U.S. patent application number 16/572486 was filed with the patent office on 2020-01-09 for foods, systems, methods, and kits for providing electrolyte replacement.
The applicant listed for this patent is Colonary Concepts LLC. Invention is credited to Michael ALLIO, Jonathan GORDON.
Application Number | 20200009079 16/572486 |
Document ID | / |
Family ID | 54333754 |
Filed Date | 2020-01-09 |
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United States Patent
Application |
20200009079 |
Kind Code |
A1 |
ALLIO; Michael ; et
al. |
January 9, 2020 |
FOODS, SYSTEMS, METHODS, AND KITS FOR PROVIDING ELECTROLYTE
REPLACEMENT
Abstract
Described herein are methods, compositions, systems, and kits
that effectively deliver a laxative to a patient along with
effective electrolyte replenishment by delivering both a laxative
and electrolytes via a food item. The food item is prepared by
either combining, mixing, or integrating the ingredients that form
the food item together with one of or both of a laxative and
electrolytes so that the ingredients in the food item either
eliminate or significantly reduce the poor taste associated with
either the electrolytes or the laxative. Eliminating or reducing
the poor taste associated with either electrolytes or laxative,
greatly improves patient satisfaction and compliance with ingesting
these substances in order to, for example, prepare the GI tract of
the patient for a medical or surgical procedure.
Inventors: |
ALLIO; Michael; (Providence,
RI) ; GORDON; Jonathan; (Providence, RI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Colonary Concepts LLC |
Palm Beach |
FL |
US |
|
|
Family ID: |
54333754 |
Appl. No.: |
16/572486 |
Filed: |
September 16, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15611390 |
Jun 1, 2017 |
10449165 |
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16572486 |
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14699973 |
Apr 29, 2015 |
9693972 |
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15611390 |
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62141758 |
Apr 1, 2015 |
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61986048 |
Apr 29, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A23L 7/126 20160801;
A23L 13/40 20160801; A61K 33/14 20130101; A61K 33/00 20130101; A61P
3/12 20180101; A61P 1/10 20180101; A23L 13/42 20160801; A23L 17/00
20160801; A61K 31/08 20130101; A61K 45/06 20130101; A23V 2002/00
20130101; A23L 13/432 20160801; A23L 33/16 20160801; A61K 31/77
20130101; A23L 33/10 20160801; A23L 7/13 20160801; A23L 29/288
20160801; A61K 33/00 20130101; A61K 2300/00 20130101; A61K 33/14
20130101; A61K 2300/00 20130101; A61K 31/08 20130101; A61K 2300/00
20130101; A23V 2002/00 20130101; A23V 2200/3202 20130101; A23V
2250/1578 20130101; A23V 2250/18 20130101 |
International
Class: |
A61K 31/08 20060101
A61K031/08; A61K 33/14 20060101 A61K033/14; A61K 33/00 20060101
A61K033/00; A23L 33/10 20060101 A23L033/10; A23L 33/16 20060101
A23L033/16; A23L 29/288 20060101 A23L029/288; A23L 7/126 20060101
A23L007/126; A23L 7/13 20060101 A23L007/13; A23L 13/40 20060101
A23L013/40; A23L 17/00 20060101 A23L017/00; A61K 45/06 20060101
A61K045/06 |
Claims
1. A method for manufacturing a composition containing polyethylene
glycol, comprising: mixing the polyethylene glycol with a food
ingredient and a hydrophobic binder at a temperature at or below
100 degrees Fahrenheit; wherein the hydrophobic binder is in a
melted state at said temperature.
2. The method of claim 1, wherein the composition is substantially
free of a thermal degradation product of the polyethylene glycol
formed at a temperature above 100 degrees Fahrenheit.
3. The method of claim 1, wherein the polyethylene glycol makes up
50% or more of the weight of the composition.
4. The method of claim 1, wherein the hydrophobic binder is
selected from the group consisting of coconut oil, lard, vegetable
shortening, palm oil, cocoa butter, butter, or margarine.
5. The method of claim 1, wherein the mixing step results in the
binder binding the polyethylene glycol and the food ingredient
together.
6. The method of claim 1, wherein the binder makes up 1% to 3% of a
total weight of the composition.
7. The method of claim 1, wherein the composition is a homogenous
mixture.
8. The method of claim 1, wherein the composition comprises a solid
food item.
9. The method of claim 8, wherein the composition is a bar.
10. The method of claim 1, wherein the mixing step forms a semi
solid mixture comprising the polyethylene glycol, the food
ingredient, and the binder.
11. The method of claim 10, comprising extruding the semi-solid
mixture to form a solid food item sheet.
12. The method of claim 10, wherein the solid food item sheet
comprises a plurality of solid bars.
13. The method of claim 1, wherein the polyethylene glycol
comprises PEG 3350.
14. The method of claim 1, wherein the mixing step further
comprises mixing a natural flavoring substance, a nature-identical
flavoring substance, an artificial flavoring substance or a
combination thereof with the polyethylene glycol, the food
ingredient, and the binder.
15. The method of claim 14, wherein the natural flavoring substance
comprises at least one of a lemon flavorant, a mint flavorant, a
ginger flavorant, a pepper flavorant, a vanilla flavorant, a
caramel flavorant or a chocolate comprising white chocolate, dark
chocolate, milk chocolate, semi-sweet chocolate, sweet chocolate,
hard chocolate, soft chocolate, bitter chocolate, Cocoa mass, cocoa
butter mix, and hard boiled toffees.
16. The method of claim 14, wherein the natural flavoring substance
comprises at least one of a lemon flavorant, a mint flavorant, a
vanilla flavorant, a caramel flavorant or a chocolate flavorant.
Description
CROSS-REFERENCE
[0001] This application is a continuation of U.S. application Ser.
No. 15/611,390, filed on Jun. 1, 2017, which is a divisional of
U.S. patent application Ser. No. 14/699,973 entitled "FOODS,
SYSTEMS, METHODS, AND KITS FOR PROVIDING ELECTROLYTE REPLACEMENT"
filed Apr. 29, 2015, which claims the benefit of U.S. Provisional
Application No. 61/986,048, filed Apr. 29, 2014, and U.S.
Provisional Application No. 62/141,758, filed Apr. 1, 2015, the
content of each applications is incorporated herein by reference in
their entireties.
BACKGROUND
[0002] Laxatives may be taken by a subject for a number of reasons.
Laxatives are, for example, prescribed for certain medical
indications such as the cleansing of the GI tract in preparation
for a medical or surgical procedure.
[0003] Laxatives may cause diarrhea in a subject which in turn may
cause electrolyte loss and acid-base imbalance.
[0004] There are numerous types of laxatives, which have a number
of different mechanisms of action. Polyethylene glycol, which is
also known as PEG, is an osmotic laxative that is used for
irrigation of the colon and GI tract in preparation for medical and
surgical procedures. A bowel preparation regimen may, for example,
prescribe the ingestion of PEG by a subject until the subject
passes watery yellow or clear stools. Such watery yellow or clear
stools in a subject are essentially diarrhea, and may be associated
with electrolyte loss and acid-base imbalance. When subjects
preparing for a medical or surgical procedure either fast or eat
only liquids in addition to taking a laxative, the effect of a
laxative induced electrolyte loss and acid-base imbalance is
typically even more significant.
[0005] PEG-3350 is sold in the U.S. in laxative compositions that
typically are to be combined with a liquid solution. Examples of
such products include MIRALAX.RTM. from Schering-Plough;
GOLYTELY.RTM., NULYTELY.RTM., and HALF-LYTELY.RTM. from Braintree
Laboratories Inc. (Braintree, Mass.); and the fruit flavored
COLYTE.RTM. from Schwarz Pharma, Inc. (Mequon, Wis.). Liquid
formulations of PEG are inconvenient, unsatisfying, and
uncomfortable to the consumer, and can cause undesirable
mouth-feel, and/or create a bloated, overwhelmed feeling in the
consumer's stomach.
SUMMARY
[0006] A subject may take an over the counter laxative, or be
prescribed a laxative for a number of reasons including, for
example, to prepare for a medical or surgical procedure.
Preparation for a medical or surgical procedure typically requires
a purging of the colon and GI tract in order to, for example,
ensure optimal visibility on colonoscopy. An estimated 17.5 million
Americans undergo colonoscopy yearly. The traditional bowel
preparation for colonoscopy (and other invasive GI surgical and
radiologic procedures) typically involves the subject drinking a
large volume of water in which a laxative and electrolytes are
dissolved. Traditional bowel preparations typically further involve
eating no solid food the entire day before the procedure. Many
subjects consider the traditional bowel preparation to be highly
unpleasant.
[0007] Generally, effective provision of a laxative presents
certain challenges. For example, laxative intake as part of a bowel
preparation is associated with electrolyte loss through the GI
tract and electrolyte imbalance. With respect to the traditional
bowel preparation, because of the significant unpleasantness of the
preparation, high numbers of patients in need of colonoscopy either
avoid the procedure altogether or are not fully compliant with the
preparation leading to inadequate visualization during the
procedure due to retained stool within the colon. Described herein
are compositions, methods, systems, and kits directed to overcoming
at least the above two challenges associated with providing a
laxative to a subject, by namely, replenishing electrolytes and
improving the bowel preparation experience to increase
compliance.
