mucous gut membrane lining the inside wall of the stomach. Anions,
or negative ions, in the gastric acid in the stomach cause a loss
of integrity in the cell walls of the mucous gut membrane that
protects the inside wall of the stomach. There is an accompanying
loss of polar lipids within the cells of the mucous gut membrane,
and an increase in free radicals. Membrane synthesis occurs mainly
through the addition of new polar lipids to the cells. Polar lipids
from the dietary supplement accordingly replace the polar lipids
lost due to the gastric acid, and enhance the cationic efficiency
of the mucous gut membrane by producing additional cations, or
positive ions, to counteract the anions in the gastric acid.
[0050] There are a number of potential sources of polar lipids that
may be used as the polar lipid supplement in the dietary supplement
of the present invention. In the preferred embodiment, oat oil is
used due to the fact that oat oil has more polar lipids per unit
volume than any other any other polar lipid source. Oat oil is also
an excellent source of antioxidants. Other oils that are also good
sources of polar lipids are soybean oil, olive oil, palm oil,
sunflower oil, corn oil, rapeseed oil, linseed oil, etc.
[0051] In the preferred embodiment of the dietary supplement of the
present invention, the polar lipid supplement is made of different
viscosity components of oat oil (or other polar lipid ingredients)
in order to affect the ultimate character of the dietary
supplement. Like most oils, oat oil may come from multiple
extractions, with the typical extraction process crushing the oats
and treating them with an extraction agent such as hexanol. The
first phase of oat oil extracted is a thin oil. The second phase of
oat oil extracted is a thick oil, which is considerably more
viscous than the first phase. The third phase of oat oil extracted
is a very thick oil that has the consistency of grease. All three
phases of the oat oil extraction process may be mixed, with the
resulting mixture being referred to herein as oat oil. Optionally,
the third phase of oat oil can be mixed with the oat oil consisting
of all three phases to further thicken it. While there are a
variety of sources for oat oil, a commercial source for the third
phase of oat oil is Swedish Oat Fiber AB in Gothenburg, Sweden,
which manufactures such a product under the trademark "Avenol."
[0052] The second primary ingredient of the dietary supplement of
the present invention is a soluble fiber to slow the transit of
feed through the stomach. With foodstuffs contained in the stomach
for a longer period of time, gastric acid will have proportionately
less time to attack the mucous gut lining protecting the inside
wall of the stomach. Also, by slowing the transit of ingested
foodstuffs through the stomach, digestion of the foodstuffs in the
stomach will be substantially enhanced. This results in
proportionately less digestion occurring in the hindgut, minimizing
the rapid fermentation phenomenon which causes a rapid reduction in
the pH level in the hindgut and a volatile fatty acid
imbalance.
[0053] There are a number of potential sources of soluble fiber
that may be used in the dietary supplement in the dietary
supplement of the present invention. In the preferred embodiment,
the soluble fiber used is .beta.-glucan (beta-glucan) that is
derived from oats. .beta.-glucan is a jelling agent that has an
increased jelling effect when water is ingested together with or
shortly after the .beta.-glucan itself is ingested. .beta.-glucan
also has a beneficial spreading effect that spreads the dietary
supplement on the inner surface of the stomach. Other soluble
fibers that are also good sources of .beta.-glucan are those
derived from barley or soybeans. .beta.-glucan is widely available
from a large number of different suppliers, and is a powder when
dried.
[0054] The third primary ingredient of the dietary supplement of
the present invention is one or more nutricines such as surfactant
amino acids which increase the integrity of the mucous gut
membrane. The nutricine(s) accomplish this by increasing the rate
of growth of cells in the mucous gut membrane. Increasing the
growth rate of these cells increases the viability of the mucous
gut membrane in its corrosive environment of gastric acid, and
better enables the mucous gut membrane to continue to protect the
inside wall of the stomach.
[0055] There are a number of potential sources of nutricines that
may be used in the dietary supplement. In the preferred embodiment,
the nutricines are amino acid-based, and include both L-threonine
and L-glutamine, which are both naturally produced amino acids
which are produced by breaking down a protein. L-threonine makes up
collagen, elastin, and enamel protein, assists in metabolism and
assimilation, and aids the digestive system by increasing the
integrity of the mucous gut membrane. L-threonine has also been
observed by the inventors to have a synergistic effect with
.beta.-glucan in further slowing motility through the stomach.
