Note: Descriptions are shown in the official language in which they were submitted.
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JUICE BEVERAGE FOR PREVENTION AND TREATMENT OF RENAL STONES
BACKGROUND
The incidence of urolithiasis is increasing worldwide. Established risk
factors for
urolithiasis include dehydration, family history, obesity, bowel disease, and
diets high in sodium
and animal protein. Additional approaches to preventing or treating
urolithiasis are needed.
While compositions that are high in citrate have been utilized in the
prevention of urolithiasis,
the inconvenience and taste of such preparations have resulted in poor patient
compliance.
While there have been attempts to produce citrate rich beverages that delivers
clinically
significant citrate to individuals such that the occurrence of kidney stones
is prevented or
reduced, as shown in US Patent No. 9,278,112 ('112 patent), these compositions
are believed to
be tasteless beverages that are problematic resulting in poor patient
compliance. Additionally,
the beverage envisioned by the 112 patent requires significant volumes to
achieve clinical
benefit.
What is needed is a beverage that are citrate rich products ¨ including
beverages
(liquids, powders, liquid concentrates) that not only prevents the onset of
kidney stones but
treats all forms of urolithiasis. Additionally, such a beverage to improve
patient compliance
should be comprised of naturally occurring sources (eg. citrus juices) that
are be fortified with
naturally occurring source(s), of added citrate or in the alternative added
citrates that are
synthesized citrate supplements. It is also desirable to consumption of such a
beverage in
consumer friendly volumes results in higher urinary citrate levels and
alkalization of urine such
as to produce urine pH at about 6 to 7.1.
A beverage is further needed in that about 8 ounces of (one serving) is
sufficient to
produce desired therapeutic effect with continued use every day having a
citrate level that is
about 4500mg (2000-6500mg) per serving. A beverage having fortified citrate
levels is further
need that may optionally contain Ca, K, Mg, Zinc, mineral supplements, vitamin
supplements
and soluble fiber is also needed. It is also desirable that such a beverage
will also contain lower
potassium levels, lower acidity levels and lower glycemic index. Additionally,
for ease of use
and patient safety, it is desirable that such a beverage has a shelf life that
is extended by various
methods of pasteurization process.
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SUMMARY
Described herein are edible, citrate-rich compositions (also referred to as
edible, citrate-
rich products), which include citrate-rich beverages (citrate-rich liquid
compositions), powders
and liquid concentrates; methods of making edible, citrate-rich compositions,
including citrate-
rich beverages (citrate-rich liquid compositions), powders and liquid
concentrates; and methods
in which such edible, citrate-rich compositions, including citrate-rich
beverages (citrate-rich
liquid compositions), powders and liquid concentrates are consumed (methods of
therapy),
which include (a) methods of preventing the onset of urolithiasis, (b) methods
of reducing
(partially or completely) the extent to which urolithiasis occurs and (c)
methods of treating
urolithiasis, by administering citrate-rich products. It is contemplated
within the scope of the
disclosure that the citrate-rich products or citrate-rich beverages may be a
combination of
naturally occurring citrate products or that naturally occurring citrate
products fortified with
synthesized citrate supplements. The preceding are referred to as methods
of
therapy/therapeutic methods.
Urolithiasis encompasses conditions in which stones are formed or reside in
the urinary
system and includes nephrolithiasis (stones in the kidneys), ureterolithiasis
(stones in the ureter)
and cystolithiasis (stones in the bladder). The most common component of
urinary calculi is
calcium, which is a major constituent of nearly 75% of stones. Calcium oxalate
makes up about
60% of all stones; mixed calcium oxalate and hydroxyapatite, 20%; and brushite
stones, 2%. Uric
acid stones occur in another 10% of individuals. The citrate-rich compositions
described herein are
particularly useful for individuals in whom calcium and/or uric acid based
stones are likely to form
or have formed. It may also be used in patients who form cystine based stones.
Edible, citrate-rich compositions, such as edible, citrate-rich liquids (e.g.,
beverages,
concentrates) and powders, can comprise naturally-occurring source(s) of
citrate (such as citrus
juices), can be fortified naturally-occurring source(s) of citrate (which
contain a (one or more, at
least one) added citrate/ citrate source and have higher citrate concentration
than the
corresponding product that is not fortified/ includes no added citrate) or can
be a combination of
naturally-occurring citrate-containing source(s) and fortified citrate-rich
products, such as a
combination of naturally-occurring citrate-rich beverage(s) and fortified
citrate-rich beverage(s).
Naturally-occurring and/or fortified citrate-rich beverages include, but are
not limited to,
juice, juice-water, carbonated, and non-carbonated beverages, shakes,
smoothies, drinkable
yogurt- type, milk products and k-cups. Citrate-rich beverages may be in a
ready-to drink form or
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available as a concentrate, retort pouch, freeze-dried beverage, or a powder
mix to be
reconstituted with water or other ingestible liquid(s). Consumption of a
sufficient volume of a
citrate-rich composition, such as a beverage described herein, results in
higher urinary citrate
levels and alkalization of urine (such as to produce urine with pH of from
about 6 to about 7.1,
including pH of about 6.0, about 6.1, about 6.2, about 6.3, about 6.4, about
6.5, about 6.6, about
6.7, about 6.8, about 6.9, about 7.0, about 7.1). A sufficient volume is
consumed to have a
therapeutic effect (with continued use), which can be solubilization of
developing or existing
stones and/or reduction (partially or completely) of future stone development.
Typically, 8 ounces of a citrate-rich beverage (one serving) described herein
is sufficient
to produce the desired therapeutic effect with continued use. Continued use
can be over several
days (e.g., two days or more, two to five days or more, a week or more, a
month or more, several
months, a year or more or over many weeks, months or years, including
essentially every day for
an individual's life. The time over which use must continue can be determined
on an individual
basis.
Continued use may be intermittent, in the sense that a citrate-rich
composition, such as a
citrate- rich beverage, may be consumed daily for a period of time (e.g., a
month) and then
consumption ends, consumption begins again (e.g., symptoms reoccur or life
status/circumstances change) and continues for a period of time, followed by
one or more
additional periods during which the citrate-rich composition, such as the
citrate-rich beverage is
consumed daily for a period of time and consumption and one or more additional
periods during
which it is not consumed.
