U.S. patent application number 10/692064 was filed with the patent office on 2004-08-12 for method and nutraceutical composition for mammals.
Invention is credited to Davenport, David F., Martin, J. Eric.
Application Number | 20040156923 10/692064 |
Document ID | / |
Family ID | 32829557 |
Filed Date | 2004-08-12 |
United States Patent
Application |
20040156923 |
Kind Code |
A1 |
Davenport, David F. ; et
al. |
August 12, 2004 |
Method and nutraceutical composition for mammals
Abstract
Provided is a nutraceutical composition including a glucosamine
based component. The composition is effective to improve fertility
in mammals, including humans and stallions. A method for improving
fertility in a mammal using glucosamine based nutraceutical
composition is also provided.
Inventors: |
Davenport, David F.;
(Knoxville, TN) ; Martin, J. Eric; (Louisville,
TN) |
Correspondence
Address: |
ST. ONGE STEWARD JOHNSTON & REENS, LLC
986 BEDFORD STREET
STAMFORD
CT
06905-5619
US
|
Family ID: |
32829557 |
Appl. No.: |
10/692064 |
Filed: |
October 23, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60420743 |
Oct 23, 2002 |
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Current U.S.
Class: |
424/727 ;
424/755; 424/757; 424/764; 424/776; 514/100; 514/440; 514/62 |
Current CPC
Class: |
A23K 50/20 20160501;
A61K 31/7008 20130101; A23K 10/37 20160501; A61K 36/28 20130101;
A61K 31/665 20130101; A61K 36/286 20130101; Y02P 60/87 20151101;
A61K 31/385 20130101; A61P 15/08 20180101; A23K 20/163 20160501;
A61K 36/185 20130101; A23V 2002/00 20130101; Y02P 60/877 20151101;
A61K 36/889 20130101; A23K 50/10 20160501; A23K 50/00 20160501;
A23K 20/174 20160501; A61P 43/00 20180101; A23L 33/10 20160801;
A23K 20/30 20160501; A61K 36/48 20130101; A61K 36/55 20130101; A61K
36/31 20130101; A23K 10/18 20160501; A61K 31/385 20130101; A61K
2300/00 20130101; A61K 31/665 20130101; A61K 2300/00 20130101; A61K
31/7008 20130101; A61K 2300/00 20130101; A61K 36/185 20130101; A61K
2300/00 20130101; A61K 36/28 20130101; A61K 2300/00 20130101; A61K
36/286 20130101; A61K 2300/00 20130101; A61K 36/31 20130101; A61K
2300/00 20130101; A61K 36/48 20130101; A61K 2300/00 20130101; A61K
36/55 20130101; A61K 2300/00 20130101; A61K 36/889 20130101; A61K
2300/00 20130101; A23V 2002/00 20130101; A23V 2250/308 20130101;
A23V 2250/1612 20130101; A23V 2250/1586 20130101; A23V 2250/1572
20130101; A23V 2250/1642 20130101; A23V 2250/72 20130101; A23V
2250/7056 20130101 |
Class at
Publication: |
424/727 ;
514/062; 514/440; 514/100; 424/776; 424/757; 424/755; 424/764 |
International
Class: |
A61K 035/78; A61K
031/665; A61K 031/385; A61K 031/7008 |
Claims
What is claimed is:
1) A nutraceutical composition comprising the following
constituents: an oil cake component, a glucosamine component, an
acid component, a mineral component, a vitamin component, and a
functional food component, wherein each constituent is present in
an effective proportion such that, when administered to a mammal in
an effective amount, the nutraceutical composition is effective to
improve fertility.
2) The composition of claim 1 wherein the oilcake component is
selected from the group consisting of soybean flower, linseed oil
cake, cottonseed oil cake, peanut oil cake, safflower oil cake,
coconut oil cake, palm oil cake, sesame oil cake, sunflower oil
cake, rapeseed oil cake, kapok oil cake, mustard seed oil cake, and
combinations thereof.
3) The composition of claim 1 wherein said glucosamine component is
a chemical selected from the group consisting of glucosamine
sulphate, glucosamine sulfate 2KCL, glucosamine sulfate NaCl,
glucosamine hydrochloride, N-acetylglucosamine, Poly-Nag.
glucosamine, and combinations thereof.
4) The composition of claim 1 wherein said acid component is
ascorbic acid and at least one derivative thereof, lipoic acid, or
dihydrolipoic acid, wherein the derivative is selected from the
group consisting of magnesium ascorbyl phosphate, sodium ascorbyl
phosphate, sodium ascorbate, ascorbyl glucoside, and combinations
thereof.
5) The composition of claim 1 wherein said mineral component
further comprises at least one mineral selected from the group
consisting of zinc, boron, chromium, manganese, and combinations
thereof.
6) The composition of claim 1 wherein said mineral acid component
is further characterized as an amino acid chelate.
7) The composition of claim 1 wherein said vitamin component
further comprises at least one vitamin selected from the group
consisting of biotin, thiamine HCL, folic acid, and combinations
thereof.
8) The composition of claim 1 wherein said functional food
component further comprises an ingredient selected from the group
consisting of prebiotic, probiotic, synbiotic and combinations
thereof.
9) The composition of claim 1 wherein the components of the
nutraceutical composition are present in the following approximate
effective proportions: between about 50 and about 200 pbw oil cake,
between about 400 to 750 pbw glucosamine component, between about
50 and about 150 pbw acid component, between about 0.0001 and about
1 pbw mineral component, between about 0.0001 about 1 pbw vitamin
component, between about 0.0001 and about 1 pbw of functional food
component.
10) The composition of claim 1 in a powder dosage form.
11) The composition of claim 1 wherein said mammal is a male
horse.
12). A nutraceutical composition comprising the following
constituents: a) soybean flour, b) glucosamine sulphate 2KCL, c)
sodium ascorbate, d) manganese, e) chromium, f) boron, g) zinc, h)
biotin, i) thiamine HCL, j) folic acid, and k) a functional food
component, wherein each constituent is present in an effective
proportion such that, when administered to a mammal in an effective
amount, the nutraceutical composition is effective to improve
fertility.
13) The composition of claim 12 wherein said mammal is a
stallion.
14) A nutraceutical composition comprising the following
constituents: a glucosamine component, and a nutrient component,
wherein each constituent is present in an effective proportion such
that, when administered to a mammal in an effective amount, the
nutraceutical composition is effective to improve fertility.
15) The composition of claim 14 wherein said nutrient component
further comprises at least one ingredient selected from the group
consisting of oil cake component, acid component, mineral
component, vitamin component, functional food component, and
combinations thereof.
16) The composition of claim 14 in a dosage form selected from the
group consisting of solid dosage form, dry powder dosage form,
liquid dosage form, and combinations thereof.
17) The composition of claim 14 where in the mammal is selected
from the group consisting of human, bovine, equine, caprine, ovine,
and porcine.
18) A nutraceutical composition comprising a glucosamine component
present in an effective proportion such that, when administered to
a mammal in an effective amount, the nutraceutical composition is
effective to improve fertility.
19) The composition of claim 18 wherein the glucosamine component
is selected from the group consisting of glucosamine sulphate,
glucosamine sulfate 2KCL, glucosamine sulfate NaCl, glucosamine
hydrochloride, N-acetylglucosamine, Poly-Nag. glucosamine, and
combinations thereof.
20) The composition of claim 18 in a dosage form selected from the
group consisting of solid dosage form, dry powder dosage form,
liquid dosage form, and combinations thereof.
21) The composition of claim 18 where in the mammal is selected
from the group consisting of human, bovine, equine, caprine, ovine,
and porcine.