[0056] L-glutamine is the most abundant amino acid in the
bloodstream, and is primarily formed and stored in skeletal muscle
and the lungs (and thus is not normally present in the stomach).
L-glutamine also increases growth hormones, and when ingested has a
substantial effect on maintaining and increasing mucosal integrity,
including enhancing the integrity of the mucous gut membrane. Thus,
L-threonine and L-glutamine both act to protect the inside wall of
the stomach by enhancing the integrity of the mucous gut membrane.
L-threonine and L-glutamine are widely available from a large
number of different suppliers, and are also powders.
[0057] These three principal ingredients of the dietary supplement
of the present invention thus protect the stomach wall from gastric
acid in three ways which are enhanced by the interaction between
the three ingredients: by providing polar lipids to strengthen the
mucous gut membrane and increase the cationic efficiency of the
mucous gut membrane; by increasing the amount of time feed is in
the stomach, thereby reducing the amount of time that the stomach
is empty and exposed to gastric acid; and by increasing the
integrity of the mucous gut membrane. In the preferred embodiment,
additional ingredients are included in the dietary supplement of
the present invention to treat and/or prevent colonic ulcers.
[0058] The additional ingredient(s) of the dietary supplement of
the present invention to treat and/or prevent colonic ulcers is one
or more nutricines which are designed to absorb and eliminate
mycotoxins and/or pathogens (i.e., bacteria) in the hindgut (the
intestines and the colon). One of the additional ingredients used
in the preferred embodiment is a mycotoxin absorbant nutricine that
absorbs or soaks up mycotoxins in the hindgut. Another additional
ingredient used in the preferred embodiment is a pathogenic
bacteria absorbant material that attracts bacteria and passes
through the digestive system together with the absorbed pathogenic
bacteria in the feces.
[0059] In the preferred embodiment, the mycotoxin absorbant
nutricine used to absorb or soak up mycotoxins in the hindgut is a
mycotoxin absorbant material marketed under the registered
trademark MYCOSORB by Alltech, Inc. Other mycotoxin absorbant
nutricines that could instead be used include the material marketed
under the trademark MYCOFIX PLUS by Biomin Distribution, Inc. and
the material marketed under the trademark D-MYCOTOC by Kanzy
Medipharm, Inc. In the preferred embodiment, the pathogenic
bacteria absorbant material that attracts bacteria and passes
through the digestive system together with the absorbed pathogenic
bacteria is a pathogenic bacteria absorbant such as the material
marketed under the trademark BIOMOS by Alltech, Inc. Other
pathogenic bacteria absorbant nutricines that could instead be used
include the material marketed under the trademark BIOSAF by S.I.
Lesaffre, Cedex, France, as well as any mannanoligosaccharide
(complex mannose sugars derived from the cell wall of yeast).
MYCOSORB and BIOMOS are available from Alltech, Inc., in
Nicholasville, Ky., and are also powders.
[0060] There is one additional ingredient that is included in the
preferred embodiment in order to keep the dietary supplement at a
neutral pH. When all of the previously mentioned ingredients of the
dietary supplement of the present invention are mixed together, the
resulting mixture will be have an acidic pH. Accordingly, an
alkaline material is added to the dietary supplement to bring it to
a neutral pH (typically a pH of approximately seven). In the
preferred embodiment, that ingredient is sodium bicarbonate (also a
powder). Alternately, other buffers could be used; for example,
tris buffers or different aluminum salts that are used as antacids
could be used instead of sodium bicarbonate.
[0061] Those skilled in the art will immediately appreciate that
the dietary supplement of the present invention is much more than
merely the sum of its ingredients, with the combination of
ingredients yielding a synergistic and highly efficacious result.