Citrate-rich beverages can be consumed by individuals (humans) known to form
stones
(who have previously formed stones, such as kidney stones, stones in the
ureter or bladder);
individuals (humans) at risk for forming kidney stones (e.g., those with a
family history of kidney
stone formation; men, such as men between 20 and 50 years of age); individuals
(humans)
in occupations predisposing to heat exposure and dehydration; individuals
(humans) with
bowel disease that leads to enteric hyperoxaluria; pregnant women and
individuals (humans)
who are non-stone formers, but who consume citrate-rich beverages described
herein,
such as as part of a preventative regimen (e.g., for preventing development of
urolithiasis). They
find use, for example, in conditions that include, but are not limited to,
hypercalciuria,
hyperuricosuria, hyperoxaluria, hypomagnesuria, hypocitraturia, cystinuria and
gouty diathesis.
These seven conditions, appreciated on metabolic evaluation (urine
collection), are
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known to increase risk of for development of urolithiasis. They can be used in
methods of
therapy for these conditions. The methods include methods of preventing the
onset of at least one
of the conditions, methods of reducing (partially or completely) the extent to
which at least one
of the condition occurs and methods of treating at least one of the conditions
once it has
occurred. In each case, the method is carried out by administering a citrate-
rich product. Further,
the edible, citrate-rich compositions can be used in military, athletic, and
outer space programs in
the global market. Particular advantages of the citrate-rich beverages
described herein are their
ease of preparation and their enjoyable taste, which will contribute to
compliance by those who
need or would benefit from their consumption. Liquid preparations of citrate
permit longer
intestinal transit time.
BRIEF DESCRIPTION OF THE FIGURES
Figures 1 and 2 are schematic representations of methods (processes) by which
citrate-
rich beverages can be produced.
DETAILED DESCRIPTION
Edible, citrate-rich compositions, including edible, citrate-rich beverages,
powders and
liquid concentrates, described comprise one or more sources of citrate, such
as one or more
citrate-containing juice(s) and/or one or more juice concentrate(s); or one or
more citrate-
containing juice(s) and/or one or more juice concentrate(s) and one or more
additional source(s)
of citrate that is not a citrate-containing juice (referred to as a non-juice
citrate source). Citrate-
containing juices include, but are not limited to, orange juice, lemon juice,
lemonade, tangerine
juice, pineapple juice, grape juice, cranberry juice, lime juice and
grapefruit juice. Concentrates
of one or more of these juices can be used. Sources of citrate that are not
citrate-containing
juices (referred to as non-juice citrate sources) include potassium citrate,
sodium citrate, calcium
citrate, zinc citrate, magnesium citrate, citric acid or any combination of
two, three, four, five or
six of potassium citrate, sodium citrate, calcium citrate, zinc citrate,
magnesium citrate, and citric
acid. Non-juice citrate sources are, for example, powders (e.g., fine or
crystalline powder), pills
or tablets.
In particular embodiments, the citrate level of an edible citrate-rich
composition, such as
citrate-rich beverages, is about 4500mg (range about 2000mg-about 6500mg) per
serving, which
equates to the typical range of oral potassium citrate given in tablets 20-
60Meq per day. It is
contemplated within the scope of this disclosure that a serving would be
approximately 8 ounces.
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On a daily (24 hour) basis, citrate intake contributed by an edible citrate-
rich composition, such
as a citrate-rich beverage, does not exceed about 6500mg. The citrate level to
be included in a
specific citrate-rich beverage can be determined using known methods and the
amount included
will vary/be determined for a particular citrate-rich composition based on
such considerations as
the severity of the condition for which the citrate-rich beverage will be
consumed, the age of the
consumer and the ability to prepare a beverage acceptable to consumers.
In specific embodiments, the citrate level ranges from about 2100mg-about
6400mg per
serving; about 2500mg-about 6400mg per serving; about 3000mg-about 6400mg per
serving;
about 3500mg- about 6400mg per serving; about 4000mg- about 6400mg per
serving; about
4500mg-about 6400mg per serving; about 5000mg-about 6400mg per serving; or
about 6000mg-
about 6400mg per serving. In other embodiments, the citrate level is any
citrate level from at
least about 2100mg per serving up to and including about 6400mg per serving,
such as at least
about 2000mg per serving; at least about 2100 mg per serving; at least about
2200mg. per
serving; at least about 2300mg per serving; at least about 2400mg per serving;
at least about
2500mg per serving; at least about 2600mg per serving; at least about 2700mg
per serving; at
least about 2800mg per serving; at least about 2900mg per serving; at least
about 3000mg per
serving; at least about 3100mg per serving; at least about 3200mg per serving;
at least 3300mg
per serving; at least 3400mg per serving; at least 3500mg per serving; at
least about 3600mg per
serving; at least about 3700mg per serving; at least about 3800mg per serving;
at least about
3900mg per serving; at least about 4000mg per serving; at least about 4100mg
per serving; at
least 4200mg per serving; at least 4300mg per serving; at least 4400mg per
serving; at least
about 4500mg per serving; at least about 4600mg per serving; at least about
4700mg per serving;
at least about 4800mg per serving; at least about 4900mg per serving; at least
about 5000mg per
serving; at least about 5100mg per serving; at least about 5200mg per serving;
at least about
5300mg per serving; at least about 5400mg per serving; at least about 5500mg
per serving; at
least about 5600mg per serving; at least about 5700mg per serving; at least
about 5800mg per
serving; at least about 5900mg per serving; at least about 6000mg per serving;
at least about
6100mg per serving; at least about 6200mg per serving; at least about 6300mg
per serving; or at
least about 6400mg per serving.
A serving is approximately 8 fluid ounces, which can be consumed in one or
more
portions. For example, an 8-ounce serving can be consumed at one time or in
more than one
portion, such as several smaller amounts in a day, the total of which is an 8-
ounce serving.
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If desired, an 8 ounce serving of a citrate-rich beverage can be diluted (to
produce a beverage
with a lower citrate concentration).
Citrate can be provided as potassium citrate, sodium citrate, calcium citrate,
zinc citrate,
magnesium citrate, citric acid, other form of citrate appropriate for
consumption by humans, or
any combination (e.g., any combination of two, three, four, five or six of
potassium citrate,
sodium citrate, calcium citrate, zinc citrate, magnesium citrate, and citric
acid). Sources of citrate
that are not citrate-containing juices are referred to as non-juice citrate
sources.
Such edible, citrate-rich compositions, such as citrate-rich beverages, may
further
comprise one or more (a, at least one) of the following: soluble calcium,
soluble potassium,
soluble magnesium, soluble zinc, mineral supplements, vitamin supplements, and
soluble fiber.
The edible, citrate-rich compositions may also comprise added sugar (e.g.,
sucrose, fructose,
glucose, honey, galactose, maltose, lactose) and/or sugar alternative(s).