22) A method for improving fertility in a mammal comprising the
step of administering to the mammal gametogenesis promoting
effective amount of a nutraceutical composition comprising the
following constituents: a) an oil cake component, b) a glucosamine
component, c) an acid component, d) a mineral component, e) a
vitamin component; and f) a functional food component, wherein each
of the constituents is present in the composition in an effective
proportion.
23) The method of claim 22 wherein the nutraceutical composition is
in an oral liquid dosage form.
24) The method of claim 22 wherein the nutraceutical composition is
in a dry powder form.
25) The method of claim 22 wherein said mammal is a stallion.
26) The method of claim 22 wherein said effective proportion
further comprises: a) between about 50 and about 200 pbw oil cake
component, b) between about 400 to 750 pbw glucosamine component,
c) between about 50 and about 150 pbw acid component, d) between
about 0.0001 and about 1 pbw mineral component, e) between about
0.0001 and about 1 pbw vitamin component, and f) between about
0.0001 and about 1 pbw of functional food component.
27) The method of claim 22 wherein said glucosamine component is a
chemical selected from the group consisting of glucosamine
sulphate, glucosamine sulfate 2KCL, glucosamine sulfate NaCL,
glucosamine hydrochloride, N-acetylglucosamine, Poly-Nag.
glucosamine, and combinations thereof.
28) The method of claim 22 wherein said acid component is ascorbic
acid and at least one derivative thereof, lipoic acid, or
dihydrolipoic acid, wherein the derivative is selected from the
group consisting of magnesium ascorbyl phosphate, sodium ascorbyl
phosphate, sodium ascorbate, ascorbyl glucoside, and combinations
thereof.
29) The method of claim 22 wherein said mineral component further
comprises at least one mineral selected from the group consisting
of zinc, boron, chromium, manganese, and combinations thereof.
30) The method of claim 22 wherein said mineral acid component is
further characterized as an amino acid chelate.
31) The method of claim 22 wherein said vitamin component further
comprises at least one vitamin selected from the group consisting
of biotin, thiamine HCL, folic acid, and combinations thereof.
32) The method of claim 22 wherein said functional food component
further comprises at least one ingredient selected from the group
consisting of prebiotic, probiotic, synbiotic, and combinations
thereof.
33) The method of claim 22 wherein the oil cake is a vegetable oil
cake.
34) The method of claim 22 wherein the oilcake component is
selected from the group consisting of soybean flower, linseed oil
cake, cottonseed oil cake, peanut oil cake, safflower oil cake,
coconut oil cake, palm oil cake, sesame oil cake, sunflower oil
cake, rapeseed oil cake, kapok oil cake, mustard seed oil cake, and
combinations thereof.
35) A therapeutic composition for the treatment, repair, or
increased production of gametocytes in mammals, comprising:
therapeutic quantities of glucosamine and salts thereof, in
combination with a nutrient component, for effectively promoting
fertility in mammals in need thereof.
36) The therapeutic composition of claim 35, wherein the
glucosamine is selected from the group consisting of glucosamine
hydrochloride, glucosamine sulphate, glucosamine sulphate 2KCL,
glucosamine sulphate NaCL, and combinations thereof.
37) The therapeutic composition of claim 36 in a dose, wherein the
dose of glucosamine ranges of from about 1 g to about 50 g per
day.
38) The therapeutic composition of claim 36, wherein the
therapeutic quantity of glucosamine for horses or large mammals is
approximately 20 g per day.
39) A method for improving fertility in a mammal comprising the
step of administering to the mammal gametogenesis promoting
effective amount of a nutraceutical composition comprising a
glucosamine component in an effective proportion.
40) The method of claim 39 wherein said glucosamine component is a
chemical selected from the group consisting of glucosamine
sulphate, glucosamine sulfate 2KCL, glucosamine sulfate NaCL,
glucosamine hydrochloride, N-acetylglucosamine, Poly-Nag.
glucosamine, and combinations thereof.
41. The method of claim 39 wherein the nutraceutical composition is
in an oral liquid dosage form, or a powder form.
42) The method of claim 39 wherein said mammal is a human, horse,
dog, cow, pig, or sheep.
43) A method for improving fertility in a mammal comprising the
step of administering to the mammal, conception, implantation, or
gestation promoting effective amount of a nutraceutical composition
comprising a glucosamine component in an effective proportion.
44) The method of claim 43 wherein said glucosamine component is a
chemical selected from the group consisting of glucosamine
sulphate, glucosamine sulfate 2KCL, glucosamine sulfate NaCL,
glucosamine hydrochloride, N-acetylglucosamine, Poly-Nag.
glucosamine, and combinations thereof.
45) The method of claim 43 wherein the nutraceutical composition is
in an oral liquid dosage form, or a powder form.
Description
[0001] Applicants claim priority benefits under 35 U.S.C.
.sctn.119(e) of U.S. Provisional Patent Application Serial No.
60/420,743 filed Oct. 23, 2002.
FIELD OF THE INVENTION
[0002] The present invention relates to therapeutic compositions
and methods for promoting fertility in mammals in need thereof.
Furthermore, the invention relates to glucosamine based
nutraceutical compositions capable of promoting fertility in a
mammal.
BACKGROUND OF THE INVENTION
[0003] Sperm and egg generating processes in mammals are constantly
subjected to stresses from physical, chemical, and biological
sources that can result in problems whereby a male or female may
become infertile or sub-fertile due to poor or insufficient semen
or egg quality. These problems may be compounded in the cases of
under or mal nourished mammals.
[0004] The treatment of sperm or egg afflictions can be quite
problematic, especially in the case of humans and animals such as
horses, where treatment is often directed at controlling the
symptoms of the afflictions and not their causes, regardless of the
stage of infertility, or sub-fertility. Improving sperm and egg
quality may be significantly hampered, in the case where the mammal
is under nourished or mal nourished and lacks the requisite
building blocks to promote spermatogenesis or oogenesis. In these
cases, medical or veterinarian assistance alone may not improve the
quality and quantity of sperm.
[0005] Sperm are produced by the well known process of
spermatogenesis where spermatogonia develop from primordial germ
cells that migrate into the testis early in embryogenesis. In
sexually mature male mammals, the spermatogonia divide to
continually renew themselves, where some sperm further divide by
meiosis to become primary spermatocytes, which in turn continue
through meiotic division I to become secondary spermatocytes. After
they complete meiotic division II, the secondary spermatocytes
produce haploid spermatids that differentiate into mature sperm.
Mature sperm comprise various components including a head and a
tail. All of the steps in the process require the continuous input
of cellular building blocks in order to adequately and correctly
produce viable mature sperm.
[0006] Eggs are produced by a well known process called oogenesis.
The process results in the formation of a large cell having a
variety of resources for the construction of the embryo.
Accordingly, oogenesis requires adequate nutrition to provide the
cellular building blocks to create the equipped cells.
[0007] The basic cellular building blocks include, among other
things, amino acids, carbohydrates, proteins, fats and saccharides.
The present invention provides compositions having effective
fertility promoting nutrients to enhance gametogenesis and the
maintenance of sperm and egg cells, which ultimately promote
fertility. Nutrients are required to play a role in the development
and function of sperm and egg. Detailed knowledge of the role
played by various nutrients or the level required for optimal
development and function of sperm and egg are not well understood.
Therefore, correcting key nutrient deficiency through
supplementation has been problematic. The present invention
overcomes these difficulties by providing compositions, mixtures,
and dosage forms containing the key nutrients needed to improve
fertility in mammals.
[0008] For many mammalian breeders, such as horse breeders,
infertility is an aggravating problem forcing breeders to seek
medical and veterinarian assistance. Such assistance may be costly
and untimely with respect to the mating season. Accordingly, lower
costing supplementation may alleviate the problems of infertility
prior to seeking assistance.