For example, the polar lipid supplement acts as a spreading agent
that enhances the efficacy of the soluble fiber and the nutricines
by spreading them to cover the entire digestive tract. The soluble
fiber slows down the passage of the polar lipid supplement and the
nutricines, giving them both more time to provide their beneficial
effects on the digestive tract. The nutricines also increase the
integrity of the gut membrane, but are much more effective in
combination with the polar lipid supplement than they would be
without it.
[0062] The relative ranges of amounts of each of the ingredients,
and their preferred amounts, will now be discussed, beginning with
the nutricines. First, the nutricines that increase the integrity
of the mucous gut membrane, which in the preferred embodiment are
L-threonine and L-glutamine, will be discussed. The range of
amounts of L-threonine is between approximately one percent and
eight percent of the dietary supplement by weight. The most
preferred amount of L-threonine is approximately two and one-half
percent of the dietary supplement by weight.
[0063] The range of amounts of L-glutamine is between approximately
one percent and five percent of the dietary supplement by weight.
It is believed that less than one percent of L-glutamine will
result in little or no efficacious result. The most preferred
amount of L-glutamine is approximately two percent of the dietary
supplement by weight.
[0064] Next, the nutricines which absorb mycotoxins and bacteria in
the hindgut, which in the preferred embodiment are BIOMOS and
MYCOSORB, will be discussed. The range of amounts of BIOMOS is
between approximately two percent and five percent of the dietary
supplement by weight, although the relative percentage of BIOMOS
could be increased to as much as ten percent if colonic ulcers are
also being treated. The most preferred amount of BIOMOS is
approximately two and one-half percent of the dietary supplement by
weight.
[0065] The range of amounts of MYCOSORB is between approximately
two percent and five percent of the dietary supplement by weight,
although the relative percentage of MYCOSORB could be increased to
as much as ten percent if colonic ulcers are being treated. The
most preferred amount of MYCOSORB is approximately two and one-half
percent of the dietary supplement by weight.
[0066] Next, the soluble fiber, which in the preferred embodiment
is .beta.-glucan, will be discussed. The range of amounts of
.beta.-glucan is between approximately ten percent and fifty
percent of the dietary supplement by weight. The preferred amount
of .beta.-glucan is approximately fifteen to forty percent of the
dietary supplement by weight. The most preferred amount of
.beta.-glucan is approximately thirty-six percent of the dietary
supplement by weight.
[0067] The polar lipid supplement will now be discussed. It is
apparent from the preceding discussion that the only non-solid
ingredient in the dietary supplement of the present invention is
the polar lipid supplement, which in the preferred embodiment is
oat oil. Since the polar lipid supplement of the preferred
embodiment consists of oat oil (which is the mixture of all three
phases of oat oil), which is a liquid, it will be appreciated by
those skilled in the art that by adding an additional amount of the
third phase of oat oil, which is a thick paste, the resulting
physical character of the polar lipid supplement will be varied,
and by doing so, the resulting physical character of the dietary
supplement in turn may also be varied. This variation is optional
and is not done in the preferred embodiment.
[0068] As an example of this optional embodiment, by using
relatively more oat oil and relatively less of the third phase of
oat oil (or none of the third phase of oat oil at all), the dietary
supplement will be thinner which will aid its administration using
a dose syringe. On the other hand, by using relatively less oat oil
and relatively more of the third phase of oat oil, the dietary
supplement will be relatively thicker. Either of the two different
formulations could be mixed with feed or encased in gelcaps. The
range of each of the two ingredients in the polar lipid supplement
is between approximately twenty and eighty percent by weight of the
polar lipid supplement.
[0069] One preferred blend of the two ingredients in this optional
embodiment of the polar lipid supplement is approximately sixty-two
percent oat oil by weight, and approximately thirty-eight percent
of the third phase of oat oil by weight. A second preferred blend
of the two ingredients in the polar lipid supplement in this
optional embodiment is that blend produced by the respective yields
of the three phases of oat oil from oats. Since oats typically
contain between twelve and sixteen percent oat oil by weight, and
between five and six percent of the third phase of oat oil by
weight, those skilled in the art will appreciate that this blend
will be between twenty-four and thirty-three percent of the third
phase of oat oil by weight.