Sugar content may be
reduced (partially or completely) through the use of sugar alternatives, such
as all natural sugar
alternatives, such as but not limited to, honey, coconut or date sugar, Stevia
or sugar alcohols
(e.g., erythritol, xylitol, sorbitol). Such citrate-rich beverages may
comprise additional
ingredients including, but not limited to, any combination of juice blends of
fruits and/or
vegetables (e.g., for flavor), coloring, flavor, natural and artificial
sweeteners, preservatives,
caffeine, protein, tea and coffee. Juice blends of fruits and/or vegetables
included, for example,
for flavor, might not be citrate-containing, but could also include some
citrate.
Edible, citrate-rich compositions, such as edible, citrate-rich beverages, can
be in the
form of a juice; juice-water; dairy-based product, such as milk, yoghurt;
liquid concentrate,
which is diluted before it is consumed or brewed or frozen, such as popsicles,
or freeze-dried.
Such compositions can also be in the form of a concentrate (liquid or powder,
for example),
which is combined with a liquid, such as milk, water, additional juice (e.g.,
a juice that is not a
citrate-containing juice described herein, such as apple juice or pear juice),
soy-based beverage,
before the composition is consumed.
In some embodiments, the citrate-rich beverages are formulated to contain
lower
potassium levels, have reduced acidity and have lower glycemic index or any
combination ofthe
three (e.g., lower potassium levels and reduced acidity; lower potassium
levels and lower
glycemic index; reduced acidity and lower glycemic index; all three).
A wide variety of citrate sources can be used in making edible, citrate-rich
compositions.
Sources of citrate include juices that contain citrate (e.g., orange juice,
lemon juice, lemonade,
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tangerine juice, pineapple juice, grape juice, cranberry juice, lime juice and
grapefruit juice and
other sources of citrate suitable/appropriate for consumption, such as citrate
in tablet or powder
form. The juice or juices used to produce a citrate-rich beverage can be in
the form of a juice
concentrate or juice in ready-to-consume form (not a juice concentrate). For
example, any
combination of orange juice, lemon juice, lemonade, tangerine juice, pineapple
juice, grape juice,
cranberry juice, lime juice, grapefruit juice, orange juice concentrate, lemon
juice concentrate,
lemonade concentrate, tangerine juice concentrate, pineapple juice
concentrate, grape juice
concentrate, cranberry juice concentrate; lime juice concentrate and
grapefruit juice concentrate
can be used to produce an edible, citrate-rich composition. The term juice is
used here to refer to
(encompasses) juice in ready-to-consume form and juiceconcentrate.
The citrate-rich beverages are formulated such that their consumption in
sufficient
quantity to prevent the onset of urolithiasis, reduce (partially or
completely) the extent to which
urolithiasis occurs, or treat urolithiasis results in a daily intake of not
more than about 4500mg
potassium or the recommended daily intake; not more than about 1200mg calcium
or the
recommended daily intake; not more than about 320-420mg magnesium or the
recommended
daily intake; not more than about 40mg of zinc or the upper tolerance level;
or any combination
of the foregoing. For example, citrate-rich beverages described herein
typically contain, per 8
ounce serving, from about 60mg to about 1000mg potassium, from about 100mg to
about 410mg
magnesium, from about 1mg to about 20mg zinc. They may also contain per 8
ounce serving,
from about 5mg to about 500mg calcium. In one embodiment, the volume of
citrate-rich
compositions, such as a citrate-rich beverage, consumed daily is from about
200m1 to about
1000m1; in these cases, the levels of the components (e.g., citrate) are
adjusted accordingly (so
that consumption of the volume from about 200m1 to about 1000m1 provides the
same amount of
citrate as in an 8 ounce serving described herein.
The adjustment can be carried out by diluting an 8 ounce serving described
herein with
sufficient additional liquid that does not contain citrate to produce the
desired volume. In
specific embodiments, at least one 8 ounce serving is consumed each day. The
volume consumed
each day can be consumed in one or more doses or servings. The citrate-rich
beverages can,
optionally, also include (be supplemented with) sodium bicarbonate.
Consumption of the citrate-
rich beverage in the amounts described can result in increased urinary citrate
excretion,
alkalization of urine and increased urinary volume. Formulation of such
beverages may be
adjusted based on the consumer's health and dietary and lifestyle
restrictions.
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Following is a description of several embodiments of citrate-rich beverages
and how they
are produced. These embodiments are provided as examples only and are not to
be considered
limiting in any way.
Citrate-rich beverages can comprise any combination of citrate-containing
edible
ingredients or components available, including citrate-containing juice(s) and
additional,
different source(s) of citrate which are not citrate-containing juice(s) (also
referred to as non-
juice citrate sources).
For example, in one embodiment, a citrate-rich beverage comprises a (at least
one; one or
more) citrate-containing juice and an additional source of citrate that is not
a citrate-containing
juice (non-juice citrate source), such as one or more of the following:
potassium citrate, sodium
citrate, calcium citrate, zinc citrate, magnesium citrate, and citric acid.
The citrate-containing
juice(s) can be, for example, at least one of the following: orange juice,
lemon juice, lemonade,
tangerine juice, pineapple juice, grape juice, cranberry juice, lime juice and
grapefruit juice. In
specific embodiments, in which the citrate-rich beverage includes a (at least
one; one or more)
citrate-containing juice and an additional source of citrate that is not a
citrate-containing juice,
the citrate-rich juice is lemon juice, lime juice, orange juice, tangerine
juice or grapefruitjuice.
In some embodiments the citrate-rich beverage comprises at least two (two or
more)
citrate-containing juices and may, optionally, also include an additional
source of citrate that is
not a citrate-containing juice. In certain embodiments, the citrate-rich
beverage includes two or
more citrate-containing juices, such as any combination of two or more of
orange juice, lemon
juice, lemonade, tangerine juice, pineapple juice, grape juice, cranberry
juice, lime juice and
grapefruit juice, and does not include an additional source of citrate that is
not a citrate-
containing juice. In these embodiments, the two or more citrate-containing
juices are any
combination of two or more citrate-containing juices in amounts sufficient to
produce a citrate-
rich beverage that includes the desired amount of citrate, such as 4500mg
(range 2000mg-
6400mg) per serving, which equates to the typical range of oral potassium
citrate given in tablets
20-60Meq per day. In certain embodiments a citrate rich beverage includes two
or more citrate-
containing juices and no additional source of citrate that is not a citrate-
containing juice, the
juices are any combination of two or more of lemon juice, lime juice, orange
juice and
grapefruit. Other citrate-containing juices can be included, such as to
provide a source of citrate
and to add to/alter the flavor of the citrate-rich beverage.