[0009] Conventional treatments for various mammalian infertility
conditions include the administration of human chorionic
gonadotrophins (hCG), human menopausal gonadotrophin
(hMG)(consisting of equal amounts of follicle stimulating hormone,
FSH, and luteinizing hormone LH), or luteinizing hormone releasing
hormone(LHRH), also known as gonadotrophin releasing hormones
(GnRH). Treatment with these hormones however, is generally
expensive, and does not always yield satisfactory results for
certain males, such as those exhibiting idiopathic
oligospermia.
[0010] An alternative medicinal treatment to the drugs described
above are low cost `natural` medicines such as various herbs which
are typically ingested over large periods of time to form part of
one's diet. Two examples of naturally occurring herbs thought to
increase the human bodies' production of male hormones include
ginseng and sarsaparilla. The roots of these herbs are thought to
have the medicinal properties. However, it is inconclusive whether
ingestion of these herbs does indeed promote spermatogenesis.
[0011] Patents of interest include U.S. Pat. No. 5,364,845 (herein
incorporated by reference) which relates to a method and
composition for the protection, treatment and repair of connective
tissue in mammals. The composition includes glucosamine and
chondroitin sulfate. The composition further includes manganese
ascorbate which catalyzes the production of collagen and
proteoglycans from the glucosamine and the chondroitin sulfate.
[0012] Furthermore U.S. Pat. No. 6,558,911 (herein incorporated by
reference) relates to male infertility, and in particular to assays
for predicting fertility in animals including human and bovines. In
some embodiments, semen samples are evaluated by measuring the
amount of ubiquitin in the sample, and in particular by measuring
the extent of ubiquitination spermatozoa. Increased levels of
ubiquitination in a sample are correlated with lower fertility.
[0013] Due to stress on sperm and egg cells from the continuously
replicating nature of spermatogenesis, and the storage of egg
cells, proper nourishment is essential to facilitate fertility and
promote adequate amounts of viable gametes. Accordingly what is
needed is a composition which alleviates, overcomes, or cures the
problem of infertility and sub-fertility by ensuring that gamete
generating tissues are nourished and have access to the cellular
building blocks necessary for spermatogenesis, oogenesis and gamete
maintenance. The compositions and methods of the present invention
are applicable to males wherein the conception rate may be affected
by physical, chemical, or biological stressors to the sperm or
developing sperm in the target organ. Moreover, the compositions
and methods of the present invention are applicable to females
wherein the egg integrity may be affected by physical, chemical, or
biological stressors to the egg or developing egg in the target
organ.
[0014] The present invention relates generally to nutraceutical
compositions and specifically to those compositions making use of
glucosamine in promoting fertility. In particular, the compositions
may be provided in dosage forms for treating infertile or
sub-fertile mammals. The present invention provides improved
compositions that require little technical expertise to use, are
rapid, and may be used either as a nutritional supplement, or as a
medicinal treatment of infertile or sub-fertile mammals.
SUMMARY OF THE INVENTION
[0015] It is an object of the invention to provide a composition
for increasing fertility in mammals.
[0016] It is the object of the present invention to increase
dietary intake of vitamins and minerals associated with the
gametogenesis in mammals.
[0017] It is a further objective of the present invention to
provide a method for improving conception rates in a mammal.
[0018] It is an object of the invention to provide a method and
composition for increasing fertility in stallions.
[0019] It is a further object of the present invention to improve
conception rates in mammals.
[0020] It is a further object of the present invention to provide
digestive tract support in mammals.
[0021] It is a further object of the present invention to provide a
nutraceutical composition having a long shelf life.
[0022] It is a further object of the present invention to provide a
nutraceutical composition that is multifunctional.
[0023] These and other objectives of the present invention are
obtained by providing a nutraceutical composition comprising a
glucosamine component present in an effective proportion such that,
when administered to a mammal in an effective amount, the
nutraceutical composition is effective to improve fertility. The
glucosamine component is selected from the group consisting of
glucosamine sulphate, glucosamine sulfate 2KCL, glucosamine sulfate
NaCl, glucosamine hydrochloride, N-acetylglucosamine, Poly-Nag.
glucosamine, and combinations of these chemicals. The composition
may further be provided in a solid dosage form, and/or a dry powder
dosage form and/or a liquid dosage form, and combinations of these
dosage forms. Mammals include human, bovine, equine, caprine,
ovine, and porcine subjects.
[0024] The objectives of the present invention are further obtained
by providing a nutraceutical composition comprising the following
constituents: an oil cake component; a glucosamine component; an
acid component; a mineral component; a vitamin component; and a
functional food component, wherein each constituent is present in
an effective proportion such that, when administered to a mammal in
an effective amount, the nutraceutical composition is effective to
improve fertility. The oil cake component is selected from the
group consisting of soybean flower, linseed oil cake, cottonseed
oil cake, peanut oil cake, safflower oil cake, coconut oil cake,
palm oil cake, sesame oil cake, sunflower oil cake, rapeseed oil
cake, kapok oil cake, mustard seed oil cake, and combinations of
these. The glucosamine component is a chemical selected from the
group consisting of glucosamine sulphate, glucosamine sulfate 2KCL,
glucosamine sulfate NaCl, glucosamine hydrochloride,
N-acetylglucosamine, Poly-Nag. glucosamine, and combinations of
these. The composition further contains an acid component such as
ascorbic acid and/or at least one derivative of ascorbic acid,
lipoic acid, or dihydrolipoic acid, wherein the derivative of
ascorbic acid is selected from the group consisting of magnesium
ascorbyl phosphate, sodium ascorbyl phosphate, sodium ascorbate,
ascorbyl glucoside, and combinations thereof. The composition may
further comprise a mineral component further comprising at least
one mineral selected from the group consisting of zinc, boron,
chromium, manganese, and combinations of these. The composition
comprises a mineral acid component characterized as an amino acid
chelate. The composition may additionally include a vitamin
component wherein said vitamin component further comprises at least
one vitamin selected from the group consisting of biotin, thiamine
HCL, folic acid, and combinations thereof. The composition may
further contain a functional food component that further comprises
an ingredient selected from the group consisting of prebiotic,
probiotic, synbiotic and combinations of these. This embodiment may
further comprise components of the nutraceutical composition
present in the following approximate effective proportions: between
about 50 and about 200 pbw oil cake, between about 400 to 750 pbw
glucosamine component, between about 50 and about 150 pbw acid
component, between about 0.0001 and about 1 pbw mineral component,
between about 0.0001 about 1 pbw vitamin component, between about
0.0001 and about 1 pbw of functional food component. Such
compositions may be administered to a patient in need thereof in an
effective amount in a powder dosage form. Suitable subjects include
a male or female mammal such as a horse.
[0025] The objectives of the present invention are further obtained
by providing a nutraceutical composition comprising the following
constituents: soybean flour, glucosamine sulphate 2KCL, sodium
ascorbate, manganese, chromium, boron, zinc, biotin, thiamine HCL,
folic acid, and a functional food component, wherein each
constituent is present in an effective proportion such that, when
administered to a mammal in an effective amount, the nutraceutical
composition is effective to improve fertility. The mammal may be,
among other things, a male or female human or horse.
[0026] The objectives of the present invention are further obtained
by providing a nutraceutical composition comprising the following
constituents: a glucosamine component, and a nutrient component,
wherein each constituent is present in an effective proportion such
that, when administered to a mammal in an effective amount, the
nutraceutical composition is effective to improve fertility. Such
composition may use a nutrient component that further comprises at
least one ingredient selected from the group consisting of oil cake
component, acid component, mineral component, vitamin component,
functional food component, and combinations of these. Such
composition may be in a dosage form selected from the group
consisting of solid dosage form, dry powder dosage form, liquid
dosage form, and combinations thereof. Such composition may be
useful for a mammal such as human, bovine, equine, caprine, ovine,
and porcine.