[0070] The range of amounts of the polar lipid supplement in the
dietary supplement of the present invention is between
approximately twenty-nine percent and eighty percent of the dietary
supplement by weight. The preferred amount of the polar lipid
supplement is between approximately forty percent and sixty-five
percent of the dietary supplement by weight. The most preferred
amount of the polar lipid supplement is approximately fifty-two and
one-half percent of the dietary supplement by weight.
[0071] For the preferred embodiment, the relative weight of the
sodium bicarbonate is approximately two percent of the dietary
supplement by weight.
[0072] The dietary supplement of the present invention may be
administered either by adding it to feed or by feeding it directly
as a dietary supplement. In the preferred embodiment, the dietary
supplement is administered daily in order to maintain an optimal
level of the ingredients in the animal's digestive tract.
Alternately, it could instead be given more or less frequently so
long as it is administered on a regular basis, although less
frequent administration may not be as effective. It may be
manufactured either as a liquid, in which case it can be added to
feed which is then fed to a horse, or as a liquid or paste and
stored in a gelatin capsule (as gelcaps), which makes for a
consistent and uniform dosage of the dietary supplement. If
manufactured as a paste, it can also be orally administered using a
dose syringe.
[0073] Since the dietary supplement of the present invention slows
the motility of foodstuffs through the digestive tract, it will be
appreciated by those skilled in the art that by orally
administering a medication in conjunction with the administration
of the dietary supplement, the medication will also spend more time
in the digestive tract. This will increase the absorption of the
medication, and will likely thereby act to enhance the therapeutic
effect of the medication. If desired, the medication can be
administered at the same time the dietary supplement is
administered, or even mixed or suspended in the dietary supplement
prior to administration of the dietary supplement.
EXAMPLE
[0074] A clinical evaluation was made of the dietary supplement of
the present invention. The formulation which was used was the
preferred embodiment, which consisted of: thirty-two and one-half
percent oat oil by weight; twenty percent of the third phase of oat
oil by weight; thirty-six percent .beta.-glucan by weight; two and
one-half percent L-threonine by weight; two percent L-glutamine by
weight; two and one-half percent BIOMOS by weight; two and one-half
percent MYCOSORB by weight; and two percent sodium bicarbonate by
weight.
[0075] The subjects of the clinical evaluation were eleven standard
bred racehorses ranging in age from four to ten, with seven being
geldings, two being stallions, and two being mares. At the
beginning of the clinical evaluation, three of the horses had grade
one ulcerations, one horse had grade one-two ulcerations, four
horses had grade two ulcerations, and one horse had grade three
ulcerations (as determined by examining them using an endoscope).
In order to measure the performance of the horses prior to the
clinical evaluation, the total earnings for each horse for the ten
starts in races prior to beginning the clinical evaluation were
obtained.
[0076] The horses were administered one ounce of the dietary
supplement of the present invention once daily together with their
hard feed (the grain diet which produces ulcerations), preferably
at their evening feeding. Administration of the dietary supplement
was with dose syringes, and the horses all willingly accepted the
dietary supplement (with its oat base, the horses all liked its
taste and willingly took it as a treat). No other change was made
in the care and treatment of the horses. During the clinical
evaluation, two of the horses were claimed, and one of the horses
was not available for post-clinical evaluation analysis, leaving
ten horses for which clinical data was obtained.
Therapeutic Results
[0077] All of the horses except one of the two which were claimed
were checked for ulcerations (as determined by examining them using
an endoscope). A random selection of four of the horses were
checked eight weeks after beginning the clinical evaluation. Two of
the horses checked at the eight-week check had not had ulcerations
at the initiation of the clinical evaluation, and had no
ulcerations at the eight-week check. One horse that had had grade
one-two ulcerations had only scarring at the eight-week check, with
the ulcerations having disappeared; this represented a substantial
improvement. The other horse that had had grade three ulcerations
had grade one ulcerations at the eight-week check, also a
substantial improvement.