[0008] Described herein are food bars comprising more than 50% by
weight of PEG-based laxatives, for example, PEG-3350, as well as
methods of making and using the same.
[0009] In an embodiment, food bars comprise more than 50% by weight
of a polyethylene glycol (PEG)-based laxative, for example,
PEG-3350. In an embodiment, the food bars described herein include
rice syrup. In an embodiment, the food bars described herein
include about 25% to about 40% by weight of rice syrup. In an
embodiment, the food bars described herein include coconut oil. In
an embodiment, the food bars described herein include about 1.5% to
about 3.0% by weight of coconut oil. In an embodiment, the food
bars described herein include glycerin. In an embodiment, the food
bars described herein include about 1.0% to about 3.0% by weight of
glycerin.
[0010] In an embodiment, the food bars described herein include a
flavorant, for example, a lemon, mint, ginger, garlic, pepper or
caramel flavorant. In some embodiments, the food bars described
herein include electrolytes, for example, sodium chloride,
potassium chloride, potassium bicarbonate, or magnesium
chloride.
[0011] Described herein are also methods of administering a
laxative to a subject by providing the subject with the food bars
described herein.
[0012] Described herein are also methods of inducing a bowel
movement in a subject by providing the subject with the food bars
described herein.
[0013] Described herein are also methods of making PEG-based
laxative-containing food bars. A method of making PEG-based
laxative-containing food bars comprises (1) mixing a PEG laxative
powder with dry ingredients, for example, sea salt or flavor
powders; (2) blending the PEG and dry ingredient mixture with
melted coconut oil and glycerin, preferably at room temperature,
for example, a temperature below 80.degree. F. (26.7.degree. C.),
to form a homogenous malleable semi-solid mixture (for example, a
fondant-like mass); (3) blending the malleable semi-solid mixture
with rice syrup to form a homogeneous dispersion; (4) optionally
folding additional ingredients, for example, rice crisps, dried
fruit, or chocolate chips, into the dispersion; and (5) forming the
dispersion into a bar, for example, of about 35 or 70 grams.
[0014] Described herein are compositions, methods, system, and kits
for purging the GI tract of a subject while replenishing
electrolyte losses and preventing electrolyte imbalance. In an
embodiment, a food item comprises a plurality of food ingredients
mixed with 1-3,000 milligrams of sodium, 1-3,000 milligrams of
potassium, 1-750 ml of water, and 5-150 grams of a laxative. The
plurality of food ingredients may comprise at least one grain, at
least one of meat or fish, and/or at least one starch. The laxative
may comprise PEG, which may further comprise PEG 3350, and PEG 3350
may comprise at least 50% by weight of said mixture. The food item
may comprise a solid or a semi-solid food. A semi-solid food item
may comprise 90% or less liquid by weight. The food item may
comprise a bar and/or the food item may comprise a meal.
[0015] In another embodiment, a purgative system comprises a
plurality of food items, wherein one or more food items comprise a
plurality of ingredients mixed with one or more of a laxative and a
salt, and wherein said plurality of food items collectively
comprise 3000-11500 milligrams of sodium, 750-4000 milligrams of
potassium, 2000-4000 ml of water, and 5-150 grams of a
laxative.
[0016] The plurality of food ingredients may comprise at least one
grain, at least one of meat or fish, and at least one starch. The
laxative may comprise PEG, which may further comprise PEG 3350, and
PEG 3350 may comprise at least 50% by weight of said mixture. The
food item may comprise a solid or a semi-solid food. A semi-solid
food item may comprise 90% or less liquid by weight. The plurality
of food items may comprise between 1 and 10 solid food items. The
purgative system or kit may further comprise at least four liters
of water. The plurality of food items may comprise bars and/or the
plurality of food items may comprise one or more meals. The
purgative system or kit may further comprise an instruction to eat
no other food items in addition to said plurality of food items
during a 36 hour period before a medical or surgical procedure. The
plurality of food items may collectively comprise about 600 to
3,000 calories.
[0017] In another embodiment, a method for replacing electrolytes
lost by a subject due to ingesting a laxative, said method
comprises providing to said providing to said subject either one
food item or a plurality of food items, wherein either said one
food item comprises a plurality of food ingredients mixed with
1-3,000 milligrams of sodium, 1-3,000 milligrams of potassium,
1-750 ml of water, and 5-150 mg of a laxative, or at least one food
item of said plurality of food items comprises a plurality of
ingredients mixed with 1-3,000 milligrams of sodium, 1-3,000
milligrams of potassium, 1-750 ml of water, and 5-150 grams of a
laxative. The method may further comprise providing to the subject
an instruction to consume said one or more food items during a 36
hour period before a medical or surgical procedure. The laxative
may comprise PEG, which may further comprise PEG 3350, and PEG 3350
may comprise at least 50% by weight of said mixture. The one food
item or the plurality of food items may comprise a solid or a
semi-solid food. A semi-solid food item may comprise 90% or less
liquid by weight. The plurality of food items may comprise between
1 and 10 solid food items. The method may further comprise
providing to the subject at least four liters of water during a 36
hour period before a medical or surgical procedure. The one food
item or the plurality of food items may be provided to the subject
during a 36 hour period before a medical or surgical procedure. The
one food item may comprise a bar or the plurality of food items may
comprises bars. The one food item may comprise a meal. The
plurality of food items may comprise one or more meals. The one
food item alone or the plurality of food items may collectively
comprise about 600 to 3,000 calories.
INCORPORATION BY REFERENCE
[0018] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The novel features of the described subject matter are set
forth with particularity in the appended claims. A better
understanding of the features and advantages of the described
subject matter will be obtained by reference to the following
detailed description that sets forth illustrative embodiments, in
which the principles of the described subject matter are utilized,
and the accompanying drawings of which:
[0020] FIG. 1 shows a schematic representation of a number of
non-limiting exemplary systems or kits each comprising different
distributions of electrolyte replacement and laxative.
[0021] FIG. 2 shows a schematic representation of a method for
replacing electrolytes lost by a subject due to ingesting a
laxative.
DETAILED DESCRIPTION OF THE INVENTION
[0022] Described herein are compositions, methods, system, or kits
for purging the GI tract of a subject while replenishing
electrolyte losses and preventing electrolyte imbalance. Before
explaining at least one embodiment of the inventive concepts
disclosed herein in detail, it is to be understood that the
inventive concepts are not limited in their application to the
details of construction, experiments, exemplary data, and/or the
arrangement of the components set forth in the following
description, or illustrated in the drawings. The presently
disclosed and claimed inventive concepts are capable of other
embodiments or of being practiced or carried out in various ways.
Also, it is to be understood that the phraseology and terminology
employed herein is for purpose of description only and should not
be regarded as limiting in any way.
[0023] In the following detailed description of embodiments of the
described subject matter, numerous specific details are set forth
in order to provide a more thorough understanding of the inventive
concepts. However, it will be apparent to one of ordinary skill in
the art that the inventive concepts within the disclosure may be
practiced without these specific details. In other instances,
well-known features have not been described in detail to avoid
unnecessarily complicating the instant disclosure.
[0024] The terms "replace" and "replenish" are used in reference to
electrolytes. Both terms are essentially interchangeable when used
in reference to electrolytes and indicate that electrolytes that
are lost are given back.
[0025] The term "electrolyte" or "electrolytes" may refer to a
quantity sufficient to replace or replenish electrolyte loss.
"Electrolytes" may refer to a plurality of types of electrolytes or
a quantity of one electrolyte.
[0026] Further, unless expressly stated to the contrary, "or"
refers to an inclusive or and not an exclusive or. For example, a
condition A or B is satisfied by any one of the following: A is
true (or present) and B is false (or not present), A is false (or
not present) and B is true (or present), and both A and B are true
(or present).
[0027] In addition, use of the "a" or "an" are employed to describe
elements and components of the embodiments herein. This is done
merely for convenience and to give a general sense of the inventive
concepts. This description should be read to include one or at
least one and the singular also includes the plural unless it is
obvious that it is meant otherwise.
[0028] The term "subject" as used herein may refer to a human
subject or any animal subject.
[0029] Finally, as used herein, any reference to "one embodiment"
or "an embodiment" means that a particular element, feature,
structure, or characteristic described in connection with the
embodiment is included in at least one embodiment. The appearances
of the phrase "in one embodiment" in various places in the
specification are not necessarily all referring to the same
embodiment.
[0030] Laxatives may be used for a number purposes including to,
for example, prepare the GI tract of a subject for a medical or
surgical procedure. Bowel preparation for both surgical and medical
procedures requires that the subject fully purge their GI tract of
food and stool prior to the procedure. For surgical procedures
involving bowel resection, a GI tract free of food and stool is
believed to improve anastomotic healing. For medical procedures
such as endoscopy, a GI tract free of food and stool is critical
for effective visualization of anomalies and growths.