In embodiments in which the citrate-rich beverage includes two or more citrate-
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containing juices and an additional citrate source that is not a citrate-
containing juice, the citrate-
containing juices can be any combination of two or more of orange juice, lemon
juice, lemonade,
tangerine juice, pineapple juice, grape juice, cranberry juice, lime juice and
grapefruit juice and
the non-juice citrate source can be potassium citrate, sodium citrate, calcium
citrate, zinc citrate,
magnesium citrate, citric acid or any combination of two, three, four, five or
six of theforegoing.
In specific embodiments, the juices are at least two of the following: lemon
juice, lime juice and
orange jui ce.
Clearly, many combinations of one or more citrate-containing juice and one or
more
additional source of citrate that is not a citrate-containing juice can be
made, to produce
inventive citrate-rich beverages, using available sources of citrate and
methods, including those
described herein. Such citrate-rich beverages typically provide, for example,
4500mg citrate
(range 2000mg-6400mg) per 8 ounce serving. Additionally, they may further
comprise one or
more (at least one) of the following: soluble calcium, soluble potassium,
soluble magnesium,
soluble zinc, mineral supplements, vitamin supplements, soluble fiber, sugar
or sugar alternative.
.. Additional ingredients that may be in such citrate-rich beverages include,
but are not limited to,
any combination of juice blends of fruits and/or vegetables, coloring, flavor,
preservatives,
caffeine, protein, tea and coffee.
Components of citrate-rich beverages described here will be selected taking
into
consideration such factors as the level of citrate desired, flavor, texture,
appearance and other
characteristics that will contribute to effectiveness, compliance and
marketability of the
beverages. As shown in Table 1, 2 and 5, there are many juices that can be
used as sources of
citrate in producing citrate-rich beverages. Additionally, Penniston and co-
workers report that
lemon juice contains 1.44 gm per ounce of juice; lime juice contains 1.38 gm
per ounce of juice;
fresh orange juice or orange juice made from concentrate contains about 0.25
gm per ounce and
grapefruit juice contains 0.0068 gm per ounce. See: Penniston, K.L. et al., J.
Endourol, 2008
Mar 22(3). 567-70. Quantitative assessment of citric acid in lemon juice, lime
juice and
commercially-available fruit juice products.
The citric acid content of commercially prepared juice drinks varies,
depending on the
manufacturer, but can range from 0.03 grams per ounce to 0.22 grams per ounce.
Some
artificially flavored and sweetened juices that contain no fruit can have more
citric acid than the
naturally-occurring citrate in citrus fruit. There are many sources of citrate
other than juices
(non-juice citrate source) that are commercially available; some of these are
represented in Table
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4.
Specific embodiments of citrate-rich beverages, which are meant to be
representative of
possible citrate-rich beverages encompassed by the invention, but not
limiting, are presented in
Table 3. In a specific embodiment, a citrate-rich beverage, such as a
cranberry lemonade
beverage, contains water (e.g., about 80-about 85%); juice concentrate (e.g.,
lemon juice
concentrate; orange juice concentrate; lime juice concentrate or a combination
of two or three
of these) (e.g., about 2 -5%); sugar (e.g., about 10- about 15%); juice
concentrate (e.g.,
cranberry juice concentrate (e.g., about 1-about 4%); citrate (e.g., about 1-
about 2.5%; e.g., zinc
citrate, potassium citrate, magnesium citrate, monosodium citrate or any
combination of two,
three or four of these).
In a specific embodiment, a citrate-rich beverage contains water (e.g., about
80- about
83%); juice concentrate (e.g., lemon juice concentrate; orange juice
concentrate; lime juice
concentrate or a combination of two or three of these) (e.g., about 2-3%);
sugar (e.g., about 12-
about 13%); juice concentrate (e.g., cranberry juice concentrate (e.g., about
1-about 2%); citrate
(e.g., total about 1.4-about 2.0%; e.g., zinc citrate, potassium citrate,
magnesium citrate,
monosodium citrate or any combination of two, three or four of these).
In a specific embodiment, a citrate-rich beverage contains water (e.g., about
80-about
83%); juice concentrate (e.g., lemon juice concentrate; e.g., about 2-3%, such
as about any of 2.1,
2.2 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, or 2.9%); sugar (e.g., about 12- about 13%);
juice concentrate (e.g.,
cranberry juice concentrate (e.g., about 1-about 2%, such as about any one of
1.1, 1.2, 1.3, 1,4,
1.5, 1.6, 1.7, 1.8, 1.9% ); citrate (e.g., total about 1.4-about 2.0%; e.g.,
zinc citrate, potassium
citrate, magnesium citrate, monosodium citrate or any combination of two,
three or four of
these). In a more specific embodiment, the citrate-rich beverage contains zinc
citrate (about
0.02%, to about 0.1 %,), magnesium citrate anhydrous (about 0.4%, to about
0.9%) and
monosodium citrate (e.g., 0.1%, about 0.2%, about 0.3% about 0.4%, about 0.5%,
about 0.6%,
about 0.7%, about 0.8%, about 0.9%).
In a specific embodiment, a citrate-rich beverage contains water (e.g., about
80-about
83%); juice concentrate (e.g., orange juice concentrate; e.g., about 2-3%,
such as about any of
2.1, 2.2 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, or 2.9%); sugar (e.g., about 12- about
13%); juice concentrate
(e.g., cranberry juice concentrate (e.g., about 1-about 2%, such as about any
one of 1.1, 1.2, 1.3,
1,4, 1.5, 1.6, 1.7, 1.8, 1.9%); citrate (e.g., total about 1.4-about 2.0%;
e.g., zinccitrate, potassium
citrate, magnesium citrate, monosodium citrate or any combination of two,
three or four of
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these).
In a specific embodiment, a citrate-rich beverage contains water (e.g., about
80-about
83%, such as about 81%, about 82%, about 83%) ); juice concentrate (e.g.,
lemon juice
concentrate; e.g., about 2-3%, such as about any of 2.1, 2.2 2.3, 2.4, 2.5,
2.6, 2.7, 2.8, or 2.9%);
sugar (e.g., about 12- about 13%); juice concentrate (e.g., cranberry juice
concentrate (e.g., about
1-about 2%, such as about any one of 1.1, 1.2, 1.3, 1,4, 1.5, 1.6, 1.7, 1.8,
1.9%); and citrate (e.g.,
total about 1.4-about 2.0%; e.g., zinc citrate (about 0.02%-about 0.1%),
magnesium citrate (about
0.7-about 0.9%), and monosodium citrate (about 0.1-0.2%).
