NZ617405B2 - Dietary Supplement for Managing Gut Health - Google Patents
Dietary Supplement for Managing Gut Health Download PDFInfo
- Publication number
- NZ617405B2 NZ617405B2 NZ617405A NZ61740512A NZ617405B2 NZ 617405 B2 NZ617405 B2 NZ 617405B2 NZ 617405 A NZ617405 A NZ 617405A NZ 61740512 A NZ61740512 A NZ 61740512A NZ 617405 B2 NZ617405 B2 NZ 617405B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- composition
- amylase inhibitor
- extract
- kiwifruit
- concentration
- Prior art date
Links
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Classifications
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Abstract
Disclosed is a dietary supplement comprising: a kiwifruit extract derived from processed kiwifruit pulp without the seeds, wherein the kiwifruit extract comprises at least one cysteine protease enzyme; an extract comprising an amylase inhibitor and/or a bifunctional proteaseamylase inhibitor which binds loosely to the cysteine protease enzyme(s) of the kiwifruit extract; and one or more suitable diluents, carriers and/or excipients. inds loosely to the cysteine protease enzyme(s) of the kiwifruit extract; and one or more suitable diluents, carriers and/or excipients.
Description
Dietary Supplement for Managing Gut Health
Field of the invention
The present invention relates to a dietary supplement and methods of use thereof. More
particularly, the invention relates to a composition comprising a kiwifruit extract in
combination with an amylase inhibitor and/or a bifunctional protease-amylase inhibitor,
particularly but not exclusively, for managing gut health or for the treatment or prevention
of digestive dysfunction, gastrointestinal disorders and/or symptoms thereof.
Background
It is known that fibre is essential for healthy bowel function and a diet rich in fibre reduces
the risk of a number of bowel problems. When fibre passes through the bowel it absorbs
water, so it increases the bulk of the waste matter. This also makes the waste softer and
increases the speed and ease with which it passes through the bowel. Fibre supplements
which contain a high amount of dietary fibre and can be taken on a daily basis to aid the
digestion process are known. However, known fibre formulations can be unpleasant and
unpalatable to consume. Also, fibre alone is not sufficient for the complete functioning of
the digestive system.
The gut microflora is also an important factor in digestive function. In humans, gut
microflora comprises more than 500 different species of bacteria that have a great
metabolic impact upon human health. The gut microflora can be divided into potentially
deleterious and potentially health-promoting species. For example, some Clostridium species
and proteolytic Bacteriodes species are considered potentially harmful because of their
association with certain acute and chronic gastrointestinal complaints. Their metabolic end
products are toxic and can cause cellular destruction in the bowel. On the other hand,
Bifidobacterium species and the lactic acid bacteria, particularly Lactobacillus species, are
considered to play an important role in a healthy gut ecosystem through their antagonistic
activities towards potential pathogens, immunomodulatory activities, production of short
chain fatty acids and reduction of microflora associated enzyme activities involved in the
production of carcinogens and genotoxins.
The consumption of food ingredients known as prebiotics can aid in treating or preventing
digestive dysfunction or gastrointestinal disorders. A prebiotic is a non-digestible food
ingredient that promotes the growth and/or activity of one or more bacteria in the digestive
system which may beneficially affect the host, thus improving host health. Known prebiotics
include dietary soluble fibres such as inulin and lactulose, which are able to survive the
digestion process and selectively stimulate beneficial members of the gut microflora, such as
bifidobacteria, in the colon.
Other compositions containing probiotics or prebiotics or a combination thereof are also
available. Some of these compositions may have unwanted side-effects such as excessive
gas production, uncomfortable bloating, or may not be tolerated by the recipient. Others are
based on synthetic materials or compounds, and as such may conflict with other
medications. Natural or organic products are becoming increasingly popular with
consumers.
Enzymes also play a role in the digestion process. In the human gastrointestinal system,
proteolytic enzymes operate by breaking down long-chain peptides or proteins into shorter
chains or individual amino acids which can then pass into the cells lining the small intestine.
These more simple compounds may be used for growth and maintenance of the body or be
converted to energy. Some vitamins present in foods are only made available to be
absorbed by the gastrointestinal lining once the material surrounding them is broken down.
For example, much of the vitamin B 12 in red meat would be unavailable if the
proteinaceous matrix was not first hydrolysed.
Typically, the human body produces most but not all of the enzymes it requires for efficient
digestion. Some disorders, diets or lifestyles can also result in the deficiency of certain
enzymes. Such enzymes can be supplemented by the food we eat or through the use of
dietary supplements, for example. However, the body may produce digestive compounds
(such as proteolytic enzymes in saliva and the gut and the low pH stomach acids) that inhibit
or break down the beneficial enzymes, making it difficult for the body to obtain the full
balance of enzymes required for efficient digestion. The presence of these digestive
compounds is a problem when trying to maintain or improve digestive function by oral
administration of pharmaceuticals, dietary supplements or other beneficial biological
products such as prebiotic enzymes, as it reduces efficacy.
Actinidia, a genus of plants cultivated mainly for its fruit (kiwifruit), grows in various
countries. The constituent cysteine protease of the fruit, actinidin, is an enzyme shown to
enhance gastric protein digestion in vitro (Reid, 2004). Zyactinase® is a freeze dried powder
derived from kiwifruit, containing the enzyme, actinidin, plant polyphenols, dietary fiber,
carbohydrates, and oligosaccharides including galactoglucomannan, a type of
oligosaccharide, which has been isolated from kiwifruit (Schroder et al, 2001).
Kiwifruit has a high density of vitamin C, vitamin E, potassium and magnesium salts, and is
also an excellent source of dietary fibre. It is also low in fat, contains no cholesterol, has a
high antioxidant potential and is particularly high in two amino acids: arginine and
glutamate. Compositions comprising kiwifruit extract from fruit of the species Actinidia
deliciosa have been shown to have a prebiotic effect and to comprise fibre and enzymes.
Such extracts provide benefits in respect of the health of the digestive system and the
treatment and prevention of digestive dysfunction and/or gastrointestinal disorders
Previous compositions comprising kiwifruit extract have been formulated in capsule form for
oral ingestion. This has the benefit that digestive enzymes cannot act on the extract until
the soft gelatine case has been broken down in the stomach. However, other formulations
for oral delivery are desirable as capsules may have a number of drawbacks. These
drawbacks include:
Flavour – capsules do not allow a flavour component to be effectively added to the
composition.
Palatability and convenience - a number of consumers dislike having to take capsules
or find it difficult to swallow capsules. Taste and problems with swallowing the capsules are
particularly important considerations when providing formulations suitable for children.
Cost - many pharmaceutical and nutraceutical companies do not have the
equipment necessary to fill soft capsules and have to transport the compositions to have
them processed, adding to the cost. This cost can increase the price the consumer pays.
Moisture - soft capsules are extremely water soluble, which helps them to dissolve
in the body. However, this means that soft capsules are very sensitive to heat and humidity.
In hot or humid climates, capsules may stick together or even break open before use.
Dietary Restrictions – soft capsules may be made out of gelatine which is
traditionally made out of animal material. Many groups, such as vegetarians, have dietary
proscriptions that prevent them from consuming these animal products. Gelatine capsules
may also violate the religious dietary restrictions of observant Jews, Muslims, Buddhists and
Hindus.
Dosage – the dosage able to be delivered in a particular volume of capsule is often
less than that possible with other dosage forms. This effectively reduces the efficacy of a
single capsule dosage in comparison to these other forms, requiring more capsules to be
taken to achieve an effective dose. This may be inconvenient and difficult for the person
taking a dietary supplement, resulting in the person not being able to comply with a
particular treatment regime.
It is an object of the invention to provide one or more compositions and/or uses that
overcome or ameliorate at least one of the disadvantages of the prior art or at least to
provide the public with a useful choice.
Summary of the invention
The inventors have conducted extensive research and have formulated a composition which
may address a number of the problems noted above. During this research, the inventors
found that when a kiwifruit extract is exposed to digestive enzymes, particularly those
present in the mouth, such as amylase, the activity of the beneficial enzyme(s) in the extract
is reduced and therefore the efficacy of the composition in the gut is also likely to be
compromised. The composition devised by the inventors may be exposed to digestive
enzymes while still retaining a desired level of enzyme activity and beneficial function in the
gut.
In a first aspect, the invention provides a composition comprising a kiwifruit extract in
combination with an amylase inhibitor and/or a bifunctional protease-amylase inhibitor, the
composition also optionally comprising one or more suitable diluents, carriers and/or
excipients.
In one embodiment, the kiwifruit extract comprises at least one cysteine protease enzyme.
In one embodiment, the at least one cysteine protease enzyme comprises actinidin.
In one embodiment, the kiwifruit extract comprises actinidin with an enzyme activity of
substantially 1500U/g to substantially 6000 U/g, in one embodiment substantially 3000U/g
to 5000U/g.
In one embodiment, the kiwifruit extract comprises at least one cysteine protease enzyme
as well as fibre and/or a pre-biotic component.
In one embodiment, the kiwifruit extract is derived by a method of extraction as described in
In one embodiment, the kiwifruit extract has the defining characteristics of the kiwifruit
extract described in and the subject of , NZ554991 or US8057831.
In one embodiment, the kiwifruit extract has the defining characteristics of a kiwifruit
enzyme complex with the brand name Zyactinase®, and more preferably Zyactinase® 45.
In one embodiment, the kiwifruit extract is a kiwifruit enzyme complex with the brand name
Zyactinase®, and more preferably Zyactinase® 45.
In one embodiment, the amylase inhibitor and/or bifunctional protease-amylase inhibitor is
as hereinafter described.