[0078] A final check of the ten horses remaining in the clinical
evaluation for ulcerations (as determined using the endoscope) was
made at sixteen weeks. The two horses that had not had ulcerations
at the initiation of the clinical evaluation also had no
ulcerations at the fifteen-week check. The horse that had had grade
three ulcerations at the start of the clinical evaluation had no
ulcerations at the sixteen-week check. Of the four horses which had
had grade two ulcerations at the start of the clinical evaluation,
two horses had improved to grade one ulcerations at the sixteen
week check, two horses had improved to grade zero-one ulcerations
at the sixteen week check, and one horse had no ulcerations at the
sixteen week check. The horse that had had grade one-two
ulcerations at the start of the clinical evaluation had no
ulcerations at the sixteen-week check. Of the two horses that had
had grade one ulcerations at the start of the clinical evaluation,
one horses had improved to grade zero-one ulcerations at the
sixteen-week check, and the other horse had no ulcerations at the
sixteen-week check. Thus, all of the horses having ulcerations
improved over the course of the sixteen-week clinical
evaluation.
Performance Results
[0079] In addition, the horses consistently performed better after
the initiation of the clinical evaluation than they had prior to
the clinical evaluation, as measured by the total earnings for each
horse for the ten starts in races subsequent to beginning the
clinical evaluation. The average earnings for the horses were
increased by sixty-three percent over their earnings for the ten
races prior to initiation of the clinical evaluation. Even more
remarkably, the two horses that were claimed during this period
were claimed for over two hundred fifty percent of their assessed
market value at the initiation of the clinical evaluation.
Blood Work Results
[0080] Complete blood work tests were run on all of the horses
immediately prior to initiation of the clinical evaluation, and
approximately every two weeks thereafter. The tests which were run
were red blood cell count ("RBC"), hemoglobin ("HGB," which is a
measure of the oxygen-carrying capacity of the blood), hematocrit
("HCT," which is the packed red blood cell volume), white blood
cell count ("WBC"), Calcium, bicarbonate ("Bicarbo," which is the
extrapolated pH of the blood), Chloride, and Total Protein. The
results of each of these tests over an eight-week period are
summarized herein.
[0081] The red blood cell count (RBC) is an indicator of athletic
ability, and a general indication of the overall health of the
horse. RBC readings from 6.8 to 12.9 are in the normal range. On
average, for the eleven horses, RBC increased from 7.94 to 9.05, an
indication of substantially increased athletic ability and enhanced
health of the horses. The level of hemoglobin (HGB) is an indicator
of the potential of the blood to carry oxygen, with higher numbers
indicating a greater capacity and an enhanced athletic ability. HGB
readings from 11 to 19 are in the normal range. On average, for the
eleven horses, HGB increased from 13.1 to 15.1, an indication of
substantially increased capacity and enhanced athletic ability.
[0082] The hematocrit (HCT) count is a measure of the percentage of
blood volume made up of red blood cells. HCT readings from 38% to
42% are normal, with the lower and upper limits being 32% and 53%,
respectively. On average, for the eleven horses, HCT was relatively
unchanged, moving from 38.8% to 39%. The white blood cell count
(WBC) is indicative of the status of the immune system and the
general health of the horses. WBC readings from 5.4 to 14.3 are in
the normal range. On average, for the eleven horses, WBC increased
from 6.2 to 6.6, an indication of a healthy immune system and an
enhanced level of general health of the horses.
[0083] Calcium is a measure of the level of calcium in the blood.
Calcium readings from 10.8 to 12.5 are normal. On average, for the
eleven horses, Calcium was relatively unchanged, moving from 11.6
to 11.5. Bicarbonate (Bicarbo) is the extrapolated pH of the blood.
Bicarbo readings from 22 to 29 are normal, with a higher number
being an important indicator of increased athletic efficiency of
the horse due to its ability to neutralize lactic acid in the
blood. On average, for the eleven horses, Bicarbo increased from 29
to nearly 31, an indication of substantially increased athletic
capacity of the horses.
[0084] Chloride is used for electrical conduction of cells in the
body. Chloride readings from 98 to 105 are normal, with an
excessively low level presenting the potential of irregular
heartbeats or a condition known as the "thumps" in which each
heartbeat stimulates the diaphragm of the horse to flutter as well.