In a specific embodiment, such as an orange strawberry beverage, a citrate-
rich beverage
contains water (e.g., about 80-about 85%); juice concentrate (e.g., lemon
juice concentrate;
orange juice concentrate; lime juice concentrate or a combination of two or
three of these) (e.g.,
about 5 ¨ about 13%); sugar (e.g., about 4 - about 9%); citric acid (e.g.,
about 0.1-about 0.5%);
citrate (e.g., total about 1-about 2.5%; e.g., zinc citrate, potassium
citrate, magnesium citrate,
monosodium citrate or any combination of two, three or four of these);
flavor(s), such as natural
flavor(s) (e.g., strawberry, orange, raspberry or a combination of two or
three of these) (e.g.,
about 0.1-about 1.0%).
In a specific embodiment, a citrate-rich beverage contains water (e.g., about
80-about
83%); juice concentrate (e.g., lemon juice concentrate; orange juice
concentrate; lime juice
concentrate or a combination of two or three of these) (e.g., about 10 -12%);
sugar (e.g., about 4-
about 6%); citric acid (e.g., about 0.1-about 0.5%); citrate (e.g., total
about 1-about 2.5%; e.g.,
zinc citrate, potassium citrate, magnesium citrate, or any combination of two
or three of these);
flavor(s), such as natural flavor(s) (e.g., strawberry, orange, raspberry or a
combination of two or
three of these) (e.g., about 0.001-about 1.0%). In a further embodiment, a
citrate-rich beverage
contains water (e.g., about 80%, about 81%, about 82% or about 83%); juice
concentrate (e.g.,
orange juice concentrate or lime juice) (e.g., about 10 -12%); sugar (e.g.,
about 4- about 6%);
citric acid (e.g., about 0.1, about 0.2%, about 0.3%, about 0.4%); citrate
(e.g., total about 1-
about 2.0%; e.g., zinc citrate (about 0.1%, about 0.2%; about 0.3%; about
0.4%), potassium
citrate (about 0.2%, about 0.3%, about 0.4%; about 0.5%; about 0.6%),
magnesium citrate (e.g.,
about 0.4%, about 0.5%, about 0.6%, about 0.7%), or any combination of two or
three of these);
fruit flavor(s), such as natural flavor(s) (e.g., strawberry, orange,
raspberry or a combination of
two or three of these) (e.g., about 0.001-about 1.0%).
In a specific embodiment, a citrate-rich beverage, such as a berry lemonade
beverage,
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contains water (e.g., about 80-about 85%); juice concentrate (e.g., lemon
juice concentrate;
orange juice concentrate; lime juice concentrate or a combination of two or
three of these) (e.g.,
about 2 -5%); sugar (e.g., about 10- about 15%); juice concentrate (e.g.,
cherry juice concentrate,
cranberry juice concentrate (e.g., about 0.2-about 4%); citrate (e.g., about 1-
about 2.5%; e.g.,
zinc citrate, potassium citrate, magnesium citrate, monosodium citrate or any
combination of
two, three or four of these); and fruit flavor, such as natural flavor (e.g.,
raspberry, orange,
strawberry or a combination of two or three of these) (e.g., about 0.1% to
about 0.6%). In a
specific embodiment, a citrate-rich beverage contains water (e.g., about 80,
about 81%, about
82%, about 83%, about 84%; about 85%); juice concentrate (e.g., lemon juice
concentrate; e.g.,
about 2%, about 3%, about 4%); sugar (e.g., about 10%, about 11%, about 12%,
about 13%,
about 14%, about 15%); juice concentrate (e.g., cherry juice concentrate;
e.g., about 0.2%, about
0.3%, about 0.4%, about 0.5%); citrate (e.g., total about 1%-about 2.5%; e.g.,
zinc citrate (e.g.
about 0.02%, about 0.03%, about 0.4%, about 0.5%), magnesium citrate (e.g.,
0.6%, about 0.7%,
about 0.8%, about 0.9%, about 1.0%), monosodium citrate (e.g., about 0.05%,
about 0.06%
about 0.07%, about 0.08%, about 0.09%, about 0.10%, about 0.11%, about 0.12%);
and fruit
flavor, such as natural flavor (e.g., raspberry flavor; e.g., about 0.1%,
about 0.4%, about 0.5%,
about 0.6%).
A specific embodiment is an edible citrate-rich composition in which citrate
is present at
(the composition comprises) a level of from about 2000mg citrate to about
6400mg citrate per 8
ounce serving.
In a further embodiment of the edible citrate-rich composition, citrate is
present at about
4500mg per 8 ounce serving and the source of citrate is at least one source
selected from the
group consisting of a citrate-containing juice, potassium citrate, sodium
citrate, magnesium
citrate, zinc citrate citric acid, and calcium citrate. The composition, in
one embodiment of the
edible citrate-rich composition, is a beverage and, for example, the citrate-
containing juice is at
least one of the following: orange juice, lemon juice, lemonade, tangerine
juice, lime juice,
pineapple juice, grape juice, cranberry juice and grapefruitjuice.
Any of these citrate-rich compositions can further comprise one or more of the
following: soluble calcium, soluble potassium, soluble magnesium, mineral
supplements, vitamin
supplements, soluble fiber in sugar-containing preparation and soluble fiber
in sugar-free
preparation. Any of these citrate-rich compositions can comprise/is
constituted with at least one
(a, one or more) of water, juice, milk, and yogurt and, in some embodiments,
the composition is
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a liquid, frozen, or freeze-dried. The citrate-rich composition can further
comprise sodium
bi carbonate.
A further embodiment is a method of reducing (partially or completely) the
extent to
which urolithiasis occurs in an individual or of treating urolithiasis in an
individual, comprising
administering a therapeutically effective amount of a citrate-rich composition
of any one of the
embodiments described herein to the individual, wherein the therapeutically
effective amount of
the citrate-rich composition is administered in at least one dose and can be
administered in
multiple doses over time. In some embodiments, the therapeutically effective
amount of the
citrate-rich composition is administered in multiple daily doses or portions
(multiple daily doses
or portions per 24 hour period).
A further embodiment is a method of increasing urinary citrate levels and
producing
alkalization of urine in an individual in need thereof, comprising
administering a citrate-rich
composition of any one of the embodiments described herein to the individual
in an amount
sufficient to increase citrate levels in the individual's urine and produce
urine of pH from about 6
to about 7.1, wherein the citrate-rich composition is administered in at least
one dose per day (at
least one dose per 24 hour period) and can be administered in multiple doses
over time. In a
specific embodiment, the citrate-rich composition is administered in one daily
dose (one dose in
a 24-hour period). In a different embodiment, the citrate-rich composition is
administered in
more than one daily dose (more than one dose in a 24-hour period). In
alternative embodiments,
the citrate-rich composition is administered for more than one day and can be
administered over
an extended period of time, which can be two or more days, a week or more, a
month or more,
many months, a year or more, many years or as needed throughout the
individual's life.