[0031] The purging of the GI tract to prepare the GI tract of a
subject for a medical or surgical procedure may take place over a
period of time of, for example, 18 to 36 hours prior to a surgical
or medical procedure. During the period of preparation, subjects
may be instructed to ingest a quantity of PEG sufficient to produce
multiple bowel movements over this period. Due to the osmotic
mechanism of PEG, subjects typically experience significant
diarrhea over the period of time that PEG is ingested and is
active. Diarrhea causes electrolyte losses directly from the GI
tract that, depending on the severity of the diarrhea experienced,
may lead to from mild to severe electrolyte imbalances in a subject
who has ingested PEG as part of a bowel preparation for a surgical
or medical procedure.
[0032] Generally, laxatives are associated with electrolyte loss
from the GI tract with accompanying electrolyte imbalance.
Electrolytes may be lost from the GI tract when, for example, the
laxatives cause diarrhea with accompanying fluid shifts.
Electrolyte imbalance may be a serious condition and may cause side
effects ranging from nausea to seizure and cardiac arrest.
[0033] Non-limiting examples of electrolytes lost by a subject due
to the actions of laxatives include sodium, potassium, chloride,
and bicarbonate. Additionally, bicarbonate is the conjugate base of
carbonic acid and a major acid buffer in a subject. Thus,
bicarbonate loss is associated with acidosis as well.
[0034] To facilitate effective colonic cleansing using laxatives
and protect the health of subjects undergoing a bowel preparation
prior to a medical or surgical procedure, a laxative may be
provided to a subject together with a quantity of electrolytes
sufficient to replenish any electrolytes lost by the subject due to
the action of the laxative. Replacing lost electrolytes over the
period in which a laxative is administered will prevent electrolyte
imbalance and acidosis in a subject along with the associated
negative side effects. Acidosis is associated with lethargy,
shortness of breath, and organ injury in more severe cases.
[0035] Many subjects find that drinking an aqueous solution of
electrolytes, in quantities sufficient to replace GI losses due to
the actions of a laxative, to be difficult, because solutions
comprising electrolytes in quantities sufficient to replace GI
losses are associated with a bad taste. Thus, for example, many
subjects fail to comply with bowel preparation regimens that
require a subject to replenish electrolytes by drinking large
volumes of electrolytes dissolved in water.
[0036] Traditional bowel preparation regimens such as GolytelyTM
provide the laxative polyethylene glycol (PEG) along with
electrolytes dissolved together in a volume of water. GolytelyTM is
reported to have a very unpleasant taste. The poor taste of
GolytelyTM is caused in significant part by the electrolytes in the
prep solution. Poor taste leads to poor compliance with the
GolytelyTM regimen. Poor compliance with the regimen both means
that electrolytes are not replenished and insufficient laxative is
ingested by the subject. Poor electrolyte replenishment leads to
electrolyte imbalance and acidosis in the subject, and poor intake
of laxative leads to inadequate preparation for medical and
surgical procedures. Electrolyte imbalance may cause complications
including, for example, dizziness, seizure, and cardiac arrest, and
poor bowel preparation may lead to surgical complication and
misdiagnosis or require the subject to undergo a new preparation
with rescheduling of the procedure.
[0037] Typically, traditional bowel preparation regimens require a
subject to take in only liquids during the period of the bowel
preparation. That is, typically, subjects are placed on a liquid
only diet during the period of the bowel preparation. Subjects are
placed on the liquid only diet during the period of bowel
preparation, because it is generally believed that subjects must be
maintained on a liquid diet in order achieve an adequately prepared
GI tract. However, if subjects are required to be on a liquid only
diet, the available means for delivering replacement electrolytes
and laxative to the subject are limited. That is, to comply with a
liquid only diet requirement, electrolyte replacement may only be
provided to a subject in aqueous solution. As explained, the
traditional aqueous solution mode of delivery of replacement
electrolytes and laxative does not promote a high degree of
compliance in subjects.
[0038] An improvement in compliance and subject satisfaction with
electrolyte replacement will occur with an improvement in the
experience of ingesting the quantity of electrolytes necessary for
replacing electrolytes lost due to the actions of the laxative.
That is, an improvement in the mode of delivery of electrolyte
replacement to subjects taking a laxative, will improve compliance
thus avoiding electrolyte imbalance and inadequate preparation of
the GI tract.
[0039] An improvement in the mode of delivery of replacement
electrolytes is achieved when subjects need not be limited to
drinking replacement electrolytes in aqueous solution. Eliminating
the liquid diet only requirement in bowel preparations may be
achieved, because using real food does not affect the quality of
the bowel preparation. Thus, replacement electrolytes both with and
without laxative may be delivered effectively to a subject via good
tasting food items. The ingredients in the food items either
overcome or substantially reduce the bad taste associated with
quantities of electrolytes used to replace electrolytes lost due to
the actions of a laxative. The improved taste and texture of food
items as opposed to aqueous solution greatly improves subject
compliance and satisfaction. For example, shakes, smoothies, and
other beverages containing replacement electrolytes are
advantageous means for delivering replacement electrolytes,
because, for example, shakes, smoothies, and beverages may be
configured to provide higher replacement electrolyte concentrations
while effectively reducing or eliminating the bad taste associated
with high concentrations of electrolytes. Thereby, for example,
shakes, smoothies, and other beverages containing replacement
electrolytes increase patient compliance with bowel preps.
[0040] Described herein are methods, compositions, system or kits,
and kits that effectively deliver a laxative to a patient along
with effective electrolyte replenishment by delivering both a
laxative and electrolytes via a food item. The food item is
prepared by one or more of combining, mixing, or integrating the
ingredients that form the food item together with one of or both of
a laxative and electrolytes so that the ingredients in the food
item either eliminate or significantly reduce the poor taste
associated with either the electrolytes or the laxative.
[0041] In an embodiment, a food item is prepared by mixing together
food ingredients with one or more of a laxative and replacement
electrolytes so that, once prepared, the food item contains one or
more of the laxative and the replacement electrolytes.
[0042] In an embodiment the food item is a low fiber food.
Non-limiting examples of low fiber foods include products made with
refined grains, strained vegetable juice, potatoes without skin,
eggs, fish, pudding, and an assortment of beverages. Food items
described herein may be prepared from low fiber, low residue
ingredients. Table I provides an exemplary listing of foods allowed
and excluded from a low fiber/low residue diet. One of skill in the
art will readily be able to identify other foods that can be used,
and those that should be avoided.
TABLE-US-00001 TABLE I Food Group Allowed Excluded Starch Cereals,
rice, pasta, and Whole grain cereals, other products made with
rice, pasta, legumes, refined grains and popcorn Vegetables
Strained vegetable juices, All vegetables Potatoes without skins
Fruits Fruit juices except prune All fruits including canned Dairy
Limited to 2 cups per day Whole milk/cream or foods including
yogurts, made with them; cheese smoothies, puddings and strained
cream soups Meats/Meat Eggs, fish, (tofu) Beef, pork, chicken,
Substitutes processed meats, dried peas/beans, peanut butter
Desserts Gelatin, pudding, sherbet, All pastries plus desserts
sorbet, custards, plain that contain skins, nuts, cake (angel
food), plain seeds and raisins cookies (sugar), yogurt, smoothies
Beverages Coffee and tea (limited), non-cola sodas, pulp free fruit
juices, pulp free fruit ice white ice tea, non-caloric teas and
beverages, freezer pops, milk (limited intake), smoothies, protein
drinks Miscellaneous Nuts, seeds
[0043] In an embodiment, the food item may be a solid, liquid, or
semi-solid food. Non-limiting examples of solid food items that
contain a laxative and electrolytes include cookies, bars,
brownies, and pancakes. Non-limiting examples of liquid foods
include shakes, juices, teas, and coffees. Non-limiting examples of
semi-solid foods include lasagna, yogurt, pasta with sauce, and
meat with sauce. In an embodiment, a semi-solid food item comprises
between 10% and 90% liquid.
[0044] In a preferred embodiment the laxative present is sufficient
to induce one or more bowel movements in the subject and the
electrolytes present are sufficient to replace any electrolyte
losses due to the laxative.
[0045] In an embodiment, a food item comprises a food bar. In an
embodiment, a food bar comprises more than 50% by weight of
PEG-based laxatives. Any food- or pharmaceutical-grade PEG polymer
may be employed in the compositions contemplated herein. PEG
polymers having an average molecular weight of at least 1000 (and
generally no greater than 20,000) are exemplary, while an average
molecular weight between about 3000 and 9000 is preferred. In some
embodiments, the laxative agent is PEG-3350. In an embodiment, the
dose of the laxative provided in each bar should be sufficient to
induce a bowel movement.
[0046] In an embodiment, a food bar comprises more than 50% by
weight of PEG-based laxatives, for example, PEG-3350. The food bars
described herein are formulated to contain a maximum amount of PEG
(for example, 50% or more, for example, up to 40 grams in a typical
70 g bar) in a single bar while still providing a reasonable bar
size, permitting comfortable consumption in a single snack or meal.
The improved taste and the convenience of the food bars described
herein can boost patient compliance and increase efficacy. In an
embodiment, a food bar comprises less than 50% by weight of
PEG-based laxatives, for example, PEG-3350. In an embodiment, a
food bar containing a PEG-based laxative further comprises
replacement electrolytes as described herein.