[0027] The objectives of the present invention are further obtained
by providing a method for improving fertility in a mammal
comprising the step of administering to the mammal gametogenesis
promoting effective amount of a nutraceutical composition
comprising the following constituents: an oil cake component, a
glucosamine component, an acid component, a mineral component, a
vitamin component, and a functional food component, wherein each of
the constituents is present in the composition in an effective
proportion. Such method further includes providing a nutraceutical
composition in an oral liquid dosage form, or a dry powder form.
The mammal may be, among other things, a male or female human or
horse. The mammal may be a stallion. Such a method having an
effective proportion comprising: between about 50 and about 200 pbw
oil cake component, between about 400 to 750 pbw glucosamine
component, between about 50 and about 150 pbw acid component,
between about 0.0001 and about 1 pbw mineral component, between
about 0.0001 and about 1 pbw vitamin component, and between about
0.0001 and about 1 pbw of functional food component. Such a method
may include a glucosamine component which is a chemical selected
from the group consisting of glucosamine sulphate, glucosamine
sulfate 2KCL, glucosamine sulfate NaCL, glucosamine hydrochloride,
N-acetylglucosamine, Poly-Nag. glucosamine, and combinations of
these chemicals. Such a method may optionally include an acid
component wherein the acid component is ascorbic acid and at least
one derivative thereof, lipoic acid, or dihydrolipoic acid, wherein
the derivative is selected from the group consisting of magnesium
ascorbyl phosphate, sodium ascorbyl phosphate, sodium ascorbate,
ascorbyl glucoside, and combinations thereof. Such a method may
optionally include a mineral component wherein said mineral
component further comprises at least one mineral selected from the
group consisting of zinc, boron, chromium, manganese, and
combinations thereof. Such a method may further include the mineral
acid component characterized as an amino acid chelate. The method
may further provide a vitamin component further comprising at least
one vitamin selected from the group consisting of biotin, thiamine
HCL, folic acid, and combinations thereof. The method optionally
may include a functional food component further comprising at least
one ingredient selected from the group consisting of prebiotic,
probiotic, synbiotic, and combinations thereof. The method may use
an oil cake which is characterized as a vegetable oil cake.
Further, the method may further include an oilcake component
selected from the group consisting of soybean flower, linseed oil
cake, cottonseed oil cake, peanut oil cake, safflower oil cake,
coconut oil cake, palm oil cake, sesame oil cake, sunflower oil
cake, rapeseed oil cake, kapok oil cake, mustard seed oil cake, and
combinations thereof.
[0028] The objectives of the present invention are further obtained
by providing a therapeutic composition for the treatment, repair,
or increased production of gametocytes in mammals, comprising:
therapeutic quantities of glucosamine and salts thereof, in
combination with a nutrient component, for effectively promoting
fertility in mammals in need thereof. Such a composition may
optionally include glucosamine selected from the group consisting
of glucosamine hydrochloride, glucosamine sulphate, glucosamine
sulphate 2KCL, glucosamine sulphate NaCL, and combinations thereof.
Such a composition may further optionally be, or be administered as
a dose, wherein the dose of glucosamine ranges of from about 1 g to
about 50 g per day. Such a composition may further optionally be
comprise a therapeutic quantity of glucosamine for horses or large
mammals which is approximately 20 g per day. The gametocytes may be
a mammalian sperm or an egg.
[0029] The objectives of the present invention may further be
obtained by providing a method for improving fertility in a mammal
comprising the step of administering to the mammal gametogenesis
promoting effective amount of a nutraceutical composition
comprising the following constituents: a glucosamine component, a
nutrient component, wherein each of the constituents is present in
the composition in an effective proportion. Such a method may
optionally be administered as an oral liquid dosage form, or a dry
powder form. Such a method is suitable for a mammal which may be a
human, horse, dog, cow, pig, sheep, or lab animal.
Definition of Terms
[0030] The following definitions apply throughout the present
specification:
[0031] The term "oil cake" refers to the refuse of flax seed,
cotton seed, or other vegetable substance from which oil has been
expressed, compacted into a solid mass, and used as food, for
manure, or for other purposes. The term further refers to suitable
vegetable substances such as soybean flower, linseed oil cake,
cottonseed oil cake, peanut oil cake, safflower oil cake, coconut
oil cake, palm oil cake, sesame oil cake, sunflower oil cake,
rapeseed oil cake, kapok oil cake, mustard seed oil cake, and the
like.
[0032] The term "nutrient" refers to any substance that furnishes
nourishment to an animal. The term further refers to substances
such as protein, fat, carbohydrate, simple sugar, functional food,
vitamin, mineral, prebiotic, probiotic, synbiotic, acid, base, or
salt that provides nourishment to an animal. The term further
refers to complexes of protein, fat, carbohydrate, simple sugar,
vitamin, mineral, prebiotic, probiotic, synbiotic, acid, base, or
salt that provides nourishment to an animal.
[0033] The term "probiotic" refers to substance or organism which
contributes to intestinal microbial balance in an animal. The term
further refers to living organisms in foods and feeds or dietary
supplements which contribute to intestinal microbial balance in an
animal.
[0034] The term "prebiotic" refers to a substance or ingredient
that when provided to the digestive tract selectively supports the
growth of beneficial bacterial species over pathogenic ones. The
term further refers to substances that do not directly colonize the
digestive tract. The term prebiotic further refers to, but is by no
means limited to yeast, yeast cultures, fungal cultures, and
preferably, certain fibers (FOS-fructooligosaccharides).
[0035] The term "synbiotic" refers to substances or ingredients
that contain both prebiotic and probiotic ingredients. The term
further refers to a prebiotic and probiotic blend for
gastrointestinal support.
[0036] The term "functional food" refers to a food which contains
one or a combination of components which affects functions in the
body so as to have positive cellular or physiological effects. The
term further refers to prebiotic(s), probiotic(s), and/or
synbiotic(s).
[0037] The term "parts by weight", abbreviated "pbw", is given its
usual and customary meaning wherein a part can be expressed with
reference to any convenient unit of measure, for example ounce or
gram. When used with respect to a component or constituent, pbw is
with reference to the total nutraceutical composition. For
components or constituents that can include water of
crystallization (hydration), pbw are based on the component or
constituent in the non-hydrated form. The term "pbw" refers to a
mix ratio as parts by weight. The term refers generally to mixing
by weight.
[0038] The term "fertility" refers to the quality or state of being
fertile. The term further refers to a male or female mammal being
capable of breeding or reproducing.
[0039] The term "mammal" refers to any of a class (Mammalia) of
warm-blooded higher vertebrates (as placentals, marsupials, or
monotremes) that nourish their young with milk secreted by mammary
glands, have the skin usually more or less covered with hair, and
include humans. The term further refers to domestic animals, such
as feline or canine subjects, farm animals, such as but not limited
to bovine, equine, caprine, ovine, and porcine subjects, wild
animals (whether in the wild or in a zoological garden), research
animals, such as mice, rats, rabbits, goats, sheep, pigs, dogs,
cats, etc., avian species, such as chickens, turkeys, songbirds,
etc., i.e., for human or veterinary medical use.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] FIG. 1 is a graph of pregnancies per cycle over time.
[0041] FIG. 2 is a graph of pregnancies per cycle over time
demonstrating pregnancies per cycle for treated and control
stallions.
[0042] FIG. 3 is a graph of sperm quantity over time demonstrating
mean concentration of sperm for treated and control stallions.