One embodiment is a method of reducing (partially or completely) the extent to
which
urolithiasis occurs in an individual or of treating urolithiasis in an
individual, comprising
administering a citrate-rich composition that comprises from about 2000mg
citrate to about
6400mg citrate per 8 ounce serving to the individual, wherein the 8 ounce
serving of the citrate-
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rich composition is administered in at least one dose or portion per day (24
hour period) and can
be administered in multiple doses over time.
Methods by which the beverages can be produced are described below. They are
representative of methods that can be used and are not intended to be limiting
in any way. All
embodiments of the citrate-rich beverages encompassed by the invention can be
made by the
methods described herein.
Figures 1 and 2 are schematic representations of methods (processes) by which
citrate-
rich beverages can be produced.
In the method, components (one or more citrate-containing juice(s) (e.g.,
citrate-
containing juice(s) in ready-to-drink/not concentrated form and/or citrate-
containing juice
concentrate(s)) and, in some embodiments, one or more additional source(s) of
citrate which is
not a citrate-containing juice) are combined, using known methods, in
sufficient amounts to
produce a citrate-rich beverage in which the citrate content is as described
in detail above.
In one embodiment, the method comprises: (a) hydrating a citrate blend, by
combining
source(s) of citrate (e.g., non-juice sources of citrate) with water and
producing a hydrated citrate
blend (which includes the citrate source(s) in water); (b) optionally, adding
or combining the
hydrated citrate blend with sugar and/or sugar alternative, if desired (an
optional
addition/combination) and mixing the resulting combination as needed to
dissolve the sugar
and/or sugar alternative in the hydrated citrate blend; (c) combining the
product of (a), if no sugar
or sugar alternative is used or the product of (b), if sugar and/or sugar
alternative is used, with
juice concentrate(s) (concentrate(s) of the citrate-containing juices to be
included in the citrate-
rich beverage), flavoring(s) and additional components and blending/mixing the
resulting
combination to dissolve the components, thereby producing a blended product;
(d) processing the
blended product under conditions under which the blended product is
pasteurized, thereby
producing a pasteurized blended product which is a citrate-rich beverage. The
method further
comprises processing the citrate-rich beverage to produce a packaged citrate-
rich beverage. In
one embodiment, the citrate blend of (a) comprises zinc citrate, magnesium
citrate and
monosodium citrate anhydrous. It is combined with sufficient water to hydrate
the citrate blend
(e.g., combined with 100 F water) and the combination is mixed, producing the
citrate blend in
water, referred to as a hydrated citrate blend. If sugar and/or a sugar
alternative is included, it is
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combined with the hydrated citrate blend and the resulting combination is
mixed until the sugar
is dissolved. In some embodiments (e.g., when the quantity/volume of
components is small), the
resulting combination is mixed for about 1 minute. The resulting product is
combined with juice
concentrate(s) (concentrate(s) of the citrate-containing juices to be included
in the citrate-rich
beverage), flavoring(s) and additional components and the resulting
combination is mixed or
blended, thereby producing a blended product. The blended product is treated
under conditions
that result in its pasteurization, thereby producing a pasteurized blended
product that is a
pasteurized citrate-rich beverage. For example, the blended product is
pasteurized under process
conditions such as bringing the product up to a temperature of about 185 F
(e.g., for about 3
seconds, using a flow rate of about 13.5m1/minute).
The pasteurized citrate-rich beverage is further processed, using known
methods, to
prepare it for storage and sale. For example, the citrate-rich beverage can be
hot filled (e.g., at
about 185 F) into containers (e.g., glass, plastic, juice box, carton, retort
pouch, can), which are
then further processed, as needed, to prepare them for storage and sale. For
example, the
containers are closed (capped, sealed), inverted briefly, chilled (e.g., in an
ice bath for about 10
minutes or more) and the final product is placed in cartons. In addition to a
hot-filled process,
aseptic packaging can be used.
In one embodiment, the method comprises combining two citrate-containing
juices, such
as lemon juice concentrate and cranberry juice concentrate; water; sugar and
non-juice citrate
sources (citrate blend), such as zinc citrate, potassium citrate, magnesium
citrate (anhydrous) and
monosodium citrate, under conditions that result in production of a citrate-
rich beverage in which
the citrate level is about 5600 mg/8 ounce serving. In a further embodiment,
the method
comprises combining a citrate-containing juice, such as orange juice
concentrate; sugar; and non-
juice citrate sources (citrate blend), such as citric acid; zinc citrate and
potassium citrate; and
flavoring, such as fruit flavor (e.g., strawberry flavor and orange flavor),
under conditions that
result in production of a citrate-rich beverage in which the citrate level is
about 5500 mg/8 ounce
serving. In another embodiment, the method comprises combining two citrate-
containing juices,
such as lemon juice concentrate and cherry juice concentrate; sugar; non-juice
citrate sources
(citrate blend), such as zinc citrate, potassium citrate, magnesium citrate
(anhydrous) and
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monosodium citrate; and flavoring, such as raspberry flavor, under conditions
that result in
production of a citrate-rich beverage which contains about 5300mg citrate/8
ounce serving.
In another embodiment, the method comprises combining two or more citrate-
containing
juices, such as lemon juice concentrate and cranberry juice concentrate;
water; sugar and non-
juice citrate sources (citrate blend), such as zinc citrate, potassium
citrate, magnesium citrate
(anhydrous) and monosodium citrate, under conditions that result in production
of a citrate-rich
beverage in which the citrate level is from about 2000mg to about 6400mg /8
ounce serving.
In alternative embodiments, two or more of the following citrate-containing
juices,
typically in the form of juice concentrates, are combined: orange juice, lemon
juice, lemonade,
tangerine juice, pineapple juice, grape juice, cranberry juice and grapefruit
juice; sufficient water
is combined with the juice concentrate(s). The two or more citrate-containing
juices (e.g., in the
form of juice concentrates) are combined in varying concentrations that result
in a citrate-rich
beverage that comprises from about 2500mg to about 6400mg per 8 ounce serving,
such as about
4500-5500mg per 8 ounce serving. For example, lemon juice, lime juice, orange
juice,
grapefruit juice or any combination of two, three or four of lemon juice, lime
juice, orange juice
and grapefruit juice can be combined in appropriate quantities to produce a
citrate-rich beverage.
In a further embodiment, a citrate-rich beverage comprises two or more of the
following
citrate-containing juices: orange juice, lemon juice, tangerine juice,
pineapple juice, grapejuice,
cranberry juice and grapefruit juice and an additional source of citrate that
is not a citrate-
containing juice (non-juice citrate source), such as a source of one or more
of the following:
potassium citrate, sodium citrate, calcium citrate, zinc citrate, magnesium
citrate, citric acid.