[0047] In an embodiment, a food bar is made without excessive
heating of PEG, for example PEG-3350, such that no significant
breakdown of the PEG occurs. Accordingly, the present inventors
have specially formulated the binding system to ensure no heating
is required to produce the bars. The innovative binders used in
making the bars can reduce the sweetness in the final product and
improve the taste of the bars. Flavorants such as lemon, mint,
ginger, garlic, pepper, chocolate, vanilla, or caramel can be added
to the bars described herein to mask the taste of PEG and to
complement (lemon, mint, ginger, garlic, pepper) or disguise
(chocolate, vanilla, or caramel) the cooling effect of PEG when
dissolved in the mouth, and/or to accommodate a high level of
electrolytes. In some bars, crisps, for example, rice crisps or
sorghum crisps can be added to provide an alternate texture.
[0048] In an embodiment, the dose of laxative provided in each bar
is sufficient to induce a bowel movement. In an embodiment, the
dose of laxative provided in each bar is insufficient to induce a
bowel movement, and the dose becomes sufficient once the bar is
provided to a subject together with additional laxative. For
example, a bar and a shake that are provided to a subject may both
contain a quantity of laxative that when taken together comprises
an amount that is sufficient to cause a bowel movement in the
subject. In an embodiment, a laxative with sufficient laxative to
induce a bowel movement is provided together with a shake that
contains a quantity of electrolytes sufficient to replace a
quantity of electrolytes lost by the subject due to the actions of
the laxative in the bar. In an embodiment, a bar contains a dose of
laxative sufficient to induce a bowel movement in a subject along
with a quantity of electrolytes sufficient to replace a quantity of
electrolytes lost by the subject due to the actions of the laxative
in the bar. In an embodiment, a bar is provided to a subject
together with a shake, wherein the shake contains a dose of
laxative sufficient to induce a bowel movement in a subject and the
bar contains a quantity of electrolytes sufficient to replace a
quantity of electrolytes lost by the subject due to the actions of
the laxative in the shake.
[0049] In addition, the ingredients used in these bars for bowl
prep are preferably low in fat (i.e., less than 15 grams of fat per
day or prep period) and bland colored (for example, white, cream,
yellow, or clear) to allow for adequate colon cleansing.
[0050] In some embodiments, the food bars described herein include
PEG-3350, rice syrup, coconut oil, and glycerin. In some
embodiments, the food bars described herein include at least 50%
(for example, about 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%,
59%, 60%, 65%, 70%, 75%, 80%, 85%) by weight of PEG-3350. In some
embodiments, the food bars described herein include about 25% to
about 40% by weight of rice syrup (for example, about 25%, 26%,
27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%,
40%); or, as an alternative to or substitute for all or part of the
rice syrup, barley syrup, barley malt syrup, maple syrup, molasses,
honey, agave syrup, or corn syrup can be used. In some embodiments,
the food bars described herein include about 1.5% to about 3.0% by
weight of coconut oil (for example, about 1.5%, 1.6%, 1.7%, 1.8%,
1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9%,
3.0%); or, as an alternative to or substitute for all or part of
the coconut oil, lard, vegetable shortening, palm oil, cocoa
butter, butter, or margarine, can be used. In some embodiments, the
food bars described herein include about 1.0% to about 3.0% by
weight of glycerin (for example, about 1.0%, 1.1%, 1.2%, 1.3%,
1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%,
2.5%, 2.6%, 2.7%, 2.8%, 2.9%, 3.0%); or, as an alternative to or
substitute for all or part of the glycerin, corn syrup or vegetable
oil can be used.
[0051] In some embodiments, the food bars described herein include
at least one flavorant, for example, a lemon flavorant, a mint
flavorant, a ginger flavorant, a pepper flavorant, a vanilla
flavorant, or a caramel flavorant. Several types of chocolates can
be added to the food bars described herein, for example, white
chocolate, dark chocolate, milk chocolate, semi-sweet chocolate,
sweet chocolate, hard chocolate, soft chocolate, bitter chocolate,
Cocoa mass, cocoa butter mix, and hard boiled toffees.
[0052] In an embodiment, the food bars described herein include
sugar or another sweetener, for example, a sweetener may comprise
aspartame, cyclamate, saccharin, stevia, sucralose, mogrosides,
lactose, sorbitol, acesulfame potassium, isomalt, mannitol,
dextrose, glucose, fructose, honey, or high fructose syrup.
[0053] In some embodiments, the food bars described herein include
salt. In some embodiments, the food bars described herein include
citric acid or citrate. In some embodiments, the food bars
described herein include a coating, for example, a yogurt
coating.
[0054] In some embodiments, the food bars described herein includes
an electrolyte, for example, sodium chloride, potassium chloride,
potassium bicarbonate, or magnesium chloride.
[0055] In some embodiments, the food bars described herein includes
one or more preservatives, such as sodium benzolate, ascorbyl
palmitate, sorbic acid, BHT or EDTA, to increase the shelf life of
the final products. The preservatives employed in the food bars of
the invention generally range from about 0% to about 5% by weight
of the total weight of the food bars.
[0056] Generally, food items used may comprise ingredients that are
flavorful and taste good so that the bad taste of the electrolytes
in the food is overcome by the taste of the food itself. If the
food item containing laxative and electrolytes is used as part of a
bowel preparation regimen compliance with the regimen will increase
due to the elimination or reduction of the bad taste caused by the
replacement electrolytes. In an embodiment, the flavor of the food
conceals the bad taste of the electrolytes. In an embodiment, the
flavor of the food conceals the bad taste of the laxative as well
as the electrolyte. In an embodiment, the flavor of the food is
achieved by adding seasonings. Non limiting examples of seasonings
are herbs and spices. In an embodiment, the flavor is achieved by
adding a natural flavoring substance. A natural flavoring substance
may be obtained from plant or animal raw materials, by physical,
microbiological or enzymatic processes. In an embodiment, the
flavor is achieved by adding a nature-identical flavoring
substance. Nature-identical flavoring substances may be obtained by
synthesis or isolated through chemical processes, which are
chemically identical to flavoring substances naturally present in
products intended for human consumption. In an embodiment, the
flavor is achieved by adding an artificial flavoring substance.
Artificial flavoring substances may typically be produced by
fractional distillation and additional chemical manipulation of
naturally sourced chemicals. One having skill in the art will know
that there numerous examples of natural, nature-identical, and
artificial flavors. Ingredients such as, for example, melted
coconut oil, rice syrup, and glycerin may be blended into a mixture
to add both thickness and flavor. Additional ingredients, for
example, rice crisps, dried fruit, or chocolate chips may be added.
Different flavors and different flavoring types may be used either
alone or in combination to provide flavors that make a food
containing an unsavory element, such as, for example, a replacement
load of electrolytes, palatable by masking the unsavory element or
elements.
[0057] In an embodiment, a food item contains a sufficient quantity
of laxatives that when ingested by a subject causes the subject to
produce a yellowy or clear liquid effluent stool. In an embodiment
one or more food items contain electrolytes in a quantity
sufficient to replenish electrolyte losses in the subject due to
the actions of the laxative. Non-limiting examples of electrolytes
contained in the food items include sodium sulfate, sodium
bicarbonate, sodium chloride; and potassium chloride.
[0058] The laxative used may be PEG or any other laxative type. If
PEG is used, PEG 3350 may be used as the laxative. PEG is available
in powder form which is a convenient form to mix together with food
ingredients when preparing the food item containing PEG and
electrolytes.
[0059] The food items containing laxative described herein are
preferably prepared without excessive heating of the laxatives
therein. For example, the food items may be prepared so that the
laxative is not heated above 80.degree. F. In some embodiments,
once the laxative has been added or is present and the mixture is
maintained at a temperature sufficiently low to prevent the
formation of PEG breakdown products, for example, below 100.degree.
F., below 95.degree. F., below 90.degree. F., below 85.degree. F.,
below 80.degree. F., below 75.degree. F., below 70.degree. F.,
below 65.degree. F., below 60.degree. F., below 55.degree. F., and
below 50.degree. F.
[0060] Laxatives such as, for example, PEG are available in powder
form which may be convenient for mixing together with both dry and
wet ingredients.
[0061] The food bars described herein are preferably made without
excessive heating of the laxatives therein, for example, by a
method that does not include heating the PEG above 80.degree. F. In
some embodiments, the methods include (1) mixing a PEG laxative
powder with dry ingredients, for example, sea salt or flavor
powders; (2) blending the PEG and dry ingredient mixture with
melted coconut oil and glycerin, preferably at room temperature,
for example, a temperature below 80.degree. F. (26.7.degree. C.),
to form a homogeneous semi-solid mixture (for example, a
fondant-like mass); (3) blending the semi-solid mixture with rice
syrup to form a homogeneous dispersion; (4) optionally folding
additional ingredients, for example, rice crisps, dried fruit, or
chocolate chips, into the dispersion; and (5) forming the
dispersion into a bar, for example, of about 35 or 70 grams. In
some embodiments, once the PEG has been added or is present, the
methods are performed at, or include maintaining the mixture and
dispersion at, a temperature sufficiently low to prevent the
formation of PEG breakdown products, for example, below 100.degree.