In one particular embodiment, the amylase inhibitor and/or bifunctional protease-amylase
inhibitor is extracted from white kidney bean. In one embodiment, the amylase inhibitor
and/or the bifunctional protease-amylase inhibitor is provided as a white kidney bean
extract.
In one particular embodiment, the extract from white kidney bean has the defining
characteristics of StarchLite®.
In one particular embodiment, the extract from white kidney bean is StarchLite®.
In one embodiment, the amylase inhibitor and/or the bifunctional protease-amylase
inhibitor is present in the composition at a minimum concentration of approximately 0.5%
(w/w) and at a maximum concentration of approximately 50% (w/w), approximately 40%,
approximately 30%, approximately 20%, approximately 10%, approximately 5%,
approximately 2%, or approximately 1%.
In one embodiment, the kiwifruit extract is present in the composition at a maximum
concentration of approximately 99.5% and at a minimum concentration of approximately
50%, approximately 60%, approximately 70%, approximately 80%, approximately 90%,
approximately 95%, approximately 98%, or approximately 99%.
The ratio of kiwifruit extract:amylase inhibitor and/or bifunctional protease-amylase
inhibitor in certain embodiments is between approximately 200:1 and 1:1, approximately
99:1 and 1:1, approximately 49:1 and 1:1, approximately 35:1 and 1:1, approximately 30:1
and 1:1, approximately 28:1 and 1:1, approximately 19:1 and 1:1, approximately 10:1 and
1:1, approximately 9:1 and 1:1, approximately 4:1 and 1:1 or is approximately 1:1.
In other embodiments, the ratio of kiwifruit extract:amylase inhibitor and/or bifunctional
protease-amylase inhibitor is approximately 34.9:1, approximately 27.5:1 or approximately
9.6:1,
In certain particular embodiments, the composition comprises kiwifruit extract at a
concentration of approximately 98 to 99.5% (w/w) and amylase inhibitor at approximately
0.5 to 2.0% (w/w), or kiwifruit extract at approximately 98.5 to 99.5% and amylase inhibitor
at approximately 0.5 to 1.5% (w/w), or kiwifruit extract at approximately 98 to 99% and
amylase inhibitor at approximately 1.0 to 2.0% (w/w), or kiwifruit extract at approximately
99% and amylase inhibitor at approximately 1%.
In certain particular embodiments the composition comprises:
a) kiwifruit extract at a concentration of approximately 97.5 to 99.5% (w/w) and
b) a bifunctional protease-amylase inhibitor at a concentration of approximately 0.5
to 2.5% (w/w); or
a) kiwifruit extract at a concentration of approximately 98 to 99.5% (w/w) and
b) a bifunctional protease-amylase inhibitor or at a concentration of approximately
0.5 to 2.0% (w/w); or
a) kiwifruit extract at approximately 98.5 to 99.5% and
b) a bifunctional protease-amylase inhibitor at a concentration of approximately 0.5
to 1.5% (w/w); or
a) kiwifruit extract at approximately 98 to 99% and
b) a bifunctional protease-amylase inhibitor at a concentration of approximately 1.0
to 2.0% (w/w); or
a) kiwifruit extract at approximately 99% and
b) a bifunctional protease-amylase inhibitor at a concentration of approximately 1%.
In other particular embodiments, the amylase inhibitor is present in the composition at
approximately 1.98% (w/w) and the kiwifruit extract is present at approximately 69.15%, the
amylase inhibitor is present in the composition at approximately 2% (w/w) and the kiwifruit
extract is present at approximately 55%, or the amylase inhibitor is present in the
composition at approximately 1.6% (w/w) and the kiwifruit extract is present at
approximately 15.38%.
In one particular embodiment, the composition comprises
a) a bifunctional protease-amylase inhibitor at a concentration of approximately 1.98%
(w/w) and
b) kiwifruit extract at approximately 69.15%;
a) a bifunctional protease-amylase inhibitor at a concentration of approximately 2% (w/w)
b) kiwifruit extract at approximately 55%;
a) a bifunctional protease-amylase inhibitor at a concentration of approximately 1.6% (w/w)
b) kiwifruit extract at approximately 15.38%.
In other particular embodiments, the suitable diluents, carriers and/or excipients may be
selected from the group comprising tableting sugar (for example Di-Pac® tableting sugar
from Domino Specialty Ingredients, Florida USA), tropical flavour, natural intense sweetener,
magnesium stearate, silicon dioxide, evaporated cane juice, rice syrup/rice syrup solids,
fructose, sunflower lecithin, natural flavors, corn starch, glycerin, sunflower oil, natural
colour from chlorophyll, tableting sugar, apple powder, citric acid, lemon powder, sucralose,
copper chlorophyllin, tropical flavour powder, natural kiwi / strawberry flavour with natural
antioxidants, sodium copper chlorophyllin.
In one embodiment, the composition is formulated in a form selected from the group
consisting of tablet form, chewable tablet form, soft chew form, powder form, powder form
for suspension in a liquid, capsule form, liquid form or soft gel form.
In one particular embodiment, the composition is formulated as a tablet and the suitable
diluents, carriers and/or excipients may be selected from the group comprising tableting
sugar, tropical flavour, natural sweetener, magnesium stearate and silicon dioxide.
In one particular embodiment, the composition is formulated as a powder for suspension in
a liquid and the suitable diluents, carriers and/or excipients may be selected from the group
comprising apple powder, citric acid, fructose, lemon powder, sucralose, copper
chlorophyllin and tropical flavour powder.
In one particular embodiment, the composition is formulated as a soft chew and the suitable
diluents, carriers and/or excipients may be selected from the group comprising evaporated
cane juice, fructose, natural kiwi / strawberry flavour with natural antioxidants, sodium
copper chlorophyllin, glycerine, rice syrup/rice syrup solids, sunflower lecithin/sunflower oil.
In one particular embodiment, the composition is formulated as a tablet and the amylase
inhibitor is present in the composition at approximately 1.98% (w/w) and the kiwifruit
extract is present at approximately 69.15%.
In one particular embodiment, the composition is formulated as a tablet and the
composition comprises
a) a bifunctional protease-amylase inhibitor at a concentration of approximately
1.98% (w/w) and
b) kiwifruit extract at approximately 69.15%.
In one particular embodiment, the composition is formulated as a powder for suspension in
a liquid and the amylase inhibitor is present in the composition at approximately 2% (w/w)
and the kiwifruit extract is present at approximately 55%.
In one particular embodiment, the composition is formulated as a powder for suspension in
a liquid and the composition comprises
a) a bifunctional protease-amylase inhibitor at a concentration of approximately 2%
(w/w) and
b) kiwifruit extract at approximately 55%.
In one particular embodiment, the composition is formulated as a soft chew and the
amylase inhibitor is present in the composition at approximately 1.6% (w/w) and the
kiwifruit extract is present at approximately 15.38%.
In one particular embodiment, the composition is formulated as a soft chew and the
composition comprises
a) a bifunctional protease-amylase inhibitor at a concentration of approximately
1.6% (w/w) and
b) kiwifruit extract at approximately 15.38%.
In a second aspect, the invention provides a method of treating or preventing digestive
dysfunction, a gastrointestinal disorder, and/or one or more symptoms associated with a
digestive disorder or a gastrointestinal disorder comprising administering to a subject a
composition as described in the first aspect.
In one embodiment, the digestive dysfunction or gastrointestinal disorder is selected from
the group comprising constipation, an inflammatory bowel condition, indigestion, gastric
reflux, bloating, gas, abdominal pain, diarrhoea, heart-burn, irritable bowel syndrome, or
one or more symptoms associated with any of these conditions.
In a third aspect, the invention provides a method of altering, maintaining and/or restoring a
balance of intestinal microflora of a subject comprising administering to the subject a
composition as described in the first aspect.
In one embodiment, the intestinal microflora is intestinal bacteria and the balance is altered
to promote the amount, growth or efficacy of beneficial bacteria.
In particular embodiments, the beneficial bacteria are selected from the group comprising
probiotic bacteria.
In further particular embodiments, the beneficial bacteria are selected from the group
comprising bifidobacteria and lactobacilli.
In further particular embodiments the beneficial bacteria are selected from the group
consisting of Lactobacillus reuteri, Lactobacillus acidophilus, Pediococcus acidilactici, and
Lactobacillus plantarum.
In one embodiment, intestinal microflora is intestinal bacteria and the balance is altered to
reduce the amount, growth or efficacy of pathogenic gut bacteria.
In one embodiment the pathogenic gut bacteria are selected from the group comprising
Bacteroides, Clostridia, coliforms, and sulphate reducing bacteria. Some examples include
Escherichia coli, E.coli 0157:H7, Salmonella typhimurium, and Staphylococcus aureus.
In a fourth aspect, the invention provides a method of maintaining and/or improving
gastrointestinal health comprising administering to a subject a composition as described in
the first aspect.
In a particular embodiment, the gastrointestinal health of a subject is maintained and/or
improved by the prevention or treatment of any one of the digestive dysfunctions,
gastrointestinal disorders, and/or one or more symptoms thereof described in the fifth
aspect and/or one or more of the following:
a. an increase in spontaneous bowel movements
b. an increase in complete spontaneous bowel movements
c. a decrease in abdominal discomfort or pain
d. a decrease in flatulence
e. a decrease in bowel urgency
f. a decrease in wind or burping
g. a decrease in bloating
In a fifth aspect, the invention provides the use of a composition according to the first aspect
in the manufacture of a medicament for treating or preventing digestive dysfunction, a
gastrointestinal disorder, and/or one or more symptoms associated with a digestive
dysfunction or gastrointestinal disorder.