They are combined in sufficient amounts to produce a citrate-rich beverage in
which the citrate
content is from about 2500mg to about 6400mg per 8 ounce serving, such as
about at least
4500mg per 8 ounce serving. The amount of each type of citrate source (citrate-
containing juice,
other source of citrate that is not a citrate-containing juice) needed to
produce a citrate-rich
beverage in which the citrate content is the desired amount (e.g., from about
2000mg to about
6400mg per 8 ounce serving, such as about 4500mg per 8 ounce serving) can be
determined
empirically, if the citrate content of each component is known or is
determined, if necessary,
using known methods. For example, the citrate content of juices, such as
orange juice, lemon
juice, and grapefruit juice is shown in Table 1 and of additional juices in
Table 5. The citrate-
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rich beverages described herein, which contain blends of natural juices, such
as, but not limited
to, citrus juices, increase urinary citrate excretion and hydration and will
offer consumers at risk
for stone formation an adjunct to medical therapy. Described herein, in
addition to a ready-to-
drink beverage, are concentrates in a solid (powder mix) or a liquid form. for
reconstitution into a
citrate-rich beverage. There are many possible combinations of components
described herein
that can be used to produce citrate-rich beverages, as well as to produce the
powder and liquid
concentrates that can be used to produce citrate-rich beverages. The liquid
formulations, both
ready to use and concentrated, may be sterilized by such methods as heat
treatment, to inhibit
contamination and increase shelf-life.
Table I Citric Acid Content of Various Fruit Juices and Commercially-Available
Juice
Formulations (Crams per Liter)*
Total citric acid
Product Type of product n Mean
SD
Lemon juice fresh, f; 011-1 fruit
2 3.82
Lime juice fresh, from fruit 2 45.8
6.86
Lemon juice, Concord Foods juice concentrate 1 39.2
Lime juice, ReaLime 100% juice concentrate 1 35.4
Lemon juice, ReaLemon 100% juice concentrate 1 , 34.1
Grapefruit juice, Florida's Ruby Red ready-to-consume 1 , 25.0
Orange juice, Tropicana Pure Premium ready-to-consume 1 16.9
Orange juice, Tropicana Light 'n Healthy ready-to-consume I 16.7
Orange j Llice fresh, from fruit 2 9.10
Limeade/limonada, Minute Maid ready-to-consume 7.30
Lemonade, Newman's Own ready-to-consume I 6.70
Lemonade, Florida's Natural ready-to-consume I 6.20
Lemonade, Minute Maid Light ready-to-consume 1 5.20
Raspberry lemonade, Minute Maid ready-to-consume 1 5.00
Lemonade, Tropicana ready-to-consume 4 4.83
6 61
Pink lemonade, Minute Maid ready-to-consume 1 4.80
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Lemonade, Tropicana Sugar-Free ready-to-consume 7 4.60 0.44
Lemonade, Minute Maid ready-to-consume 4.40
Lemonade mix, Crystal Light drink mix - 4.20 0.71
Pink lemonade mix, Crystal Light drink mix - 3.40
Raspberry lemonade mix, Crystal Light drink mix 3.10
Lemonade mix, Kool-Aid Sugarfree drink mix 1 2.10
Lemonade mix, Country Time drink mix 1 1.60
Crystallized lemon, True Lemon dry mix 1 0.92
*Penniston, K.L. et al., J Endourol. 2008 March; 22(3): 567-570. Quantitative
Assessment of Citric Acid in Lemon Juice, Lime Juice, and Commercially-
Available Fruit
Juice Products
Table 2 Components of commercially-availableproducts
Citrate g/1 Citrate mg /8 oz Carbs g/ 8oz I
Calories /8oz
Lemon Juice 48 9896 19.6 57
Tropicana
Orange Juice 16.7 3443 26 1.1.0
Lemonade
Minute Maid
Light 5.2 1072 4 5
Lemonade
Minute Maid 4.4 907 78 100
Raspbeny
Lemonade
Minute Maid 5.() 1030 29 1.1.0
Cranberry
Lemonade
Minute Maid 32 120
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Table 3 Citrate-rich beverages
Name Citrate 2/1 Citrate mg /8 oz Carbs
2/ 8oz Calories
1 23.8 5640 33 130
2 22.6 5350 33 130
3 23.3 5510 28 11.0
Table 4 Examples of sources of citrate
,
1... l WI, redient Name Supplier
Zinc Citrate Jungbunzlauer
...
Tri magnesium Jungbunzlauer
Citrate Anhydrous
Potassium Citrate , Jungbunzlauer .
Monosodium Citrate , Jungbunzlauer .
, Citric Acid Jungbunzlauer
Lemon Juice Concentrate , Vi taPakt
Orange Juice Concentrate , Vi taPakt
Cranberry Juice Concentrate, Ocean Spray
Essence Returned ..
Table 5
SODIUM POTASSIUM CALCIUM MAGNESIUM CITRATE OXALATE
(mEq/liter) (mEgiliter) (mg/liter) (mg/liter) (mg/liter) (mg/liter)
Apple 1.6 29.4 41 43 52.1 12.1
Orange 0.5 533 96 110 8,140 Too !owl detect
Grape - 0.2 8:3 34 44 1,735 Too low to detect
Tangerine 0.5 40.2 54 97 8,523 5.5
Pineapple None Detected 30.4 105 116 5,860 20.5
Limeade 0.9- 4.2 34 13 6,648 Too low to detect
Lemonade 0.1 0.5 11 10 6,189 Too low to detect
Pineapple- 0.2 44 88 118 6,285 14.8 -
orange-
banana
Grapefruit 0.1 37.7 101 96 14,500 8.1
Resnick, MI, Pak, CYC. UROUTHIASIS A MEDICAL AND SURGICAL REFERENCE.
'N.B. Saunders Company, 1990. P. 162.
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Example 1 Citrate Blend Formulations:
Flavor profiles were identified that can act as vehicle to deliver high
citrate level beverage that
cater to consumer flavor interest. Marketable flavor profiles against
prominent citrate sources were
identified. Formulations prototype development include lemonade, orange and/or
pineapple.
Bench top experiments were conducted to assess the optimal level of citrate
that could make a
health impact while maintaining a quality flavor profile and an appropriated
caloric level. Samples
were developed and prototypes presented included: Cranberry Lemonade, Berry
Lemonade,
Orange Cranberry, Orange Pineapple and Orange-Pineapple-Mango.