F., below 90.degree. F., below 80.degree. F., below 75.degree. C.,
below 70.degree. C., below 65.degree. C., below 60.degree. C.,
below 55.degree. C., below 50.degree. C., below 45.degree. C.,
below 40.degree. C., below 35.degree. C., or below 30.degree. C.
The dispersion can be, for example, extruded to form a sheet for
die cutting, or into individual bars of the desired shape and size,
using any suitable extruding apparatus known in the art.
[0062] The laxative agents can be incorporated in the bars by any
method including mixing in as an ingredient, and/or by inclusion in
or as a coating, topping, or glaze.
[0063] Prior to packaging the food bars described herein, the food
bars may, optionally, be irradiated in order to kill microorganisms
that may have contaminated the food bars during their preparation.
Such irradiation should not diminish the effectiveness of the
PEG-based laxatives contained therein.
[0064] The resulting food bars may then be packaged in any manner
known by those of skill in the art for packaging food bars. The
preferred method of packing the food bars is by hermetically
sealing each food bar within a film having oxygen barrier
properties, such as a foil laminate, purging the inner space of the
wrapper with nitrogen (to create a nitrogen blanket), placing a
group of the wrapped food bars in an aluminum can, having the air
present in the aluminum can removed with a vacuum, and replacing
the removed air with nitrogen. When packaged in this manner, the
food bars described herein have a shelf life at normal room
temperature (from about 59.degree. F. to about 86.degree. F.) of
about two years. In an embodiment, food bars packaged in the manner
described herein have a shelf life at normal room temperature of
about six months to a year. In some embodiments, a kit is provided
that includes the food bars described herein as a snack or meal. In
some embodiments, the kit also includes other food and/or beverages
that the subject will consume. The kit can also include
instructions for use in a method described herein. In some
embodiments, the food bars are provided in prepackaged form, for
example, packed in a container, for example, in a shelf stable,
refrigerated, or frozen form. The food bars can be purchased, for
example, from a pharmacy or other retail outlet.
[0065] Electrolytes may be combined with one or more of a laxative
and a plurality of food ingredients as a salt or the electrolytes
may be dissolved in solution. Electrolytes may be combined with
food ingredients so that a food item may be prepared so that, once
prepared, the food item, for example, contains a laxative along
with 1-3,000 milligrams of sodium, 1-3,000 milligrams of potassium,
or 1-750 ml of water.
[0066] For example, a serving of lasagna may be prepared by combing
lasagna ingredients such as, for example, noodles and sauce, with
laxative along with 1-3,000 milligrams of sodium, 1-3,000
milligrams of potassium, or 1-750 ml of water. The prepared lasagna
containing the laxative and replacement electrolytes serves as the
medium for delivering the laxative and electrolytes to the subject,
and the flavoring provided by the food ingredients that are
intermixed with the laxative and replacement electrolytes either
eliminate or greatly reduce the poor taste associated with laxative
and/or electrolytes.
[0067] Exemplary quantities of electrolyte salts that may be added
either together or separately to one food item or more than one
food item in order to replenish electrolytes lost by a subject
taking a laxative may be further seen in table II.
TABLE-US-00002 TABLE II Approximate Quantity Compound Name Added in
Grams Sodium sulfate 20-30 Sodium bicarbonate 6-7 Sodium chloride
5-6 Potassium chloride 2-3
[0068] Exemplary quantities of electrolytes, water, and laxative
contained in either one food item or collectively in a number of
food items, such as the collective food items in a system or kit,
may be found in table III and table IV respectively.
TABLE-US-00003 TABLE III Individual Items Food Item Sodium (mg)
Potassium (mg) Water (ml) PEG (gm) Solid item 1-3000 1-1000 1-750
0-150 Semi-Solid 1-3000 1-1000 1-750 0-150 item Liquid item 1-3000
1-1000 1-750 0-150
TABLE-US-00004 TABLE IV Complete Kit Food Item Sodium (mg)
Potassium (mg) Water (ml) PEG (gm) Kit 3000-11500 750-4000
2000-4000 200-420
[0069] In an embodiment, the laxative used may be PEG and may
further be PEG 3350. The PEG 3350 may have a weight of about 5-300
grams. Thus for example, a serving of lasagna weighing a total of
500 grams may contain 150 grams of laxative.
[0070] In an embodiment, the weight of the laxative makes up at
least 95% of the weight of the food item. In an embodiment, the
weight of the laxative makes up at least 90% of the weight of the
food item. In an embodiment, the weight of the laxative makes up at
least 85% of the weight of the food item. In an embodiment, the
weight of the laxative makes up at least 80% of the weight of the
food item. In an embodiment, the weight of the laxative makes up at
least 75% of the weight of the food item. In an embodiment, the
weight of the laxative makes up at least 70% of the weight of the
food item. In an embodiment, the weight of the laxative makes up at
least 65% of the weight of the food item. In an embodiment, the
weight of the laxative makes up at least 60% of the weight of the
food item. In an embodiment, the weight of the laxative makes up at
least 55% of the weight of the food item. In an embodiment, the
weight of the laxative makes up at least 50% of the weight of the
food item. In an embodiment, the weight of the laxative makes up at
least 45% of the weight of the food item. In an embodiment, the
weight of the laxative makes up at least 40% of the weight of the
food item. In an embodiment, the weight of the laxative makes up at
least 35% of the weight of the food item. In an embodiment the
weight of the laxative makes up at least 30% of the weight of the
food item. In an embodiment, the weight of the laxative makes up at
least 25% of the weight of the food item. In an embodiment, the
weight of the laxative makes up at least 20% of the weight of the
food item. In an embodiment, the weight of the laxative makes up at
least 15% of the weight of the food item. In an embodiment, the
weight of the laxative makes up at least 10% of the weight of the
food item. In an embodiment, the weight of the laxative makes up at
least 5% of the weight of the food item.
[0071] In an embodiment, a food item may comprise a bar similar to
a candy bar or other dessert bar or a protein bar. In an
embodiment, a food item may comprise a meal such as, for example, a
serving of pasta with sauce.
[0072] In an embodiment, a food item containing a laxative and
electrolytes may comprise, for example, about 20 calories. In an
embodiment, a food item containing a laxative and electrolytes may
comprise, for example, about 40 calories. In an embodiment, a food
item containing a laxative and electrolytes may comprise, for
example, about 80 calories. In an embodiment, a food item
containing a laxative and electrolytes may comprise, for example,
about 100 calories. In an embodiment, a food item containing a
laxative and electrolytes may comprise, for example, about 150
calories. In an embodiment, a food item containing a laxative and
electrolytes may comprise, for example, about 200 calories. In an
embodiment, a food item containing a laxative and electrolytes may
comprise, for example, about 250 calories. In an embodiment, a food
item containing a laxative and electrolytes may comprise, for
example, about 300 calories. In an embodiment, a food item
containing a laxative and electrolytes may comprise, for example,
about 350 calories. In an embodiment, a food item containing a
laxative and electrolytes may comprise, for example, about 400
calories. In an embodiment, a food item containing a laxative and
electrolytes may comprise, for example, about 450 calories. In an
embodiment, a food item containing a laxative and electrolytes may
comprise, for example, about 550 calories. In an embodiment, a food
item containing a laxative and electrolytes may comprise, for
example, about 600 calories. In an embodiment, a food item
containing a laxative and electrolytes may comprise, for example,
about 650 calories. In an embodiment, a food item containing a
laxative and electrolytes may comprise, for example, about 700
calories. In an embodiment, a food item containing a laxative and
electrolytes may comprise, for example, about 750 calories. In an
embodiment, a food item containing a laxative and electrolytes may
comprise, for example, about 800 calories. In an embodiment, a food
item containing a laxative and electrolytes may comprise, for
example, about 850 calories. In an embodiment, a food item
containing a laxative and electrolytes may comprise, for example,
about 900 calories. In an embodiment, a food item containing a
laxative and electrolytes may comprise, for example, about 1000
calories.
[0073] In an embodiment, a system or kit for purging the GI tract
of a subject while replenishing electrolytes comprises a plurality
of food items. A plurality of food items may comprise, for example,
2 to 10 food items that are provided for a subject to consume while
preparing for a medical or surgical procedure. The system or kit
may comprise of multiple meals such as breakfast, lunch, and
dinner. In an embodiment the food is a low fiber food. The food may
be a solid, liquid, or semi-solid food. Non-limiting examples of
solid foods that contain a laxative and electrolytes include
cookies, bars, brownies, and pancakes. Non-limiting examples of
liquid foods include shakes, juices, teas, and coffees.
Non-limiting examples of semi-solid foods include lasagna, yogurt,
pasta with sauce, and meat with sauce.
[0074] One or more food items within the system or kit may be
identical, or one or more food items may be different. Similarly,
one or more food items within the system or kit may contain
replacement electrolytes only, one or more food items within the
system or kit may contain laxative only, one or more food items in
the system or kit may contain replacement electrolytes and
laxative, and one or more food items within the system or kit may
contain neither laxative or replacement electrolytes. Similarly,
one or more food items within the system or kit may comprise
replacement electrolytes that are identical in terms of type or
quantity to the replacement electrolytes contained in one or more
food items in the system or kit, and one or more food items within
the system or kit may comprise replacement electrolytes that differ
in term of type or quantity from replacement electrolytes contained
in one or more food items within the system or kit. Similarly, one
or more food items within the system or kit may comprise laxative
that is identical in terms of type or quantity to the laxative
contained in one or more food items in the system or kit, and one
or more food items within the system or kit may comprise laxative
that differs in term of type or quantity from the laxative
contained in one or more food items within the system or kit.