In one embodiment, the digestive dysfunction or gastrointestinal disorder is selected from
the group comprising constipation, an inflammatory bowel condition, indigestion, gastric
reflux, bloating, gas, abdominal pain, diarrhoea, heart-burn, irritable bowel syndrome, or
one or more symptoms associated with any of these conditions.
In a sixth aspect, the invention provides the use of a composition according to the first
aspect in the manufacture of a medicament for altering, maintaining and/or restoring a
balance of intestinal microflora of a subject.
In one embodiment, the microflora is intestinal bacteria and the balance is altered to
promote the amount, growth or efficacy of beneficial bacteria.
In particular embodiments, the beneficial bacteria are selected from the group comprising
probiotic bacteria.
In further particular embodiments, the beneficial bacteria are selected from the group
comprising bifidobacteria and lactobacilli.
In further particular embodiments the beneficial bacteria are selected from the group
consisting of Lactobacillus reuteri, Lactobacillus acidophilus, Pediococcus acidilactici, and
Lactobacillus plantarum.
In one embodiment, the balance of intestinal bacteria is altered to reduce the amount,
growth or efficacy of pathogenic gut bacteria.
In one embodiment, the pathogenic gut bacteria are selected from the group comprising
Bacteroides, Clostridia, coliforms, and sulphate reducing bacteria. Some examples include
Escherichia coli, E.coli 0157:H7, Salmonella typhimurium, and Staphylococcus aureus.
In a seventh aspect, the invention provides the use of a composition according to the first
aspect in the manufacture of a medicament for maintaining and/or improving
gastrointestinal health.
In a particular embodiment, the gastrointestinal health of a subject is maintained and/or
improved by the prevention or treatment of any one of the digestive dysfunctions,
gastrointestinal disorders, and/or one or more symptoms thereof described in the fifth
aspect or one or more of the following:
a. an increase in spontaneous bowel movements
b. an increase in complete spontaneous bowel movements
c. a decrease in abdominal discomfort or pain
d. a decrease in flatulence
e. a decrease in bowel urgency
f. a decrease in wind or burping
g. a decrease in bloating
The invention may also be said broadly to consist in the parts, elements and features
referred to or indicated in the specification of the application, individually or collectively, in
any or all combinations of two or more of said parts, elements or features, and where
specific integers are mentioned herein which have known equivalents in the art to which the
invention relates, such known equivalents are deemed to be incorporated herein as if
individually set forth.
Brief description of the figures
Figure 1 shows the number of spontaneous bowel movements over a four week trial of a
composition of the invention.
Figure 2 shows the number of complete spontaneous bowel movements over a four week
trial of a composition of the invention.
Figure 3 shows the degree of abdominal discomfort over a four week trial of a composition
of the invention
Figure 4 shows the degree of flatulence over a four week trial of a composition of the
invention
Figure 5 shows the bowel urgency over a four week trial of a composition of the invention
Detailed description of the invention
The following is a description of the present invention, including preferred embodiments
thereof, given in general terms. The invention is further elucidated from the disclosure
given under the heading “Examples” herein below, which provides experimental data
supporting the invention, specific examples of various aspects of the invention, and means
of performing the invention.
As used herein, the terms “treatment” or “treat”, or similar, are to be considered in their
broadest context. The terms do not necessarily imply that a subject is treated until total
recovery. Accordingly, these terms include the amelioration of the symptoms or severity of
a particular condition or preventing or otherwise reducing the risk of developing a particular
condition.
A “subject” as referred to herein refers to any animal, preferably mammals and including
humans.
“Prebiotic material” refers to any non-digestible components of the kiwifruit extract that
beneficially affect the host by selectively promoting the growth and/or activity of one or
more health promoting microflora, for example bacteria, in the gut.
A “bifunctional protease-amylase inhibitor” as referred to herein is any compound, extract
or composition that has the dual function of being able to at least suppress or retard the
function or activity of one or more amylase and one or more protease enzymes. It will be
understood by one of skill in the art that the suppression or retardation of the function or
activity of a protease may occur at the same time or at a different time to the suppression or
retardation of the function or activity of an amylase. The bifunctional function of the
inhibitor may be the result of a single compound or two or more compounds in an extract or
composition. Use of the term “inhibitor” should not be taken to imply that an amylase
and/or protease is completely inhibited, although this may be preferred.
“Symptoms associated with a digestive disorder or a gastrointestinal disorder” should be
taken to include abdominal discomfort or pain, flatulence, bowel urgency, wind or burping,
bloating, alteration of bowel habits, constipation, diarrhea, reduced bowel movements,
feeling of incomplete evacuation, anal burning, hard stools and heartburn for example.
Throughout the specification, unless the context requires otherwise, percentages provided
are percentage w/w.
A number of different compounds were tested in conjunction with a kiwifruit extract to
determine whether they affected the enzyme activity of the kiwifruit extract, which could
affect the ability of the extract to maintain a healthy gastrointestinal tract. During this
research, the inventors found that eating kiwifruit did not have the same beneficial effects
as consuming an encapsulated kiwifruit extract. In light of this, they hypothesised that one
or more salivary enzymes were reducing the efficacy of the beneficial enzymes prior to
reaching the stomach. Saliva contains a number of enzymes that could have been causing
this effect including α-amylase (EC3.2.1.1), lingual lipase, lysozyme, salivary lactoperoxidase,
lactoferrin, immunoglobulin A, salivary acid phosphatases A+B, N-acetylmuramoyl-L-alanine
amidase, NAD(P)H dehydrogenase (quinone), superoxide dismutase, glutathione transferase,
class 3 aldehyde dehydrogenase, glucosephosphate isomerise and tissue kallikrein (Boron,
2008).
Analysis of the kiwifruit extract showed that it contained three main components found to
act synergistically in providing beneficial health effects: soluble fibre, a pre-biotic
component and one or more cysteine protease enzymes.
Capsule dosage forms are effective in shielding the extract from salivary enzymes that the
inventors have shown degrade the beneficial enzymes and reduce overall therapeutic
efficacy. However, as noted previously, dosage forms other than capsules may be desirable.
Tests of kiwifruit extract (example 3) in the presence of saliva showed that a white bean
extract increased the kiwifruit extract enzyme activity. The inventors contemplate that the
finding may be explained by a protective function of the white bean extract from the salivary
amylase and/or salivary protease present. White bean extract contains an effective amylase
inhibitor which the inventors believe may prevent the breakdown of the pre-biotic
component by the action of salivary amylase.
Further to the above effect, the inventors surprisingly found that white bean extract also
enhanced the activity of enzyme(s) in the kiwifruit extract in the absence of saliva (see
examples 1 and 2). Further, the inventors found that compositions of the invention have a
high stability.
Without wishing to be bound by theory, the inventors believe that these surprising effects
can be explained if the white bean extract contains bifunctional enzymatic activity as both a
protease inhibitor and an amylase inhibitor. Protease inhibitors such as serine protease
inhibitors exhibit some structural homology to cysteine proteases which are found in the
kiwifruit extract. It is hypothesised that in the absence of the white bean extract, cysteine
protease activity breaks down components of the kiwifruit extract enzyme complex and
other components and reduces its efficacy and activity. The inventors believe that with
white bean extract present, the serine protease inhibitor binds loosely to the cysteine
protease temporarily inhibiting the cysteine protease activity resulting in greater stability of
the kiwifruit enzyme complex and consequently a longer shelf life. When the kiwifruit
extract is formulated as a capsule on its own without white bean extract, the one or more
cysteine proteases in the kiwifruit extract may break down the capsule and the other
components of Zyactinase® resulting in a reduced shelf life.
In addition, the inventors contemplate that the increased enzyme activity of the kiwifruit
extract may be explained by the detachment of the loosely bound serine protease inhibitor
in white bean extract from the cysteine protease in the kiwifruit extract due to the lower pH
on entering the stomach (as simulated during the enzyme assays in examples 1 to 3). The
inventors believe this causes a change in the active binding site of the enzyme complex
which in turn modifies the reaction mechanism and therefore alters the activation energy of
the reaction resulting in an increased kiwifruit extract enzyme complex efficacy and activity.
While the inventors have demonstrated the effects using a white bean extract, it is
envisaged that any amylase inhibitor and/or a bifunctional protease-amylase inhibitor when
provided either together or individually would have similar effects and is within the scope of
the invention.
The present invention goes at least some way towards addressing the problem of inhibition
or breakdown of beneficial enzymes in the kiwifruit extract prior to or during passage into
the gastrointestinal tract, and further, enhances the enzymatic activity of the kiwifruit
extract.
The invention provides a composition comprising a kiwifruit extract in combination with an
amylase inhibitor and/or a bifunctional protease-amylase inhibitor wherein the composition
may also further comprise one or more suitable diluents, carriers and/or excipients.
“Kiwifruit extract” as referred to herein is an extract from the whole fruit of a kiwifruit
comprising at least one cysteine protease enzyme. In one embodiment, the at least one
cysteine protease enzyme comprises actinidin. In one embodiment, the kiwifruit extract
comprises actinidin with an enzyme activity of substantially 1500U/g to substantially 6000
U/g, preferably substantially 3000U/g to 5000U/g when measured using the Vital Foods
method as described in example 2 herein. In one embodiment, the kiwifruit extract
comprises one or more cysteine protease enzymes, fibre and a pre-biotic component.