[0043] FIG. 4 is a graph of spermatozoa quantity over time
demonstrating mean motility for treated and control stallions.
[0044] FIG. 5 is a graph showing motility % over time demonstrating
motility for treated and control stallions.
[0045] FIG. 6 is a graph showing normal morphology % over time
demonstrating mean normal sperm morphology for treated and control
stallions.
[0046] FIG. 7 is a graph showing viability (%) over time
demonstrating mean viability for treated and control stallions.
DETAILED DESCRIPTION
[0047] The composition of the present invention includes an oil
cake component, a glucosamine component, an acid component, a
mineral component, a vitamin component, and preferably a symbiotic
component. According to the principles of the present invention, a
composition of oil cake, an acid component, a mineral component, a
vitamin component, and preferably a symbiotic component, and in
combination with a glucosamine component, all of which are
introduced from or produced outside the mammal, are administered to
a mammal in need thereof. The composition is provided so as to be
available for use by the mammal's spermatogenesis processes to
manufacture sperm and promote sperm maintenance, and thus is useful
in the prophylaxis or treatment, for example, of conditions or
diseases in which enhanced sperm quality or sperm proliferation are
desirable, among other desirable activities. The composition is
further provided so as to be available for use by the mammal's
oogenesis processes to manufacture egg and promote egg maintenance,
and thus is useful in the prophylaxis or treatment, for example, of
conditions or diseases in which enhanced egg quality or egg
proliferation are desirable, among other desirable activities, such
as enhancing attachment sites on the egg to improve conception.
[0048] Glucosamine is rapidly available to mammals after oral
administration, and is a very small building block type nutrient
that is found ubiquitously in mammalian tissue. Glucosamine is
actively concentrated in some tissues such as connective tissue and
all mucosal linings. Many important reproductive cells and
structures contain large concentrations of glucosamine. Most of the
glucosamine containing structures mentioned contain the acetylated
form of glucosamine linked together by sulphur bonds. However, this
form has been shown to be highly utilized in the digestive tract,
with only small amounts being absorbed by the body. Absorption of
the acetylated form occurs via passive diffusion. Glucosamine
sulphate is, however, absorbed actively from the digestive tract
using a glucose transporter. This active absorption has been shown
to be over 90% efficient within 30 minutes in at least 3 species.
The acetylation of glucosamine sulphate as well as its conversion
to galactosamine is readily performed in most tissues. Supplying
large amounts of a purified nutrient alone may not positively
affect the desired systems and can have negative effects.
Furthermore, both chondroitin sulfate and injectable PSGAG's may
cause decreased stallion reproductive performance due to the large
size of these molecules.
[0049] Several male and female reproductive structures utilize
glucosamine, including but not limited to, lining of the uterus and
cervix, Zona pellucida of the egg, attachment site of egg to sperm,
implantation site of the embryo into the uterus, cell to cell
adhesion in early development of the cumulus mass, testies, sperm
membrane, seminal fluid, and the acrosomal end of the sperm.
Moreover, glucosamine plays a role in a variety of chemical
reactions, including a role in Acrosomal reaction. Administered
glucosamine localizes to male reproductive tissues, where it
becomes available for spermatogenesis. Administered glucosamine
localizes to female reproductive tissues, where it becomes
available for oogenesis, conception and embryonic development.
Moreover, it has been surprising found that supplementation with
glucosamine enhances the seminal fluids and uterus to create a more
favorable environment for conception, implantation, and gestation
leading to improved fertility.
[0050] The glucosamine component is the base of the composition and
may include glucosamine sulphate, glucosamine sulfate 2KCL,
glucosamine sulphate NaCL, glucosamine hydrochloride,
N-acetylglucosamine and Poly-Nag. glucosamine. It has been found
that glucosamine sulfate 2KCL is preferred in certain embodiments.
The glucosamine component is, preferably, in a salt form so as to
facilitate its delivery and uptake by the mammal. The salt forms
include glucosamine hydrochloride, glucosamine sulfate, glucosamine
sulphate NaCL, and glucosamine sulphate 2KCL.
[0051] Various amounts of glucosamine may be added to the
composition of the present invention. The composition may contain
between about 400 to 750 pbw glucosamine component, optionally
between about 500 to about 700 pbw glucosamine component,
preferably about 600 pbw glucosamine component. For example 1 Kg of
composition preferably comprises about 600 g of glucosamine
component such as glucosamine sulphate 2 KCL. The glucosamine
component may be supplied from any distributor of glucosamine
components. Moreover, in some embodiments, the glucosamine
component may comprise 100% of the composition.
[0052] Another component of the composition is oil cake. Examples
of the suitable oil cakes include vegetable oil cakes such as
soybean oil cake, linseed oil cake, cottonseed oil cake, peanut oil
cake, safflower oil cake, coconut oil cake, palm oil cake, sesame
oil cake, sunflower oil cake, rapeseed oil cake, kapok oil cake and
mustard seed oil cake. Soybean flower is the preferred oil cake in
certain embodiments. The oil cake component is a source of protein
for mammals such as a horses, cattle or sheep and provides a major
portion of the protein for spermatogenesis. Protein is one of the
main building blocks of the body, and is a major component of
muscles, the nervous system and connective tissue. Adequate dietary
protein is essential for maintenance, growth, lactation and
reproduction. Oil cake provides the additional benefit of
increasing the intake and digestibility of roughages in a mammals
diet, such as a horse, making cellular building blocks available
for gametogenesis. The oil cake component provides an optimal
source of protein to promote gametogenesis.
[0053] Various amounts of oil cake may be added to the composition
of the present invention. The composition may contain between about
50 to 200 pbw oil cake component, optionally between about 75 to
about 150 pbw oil cake component, preferably about 145 pbw oil cake
component. For example 1 Kg of composition preferably comprises
about 145 g of oil cake component such as soybean flower. The oil
cake component may be supplied from any distributor of oil
cake.
[0054] Another component of the composition is acid. Suitable acid
component of the composition include ascorbic acid, derivatives of
ascorbic acid, lipoic acid, and dihydrolipoic acid. The derivatives
of ascorbic acid include magnesium ascorbyl phosphate, sodium
ascorbyl phosphate, sodium ascorbate, and ascorbyl glucosides.
Preferably the acid component is sodium ascorbate in certain
embodiments.
[0055] Various amounts of acid component may be added to the
composition of the present invention. The composition may contain
between about 50 to 150 pbw acid component, optionally between
about 75 to about 125 pbw acid component, preferably about 100 pbw
acid component. For example 1 Kg of composition preferably
comprises about 100 g of acid component such as sodium ascorbate.
The acid component may be supplied from any distributor of acid
components.
[0056] Another component of the present invention is a mineral
component. Minerals act as cofactors for enzymes for almost every
reaction in the body and mineral deficiency affects immune system
function, bone density, protein, fat, and carbohydrate metabolism.
It has been found that providing a mineral component in the
composition promotes fertility for mammals in need thereof. The
mineral component is preferably provided in an amino acid chelate
form due to the increased bioavailability of these forms. Less
preferably, other organic mineral complexes such as sulfates,
citrates, gluconates, and lactates may be utilized and have been
found to have higher biological value than the least preferred
inorganic mineral complexes (oxides, carbonates). Several minerals
are associated with increased reproductive performance in both
males and females. The form that minerals are supplied in is
critical. All of the minerals listed below have reported toxic
effects on reproduction, when exposure is to the inorganic forms,
and beneficial effects when exposure is from organic forms.
[0057] Boron is an ultra-trace mineral and is a good example of a
nutrient that is beneficial to the spermatogenic cycle, embryonic,
and fetal development when provided in an organic form. However, if
the exposure is to an inorganic form, testicular damage and
mutagenic effects are common. Boron is involved in the production
of many sex hormones.