On average, for the eleven horses, Chloride decreased only slightly
from 100 to 98.9, representing an idiopathic phenomenon but one
with no negative effect on the horses. Total Protein is the total
amount of protein in the blood. Total Protein readings from 5.8 to
7.5 are normal. On average, for the eleven horses, Total Protein
increased from 6.1 to 6.5, clearly demonstrating an enhanced level
of absorption of nutrients which is indicative of improved function
in the digestive tract.
[0085] The blood tests are entirely consistent with the therapeutic
results and the performance results discussed above. The horses are
demonstrably healthier as measured by four significant criteria,
namely the red blood cell count (RBC), the level of hemoglobin
(HGB), the level of Bicarbo, and the level of Total Protein.
Further, these criteria indicate that the horses are likely to more
athletic and better performing, a conclusion that has been
confirmed by the performance results documented above.
Subjective Results
[0086] There is yet another indicator of the substantial benefit
conferred on the horses through the use of the dietary supplement
of the present invention. That indicator is the subjective
observations of the trained horse professionals, including
trainers, veterinarians, riders (including jockeys), and owners, as
well as horse enthusiasts. The horses taking the dietary supplement
were more active, appeared to be healthier (many people described
the horses as having a "glow" which they had not previously had),
and appeared to be more contented (no doubt due to the absence of
ulcers). In addition, they were more responsive in the view of
their trainers and jockeys. These subjective results coincided
completely with the objective results discussed above. It will be
readily apparent to those skilled in the art from the preceding
discussion of the ingredients of the dietary supplement of the
present invention and their interaction that the benefits achieved
by the dietary supplement of the present invention is substantially
greater than the sum of the benefits of each of the dietary
supplement's ingredients separately.
[0087] It may therefore be appreciated from the above detailed
description of the preferred embodiment of the present invention
that it teaches a dietary supplement which efficaciously treats
digestive tract ulcers in horses and, potentially, in other animals
and even humans as well. The dietary supplement of the present
invention can be fed to any animal including, but not limited to,
avian, bovine, porcine, equine, ovine, caprine, canine, and feline
species. In addition to having the effect of efficaciously treating
digestive tract ulcers, the dietary supplement of the present
invention demonstrates efficacy in the prevention of such digestive
tract ulcers as well. The dietary supplement of the present
invention is effective in treating and/or preventing gastric
ulcers, and in treating colonic ulcers as well.
[0088] The dietary supplement of the present invention does not
interfere with the proper digestion of foodstuffs while it is
treating and/or preventing digestive tract ulcers. It consists
entirely of safe and natural ingredients rather than drugs. The
dietary supplement of the present invention is orally
administrable, thereby making its dispensation a simple matter. It
can also be packaged in single doses to make its administration as
convenient as is possible.
[0089] The dietary supplement of the present invention is stable
and has a long shelf life, and requires no special care to be
provided by the user throughout its shelf life prior to usage. The
dietary supplement of the present invention is also inexpensive
relative to previously known dietary tract ulcer treatments,
thereby enhancing its market appeal and affording it the broadest
possible market. Finally, all of the aforesaid advantages and
objectives of the dietary supplement of the present invention and
its method of administration are achieved without incurring any
substantial relative disadvantage.
[0090] Although the foregoing description of the dietary supplement
of the present invention has been shown and described with
reference to particular embodiments and applications thereof, it
has been presented for purposes of illustration and description and
is not intended to be exhaustive or to limit the invention to the
particular embodiments and applications disclosed. It will be
apparent to those having ordinary skill in the art that a number of
changes, modifications, variations, or alterations to the invention
as described herein may be made, none of which depart from the
spirit or scope of the present invention. The particular
embodiments and applications were chosen and described to provide
the best illustration of the principles of the invention and its
practical application to thereby enable one of ordinary skill in
the art to utilize the invention in various embodiments and with
various modifications as are suited to the particular use
contemplated. All such changes, modifications, variations, and
alterations should therefore be seen as being within the scope of
the present invention as determined by the appended claims when
interpreted in accordance with the breadth to which they are
fairly, legally, and equitably entitled.
* * * * *