While there are beneficial effects of these components, it may also be desirable to remove
the fibre component and/or a pre-biotic component and it is contemplated that the kiwifruit
extract may comprise any one or more of these in addition to at least one cysteine protease
enzymes. In one embodiment, the extract is derived from a kiwifruit in the Actinidia family
or a hybrid thereof. In a particular embodiment, the kiwifruit is of the species Actinidia
deliciosa (formerly classified as Actinidia chinensis), Actinidia chinensis, Actinidia arguta or a
hybrid derived from one or more of these species.
In a further embodiment, compositions of the invention comprise kiwifruit extract that has
been processed to include an additional, increased or decreased proportion of one or more
components. For example such components may include: kiwifruit derived enzymes, fibre
or pre-biotic components; components, such as enzymes, derived from different extracts
including plant and bacterial extracts; pro-biotic bacteria (examples of which are defined
herein); additional synthetically produced components including enzymes.
In one embodiment, the kiwifruit extract referred to herein is an extract prepared from the
kiwifruit pulp (i.e. kiwifruit without the seeds or skin). In a further embodiment, the kiwifruit
extract is prepared according to the method(s) set out in WO2008/136689 or
WO2006/118476. In one embodiment, the kiwifruit extract has the defining characteristics
of the kiwifruit extract described in and the subject of WO2008/136689 or WO2006/118476.
In an alternative embodiment, the kiwifruit extract has the defining characteristics of a
kiwifruit enzyme complex with the brand name Zyactinase®, and more preferably
Zyactinase® 45. In a particular embodiment, the kiwifruit extract is the kiwifruit enzyme
complex with the brand name Zyactinase®, and more preferably Zyactinase® 45.
Zyactinase® is the primary active ingredient present in Phloe® capsules produced by and
available from Vital Food Processors Limited, New Zealand.
While the experiments and preferred ratios of compositions defined herein use kiwifruit
extract extracted according the method described above, it should be appreciated that
kiwifruit extracts extracted according to other methods are also encompassed within the
invention.
In broad terms, an “amylase inhibitor” is a compound, extract or composition that results in
at least some suppression or retardation of the function or activity of one or more amylase
enzymes. Use of the term “inhibitor” should not be taken to imply that the amylase activity
is completely inhibited, although this may be preferred. In one embodiment, the amylase
inhibitor is a protein. Amylase inhibitors may also be identified by their action in
suppressing the activity of α-amylase for example by methods described in Rakhimova et al.
(2008), Sharma and Gupta (2001) and Mosolov et al. (2001).
Several studies have shown that amylase inhibitors are effective in reducing starch digestion
in all parts of the gastrointestinal tract (reviewed in Obiro, Zhang and Jiang (2008)). This
research indicates that an amylase inhibitor is active against salivary and pancreatic
amylases throughout the gastrointestinal tract. Accordingly, the inventors contemplate the
invention also being applicable to encapsulated kiwifruit extract that is released in the
stomach or further along the gastrointestinal tract.
Skilled persons will readily appreciate amylase inhibitors of use in the invention. However,
by way of example only, amylase inhibitors can be extracted from several types of plants,
especially those in the legume family. Currently available α-amylase inhibitors are commonly
extracted from either white kidney bean (Phaseolus vulgaris) or wheat (Triticum aestivum)
although they can also be found in Lens culinaris, Psophocarpus tetragonolobus, Cicer
arietinum, Vigna aconitifolia, oats, sorghum, rye, barley, mango seeds, kiwifruit seeds and
potatoes. An example of a commercial preparation of amylase inhibitor is StarchLite® (page
7, Obiro, Zhang and Jiang (2008)) produced by PharmaChem Laboratories Inc., New Jersey.
This preparation has “Generally Recognised As Safe” (GRAS) status by the United States
Food and Drug Administration under sections 201(s) and 409 of the Federal Food, Drug, and
Cosmetic Act.
While amylase inhibitors have been used in weight loss products, they have not previously
been used or postulated as being effective for the enhancement of the efficacy of kiwifruit
extracts for managing gut health or for the treatment or prevention of a variety of
gastrointestinal disorders.
As mentioned hereinbefore, the invention may be performed using a bifunctional protease-
amylase inhibitor. In one embodiment it is a serine protease-amylase inhibitor, or a trypsin-
amylase inhibitor. “Bifunctional protease-amylase inhibitors” are defined hereinbefore and
can include any suitable compound, extract or composition having a protease-amylase
inhibitory activity.
Skilled persons will readily appreciate bifunctional protease-amylase inhibitors of use in the
invention. However, by way of example only, they may be extracted from several types of
plants, especially those in the legume family, from white kidney bean (Phaseolus vulgaris) ,
wheat (Triticum aestivum), Lens culinaris, Psophocarpus tetragonolobus, Cicer arietinum,
Vigna aconitifolia, oats, sorghum, rye, barley, mango seeds, kiwifruit seeds and potatoes.
Bifunctional protease-amylase inhibitors may be identified by their action in suppressing the
activity of trypsin and α-amylase for example by methods described in Rakhimova et al.
(2008), Sharma and Gupta (2001) and Mosolov et al. (2001).
In one embodiment, the bifunctional protease-amylase inhibitor is white bean extract, in
one particular embodiment it is a white bean extract having the defining characteristics of
Starchlite®. In one particular embodiment, it is Starchlite®
As used herein, the phrase "suitable diluents, carriers and/or excipients" is intended to
include substances that are useful in preparing a composition, may be co-administered with
composition of the invention while allowing it to perform its intended function, and are
generally safe, non-toxic and neither biologically nor otherwise undesirable. Suitable
diluents, carriers and/or excipients include those suitable for veterinary use as well as
human use. Examples of suitable diluents, carriers and/or excipients include solutions,
solvents, dispersion media, delay agents, emulsions and the like.
Those of ordinary skill in the art will readily appreciate a variety of suitable diluents, carriers
and/or excipients which may be employed in compositions of the invention. However, by
way of example, suitable diluents, carriers and/or excipients for use may be selected from
the group comprising tableting sugar (for example Di-Pac® tableting sugar from Domino
Specialty Ingredients, Florida USA), tropical flavour, natural intense sweetener, magnesium
stearate, silicon dioxide, evaporated cane juice, rice syrup/rice syrup solids, fructose,
sunflower lecithin, natural flavors, corn starch, glycerin, sunflower oil, natural colour from
chlorophyll, tableting sugar, apple powder, citric acid, lemon powder, sucralose, copper
chlorophyllin, tropical flavour powder, natural kiwi / strawberry flavour with natural
antioxidants, sodium copper chlorophyllin.
Examples of suitable diluents, carriers and/or excipients for use in tablet form include
tableting sugar (for example Di-Pac® tableting sugar from Domino Specialty Ingredients,
Florida USA), tropical flavour, natural intense sweetener, magnesium stearate and silicon
dioxide.
Examples of suitable diluents, carriers and/or excipients for use in soft chew form include
evaporated cane juice, rice syrup, fructose, sunflower lecithin, natural flavors, corn starch,
glycerin, sunflower oil and natural color from chlorophyll.
Examples of suitable diluents, carriers and/or excipients for use in capsule form include
isomalt, magnesium stearate, silicon dioxide.
Examples of suitable diluents, carriers and/or excipients for use in powder for suspension in
a liquid form include apple powder, citric Acid, lyophilized lemon, fructose, sucralose, copper
chlorophyll and tropical flavour.
Additionally, it is contemplated that a composition in accordance with the invention may be
formulated with one or more additional ingredients, including for example colouring agents,
flavouring agents or active ingredients which may be of benefit to a subject in particular
instances.
Ingredients identified in accordance with this embodiment of the invention may be
formulated with one or more suitable carriers, diluents and/or excipients, according to
standard procedures as would be known and understood by one of skill in the art, having
regard to the desired dosage form. It should be understood that the process used to
produce the formulation should minimise heating or other steps that may denature the
active enzymes in the composition. Exemplary methods that may be used to produce a soft
chew formulation are described in US 6,517,886 and 6,482,465.
Further embodiments of the invention may contain extracts made into liquid compositions,
or included in foodstuffs and beverages. For example, the compositions of the present
invention may be incorporated in frozen or chilled desserts; blended with sugar or prepared
as a sprinkle on product for use on breakfast cereals and fruit; incorporated into a wide
variety of drinks and beverages; blended with milk or cream; blended with yoghurt, or ice
cream; encapsulated and administered orally or as a suppository; pressed into tablet form to
be administered orally or formed into a drench for oral administration.
The optimal amount of kiwifruit extract, bifunctional compound and/or amylase inhibitor
present in the composition may differ according to the particular dosage form and the unit
dosage required.
In one embodiment, the amylase inhibitor and/or bifunctional protease-amylase inhibitor is
present in the composition at a minimum concentration of 0.5% (w/w) and at a maximum
concentration of approximately 50%, approximately 40%, approximately 30%,
approximately 20%, approximately 10%, approximately 5%, approximately 2%,or
approximately 1%.
In one embodiment, the kiwifruit extract is present in the composition in a maximum
concentration of approximately 99.5% and at minimum concentration of approximately
50%, approximately 60%, approximately 70%, approximately 80%, approximately 90%,
approximately 95%, approximately 98%, or approximately 99%.
In one particular embodiment the composition comprises kiwifruit extract at a concentration
of approximately 98 to 99.5% (w/w) and amylase inhibitor at approximately 0.5 to 2.0%
(w/w), or kiwifruit extract at approximately 98.5 to 99.5% and amylase inhibitor at
approximately 0.5 to 1.5% (w/w), or kiwifruit extract at approximately 98 to 99% and
amylase inhibitor at approximately 1.0 to 2.0% (w/w), or kiwifruit extract at approximately
99% and amylase inhibitor at approximately 1%.