[0058] Chromium is also an ultra-trace mineral whose deficiency can
cause a decrease in sperm count, but exposure to inorganic forms
can cause severe testicular damage, improper testicular
development, or neoplasia. Many positive effects on female
reproductive efficiencies and lactation improvements have been
found.
[0059] Manganese is a trace mineral that is essential for growth,
reproduction, prevention of skeletal abnormalities, and congenital
ataxia. Manganese usually localizes in the cell's mitochondria.
Manganese is the metal cofactor (preferred) for a number of
glycosyltransferases which provides the link between biochemical
function and deficiency symptoms. Manganese also plays an important
role in carbohydrate, lipid, and brain metabolism. Research has
shown that manganese plays a large part in attachment and
conception. Exposure to inorganic manganese causes extremely
reduced male fertility.
[0060] Zinc is a trace mineral whose deficiency has negative
effects on testosterone levels and sperm development. Normal growth
and lactation are both dependant on the presence of adequate
amounts of zinc. Exposure to inorganic zinc causes harm to male and
female reproductive tissues.
[0061] Suitable minerals for the composition include zinc, boron,
chromium and manganese, however any mineral associated with
increase reproductive performance in males can be used. Various
amounts of organic manganese, chromium, boron and zinc may be used.
The composition may contain between about 0.001 to 1.0 pbw mineral
component, optionally between about 0.004 to about 0.0095 pbw
mineral component, preferably about 0.009 pbw mineral component.
For example 1 Kg of composition preferably comprises about 9 g of
mineral component.
[0062] The mineral component preferably is a mixture of minerals
having various amounts of each mineral. 1 Kg of composition may
contain between about 3 g to about 4.5 g of manganese, preferably 4
g; between about 0.0 .mu.g to about 0.2 g of chromium, preferably
0.15 g; about 0.5 to about 0.1 g of boron, preferably 0.75 g; and
about 2 to about 4 g of zinc, preferably 3 g.
[0063] Most preferably, the mineral component is a mixture of
various fertility promoting minerals in amino acid chelate (AAC)
form. The AAC form comprises a complex between the amino acid and
the mineral. Preferably the AAC mineral component is a mixture of
zinc AAC, boron AAC, chromium AAC and manganese AAC having various
amounts of each mineral. 1 Kg of composition may contain between
about 15 g to about 30 g of manganese AAC (16%), preferably 25 g;
between about 3 g to about 9 g of chromium AAC (2.5%), preferably 6
g; about 0.5 to about 0.1 g of boron AAC (2.5%), preferably 30 g;
about 10 to about 20 g of zinc AAC (20%), preferably 15 g.
Accordingly, the composition contains between about 0.025 to 0.100
pbw mineral component in complex form, optionally between about
0.50 to about 0.085 pbw mineral component in complex form,
preferably about 0.076 pbw mineral component in complex form. For
example 1 Kg of composition preferably comprises about 76 g of
mineral component in AAC form. Preferably, the minerals are
elemental amounts of albion chelates.
[0064] Another component of the present invention is a vitamin
component. Vitamins are categorized into two distinct classes:
water soluble and fat soluble. Water soluble vitamins are not
stored in the body; they are excreted if not utilized soon after
ingestion. Fat soluble vitamins (Vitamins A, D, E, and K) are
stored and have more of a potential for toxicity. Horses on premium
commercial feeds rarely develop a clinical deficiency of an
individual mineral or vitamin because the feeds are appropriately
fortified. General supplements should not be used to try to make a
good ration out of poor quality feedstuffs. They can be used to
support horses that are under more stressful conditions such as
performance, reproductively active, diseased, or geriatric.
[0065] Folic acid is a water soluble vitamin that plays critical
roles in the normal reproduction of cells. A deficiency of folate
has been associated with defects in pre-implantation embryos and
the neural, skeletal, digestive and urinary tracts of developing
fetuses.
[0066] Biotin is a water soluble vitamin that has been heavily
researched in many species with respect to its effect on female
reproductive performance parameters and gamete development. The
most well documented effects are on sow conception rates and return
to estrus post parturition. Many effects of biotin on prenatal
development have also been established.
[0067] Thiamine is a water soluble vitamin that is crucial to the
viability and motility of sperm. Normal development in the uterus
depends on the presence of thiamine.
[0068] Suitable vitamins for the composition include biotin,
thiamin HCL, and folic acid; however any vitamin associated with
increase reproductive performance in males can be used. Various
amounts of each vitamin may be used. The composition may contain
between about 0.001 to 1.0 pbw vitamin component, optionally
between about 0.004 to about 0.0095 pbw vitamin component,
preferably about 0.013 pbw vitamin component. For example 1 Kg of
composition preferably comprises about 13 g of vitamin
component.
[0069] The vitamin component preferably is a mixture of vitamins
having various amounts of each vitamin. 1 Kg of composition may
contain between about 0.2 g to about 1 g of biotin (1%), preferably
0.5 g; between about 5.0 g to about 15 g of thiamin HCL (87.4%),
preferably 11 g; about 0.5 to about 1.5 g of folic acid, preferably
0.95 g.
[0070] Prebiotics are ingredients that when provided to the
digestive tract selectively support the growth of beneficial
bacterial species over pathogenic ones. Prebiotics do not directly
colonize the digestive tract. Prebiotics include yeast, yeast
cultures, fungal cultures, and preferably, certain fibers
(FOS-fructooligosaccharides). Probiotics are the actual bacterial
species that, when introduced to the digestive tract actually
colonize and produce beneficial effects. Preferably probiotics of
the composition include Lactobacillus and Bifido. Synbiotics are
products that contain both prebiotic and probiotic ingredients.
Ingredients of this type are important to include in a nutritional
support program. As used herein, synbiotic refers to a prebiotic
and probiotic blend for gastrointestinal support. The synbiotic of
the present composition is preferably a prebiotic and probiotic
blend of Lactobacillus and Bifido, and FOS-fructooligosaccharides.
Although various amounts of these ingredients may be combined in a
mixture, supplied blends are available from distributors of theses
substances. Suitable blends for preferred embodiments of the
present invention include probiotics from UAS Laboratories (product
name is UAS Probiotic Blend), including the ingredients
Bifidobacterium longum and Lactobacillus acidophilus, rice starch
and fructooligosaccharides. The potency is over 10 billion Colony
Forming Units per gram at the time of manufacture. This product may
be blended with other constituents of the present invention.
[0071] Other nutrients may be used to support the digestive tract
in mammals to promote fertility. For example,
N-acetyl-D-glucosamine is a structural component of all mucosal
surfaces. Supplementation with N-acetylglucosamine may help firm up
the structural matrix of the intestinal tract. Though glucosamine
appears to be highly absorbable, N-acetyl-glucosamine is directly
incorporated into the intestinal mucosa and is not absorbed when
provided orally. This improves the overall health of the intestinal
tract under stress thereby contributing to its healing and
increased absorption of other nutrients. Glutamine supplementation
may further be incorporated to meet increased energy needs of the
enterocytes in diseased or stressed states. 80% of the dietary
intake of the amino acid glutamine is used by the enterocytes as
energy in normally functioning digestive tracts. Increased intakes
will support cell replication and function. Arginine has been found
in human burn patients to promote the release of intestinal
hormones and growth factors in the intestinal tract when given
orally. It also increases blood flow to the digestive tract which
promotes fertility by ensuring that nutrients have a greater chance
of being absorbed.