[0075] For example, a food system or kit may comprise a 600 gram
serving of lasagna and a 100 gram serving of pudding. In an
exemplary embodiment, the lasagna and pudding may both comprise 6
grams of sodium bicarbonate. In an exemplary embodiment, the
lasagna alone may comprise 6 grams of sodium bicarbonate and the
pudding may comprise no replacement electrolytes. In an exemplary
embodiment, the lasagna alone may comprise 6 grams of sodium
bicarbonate and the pudding comprises 5 grams of sodium chloride.
It should be understood that these examples are illustrative, and
are not meant to limit the subject matter here described in any
way. It should be further understood that many other possible
combinations are achievable using the systems or kits described
here.
[0076] For further example, the food items in the system or kit may
also contain total amount of electrolyte replacement or laxative
that collectively comprises a target quantity. For example, a
system or kit may comprise a 600 gram serving of lasagna and a 100
gram serving of pudding. In an exemplary embodiment, the lasagna
may comprise 5 grams of sodium bicarbonate and the pudding may
comprise 1 gram of sodium bicarbonate, collectively totaling 6
grams of sodium bicarbonate within the system or kit. The
collective delivery of electrolyte replacement or laxative is, for
example, highly advantageous because it allows smaller more
palatable quantities of electrolytes to be delivered within each
food item and also helps to ensure that the electrolytes will be
delivered throughout the course of the bowel preparation regimen
in, for example, multiple meals. It should be understood that these
examples are illustrative, and are not meant to limit the subject
matter here described in any way. It should be further understood
that many other possible combinations are achievable using the
systems or kits described here.
[0077] FIG. 1 shows a schematic representation of a number of
non-limiting exemplary systems or kits each comprising different
distributions of electrolyte replacement and laxative. An exemplary
system or kit 102 comprises three food items, A, B, and C. In
exemplary system or kit 102, food item A comprises laxative and
electrolyte replacement, food item B comprises laxative, and food
item C comprises laxative. An exemplary system or kit 104 comprises
two food items, A and B. In exemplary system or kit 104, food item
A comprises laxative and electrolyte replacement, and food item B
comprises laxative and electrolyte replacement. An exemplary system
or kit 106 comprises three food items, A, B, and C. In exemplary
system or kit 106, food item A comprises electrolyte replacement,
food item B comprises electrolyte replacement, and food item C
comprises laxative and electrolyte replacement. An exemplary system
or kit 108 comprises three food items, A, B, and C. In exemplary
system or kit 108, food item A comprises electrolyte replacement,
food item B comprises electrolyte replacement, and food item C
comprises laxative. An exemplary system or kit 110 comprises three
food items, A, B, and C. In exemplary system or kit 108, food item
A comprises laxative and electrolyte replacement, food item B
comprises laxative, and food item C comprises neither laxative nor
electrolyte replacement.
[0078] It should be understood that the examples provided herein of
the composition of the system or kit described apply in the same
way to laxatives, and in no way are the examples meant to contain
all the possible combinations and permutations of the system or kit
described herein as it is understood that numerous combinations and
permutations are possible. Likewise, it should be understood that
food items may comprise laxatives together with replacement
electrolytes or the food items may contain laxative alone or
replacement electrolytes alone, as well as any other possible
combinations and permutation of different replacement electrolytes
in terms of quantity and type combined with different laxative in
terms of quantity and type.
[0079] The system or kit may be provided to a subject to be
ingested within a period of time comprising of, for example, 36
hours before a medical or surgical procedure. The system or kit may
be provided to a subject to be ingested within a period of time
comprising of, for example, 30 hours before a medical or surgical
procedure. The system or kit may be provided to a subject to be
ingested within a period of time comprising of, for example, 24
hours before a medical or surgical procedure. The system or kit may
be provided to a subject to be ingested within a period of time
comprising of, for example, 18 hours before a medical or surgical
procedure. It should be understood that the above examples are
exemplary only and the system or kits described here may be
ingested over other periods of time.
[0080] The food items contained in the systems or kits described
herein may be ingested at different times. That is, the entire
system or kit need not be ingested at once. For example, a system
may comprise of three food items, A, B, and C, wherein A, B, and C
all contain a quantity of replacement electrolytes and laxative.
Item A may, for example, be ingested at a time that is 18 hours
from a scheduled medical or surgical procedure, item B may, for
example, be ingested at a time 6 hours later, and item C may, for
example, be ingested at a time 6 hours after ingestion of item B.
In this way the laxative and electrolytes that are provided to the
subject may be spread out over time. In this way, the quantity of
bad tasting elements that a subject must ingest may be delivered
over time. Using multiple food items to deliver the laxative and
replacement electrolytes over time allows for smaller quantities of
those elements to be in each item of the system or kit. When there
is a relatively small quantity (compared to for example the
traditional preparations) of laxative and replacement electrolytes
in the individual food items, each item will be more palatable to a
subject thus ensuring compliance with the regimen and proper
electrolyte replacement.
[0081] In the example above that used food items A, B, and C to
deliver electrolytes and laxative over the course of 18 hours, the
electrolyte replacement and laxative delivery may be optimized. For
example, laxative delivery may be arranged to produce the highest
likelihood of compliance and proper cleansing of the bowel. For
example, a larger laxative dose may be given initially with food
item A with the laxative quantity tapering with later ingested
items B and C. Electrolyte replacement is then provided in a way
that will optimize electrolyte replacement. In general, electrolyte
replacement may be optimized in, for example, electrolyte quantity
and electrolyte absorption efficiency. That is, for example, the
electrolyte replacement is spread throughout the items of the
system or kit to match the actions of the laxative. For example, a
larger laxative dose will be given contemporaneously or relatively
contemporaneously with a larger electrolyte replacement dose so
that the loss of electrolytes due to diarrhea losses can be
replaced proportionally and effectively.
[0082] In a preferred embodiment, the system or kit collectively
contains sufficient laxative to induce one or more bowel movements
in the subject and the electrolytes present are collectively
sufficient to replace any electrolyte losses due to the laxative.
If used as a bowel preparation for a medical or surgical procedure
the system or kit may collectively contain sufficient laxative to
induce a yellowy or clear effluent stool in a subject, and
sufficient electrolytes to replenish any electrolytes lost due to
the action of the laxative.
[0083] The system or kit may, for example, comprise a plurality of
foods. For example, the system or kit may comprise 1-10 solid food
items, 1-10 semi-solid food items, or 1-10 liquid food items or all
possible combinations or permutations thereof. The system or kit
may comprise a plurality of meals. For example, the system or kit
may comprise the meals of breakfast, lunch, and dinner.
[0084] For example, breakfast may comprise a breakfast bar
comprising for example chocolate, peanut butter, and oats mixed
with laxative and electrolytes. Breakfast may further comprise
oatmeal mixed with electrolytes only. Lunch may comprise meatloaf
with gravy containing both laxative and electrolytes. Lunch may
further comprise a desert such as a pudding containing neither
laxative or replacement electrolytes. Dinner may comprise lasagna
with replacement electrolytes only. The exemplary system or kit
described comprises of 5 total food items some items containing
laxative only, some items containing replacement electrolytes only,
some items containing laxative and replacement electrolytes, and
some items containing neither. It should also be understood that a
system or kit may comprise more than 10 food items as well.
[0085] A semi-solid food may comprise a food with both solid and
liquid components mixed together. For example, semi-solid food may
comprise a chicken vegetable soup which comprises the solid chicken
and vegetables as well as a liquid broth. A semi-solid food that
comprises both solid and liquid components mixed together may
comprise a percent of solid by weight. For example, a semi-solid
food may comprise 10% solid by weight and 90% liquid by weight. For
example, in a semi-solid food item weighing 100 grams, if 10%
comprises solid food, the solid component weighs 10 grams and the
liquid component weighs 90 grams. It should be understood that a
semi-solid food may comprise more than 10% solid by weight as well
as less than 10% solid by weight. A semi-solid food may comprise,
for example, 90% or less liquid by weight. A semi-solid food may
comprise, for example, 80% or less liquid by weight. A semi-solid
food may comprise, for example, 70% or less liquid by weight. A
semi-solid food may comprise, for example, 60% or less liquid by
weight. A semi-solid food may comprise, for example, 50% or less
liquid by weight. A semi-solid food may comprise, for example, 40%
or less liquid by weight. A semi-solid food may comprise, for
example, 30% or less liquid by weight. A semi-solid food may
comprise, for example, 20% or less liquid by weight. A semi-solid
food may comprise, for example, 10% or less liquid by weight.
[0086] A semi-solid food may also comprise a food having a
relatively high viscosity. A semi-solid food may comprise for
example yogurt or pudding.
[0087] In an embodiment the system or kit comprises instructions to
be provided to a subject. Instructions may comprise written,
pictorial, or video instructions and may be provided on numerous
different media including a sheet of paper or the screen of a
computing device such as a computer, laptop, tablet or smartphone.