In one particular embodiment the composition comprises:
a) kiwifruit extract at a concentration of approximately 97.5 to 99.5% (w/w) and
b) a bifunctional protease-amylase inhibitor at a concentration of approximately 0.5
to 2.5% (w/w); or
a) kiwifruit extract at a concentration of approximately 98 to 99.5% (w/w) and
b) a bifunctional protease-amylase inhibitor at a concentration of approximately 0.5
to 2.0% (w/w); or
a) kiwifruit extract at approximately 98.5 to 99.5% and
b) a bifunctional protease-amylase inhibitor at a concentration of approximately 0.5
to 1.5% (w/w); or
a) kiwifruit extract at approximately 98 to 99% and
b a bifunctional protease-amylase inhibitor at a concentration of approximately 1.0
to 2.0% (w/w); or
a) kiwifruit extract at approximately 99% and
b) a bifunctional protease-amylase inhibitor at a concentration of approximately 1%.
The ratio of kiwifruit extract:amylase inhibitor and/or bifunctional protease-amylase
inhibitor in certain embodiments is between approximately 200:1 and 1:1, approximately
99:1 and 1:1, approximately 49:1 and 1:1, approximately 35:1 and 1:1, approximately 30:1
and 1:1, approximately 28:1 and 1:1, approximately 19:1 and 1:1, approximately 10:1 and
1:1, approximately 9:1 and 1:1, approximately 4:1 and 1:1 or is approximately 1:1.
In other embodiments, the ratio of kiwifruit extract:amylase inhibitor and/or bifunctional
protease-amylase inhibitor is approximately 34.9:1, approximately 27.5:1 or approximately
9.6:1.
In one particular embodiment, the amylase inhibitor is present in the composition at
approximately 1.98% (w/w) and the kiwifruit extract is present at approximately 69.15%, the
amylase inhibitor is present in the composition at approximately 2% (w/w) and the kiwifruit
extract is present at approximately 55%, or the amylase inhibitor is present in the
composition at approximately 1.6% (w/w) and the kiwifruit extract is present at
approximately 15.38%.
In one particular embodiment, the composition comprises
a) a bifunctional protease-amylase inhibitor at a concentration of approximately 1.98%
(w/w) and
b) kiwifruit extract at approximately 69.15%;
a) a bifunctional protease-amylase inhibitor at a concentration of approximately 2% (w/w)
b) kiwifruit extract at approximately 55%;
a) a bifunctional protease-amylase inhibitor at a concentration of approximately 1.6% (w/w)
b) kiwifruit extract at approximately 15.38%.
Kiwifruit extract is effective in the treatment or prevention of digestive dysfunction,
gastrointestinal disorders, and/or one or more symptoms thereof. Kiwifruit extract is of
particular use in treating constipation. The prebiotic material present in kiwifruit extract can
influence the balance of gastrointestinal bacteria, with a preferential promotion of the
growth of beneficial bacteria and concomitant reduction in the growth of harmful bacteria
(). Kiwifruit extract also has use in the maintenance or improvement of
gastrointestinal health.
The present invention provides an improved composition that may be used: to treat or
prevent digestive dysfunction, gastrointestinal disorders, and/or one or more symptoms
thereof; for altering, maintaining and/or restoring a balance of intestinal microflora of a
subject ; in maintaining and/or improving the gastrointestinal health of a subject. The
activity of enzymes in the kiwifruit extract is enhanced and the effect of salivary and
pancreatic substances that limit the enzyme activity of the extract is reduced. These effects
result in a composition with increased efficacy for the above uses when compared to the
efficacy of known compositions.
The digestive dysfunction and/or gastrointestinal disorders that the invention may be used
to treat includes, but is not limited to constipation, inflammatory bowel conditions,
indigestion, gastric reflux, bloating, gas, abdominal pain, diarrhoea, heart-burn, irritable
bowel syndrome, or symptoms associated with any of these conditions.
Maintaining and/or improving the gastrointestinal health of a subject could involve the
prevention or treatment of any one of the digestive dysfunctions, gastrointestinal disorders,
and/or symptoms thereof noted hereinbefore and could also involve promoting one or more
of the following:
a. an increase in spontaneous bowel movements
b. an increase in complete spontaneous bowel movements
c. a decrease in abdominal discomfort or pain
d. a decrease in flatulence
e. a decrease in bowel urgency
f. a decrease in wind or burping
g. a decrease in bloating
According to the American Gastroenterological Association, among healthy people the
frequency of bowel movements may vary from three movements a day to three per week.
Constipation may be suspected if there is difficulty or pain when passing a hardened stool or
if greater than three days pass between bowel movements. Contributing factors to
constipation include:
• Gender (being female)
• Age (being older)
• Diet
• Lifestyle choices
• Use of certain medications
• Bowel habits
Irritable bowel syndrome (IBS) is a symptom-based diagnosis characterized by chronic
abdominal pain, discomfort, bloating, and alteration of bowel habits. As a functional bowel
disorder, IBS has no known organic cause. Constipation or diarrhea may also occur with
either being dominant, or they may alternate. Although there is no cure for IBS, there are
treatments that attempt to relieve symptoms, including dietary adjustments, medication
and psychological interventions.
IBS occurs when the bowel becomes irritated and results in spasms causing abdominal pain.
Constipation results in reduced bowel movements, feeling of incomplete evacuation, anal
burning and hard stools. Prolonged constipation particularly with prolonged use of laxatives
can over time result in inflammation leading to IBS. IBS can also result from damage during
gastro infections, which is why the prebiotic component of Zyactinase® helps relieve IBS by
promoting growth of beneficial bacteria.
The key difference between constipation and IBS is the presence of abdominal pain. In the
clinical trial results (example 7), abdominal pain was measured and it was shown that a
composition of the invention had a clinically significant effect in relieving abdominal pain.
Abdominal pain is often caused as a result of gas and bloating therefore the results of the
study indicate that these aspects were also treated. Additionally, flatulence and burping
(collectively, gas) were reduced when using a composition of the present invention. Bowel
urgency, which is an indication of diarrhea, was also reduced when using compositions of
the invention.
The inventors also have preliminary results indicating that compositions of the invention
have particular efficacy in treating indigestion and gastric reflux.
The symptoms treated by compositions of the invention are also symptoms of inflammatory
bowel disorders, heartburn and IBS. As such, the results presented by the inventors provide
strong evidence that compositions of the invention promote laxation thus treating
constipation as well as relieving the symptoms of IBS and other gastro-intestinal disorders
referred to herein.
In providing a composition for altering, maintaining and/or restoring a balance of intestinal
microflora (for example bacteria) of a subject, the invention may maintain or stimulate the
growth of at least one beneficial bacteria in the gut and/or inhibit or suppress the growth of
at least one harmful or pathogenic bacteria in the gut. Preferably the beneficial bacteria are
selected from the group comprising probiotic bacteria. More preferably the beneficial
bacteria are selected from the group comprising bifidobacteria and lactobacilli. Some
examples include Lactobacillus reuteri, Lactobacillus acidophilus, Pediococcus acidilactici,
and Lactobacillus plantarum. Preferably the harmful bacteria are selected from the group
comprising pathogenic bacteria. More preferably the harmful bacteria are selected from the
group comprising bacteroides, Clostridia, coliforms, and sulphate reducing bacteria. Some
examples include Escherichia coli (for example E.coli 0157:H7) , Salmonella typhimurium, and
Staphylococcus aureus. Most preferably the harmful bacteria are selected from the group
comprising gram negative pathogenic bacteria. Materials and methods for analysing levels
and identity of beneficial and pathogenic gut bacteria are found in NZ554991 which is
incorporated herein by reference.
The gastrointestinal health of the subject may be assessed by the incidence of symptoms
associated with one or more gastrointestinal disorders which include, but are not limited to
constipation, inflammatory bowel conditions, indigestion, gastric reflux, bloating, gas,
abdominal pain, diarrhoea, heart-burn and irritable bowel syndrome.
The dosage provided and the length of the administration programme may differ depending,
for example, on the requirement for treatment, the severity of the gastrointestinal disorder,
the age and/or the general health of the subject. However, by way of example, a dosage
range of 375mg to 11g, for example 500mg to 3g of kiwifruit extract may be administered
per day. For minor digestive dysfunction and/or gastrointestinal disorders, for altering,
maintaining and/or restoring a balance of intestinal microflora of a subject and for
maintaining and/or improving the gastrointestinal health of a subject, the dosage may
comprise, for example a dose of approximately 1000-1300mg per day, for example 1150 mg.
For more serious digestive dysfunction and/or gastrointestinal disorders, approximately 2.5g
of kiwifruit extract may be administered per day, for example. It should be appreciated that
the daily desired dose may be delivered in a single dose or two or more divided doses. In
one embodiment, the composition is administered at a daily dose of 1150mg as two unit
doses of 575mg each. Preferably, the composition is administered prior to food.
The invention will now be described, by way of example only, which reference to the
following Examples and Experiments.
Examples
The kiwifruit extract referred to in the below examples is Zyactinase®, and is prepared
according to the method(s) set out in WO2008/136689 or WO2006/118476. The white bean
extract is StarchLite® as referred to hereinbefore.
Example 1
A large number of commercially available dietary supplements and in-house preparations
were tested in combination with kiwifruit extract for synergistic activity. A number of these
extracts contained protease enzymes which the inventors hypothesised would enhance the
activity of the Zyactinase® enzymes. This turned out not always to be the case and instead
adding further proteases appeared to block the Zyactinase® activity. From these
experiments, the inventors surprisingly found that the amylase inhibitor (which is postulated
to protect the proteases rather than supplement them) white bean extract stood out as
being effective in enhancing the enzyme activity of the kiwifruit extract. Further tests were
conducted on this extract and are detailed below.