[0072] A subject in whom administration of a nutraceutical
composition of the invention in an effective therapeutic regiment
for a disease or condition exemplified above, but not so limiting,
is preferably a mammal. Thus, as can be readily appreciated by one
of ordinary skill in the art, the methods and nutraceutical
compositions of the present invention are particularly suited to
administration to any animal, particularly a mammal, and including,
but not limited to, humans, domestic animals, such as feline or
canine subjects, farm animals, such as but not limited to bovine,
equine, caprine, ovine, and porcine subjects, wild animals (whether
in the wild or in a zoological garden), research animals, such as
mice, rats, rabbits, goats, sheep, pigs, dogs, cats, etc., avian
species, such as chickens, turkeys, songbirds, etc., i.e., for
human or veterinary medical use.
[0073] The appropriate effective dosage of an agent of the
invention may be readily determinable to the ordinary skilled
worker with the understanding that the composition may be supplied
to the average size stallion (up to 1300 pounds) at a rate of 20 g
per day. The dosage may be supplied once a day, twice a day, or
three times a day, preferably twice a day. For example, a 20 g
dosage form would be divided into two 10 g forms and provided in
the morning and evening. Supplementation should begin 60 days prior
to the breeding season, to support all stages of the spermatogenic
cycle. As supported in the examples, infra, a dosage approximately
equal to the equivalent of 15 g/day to about 25 g/day, and more
preferably, about 20 g/day is therapeutically effective in the
fertility challenged stallions. The dosing schedule may vary,
depending on the circulation half-life, and the formulation
used.
[0074] The compositions are intended to be supplemented to male or
female mammals. For example, in the equine group, supplementation
may be provided to a stallion or a mare. It is noted however, that
mares which become pregnant due to a deficiency being filled by
compositions of the present invention may lose the pregnancy if
supplementation is discontinued before foaling. Ending
supplementation prior to full gestation in the female is not
recommended. Accordingly, supplementation to stallions may be more
cost effective.
[0075] The composition of the present invention preferably
includes, in certain embodiments, glucosamine sulphate 2KCL (a
quality chondroprotective), soybean flour, sodium ascorbate
(product stabilizer and increases shelf life), biotin, boron amino
acid chelate, manganese amino acid chelate, zinc amino acid
chelate, synbiotics (Prebiotic & Probiotic Blend for GI
support), Thiamine HCl, chromium amino acid chelate, and folic
Acid.
[0076] The composition of the present invention preferably includes
in certain embodiments the following constituents; a) a glucosamine
component; and b) a nutrient component. In such embodiments each
constituent is present in an effective proportion such that, when
administered to a mammal in an effective amount, the nutraceutical
composition is effective to improve fertility. In such embodiments
that glucosamine component is between about 400 to about 700 pbw of
the composition. In such embodiments, the nutrients may range
between 1 and 600 pbw of the composition. Although not preferred a
filler containing no nutrients may be included.
[0077] In other preferred embodiments the composition of the
present invention preferably includes only a glucosamine component.
In such embodiments the glucosamine component is present in an
effective proportion such that, when administered to a mammal in an
effective amount, the nutraceutical composition is effective to
improve fertility. In such embodiments the glucosamine component is
virtually all of the composition. For example such embodiments
include glucosamine sulphate, glucosamine sulfate 2KCL, glucosamine
sulphate NaCL, glucosamine hydrochloride, N-acetylglucosamine and
Poly-Nag. glucosamine and mixtures thereof. It has been found that
100% glucosamine sulfate 2KCL is preferred in certain embodiments.
The glucosamine component is, preferably, in a salt form so as to
facilitate its delivery and uptake by the mammal. The salt forms
include glucosamine hydrochloride, glucosamine sulfate, glucosamine
sulphate NaCL, and glucosamine sulphate 2KCL.
[0078] Benefits of the present invention include:
[0079] Multi-functional promotion of reproduction,
gastro-intestinal and connective tissues;
[0080] Enhanced fertility;
[0081] Improved conception rate;
[0082] Digestive tract support;
[0083] Support of joint and other connective tissues;
[0084] Ultra concentrated;
[0085] No palatability problems;
[0086] Long shelf life;
[0087] Veterinarian supported and formulated.
[0088] The various components are generally mixed by weight in a
blender or mixing bowl, which may include utilizing an accurate
scale (e.g. gram scale). However, mixing by volume may also be
appropriate.
[0089] The composition may be administered to a variety of dosage
forms known in the art including a capsule, tablet, or dry powder
form. Capsules and tablets are manufactured according to known
techniques where the mixture of components is either filled in a
capsule, or compressed into a tablet. Preferably, the compositions
are administered in a dry powder dosage form for ease of
supplementation to feed.
[0090] Having discussed the composition of the present invention,
it will be more clearly perceived and better understood from the
following specific examples.
[0091] For large mammals such as horses, the composition I is
administered as filled scoops.
1 Level Scoopful (5 cc) Large Animal (Equine) Composition I Soybean
Flower 145 g Glucosamine Sulphate 2 KCL 600 g Sodium ascorbate 100
g Manganese 4.0 g Chromium 0.15 g Boron 0.75 g Zinc 3.0 g Biotin
(1%) 0.50 g Thiamin HCL (87.4%) 11.362 g Folic Acid (95%) 0.95 g
Probiotic blend 15 g
[0092] Preferrably, the following composition, composition II, is
used for large mammal such as a horse.
2 Level Scoopful (5 cc) Large Animal (Equine) Composition II
Soybean Flower 145 g Glucosamine Sulphate 2 KCL 600 g Sodium
ascorbate 100 g Manganese AAC (16%) 25 g complex Chromium AAC
(2.5%) 6.0 g complex Boron AAC (2.5%) 30 g complex Zinc AAC (20%)
15 g complex Biotin (1%) 50 g complex Thiamin HCL (87.4%) 13 g
complex Folic Acid (95%) 1.0 g complex Probiotic blend 15 g
[0093] The following case study was conducted with mammals. The
unexpected increased fertility of stallions demonstrates the
effectiveness of the treatment.
Case #1
[0094] A study was conducted to evaluate the effect of a
composition comprising glucosamine sulphate 2KCL, soybean flour,
sodium ascorbate (product stabilizer and increase shelf life),
biotin, boron amino acid chelate, manganese amino acid chelate,
zinc amino acid chelate, synbiotics (prebiotic and probiotic blend
for GI support), Thiamine HCl, Chromium Amino Acid Chelate, and
folic acid on pregnancies per cycle and semen quality among
commercial breeding stallions on a farm in middle Tennessee.
Walking Horse stallions (n=12) were fed the nutritional supplement
(treatment group) or a placebo (control group) as a top dressing on
a commercial concentrate feed ration beginning in late April. Mares
were bred using artificial insemination between mid-April and
mid-August. Semen quality (ejaculate volume, sperm concentration,
motility, morphology and viability) was evaluated during a 20-week
period between early-April and mid-August. For purposes of
comparison with data gathered in the treatment year, pregnancy data
from the previous season was retrospectively evaluated for the
control and treatment stallions. Pregnancy data was analyzed using
a mixed model ANOVA procedure (PROC Mixed) with repeated measures,
while semen quality data was analyzed using PROC GLM with repeated
measures. In the year prior to treatment, mares were pregnant in
65/215 (30%) and 83/351 (24%) cycles following breeding to control
and treatment stallions, respectively. During the treatment year,
mares were pregnant in 53/179 (30%) and 86/223 (39%) cycles when
bred to control and treatment stallions, respectively.
[0095] The proportion of pregnancies was not different between the
pretreatment and treatment years for the control stallions, while
the treatment stallions achieved a significantly higher proportion
of pregnancies during treatment as compared with the previous
season (P<0.05). However, the proportion of pregnancies did not
differ between treatment and control stallions in the treatment
year (P>0.05). Semen quality did not differ between treatment
and control stallions. Results of this study provide evidence that
the provided composition may improve pregnancies per cycle for
stallions.