Instructions may provide the subject with direction as to how to
organize the plurality of foods into meals so that, for example,
the proper amount of laxative and electrolytes will be ingested by
the subject at the proper time. Instructions may similarly direct a
subject as to the proper time to eat a particular meal.
Instructions may direct a subject to complete the system or kit
within a specific period of time, such as, for example, within 24
to 36 hours before a medical or surgical procedure.
[0088] In an embodiment, the system or kit also comprises an amount
of liquid for a subject to drink. The quantity of liquid may be
sufficient to replenish fluid losses and shifts due to the action
of the laxative. For example the system or kit may comprise four
liters of water that may be divided into smaller servings. Water
provided with the system or kit may for example have bicarbonate
added so as to make the water's pH basic. The water may, for
example, contain electrolytes as well as flavorings. It should be
understood that an amount of water greater or less than four liters
may also be provided. Likewise, it should be also understood, that
the liquid provided may be a juice, tea, coffee, or other flavored
drink.
[0089] In an embodiment, a food item contains 50% by weight or more
of a laxative. In an embodiment, a food item contains 40% by weight
or more of a laxative. In an embodiment, a food item contains 30%
by weight or more of a laxative. In an embodiment, a food item
contains 20% by weight or more of a laxative. In an embodiment, a
food item contains 10% by weight or more of a laxative. It should
be understood that amounts less than 10% are suitable as well. The
laxative may comprise PEG and may further comprise PEG 3350. In an
embodiment the amount of PEG 3350 contained in one food item or
contained collectively in a plurality of food items comprises
200-300 grams of PEG 3350.
[0090] In an embodiment, the plurality of food items provided in
the system or kit are the only food items ingested by the subject
during a certain period. A subject may be instructed to drink
liquid that is not provided in the system or kit in addition to
eating only the food items provided in the system or kit.
[0091] In an embodiment, the system or kit provides nutrition to
the subject as well during the period which the system or kit is
used. If, for example, the system or kit is used over a period of
24 to 36 hours then the system or kit may collectively provide a
quantity of calories that is sufficient for a subject. The quantity
of calories may vary for adults and children and for male and
female subjects. The system or kit may also comprise lite versions
of the meals and food items which comprise low calorie versions of
the meals and food items. The lite versions of the meals and food
items will still however provide the same amount of laxative and
electrolytes. The collective calorie content of the plurality of
food items in the system or kit may comprise between 600-3,000
calories. It should be understood that other calorie quantities are
suitable as well including calorie amounts less than 600 calories
and more than 3,000 calories.
[0092] Food items within the system or kit may comprise, for
example, about 20 calories. Food items within the system or kit may
comprise, for example, about 40 calories. Food items within the
system or kit may comprise, for example, about 80 calories. Food
items within the system or kit may comprise, for example, about 100
calories. Food items within the system or kit may comprise, for
example, about 150 calories. Food items within the system or kit
may comprise, for example, about 200 calories. Food items within
the system or kit may comprise, for example, about 250 calories.
Food items within the system or kit may comprise, for example,
about 300 calories. Food items within the system or kit may
comprise, for example, about 350 calories. Food items within the
system or kit may comprise, for example, about 400 calories. Food
items within the system or kit may comprise, for example, about 450
calories. Food items within the system or kit may comprise, for
example, about 500 calories. Food items within the system or kit
may comprise, for example, about 550 calories. Food items within
the system or kit may comprise, for example, about 600 calories.
Food items within the system or kit may comprise, for example,
about 650 calories. Food items within the system or kit may
comprise, for example, about 700 calories. Food items within the
system or kit may comprise, for example, about 750 calories. Food
items within the system or kit may comprise, for example, about 800
calories. Food items within the system or kit may comprise, for
example, about 850 calories. Food items within the system or kit
may comprise, for example, about 900 calories. Food items within
the system or kit may comprise, for example, about 100
calories.
[0093] Similarly the food items in the system or kit provide other
elements of a typical diet. This may comprise protein, fat,
minerals and vitamins. The protein, fat, minerals, and vitamins
provided by food items are in quantities that are in accordance
with a healthy diet and the dietary needs of a particular
subject.
[0094] In an embodiment, a system or kit will comprise a plurality
of food items that are appropriate for individuals with special
dietary requirements. Non-limiting examples of special diets
include diabetic diets, renal diets, low sodium diets, gluten free
diets, low calorie diets, high protein diets, vegetarian diets,
vegan diets, kosher diets, and halal diets.
[0095] Electrolytes that are lost due to GI losses are replaced per
orally in one or more food items. Generally, oral replacement of
electrolytes is a less efficient mode of electrolyte replacement
relative to intravenous replacement. Because oral replacement of
electrolytes is less efficient than intravenous replacement, oral
replacement typically requires a far larger quantity of
electrolytes provided per orally than intravenously to measurably
raise the intravenous levels of electrolytes. Electrolytes
contained in one or more food items may comprise salts of
electrolytes or the electrolytes may be in solution. When one or
more food items in a plurality of food items comprise replacement
electrolytes, the quantity of replacement electrolytes present is
the collective quantity of replacement electrolytes present in the
plurality of food items.
[0096] FIG. 2 shows a schematic representation of a method 200 for
replacing electrolytes lost by a subject due to ingesting a
laxative. In an embodiment the subject has ingested the laxative as
a preparation of the subject's digestive tract for a medical or
surgical procedure. Non-limiting examples of medical and surgical
procedures include colonoscopy and bowel resection.
[0097] In a step 202, either one food item or a plurality of food
items are prepared, wherein the one food item comprises food
ingredients mixed with one or more of a laxative and replacement
electrolytes provided, for example, in the form of a salt, and
wherein at least one food item of the plurality of food items
comprises food ingredients mixed with one or more of a laxative and
a salt. The food ingredients and the laxative and replacement
electrolytes may be mixed together in a way that ensures
homogeneity or near homogeneity of the components. One food item
may be provided that comprises food ingredients mixed together with
one or more of a laxative such as, for example, PEG 3350, and at
least one salt. Quantities of PEG and electrolytes contained within
the one food item may comprise, for example, 1-3,000 milligrams of
sodium, 1-3,000 milligrams of potassium, 1-750 ml of water, and
5-150 grams of PEG.
[0098] A plurality of food items may be provided wherein at least
one food item comprises food ingredients mixed together with one or
more of a laxative and a salt. Quantities of PEG and electrolytes
collectively contained within the plurality of food items may
collectively comprise, for example, 3000-11500 milligrams of
sodium, 750-4000 milligrams of potassium, 2000-4000 ml of water,
and 200-420 grams of PEG.
[0099] In a step 204, a subject is provided with one or more food
items. The food items may be delivered to the home of the subject.
The food items may be sold over the counter at a store or pharmacy.
The food items may require a prescription to purchase. The food
items may be provided by a physician in his or her office.
[0100] In a step 206, the subject may be provided with
instructions. Instructions may comprise written, pictorial, or
video instructions and may be provided on numerous different media
including a sheet of paper or the screen of a computing device such
as a computer, laptop, tablet or smartphone. Instructions may
provide the subject with direction as to how to organize the
plurality of foods into meals so that, for example, the proper
amount of laxative and electrolytes will be ingested by the subject
at the proper time. Instructions may similarly direct a subject as
to the proper time to eat a particular meal. Instructions may
direct a subject to complete the system or kit within a specific
period of time, such as, for example, within 24 to 36 hours before
a medical or surgical procedure.
[0101] In a step 208, the subject may be provided with a liquid to
drink. The quantity of liquid may be sufficient to replenish fluid
losses and shifts due to the action of the laxative. For example
the system or kit may comprise four liters of water that may be
divided into smaller servings. Water provided with the system or
kit may for example have bicarbonate added so as to make the
water's pH basic. The water may, for example, contain electrolytes
as well as flavorings. It should be understood that an amount of
water greater or less than four liters may also be provided.
Likewise, it should be also understood, that the liquid provided
may be a juice, tea, coffee, or other flavored drink.
[0102] In a step 210, the subject may have a medical or surgical
procedure performed.
[0103] The food bars described herein may be consumed or provided
for consumption, for example, by a subject preceding a procedure
that requires a clean bowel, i.e., a medical procedure such as a
surgical or diagnostic procedure, to prepare the bowel for the
procedure. Such procedures include colonoscopy, intestinal surgery,
virtual colography, fiberoptic endoscopy, sigmoidoscopy, wireless
capsule endoscopy (WCE) (which uses a miniaturized scope
administered in a "pill" form) and barium studies (barium enema),
inter alia.
[0104] In some embodiments, the ingestion of these food bars can
start at 72, 48, 36, 24, or 12 hours prior to a scheduled
procedure; these food bars can be consumed up to a few hours prior
to the procedure, for example, up to about 2, 3, 4, 5, or 6 hours
prior to the procedure. In general, these methods of preparing the
bowel do not include the use of a high-volume liquid prep as is
known in the art (described above) for whole bowel irrigation. An
enema, for example, a tap water enema, may be used in some cases.