Method
The enzyme activity of the kiwifruit extract was analysed according to the method detailed
below.
The following reagents were prepared:
8% Trichloroacetic acid, 2M NaOH and 50mM Citrate Buffer containing 10mM EDTA. The
citrate buffer was prepared using 1.05g citric acid + 80 ml deionised water + add 1 ml of 1M
EDTA stock solution; take to pH 6.25 by addition of 2N NaOH and top up to 100ml by
deionised water.
Azocasein substrate solution (5mg/ml) was prepared using both water and 50mM citrate
buffer containing 10mM EDTA (10ml each for every 100mg substrate). Kiwifruit extract
sample solution (50mg/ml) was prepared using 0.2g kiwifruit extract dissolved in 2ml citrate
buffer (50mM citrate buffer containing 10mM EDTA) and 2ml distilled water
The following method was used to analyse actinidin enzyme activity: 1) Add 0.25 ml of
kiwifruit extract sample solution in 4 centrifuge tubes (1.5ml capacity), two active and two
blank. 2) Add 0.5ml of 8% Trichloroacetic acid in 2 blank tubes to calibrate a zero reading. 3)
Add 0.5ml of Substrate solution in all 4 tubes. 4) Incubate all the tubes at 35 for 120 min.
) Add 0.5ml of 8% Trichloroacetic acid to the two active tubes. 6) Centrifuge for 5
minutes. 7) Remove two lots of 0.75 ml of supernatant into centrifuge tube; add 0.1 ml of
2N NaOH. 8) Measure absorbance at 420 nm by UV-Vis spectrophotometer in a quartz cell
(optical path length :10 mm). The initial absorbance is zeroed by blank and then the active
sample is added and absorbance noted. 9) Enzyme activity in units per milligram is
calculated as follows
Absorbance @ 420nm
= U/g
Calibration factor x Conc. of kiwifruit extract in solution (g)
White bean extract was added to kiwifruit extract in 2%, 5%, 10%, 20% and 50%
concentrations (w/w). The kiwifruit extract was present at the reciprocal percentage
amount. A control sample was prepared with 0% white bean extract inhibitor. The white
bean extract used was StarchLite® produced by PharmaChem Laboratories Inc., New Jersey.
No saliva was added to the solutions.
Results
Concentration of white bean Absorbance Actinidin enzyme activity
extract (%w/w) (U/g)
0 0.620 198.4
2 0.785 251.2
0.515 164.8
0.221 70.72
0.495 158.4
50 0.402 128.64
Conclusions
This experiment demonstrates that 2% white bean extract added to kiwifruit extract
enhances enzyme activity when compared to a control extract without white bean extract.
At higher concentrations, the amount of kiwifruit extract was reduced and therefore we
would also expect a concomitant reduction in enzyme activity. Despite this expectation, it
was observed that enzyme activity at 50% kiwifruit extract, 50% white bean extract was
greater than the activity expected with only 50% of the enzyme present. This shows that the
white bean extract is enhancing enzyme activity even at this concentration.
Example 2
The inventors used an enzyme assay (referred to as the Vital Foods method) described
below to determine the enzyme activity of the kiwifruit extract. The principle of the assay
relies on the ability of the enzymes to liberate milk casein as a substrate. The undigested
casein is removed by precipitation using trichloroacetic acid solution, then the amount of
the resultant soluble decomposition product is measured by spectrophotometric analysis
absorbance in 275nm.
Method
The following reagents are required: 0.1M hydrochloric acid test solution, 1M sodium
hydroxide reagent, 0.1M sodium hydroxide reagent, 1mg/ml tyrosine standard solution,
50μg/ml tyrosine standard solution, 0.11M trichloroacetic acid solution, 0.05M cysteine -
EDTA solution, 0.05M disodium hydrogen phosphate solution.
The cysteine-EDTA solution should be prepared according to the following method: take
70ml of water and add 0.875g of special grade L-cysteine monohydrochloride monohydrate;
add 0.223g of disodium ethylenediamine tetraacetic acid; control the pH into 4.50 with 1M
sodium hydroxide test solution; add water to make 100ml.
The substrate should be prepared according to the following method: weigh 1g of milk
casein (Hammerstein No. 2242 produced by Merck & Co., Inc.); dry it at 105 degrees C for 2
hours; weigh the amount corresponding to 3.0 g of the dried matter; add 400ml of 0.05M
disodium hydrogen phosphate solution little by little so as not to generate granular lumps
and apply heat to 60-70 degrees C for 15 minutes to dissolve it therein; after cooling it,
control the pH to 8.00 with 1M (or 0.lM) sodium hydroxide test solution; add water to make
500ml.
A sample solution should be prepared according to the following method: weigh 4.0g of
sample; add distilled water to make 100ml; dissolve the sample completely by using a vortex
mixer or magnetic stirrer; leave it at 4 degrees C for 1 hour; take 1ml of solution and add 4ml
of 0.05M cysteine-EDTA (ethylenediamine tetraacetic) to make the final volume to 5ml.
The analysis procedure should be carried out according to the following method:
1. Active sample: place 5ml of substrate in each screw cap test tube; leave them in an
incubator, which has been set to 37 ± 0.5 degrees C in advance, for 10 minutes; add each
1ml of sample solution and agitate it with a vortex mixer; leave them at 37 ± 0.5 degrees C
for 10 minutes; add each 5ml of 0.11M trichloroacetic acid solution and agitate it with the
vortex mixer; leave them at 37 ± 0.5 degrees C for 30 minutes; centrifuge at 5000rpm for 15
minutes; measure the absorbance (A ) on this liquid in a wavelength of 275nm using water
as a control (blank).
2. Control sample: place 5ml of 0.11M trichloroacetic acid solution in each screw cap test
tube; leave them in an incubator, which has been set to 37 ± 0.5 degrees C in advance, for 10
minutes; add each 1ml of sample solution and agitate it with a vortex mixer; leave them at
37 ± 0.5 degrees C for 10 minutes; add each 5ml of substrate and agitate it with the vortex
mixer; leave them at 37 ± 0.5 degrees C for 30 minutes; centrifuge at 5000rpm for 15
minutes; measure the absorbance (A ) on this liquid in a wavelength of 275nm using water
as a control (blank).
Measure absorbance A of tyrosine standard solution at 275 nm using water as the
reference. Measure absorbance A of 0.1 mol/L hydrochloric acid at 275 nm using water as
the reference. One unit of the enzyme activity is defined as the amount of enzyme that
increases the absorbance equivalent to 1μg of tyrosine per minute when the test is
performed under the conditions of this procedure.
(A - A )· 50 11 1000
Enzyme activity in this product (units per gram) = · ·
A - A 10 W
s so
Where W indicates the weight (mg) of the sample in 1 ml of the sample solution
The mean value of two repetitions for each sample treatment was taken to provide a
measurement of actinidin enzyme activity. White bean extract at different concentrations
(% w/w) was combined with kiwifruit extract (at the reciprocal percentage amount w/w) to
provide 4.0g for sample preparation as outlined above. No saliva was added to the samples.
Results
Treatment Enzyme Units (U/g)
White bean extract (0%) + kiwifruit extract 5790
White bean extract (1%) + kiwifruit extract 6130
White bean extract (2%) + kiwifruit extract 5674
White bean extract (5%) + kiwifruit extract 5461
Conclusions
This experiment supports the conclusions from Example 1 that white bean extract added to
kiwifruit extract enhances enzyme activity when compared to a control extract without
white bean extract. This assay suggests that the highest enzyme activity for this particular
formulation is obtained when using a white bean extract concentration of 1%.
Example 3
Method
The “Vital Foods” method outlined above was used to determine the enzyme activity of
kiwifruit extract in a composition comprising white bean extract and kiwifruit extract in the
presence of saliva.
4ml of saliva was mixed with a 4g sample of a composition comprising kiwifruit extract and
white bean extract for 2 minutes. The white bean extract was present in the composition at
2% (w/w) and the kiwifruit extract was present at 98% (w/w). The mean value of two
repetitions for each sample treatment was taken to provide a measurement of enzyme
activity.
Results
Treatment Enzyme activity U/g
Kiwifruit extract + saliva 4541
White bean extract (2%) + kiwifruit extract + saliva 5151
Conclusion
This result demonstrates that in the presence of saliva, the enzyme activity is higher if white
bean extract is present. This finding supports the inventor’s hypothesis that salivary
amylases in the saliva are inhibiting enzyme activity of the extract.
Clinical studies
Confidential clinical studies have been conducted in humans to determine the efficacy of a
composition of the invention when formulated as a powder mixed in liquid. Results from
these studies are presented in examples 4 to 7 below.
Example 4
Method
An initial trial involved three volunteer elderly subjects (female between 75 to 80 years old)
with chronic constipation. These subjects normally took a regular daily dose of 10ml of
lactulose once a day (unless more was required to induce a bowel movement) for relieving
chronic constipation. Lactulose dosing was stopped during the trial. These three subjects
had previously used KiwiCrush (frozen Kiwifruit extract composition without WBE) and had
found that 250ml twice a day resolved their constipation.
A dose titration was set up. Four formulations were made of Kiwifruit extract plus white
bean extract (Starchlite®) to test how the drink powder formulation of kiwifruit extract was
working in comparison to KiwiCrush® (frozen format) and to determine whether white bean
extract made any difference.