Table 5 Citrate Blend Formulation
F:on)-404. stimmilry:
Coniwry -------
Ingmciiont: Petettitage¨
:
Wate .a2:17.1%
+
tOncOVA0 23441%
Stip i=
............... ka*Ci>0061.414 t2:05%
znz citsm Ã0,10.%:
MV-.,x=Wil.106V0 0.9M
Mtx*o,000 MVO: +
IOW
Table 6 Citrate Blend Formulation Analysis
*Amp* nuutt crAubetniLmon4de
Elmowk P EittiViitka
SWetreMtetry
_______________________________________ s.ki0;e3Vis3
<.c.pizr n
I$;n:
76:1 3i.Z.VS:
:44
VM ...............................
$1*i*: (k=NNity:* I g031::
osvOie 41.3W 'WO fç
cA
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Table 7 Citrate Blend Formulation
Berly.:Laracit)p0
===. rngrediertt. Percentage
J:if.:f=<:K.ommtnte Z 746%.
0,411Zb. .
.Ziot ,s3tt :
atr=at. cpat"..
ktho
ma..15metacitt4,4
Tot41 1.01:000%.
z
Table 8 Citrate Blend Formulation Analysis
*quote. N:*otet liktryltA4.060&.
=
sLoK:K*K*K*A4=44='ii,d,*K*K:K:K:K:A
Vkawbb3 by ICP:ItrOs.i6.u.
:Stottrottietry
Cki
.62()Si
Coppt.I _______________________________ ii
rt.
5
1.=µ;µ,:41$6. $:
k5=:,
31,17
Stall& (ZostANit'SSiL.
Ci: AM
15
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Table 9 Citrate Blend Formulation
Otarqe Strawberty .....................
ingredient Percentage
wino- 80,952%
fl
Grange
Cow:entrate
=ar
Citric Add 019ft
Citratt Bifmd
Potassium Citute 0.627%
Mapcsium Citrate 0,797%
Atthydrom
MonmodiumCtrt 0.4111.%
etti Str4wberry Natura 0,107%
Fiavm WONF 133.90550 ................
Naturzg Fruit Ftwor 0,003%
Ong 219-Ce
Total 10000%
Table 10 Citrate Blend Formulation Analysis
.5atripk Name: Orange StrAwberry
mm:E:mom:000000000:
22222221*.git.ttgigigigigigig TiMigigigiA4*4.12222222
ono by.ICP .1Craiviikua
Suettrometra,
IS .1 ailiServitiz Size
0.147 ma.eServit Size
Itort 0..130 luw.tiercit, Sizt
RI:1;413e.6xsra 35e.= mg:"Servisxgt
N.1:mkpmese 0.0317 mti,,:iServitig
Size
:Si. 5 in.gzSerzit4 Size
:Nita ............................. 798 mg:Se:mina Sixe
1:37 mzilServine, E.
0,76i;) aigiServing. Size
Speeitie Gravite'' 1 :064 .1zSuiL
Orgastie Aeiti3*. 3510 mg.:Serving Size
Cixi A6<:1
10
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Table 11 Nutritional Summary
Nutritional Summary:
<460mg/
Product Targets >4500mg <350mg/day <15 mg/day
<4500 mg/day serving Calories g CHO g Sugar
Formula Citrate Mg Zn K Na per
Code Description (mg/serving) (mg/serving) (mg/serving) (mg/serving)
(mg/serving) serving g/serving g/serving
Cranberry U*K**
2129 1 0 71 3 130 32
31
7.no citrate Lemonade !i!i!ine
Cranberry FK**
Ii11.1614.0113 56-41Y 4997 17,:k 356 gl.pg 15
7 70 .,246 130 1311'
^ Lemonade MM
Berry MM
2080 K-44, 11 *4-4K 0 68 3 130 33 30
no citrate Lemonade MM
Ii11.1614.0213 Berry .-.535(1- 4990 AP. 361 gpg 15 4 67 147 132 Ai)
^ Lemonade !!!!!!!!!!!
Orange
4U 2105 0 0 ---- 280 ---- 12
114 28 26
7.no citrate Strawberry Tee
1)11614.03C
Orange
5510 4819 -,3=51:V 309 MI.M 0 -,719.8 812 137 122 111 28 26..
Strawberry
Values in the left columns were lab reported (citrate, Mg, Zn, K and Na)
results. Values in the
right columns were calculated values (citrate, Mg, Zn, K and Na). Actual
analytical were
conducted at Covance Laboratories.
The target for magnesium was 350mg/serving. However, the daily value (DV) for
Mg is
400mg/serving. Some prototypes were formulated slightly above the
350mg/serving target to
minimize the use of potassium and sodium.
Calculated values were based on 8 fluid ounces (236.6g). Analytical results
are reported
slightly higher as the values account for specific gravity (density) value at
¨1.065g/mL.
Minimum citrate, magnesium, potassium, zinc and sodium values were calculated
by
accounting for the nutrients present in the formula without the addition of
the citrate blends
(i.e. magnesium citrate, potassium citrate, zinc citrate and/or sodium
citrate). Calculations were
prepared using the reported values in the raw material specifications.
Table 12 Citrate Blend Formulation pH
Summary of pH, titratable acidity, and Brix
Product pH %TA Brix
Cranberry Lemonade 3.50 1.29 16.80
Berry Lemonade 3.63 1.16 16.40
Orange Strawberry 4.15 1.42 15.20
*pH, Titratable Acidity (%TA) and Brix were analyzed in the QA/QC laboratory
at Umass.
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PCT/US2017/057858
Example 2 Method of Manufacture
Samples were batch prepared and then pasteurized. The order of addition was as
follows:
1. Blend citrates + water, heat to at least 100 F, mix until dissolved.
2. Add sugar, mix until dissolved.
3. Add concentrates and flavor, mix until dissolved.
4. Heat treat to 185 F (pasteurize)
5. Hot fill in glass bottles (at 185 F)
6. Invert
Prototype processing assessment samples were prepared using a pilot scaled
plate heat
exchanger (Armfield FT43A). In order to process a shelf stable, hot-fill
process, product was
processed above the minimal food safety recommendations (FDA Juice Guidance
recommends
heat processing at juice at 160 F for 3 seconds). Conservative hot fill
processing conditions
were used for pilot plant prototypes using a 185 F (for at least 3 seconds)
and a flow rate of
13.5m1/min. This process condition could likely be reduced once a final
process operation is
considered. Hot filling at 185 F (with inversion) was done to ensure that
spoilage organisms
were not introduced during filling. FDA guidance for food safety juice
processing was used as
a reference for juice time/temperature conditions.
What is claimed is:
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