[0096] The composition was provided to a Tennessee Walking Horses
at a commercial breeding farm in middle Tennessee. Stallions (n=12)
standing at stud and the mares booked to them and managed on the
farm during the 2000 (n=338) and 2001 (n=255) seasons were included
in the study. Stallions were grouped by age and then randomized to
a treatment or control group for the 2001 season. Fertility data
from the 2000 breeding season was collected from farm records for
comparison with reproductive performance in the 2001 season.
[0097] Farm personnel were blinded to the group assignment of each
stallion. Stallions were fed the nutritional supplement (treatment
group) or a placebo consisting of inert and inactive ingredients
(control group). A total of 15 grams of treatment or placebo was
divided between AM and PM feedings and fed as a top dressing on a
concentrate feed ration starting on Apr. 23, 2001.
[0098] Breeding management was consistent among all horses in the
study and representative of large commercial breeding facilities
around the country. All mares were bred by artificial insemination.
Semen was collected by artificial vagina from each stallion as
required for breeding management of the mares. Ejaculate volume,
concentration of sperm, and motility were assessed by farm
personnel trained in semen analysis. Total sperm number in an
ejaculate was calculated from the volume and sperm concentration
data. Slides were prepared using an eosin-nigrosin morphology stain
and sent to an outside laboratory for evaluation of sperm
morphology and viability. Results were reported as a percentage of
morphologically normal sperm and sperm excluding stain
(viable).
[0099] The evaluation period for pregnancy outcome in each year was
divided into 5 time periods. Time period 1 (T1) included data
between February 1.sup.st and April 24.sup.th. Time periods 2-5
(T2-T5) consisted of 4 week intervals from April 25.sup.th through
the middle of August. The evaluation period for semen quality
included 3 pre-treatment weeks (WK1-WK3) and 17 weeks (WK4-WK20) of
treatment.
[0100] Pregnancy data was analyzed using a mixed model ANOVA
procedure (PROC Mixed) with repeated measures. The model consisted
of a dependent variable, percent pregnant and independent class
variables, treatment, year and time period (1-5). Stallion was
included in the model as a random factor. Semen quality data was
analyzed using PROC GLM with repeated measures.
[0101] All mares were bred by artificial insemination, therefore
effects on conception rates were not due to changes in total sperm
per ejaculate. Only mares bred on farm using fresh semen and whose
16-day pregnancy status confirmation was preformed on farm were
used. These selection criteria resulted in a higher proportion of
"problem mares" which explains the below industry average
conception rates for both the control and treatment groups.
[0102] Stallion ages ranged from 5 to 26 years. Control stallions
were bred to 127 and 100 mares and the treatment stallions to 211
and 155 mares in the 2000 and 2001 seasons, respectively. The
control and treatment stallions settled mares in 65/215 (30%) and
83/351 (24%) cycles in 2000 and in 53/179 (30%) and 86/223 (39%)
cycles in 2001 during the T2-T5 periods, respectively.
[0103] The proportion of pregnancies was not different between the
2000 and 2001 season in the T2-T4 periods for the control stallions
(P>0.05). Treatment stallions achieved a significantly higher
proportion of pregnancies during the same periods T2-T4 in 2001
when compared with the same period in 2000 when they were not
receiving the supplement (P<0.05). FIG. 1 and FIG. 2 The
increase in proportion of pregnancies was consistent across all the
treatment stallions (n=6) while all control stallions (for which
2000 fertility data was available, n=3) experienced a slight
decline in fertility during 2001. The proportion of pregnancies did
not differ statistically between treatment and control stallions
during T2-T4 in 2001 (P>0.05). The LS means for pregnancies per
cycle over all time periods in the 2000 and 2001 seasons are
presented in FIG. 1 which shows a graph of pregnancies per cycle
over time representing that the LS means +/-SE for pregnancies per
cycle for stallions assigned to the treatment group (not
supplemented in 2000)(n=6), as well as FIG. 2 which shows a graph
of pregnancies per cycle over time demonstrating LS means +/-SE for
pregnancies per cycle for treated (n=6) and control (n=4) stallions
in the 2001 season. The arrow in FIG. 2 indicates time that
treatment and placebo were started.
[0104] Semen was available from all treatment (n=6) and control
(n=4) stallions for WK1-15 of the evaluation period in 2001.
However, between WK16 and WK20 motility, concentration and total
number of sperm data were unavailable in some weeks for some of the
stallions. Therefore the results reported for WK16-20 are based on
fewer stallions in each group. Mean motility, concentration and
total number of sperm were not significantly different (P=0.888,
0.958, and 0.567, respectively) between the treatment and control
stallions during the 20-week evaluation period in the 2001 season.
This is accurately demonstrated by making references to FIG. 3,
FIG. 4, and FIG. 5. FIG. 3 shows a graph of sperm quantity over
time (weeks) demonstrating mean concentration of sperm for treated
(n=6) and control (n=4) stallions in the 2001 season. An arrow in
FIG. 3 indicates time that treatment and placebo were started.
Weeks 16 through 20 data points represent fewer than all stallions.
FIG. 4 shows a graph of spermatozoa quantity over time
demonstrating mean motility for treated (n=6) and control (n=4)
stallions in the 2001 season. The arrow in FIG. 4 indicates time
that treatment and placebo were started. Weeks 16 through 20 data
points represent fewer than all stallions. FIG. 5 shows a graph of
motility (%) over time (weeks) demonstrating mean motility for
treated (n=6) and control (n=4) stallions in the 2001 season. An
arrow indicates time that treatment and placebo were started. Weeks
16-20 data points represent fewer than all stallions.
[0105] Morphology and viability data was available for all
stallions during the entire 20-week semen evaluation period. Mean
normal morphology and sperm viability varied considerably during
the evaluation period. However neither were different (P=0.929 and
0.774, respectively) between the treatment and control stallions.
This is accurately demonstrated by making reference to FIG. 6 and
FIG. 7. FIG. 6 is a graph showing normal morphology % over time
demonstrating mean normal sperm morphology for treated (n=6) and
control (n=4) stallions in the 2001 season. An arrow indicates time
that treatment and placebo were started. Weeks 16 through 20 data
points represent fewer than all stallions. FIG. 7 is a graph
showing viability (%) over time demonstrating mean viability for
treated (n=6) and control (n=4) stallions in the 2001 season. An
arrow in FIG. 7 indicates time that treatment and placebo were
started.
[0106] Apparently many nutrients appear to play in role in the
development and function of sperm. Detailed knowledge of the role
played by various nutrients or the level required for optimal
development and function of sperm is not well understood. This
example evaluated the effect of a nutritional supplement designed
to provide a combination of ingredients to benefit the
reproductively active stallion. Fertility was improved among
stallions receiving the nutritional supplement over that observed
during the previous breeding season. Loss of 2 control group
stallions may have contributed to an inability to demonstrate a
statistically significant difference in proportion of pregnancies
among treatment and control groups for the 2001 season. The
proportion of pregnancies increased significantly during the
treatment period, T2-T4 in 2001 compared with the same time period
in 2000 while fertility among control stallions remained unchanged.
This study ruled out morphological and number of sperm as the
mechanism for the increased conception rate. This leaves enhanced
attachment site structures as leading mode of action.
[0107] This case demonstrates the efficacy of the compositions of
the present invention. The pregnancies of the animals after
treatment demonstrate the improvement in the conditions of the
disorder from which the animal suffered prior to treatment with one
composition of the present invention.
[0108] Obviously, many modifications may be made without departing
from the basic spirit of the present invention. Accordingly, it
will be appreciated by those skilled in the art that within the
scope of the appended claims, the invention may be practiced other
than has been specifically described herein.
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