A: Kiwifruit extract (powder in liquid form) + 0% White bean extract
B: Kiwifruit extract (powder in liquid form) + 1% White bean extract
C: Kiwifruit extract (powder in liquid form) + 2% White bean extract
D: Kiwifruit extract (powder in liquid form) + 3% White bean extract
The formulations were dispensed in sachets of 10g (with 55% Kiwifruit extract (Zyactinase®))
and administered in 250ml of water. Two sachets were administered approximately 12
hours apart until a bowel movement occurred. 250ml KiwiCrush® contained the same
amount of kiwifruit extract (Zyactinase®) as one sachet.
Results
KiwiCrush: Normal bowel movement within 24 hours of 500 ml
A: Bowel movement within 48 hours, stool was hard and 4 sachets needed to achieve bowel
movement
B: Semi hard bowel movement within 24 hours, 2-3 sachets required to achieve bowel
movement
C: Normal bowel movement within 12 hours following 2 sachets
D: Bowel movement within 48 hours, stool was hard 4 sachets required to achieve bowel
movement.
Conclusion
The results indicate that all formulations were effective and that in particular formulation C
containing kiwifruit extract and WBE was the most effective and better than the KiwiCrush®
formulation which did not contain the WBE.
Example 5
Method
Blind trials were undertaken at three different locations on a total of 37 subjects. Elderly
subjects were chosen based on a history of chronic constipation requiring ongoing use of
lactulose (a strong laxative) either due to prolonged use of various medications or simply
due to old age. All subjects were aged between 65 to 95 years old. Subjects were provided
the treatment and the number of bowel movements within the next 24 hours was recorded
by nursing staff, as well as whether lactulose was required and the required dose.
Four formulations containing varying concentrations of white bean extract
A: Kiwifruit extract (powder in liquid form) + 0% White bean extract
B: Kiwifruit extract (powder in liquid form) + 1% White bean extract
C: Kiwifruit extract (powder in liquid form) + 2% White bean extract
D: Kiwifruit extract (powder in liquid form) + 3% White bean extract
Kiwifruit extract was present in the dose at a concentration of 55% for each formulation.
The compositions were administered as a powder for suspension in water. One sachet of
powder contained 10g of formulation. The white bean extract used was StarchLite® and the
kiwifruit extract used was Zyactinase®.
All of these facilities were currently using KiwiCrush® at the time and thus this was a
comparison between the powder and frozen format
A preliminary trial was conducted on 17 of the subjects with the following results:
KiwiCrush®: Subjects were having generally normal bowel movements within 24 hours on
one to two glasses (250 ml) per day
A: Bowel movement within 24 hours, stool was harder than usual and needed to take up to
2 sachets
B: Semi hard bowel movement within 24 hours, needed 1-2 sachets
C: Normal bowel movement with 12 hours on 1-2 sachets
No bloating or abdominal discomfort was reported.
Following this preliminary trial, a more robust trial was conducted with 20 subjects over nine
days. One sachet (10g) of composition was administered as a powder suspension in water
formulation prior to the evening meal on day one. Treatment on day one was followed by
one week of normal (i.e. lactulose only) treatment followed by a second day of treatments
on day 9. Treatments were randomly assigned and swapped during the day 9 treatment.
Results
Day 1 results summary:
Treatment A (0%) = limited help with bowel movement, high dose of lactulose required
Treatment B (1%) = bowels working sufficiently without the need for lactulose
Treatment C (2%) = good bowel movements, no lactulose required
Treatment D (3%) = some help but complemented by a dose of lactulose
Using one sachet of the 2% composition, at least one bowel movement was obtained in less
than 12 hours. Using the same amount of the 3% composition, bowel movements did not
occur and lactulose at the normal dosage was required for bowel movement to occur. 0%
treatment resulted in little help with bowel movement and a high dose of lactulose was
required. The 1% composition was effective but lactulose was still required to induce bowel
movements.
Day 9 results supported the results from day 1 which showed that the 2% composition
resulted in most bowel movements and least lactulose required.
Conclusion
These results show that a composition comprising white bean extract and a kiwifruit extract
has increased efficacy for increasing bowel movements and therefore reducing the incidence
of constipation when compared to a kiwifruit extract alone. Additionally, the results show
that the 2% white bean extract composition was the most effective for increasing bowel
movements. The reduction in constipation may also lead to a reduction in associated
gastrointestinal disorders.
Example 6
Method
A further trial was conducted for one week with 2 doses of a 10g formulation containing 2%
white bean extract, 98% Kiwifruit extract in 250ml of water, administered twice a day.
Results
The amount of lactulose required declined over the period to 2ml or no lactulose. All
subjects receiving the composition comprising 2% white bean extract reported less urgency,
reduced flatulence, wind and bloating.
Conclusion
These results show that a composition comprising white bean extract and a kiwifruit extract
has increased efficacy for increasing bowel movements and therefore reducing the incidence
of constipation when compared to a kiwifruit extract alone.
Example 7
Method
The investigational product for this double blinded placebo controlled clinical trial was Kivia
Powder (Vital Food Processors Ltd, Auckland, New Zealand), containing the active ingredient
Zyactinase® at a dose of 5.5g per 10g dose (55%). Kivia Powder is an extract of kiwifruit.
Additional ingredients included apple powder, fructose, lemon powder, vital spirulina, citric
acid, tropical flavor, sucralose, and white kidney bean extract (2% w/w). The placebo was a
combination of inactive components, including lemon powder, vital spirulina, citric acid,
fructose, sucralose, and tropical flavor.
87 subjects were included in the study, all being healthy men (n=32) and women (n=55),
between 18 and 65 years of age with a body mass index (BMI) between 20-35 kg/m2. Mean
age for each group was 38±14 years for the Treatment group and 41±14 years for the
Placebo group. The subjects had symptoms consistent with Occasional Constipation defined
as three or fewer defecations per week plus at least 1 of the following during the 2 week
run-in period:
• Straining during at least 25 percent of defecations.
• Lumpy or hard stools in at least 25 percent of defecations.
• Sensation of incomplete evacuation for at least 25 percent of defecations.
• Sensation of anorectal obstruction/blockage for at least 25 percent of defecations.
• Manual manoeuvres to facilitate at least 25 percent of defecations (eg, digital
evacuation, support of the pelvic floor).
The study was a randomized, double-blind, placebo-controlled parallel-design study where
subjects took either a) the study product or b) a placebo, daily for four weeks.
The study was conducted at the Staywell Research clinical research site located in
Northridge, CA and Medicus Research was the CRO for this study. IRB approval was received
(Copernicus Group IRB, Cary, NC) prior to the initiation of any study related activities. The
numbers of spontaneous bowel movements and complete spontaneous bowel movements
were investigated. The secondary objective was to determine the efficacy of a composition
of the invention compared to placebo on gut health based on diary information. Endpoints
included stool form (Bristol Stool Scale), bowel urgency, abdominal bloating, abdominal
discomfort, satisfaction with bowl habits, flatulence and burping.
Results
The primary endpoint of this study was bowel movement frequency. The numbers of
spontaneous bowel movements (SBM)(figure 1) and complete spontaneous bowel
movements (CSBM)(figure 2) were investigated. A complete spontaneous bowel movement
is a bowel movement during which the subject answered “yes” to the question “Have you
completely emptied your bowel?”.
By week 3, the average number of SBM was significantly higher in the group obtaining a
composition of the invention (p=0.000) and this difference remained statistically significant
at week 4 (p=0.020).
By week 2, the average number of CSBM was significantly higher in the group obtaining a
composition of the invention (p=0.001).
Abdominal discomfort or pain (figure 3) was significantly lower in the group obtaining a
composition of the invention at weeks 1 and 3 (p<0.05) and flatulence (figure 4) was
significantly lower in the group obtaining a composition of the invention at weeks 2 and 3
(p<0.05).
Bowel urgency (figure 5) was reduced in the treatment group vs. the placebo group from
weeks 2 to 5. The percent reduction (active vs. placebo) in bowel urgency at weeks 2 to 5
were respectively, -26% (p<0.05), -25% ,-32% (p<0.05), and -26%.
Between group comparisons demonstrated that by week 2, there were significantly more
Type 4 Bowel movements (sausage shaped and smooth) in the group obtaining a
composition of the invention compared to the placebo group (p=0.020) and by week 3 there
were significantly more Type 5 Bowel movements (soft blobs with clear cut edges) in the
group obtaining a composition of the invention compared to the placebo group (p=0.041).
Conclusion
In a population with occasional constipation, compositions of the invention appear to
significantly increase the frequency of Spontaneous Bowel Movements and Complete
Spontaneous Bowel Movements, as well as reduce the severity of abdominal discomfort,
frequency of flatulence, and urgency associated with bowel movements when compared to
placebo. The composition also improved stool form compared to placebo and did not cause
any increase in burping. The product was safely administered for 4 weeks.
Example 8
A higher stability and extended shelf life is a desirable characteristic for consumers and
vendors of the composition. The inventors found that the compositions of the invention
have an unexpectedly high stability and shelf life.
Method
Each product was stored at room temperature (20 C-35 C) and 60% RH in plastic bottles.
Actinidin enzyme activity was analysed according to the method outlined in Example 1.
Analyses were carried out at set time points (including a control at time=0).
The compositions contained the following ingredients:
Tablets - Di-Pac® tableting sugar (Domino Specialty Ingredients, Florida USA), tropical
flavour, natural intense sweetener, magnesium stearate, silicon dioxide, StarchLite (1.98%)
and Zyactinase® (69.15%).
Soft chew - evaporated cane juice, rice syrup, fructose, sunflower lecithin, natural flavors,
corn starch, glycerin, sunflower oil, natural color from chlorophyll, StarchLite (1.6%) and
Zyactinase® (15.38%).