As noted above, food bars for use in preparing the subject for a
procedure will preferably be prepared from low fiber, low residue
ingredients. In these embodiments, the subject is provided with and
consumes a number of the bars sufficient to induce the presence of
watery yellow stools with light yellow or clear effluent within
about 6-8 hours of the initiation of the prep; this effluent is a
clinical indicator of an adequate cleansing of the colon and is
used as a clinical guide and surrogate marker for an adequate colon
cleansing to permit a thorough inspection of the lining of the
colon. In some embodiments, the number of bars provided for
consumption is sufficient to provide 200-400 grams of PEG per
menu.
[0105] While preferred embodiments of the presently described
subject matter have been shown and described herein, it will be
obvious to those skilled in the art that such embodiments are
provided by way of example only. Numerous variations, changes, and
substitutions will now occur to those skilled in the art without
departing from the described subject matter. It should be
understood that various alternatives to the embodiments of the
subject matter described herein may be employed in practicing the
described subject matter. It is intended that the following claims
define the scope of the described subject matter and that methods
and structures within the scope of these claims and their
equivalents be covered thereby.
[0106] Further details are illustrated by the following
non-limiting Examples section.
EXAMPLES
Example 1
Lemon Cooler Bar
[0107] Lemon cooler bar is an example of a food bar that contains
either more than 50% of PEG by weight or less than 50% PEG by
weight. Table V lists exemplary ingredients of a lemon cooler bar
and the percentage and quantity of the exemplary ingredients.
TABLE-US-00005 TABLE V Ingredient Percentage Quantity per 1000
Grams PEG 55.07% 550.73 Rice Syrup 30.82% 308.21 Sugar 6.41% 64.13
Coconut Oil 2.94% 29.37 Glycerin 1.47% 14.69 Citric acid 0.12% 1.17
Total 100.00% 1000.00 grams
[0108] Additional ingredients included lemon yogurt coating,
vanilla flavor, and lemon flavor. The lemon cooler bars were
produced without excessive heating of PEG, for example PEG-3350. To
produce the lemon cooler bars, PEG, for example, PEG-3350, was
first mixed with the dry ingredients such as sugar, vanilla, and
lemon flavor powders. The mixture of the dry ingredients was
blended with melted coconut oil and glycerin at room temperature,
for example, a temperature below 80.degree. F. (26.7.degree. C.),
to form a fondant-like mass. The fondant-like mass was blended with
rice syrup and mixed sufficiently to ensure a homogeneous
dispersion of the ingredients. The mixture was then shaped into
bars of about 70 grams. About 1.5 gram of melted lemon burst yogurt
coating was added in a drizzle pattern on each bar. When dissolving
in the mouth, PEG produces a cooling effect, which can be utilized
in choosing the flavor for the bar, such as the refreshing lemon
flavor.
[0109] Table VI shows the nutritional breakdown of an exemplary
lemon cooler bar.
TABLE-US-00006 TABLE VI Item Quantity PEG 38.6 g Na 20.7 mg K 9.22
mg Fiber 0.08 g Fat 2.52 g Calorie 119.39 Total 71.5 grams
[0110] Table VII shows a nutritional breakdown of a second
embodiment of a lemon cooler bar.
TABLE-US-00007 TABLE VII Item Quantity PEG 35.44 g Na 18.63 mg K
8.30 mg Fiber 0.07 g Fat 2.27 g Calorie 107.45 Total 64.35 g
Example 2
Salted Caramel Crisp Bar
[0111] Salted caramel crisp bar is another example of a food bar
that contains either more than 50% of PEG by weight or less than
50% PEG by weight. Table VIII lists exemplary ingredients of a
salted caramel crisp bar and the percentage and quantity of the
exemplary ingredients.
TABLE-US-00008 TABLE VIII Ingredient Percentage Quantity per 1000
Grams PEG 50.00% 500 Rice Syrup 32.00% 320 Coconut Oil 2.00% 20
Glycerin 2.00% 20 Total 100.00% 1000.00 grams
[0112] Additional ingredients include sea salt, rice crisps and
caramel flavor.
[0113] The salted caramel crisp bars were produced without
excessive heating of PEG-3350. To produce the salted caramel crisp
bars PEG-3350, was first mixed with the dry ingredients such as sea
salt and caramel flavor powders. The mixture of the dry ingredients
was blended with melted coconut oil and glycerin at room
temperature, for example, a temperature below 80.degree. F.
(26.7.degree. C.), to form a fondant-like mass. The fondant-like
mass was then blended with rice syrup and mixed sufficiently to
ensure a homogeneous dispersion of the ingredients. Rice crisps
were gently folded in the mixture. The mixture was shaped into bars
of about 70 grams. When dissolving in the mouth, PEG produces a
cooling effect, which can be disguised by the caramel flavor of the
bar. Rice crisps were added to give an alternative texture and may
improve taste and boost compliance.
[0114] Table IX shows the nutritional breakdown of an exemplary
salted caramel crisp bar.
TABLE-US-00009 TABLE IX Item Quantity PEG 35 g Na 156 mg K 9.51 mg
Fiber 0.228 g Fat 1.63 g Calories 125.26 Total 70 grams
[0115] Table X shows a nutritional breakdown of a second embodiment
of a salted caramel crisp bar.
TABLE-US-00010 TABLE X Item Quantity PEG 31.50 g Na 140.40 mg K
8.56 mg Fiber 0.21 g Fat 1.47 g Calories 112.73 Total 63 grams
Example 3
Savory Humus Bar
[0116] A savory humus bar is produced in accordance with the
methods described herein. Table XI shows a nutritional breakdown of
an exemplary savory humus bar.
TABLE-US-00011 TABLE XI Item Quantity PEG 23.31 g Na 341.91 mg K
10.85 mg Fiber 1.29 g Fat 7.17 g Calories 158.48 Total 63 grams
Example 4
Vanilla Shake
[0117] A vanilla shake is produced in accordance with the methods
described herein. Table XII shows a nutritional breakdown of an
exemplary vanilla milkshake.
TABLE-US-00012 TABLE XII Item Quantity PEG 114.38 g Na 101.91 mg K
289.19 mg Fiber 0.00 g Fat 0.13 g Calories 134.52 Total 339.29 g/11
fl. oz.
Example 5
Ginger Candy
[0118] A ginger candy is produced in accordance with the methods
described herein. Table XIII shows a nutritional breakdown of an
exemplary ginger candy.
TABLE-US-00013 TABLE XIII Item Quantity PEG 0 g Na 5 mg K 0 mg
Fiber 0.1 g Fat 0.1 g Calories 15.4 Total 4 g
Example 6
Banana Strawberry Refresher
[0119] A banana strawberry refresher is produced in accordance with
the methods described herein. Table XIV shows a nutritional
breakdown of an exemplary banana strawberry refresher.
TABLE-US-00014 TABLE XIV Item Quantity PEG 116.63 g Na 12.61 mg K
3.58 mg Fiber 0.28 g Fat 0.00 g Calories 72.08 Total 339.29 g/11 fl
oz
Example 7
Chicken and Rice
[0120] Chicken and rice is produced in accordance with the methods
described herein. Table XV shows a nutritional breakdown of
exemplary chicken and rice.
TABLE-US-00015 TABLE XV Item Quantity PEG 0 g Na 2130 mg K 250 mg
Fiber 1 g Fat 1 g Calories 230 Total 8.5 oz
Example 9
Crackers
[0121] Crackers are produced in accordance with the methods
described herein. Table XVI shows a nutritional breakdown of
exemplary crackers.
TABLE-US-00016 TABLE XVI Item Quantity PEG 0 g Na 33.75 mg K 0 mg
Fiber 0.27 g Fat 0.54 g Calories 45 Total 6 each
Example 12
Ziti Minestrone
[0122] Ziti Minestrone is produced in accordance with the methods
described herein. Table XVII shows a nutritional breakdown of
exemplary ziti minestrone.
TABLE-US-00017 TABLE XVII Item Quantity PEG 0 g Na 2830 mg K 150 mg
Fiber 2 g Fat 1 g Calories 160 Total 13 oz.
Example 13
Garlic Crackers
[0123] Garlic crackers are produced in accordance with the methods
described herein. Table XVIII shows a nutritional breakdown of
exemplary garlic crackers.
TABLE-US-00018 TABLE XVIII Item Quantity PEG 0 g Na 120 mg K 0 mg
Fiber 0.7 g Fat 1.1 g Calories 45 Total 3 each
Example 14
A System
[0124] One or more of the food items above may be provided to a
patient prior to a medical or surgical procedure. Table XIX shows
an exemplary system comprising multiple food items as described
herein and in the above examples. Also shown is an exemplary
schedule for the patient to consume the food items in order to
deliver the laxative and replacement electrolytes to fully purge
the GI tract of the patient while effectively replacing
electrolytes by the action of the laxative.
TABLE-US-00019 TABLE XIX MORNING - DINNER - 4.5 hr prior to LUNCH -
Noon SNACK - 3 pm 6 pm SNACK - 8pm procedure Chicken & Rice
Lemon Cooler Ziti Minestone Vanilla Banana Bar Milkshake Strawberry
Refresher Water Electrolyte Garlic Crackers Salted Caramel
Supplement Crisp Bar (optional) Crackers Water Electrolyte
Supplement (optional) Ginger Candy
* * * * *