Powder for suspension in a liquid - apple powder, citric Acid, lyophilized lemon, fructose,
sucralose, copper chlorophyll, tropical flavour, Starchlite (2%), Zyactinase® (55%),
Results
Powder for suspension in a liquid
Time Interval Actinidin enzyme Activity (U/g)
0 time 4600
2 weeks 4602
4 weeks 4556
Tablets
Time Interval Actinidin enzyme Activity (U/g)
0 time 2001
1 month 1967
Chews
Time Interval Actinidin enzyme Activity (U/g)
0 time 1041
1 month 805
2 months 795
3 months 790
Conclusion
The substantial maintenance of the enzyme activity over a period of months indicates
suitability of products of the invention for product use.
The invention has been described herein, with reference to certain preferred embodiments,
in order to enable the reader to practice the invention without undue experimentation.
However, a person having ordinary skill in the art will readily recognise that many of the
components and parameters may be varied or modified to a certain extent or substituted for
known equivalents without departing from the scope of the invention. It should be
appreciated that such modifications and equivalents are herein incorporated as if
individually set forth. The invention also includes all of the steps, features, compositions and
compounds referred to or indicated in this specification, individually or collectively, and any
and all combinations of any two or more of said steps or features.
Furthermore, titles, headings, or the like are provided to enhance the reader’s
comprehension of this document, and should not be read as limiting the scope of the
present invention.
The reference to any prior art in this specification is not, and should not be taken as, an
acknowledgment or any form of suggestion that that prior art forms part of the common
general knowledge in any country in the world.
The entire disclosures of all applications, patents and publications, cited above and below, if
any, are hereby incorporated by reference.
Throughout this specification and any claims which follow, unless the context requires
otherwise, the words “comprise”, “comprising” and the like, are to be construed in an
inclusive sense as opposed to an exclusive sense, that is to say, in the sense of “including,
but not limited to”.
References
Boron, W. F. (2003). Medical Physiology: A Cellular And Molecular Approaoch.
Elsevier/Saunders. pp. 1300
Mosolov, V.V. Grigor’eva, L.I., Valureva, T.A. (2001) Plant proteinase inhibitors as
multifunctional proteins (Review). Applied Biochemistry and Microbiology 37(6) 545-551.
Obiro, W. C., Zhang, T., Jiang, B., (2008). The nutraceutical role of the Phaseolus vulgaris α-
amylase inhibitor. British Journal of Nutrition, 100: 1-12
Rakhimova, S.K., Mejlumyan, L.G., Yuldashev, P.H., and Sagdullaev, B.T. (2008). Bifunctional
inhibitor from corn cultivated in Uzbekistan. Chemistry of Natural Compounds Vol 44, (1),
59-62.
Sharma A, Gupta M.N. ( 2001). Three phase partitioning as a large-scale separation method
for purification of a wheat germ bifunctional protease/amylase inhibitor. Process
Biochemistry 37(2) 193-196.
Schroder R, Nicholas P, Vincent S.J, Fischer M, Reymond S, and Redgewell R.J. (2001)
Purification and characterisation of a galactomannan from kiwifruit (Actinidia delicisiosa).
Carbohyr Res. Apr 12: 331 (3) 291-306.
Reid, J. D., Hussain, S., Bailey, T. S. F., Sonkaria, S., Sreedharan, S. K., Thomas E. W., Resmini,
M., Brocklehurst, K. (2004). Isomerization of the uncomplexed actinidin molecule: kinetic
accessibility of additional steps in enzyme catalysis provided by solvent perturbation.
Biochem. J. 378, 699–703
Claims (18)
1. A composition comprising: a kiwifruit extract derived from processed kiwifruit pulp without the seeds, wherein the kiwifruit extract comprises at least one cysteine protease enzyme; an extract comprising an amylase inhibitor and/or a bifunctional protease- amylase inhibitor which binds loosely to the cysteine protease enzyme(s) of the kiwifruit extract; and one or more suitable diluents, carriers and/or excipients.
2. A composition as claimed in claim 1, wherein the amylase inhibitor and/or bifunctional protease-amylase inhibitor is extracted from a plant in the legume family or is extracted from a plant or seed selected from the group comprising white kidney bean, wheat, Lens culinaris, Psophocarpus tetragonolobus, Cicer arietinum, Vigna aconitifolia, oats, sorghum, rye, barley, mango seeds, kiwifruit seeds and potatoes.
3. A composition as claimed in claim 1 or 2 wherein the at least one cysteine protease enzyme comprises actinidin.
4. A composition as claimed in any one of the preceding claims wherein the kiwifruit extract further comprises fibre and/or prebiotic material.
5. A composition as claimed in claim 3 wherein the kiwifruit extract has an actinidin enzyme activity in the range of 1500 U/g to 6000 U/g.
6. A composition as claimed in any one of the preceding claims wherein the amylase inhibitor and/or bifunctional protease-amylase inhibitor comprises white bean extract.
7. A composition as claimed in any one of the preceding claims wherein the bifunctional protease-amylase inhibitor is a serine protease-amylase inhibitor or a trypsin-amylase inhibitor and/or suppresses the activity of trypsin and α-amylase.
8. A composition as claimed in any one of the preceding claims wherein the amylase inhibitor and/or bifunctional protease-amylase inhibitor is present in the composition at a minimum concentration of 0.5% (w/w) and at a maximum concentration of 50% (w/w).
9. A composition as claimed in any one of the preceding claims wherein the ratio of kiwifruit extract:amylase inhibitor and/or bifunctional protease-amylase inhibitor is between 200:1 and 1:1.
10. A composition as claimed in any one of the preceding claims wherein the ratio of kiwifruit extract:amylase inhibitor and/or bifunctional protease-amylase inhibitor is 34.9:1, 27.5:1 or 9.6:1.
11. A composition as claimed in any one of the preceding claims wherein the kiwifruit extract is present in the composition at a concentration in the range of 98 to 99.5% (w/w) and the amylase inhibitor is present at a concentration in the range of 0.5 to 2.0% (w/w); or wherein the composition comprises kiwifruit extract at a concentration in the range of 97.5 to 99.5% (w/w) and a bifunctional protease-amylase inhibitor at a concentration in the range of 0.5 to 2.5% (w/w); or wherein the composition comprises an amylase inhibitor in a concentration of 1.98% (w/w) and a kiwifruit extract in a concentration of 69.15% (w/w); or wherein the composition comprises an amylase inhibitor in a concentration of 2% (w/w) and a kiwifruit extract in a concentration of 55% (w/w); or wherein the composition comprises an amylase inhibitor in a concentration of 1.6% (w/w) and a kiwifruit extract in a concentration of 15.38% (w/w); or wherein the composition comprises a bifunctional protease-amylase inhibitor at a concentration of 1.98% (w/w) and a kiwifruit extract in a concentration of 69.15% (w/w); or wherein the composition comprises a bifunctional protease-amylase inhibitor at a concentration of 2% (w/w) and a kiwifruit extract in a concentration of 55% (w/w); or wherein the composition comprises a bifunctional protease-amylase inhibitor at a concentration of 1.6% (w/w) and kiwifruit extract in a concentration of 15.38% (w/w).
12. A composition as claimed in any one of the preceding claims wherein the composition is formulated in a form selected from the group consisting of tablet form, chewable tablet form, soft chew form, powder form, powder form for suspension in a liquid, capsule form, liquid form and soft gel form.
13. A composition as claimed in any one of the preceding claims for use in treating or preventing digestive dysfunction, a gastrointestinal disorder, and/or one or more symptoms associated with a digestive disorder or a gastrointestinal disorder, optionally selected from the group comprising constipation, an inflammatory bowel condition, indigestion, gastric reflux, bloating, gas, abdominal pain, diarrhoea, heart-burn, irritable bowel syndrome or symptoms associated with any of these conditions.
14. A composition as claimed in any one of the preceding claims for use in altering, maintaining and/or restoring a balance of intestinal microflora of a subject.
15. A composition as claimed in claim 14, wherein the balance is altered to promote the amount, growth or efficacy of beneficial bacteria, such as probiotic bacteria, optionally selected from the group comprising bifidobacteria and lactobacilli and preferably Lactobacillus reuteri, Lactobacillus acidophilus, Pediococcus acidilactici, and Lactobacillus plantarum.
16. A composition as claimed in claim 14, wherein the balance is altered to reduce the amount, growth or efficacy of pathogenic gut bacteria, optionally selected from the group consisting of Bacteroides, Clostridia, coliforms, sulphate reducing bacteria, Escherichia coli, E.coli 0157:H7, Salmonella typhimurium, and Staphylococcus aureus.
17. A composition as claimed in any one of claims 1 to 12 for use in maintaining and/or improving gastrointestinal health, by promoting one or more of the following: a. an increase in spontaneous bowel movements b. an increase in complete spontaneous bowel movements c. a decrease in abdominal discomfort or pain d. a decrease in flatulence e. a decrease in bowel urgency f. a decrease in wind or burping g. a decrease in bloating.
18. A composition as claimed in claim 1, substantially as hereinbefore described with particular reference to any one or more of the examples and/or figures.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161486662P | 2011-05-16 | 2011-05-16 | |
US61/486,662 | 2011-05-16 | ||
PCT/NZ2012/000066 WO2012158048A1 (en) | 2011-05-16 | 2012-05-16 | A dietary supplement |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ617405A NZ617405A (en) | 2015-12-24 |
NZ617405B2 true NZ617405B2 (en) | 2016-03-30 |
Family
ID=
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