Note: Descriptions are shown in the official language in which they were submitted.
` ~ ~7 ~9 O
Case 2766-CIP-1
Description
LOW-CALORIE FOODS
TECHNICAL FIELD
This invention relates to the fabrication and
05 manufacture of low-calorie food products which
contain a high level of polysaccharides (e.g.,
polydextrose, polymaltose, modified polydextrose,
etc.) and/or polyols (e.g., sorbitol, glycerol,
erythritol, xylitol, mannitol, galactitol, etc.~.
The substitution of non-nutritive, non-fiber bulking
agents, such as polysaccharides and polyols, for all
or a portion of the caloric, metabolically-active
ingredients such as starch or sucrose is well known
as a technique of reducing the caloric value of a
foodstuff. It has been found, however, that the
ingestion of polysaccharides and/or polyols in
amounts as low as 30 to 100 grams per day can cause
some people to suffer from gastrointestinal discom-
fort and diarrhea. Accordingly, the use of these
materials in low-calorie food products has been
limited.
The production of both soluble and insoluble
polysaccharide materials is known to the art, as ex-
emplified by U.S. Patent Number 3,766,165 which
teaches polycondensation of saccharides at reduced
pressure in the presence of polycarboxylic acids cat-
alysts. This patent also discloses the inclusion of
food acceptable polyols in the saccharide-carboxylic
2~
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acid reaction mixture prior to polycondensation to
yield a modified polysaccharide having improved
color and taste. U.S. Paten-t Number 3,876,794 dis-
closes the use of these polysaccharides in various
05 dietetic foods and U.S. Patent Number 4,042,714
discloses modified polydextrose-based, farinacious
food compositions. All of these patents are
assigned to Pfizer Inc., New York, New York,
DISCLOSURE OF INVENTION
The present invention relates to the control of
diarrhea induced by ingesting low-calorie foodstuffs
which contain polysaccharides and/or polyol mate-
rials. According to this invention, dietary fiber
preparations are incorporated into polysaccharide
and/or polyol-containing foodstuffs at a level
sufficient to exhibit an antidiarrheal effect.
As will be recognized by those skilled in the
art, small amounts, typically up to about 5% dry
weight basis of the total dietary intake, of poly-
saccharides and polyols can be ingested without
causing any adverse gastrointestinal effects.
Various individuals will be able to ingest varying
amounts of polysaccharides and/or polyols without
adverse effect; however, as the diets of the indivi-
duals consuming a polysaccharide and/or polyol-con-
taining foodstuff is not controlled by the food
manufacturer, it is advisable to take preventitive
measures in connection with all foodstuff which
contain significant amounts of polysaccharides
and/or polyols. This will particularly be true when
the foodstuff is marketed as a low-calorie product
and is but one of a series of low-calorie, polysac-
charide and/or polyol-containing products which a
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weight conscious consumer might ingest during the
day.
The polysaccharides that are contemplated for
use in this invention include polyglucose and poly-
05 maltose in either their soluble or insoluble form.
The materials may be homopolymers -of glucose and
maltose or be modified polymers of these materials,
such as described in the aforementioned Pfizer
patents. For instance, the glucose or maltose
moieties may be esterified or contain a chemically
bonded, food-acceptable polyol such as sorbitol.
The polyols that are contemplated for use in
this invention may be any of the polyhydric alcohols
suitable for use in foods, including glycerol,
sorbitol, propylene glycol, mannitol, xylitol,
erythoritol and galactitol.
The dietary fiber preparations evaluated for
use in this invention include edible fiber materials
derived from grains, fruits and vegetables which
contain an amount of cellulose fiber. Materials
wherein the dietary fiber consists essentially of
hemi-cellulose or consists essentially of pectin
substances and which do not contain any cellulosic
fiber have not been found suitable for purposes of
this invention. Among the dietary fiber prepara-
tions which have been found to reduce severity of
polysaccharide and/or polyol-induced diarrhea are
corn hull fiber, wheat bran, and alpha-cellulose;
however, preferred for use in this invention are the
fiber materials known as soy fiber concentrate
(SFC), citrus albedo, especially orange albedo,
pineapple core bulking agent and sugar beet pulp
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bulking agent. These materials are preferred be-
cause their anti-diarrheal activity has been demon-
strated to be higher than the other dietary fiber
materials which have been tested. Specifically, rat
05 studies have shown that at certain identical levels,
several dietary fibers are capable of reducing
polysaccharide and/or polyol-induced diarrhea;
whereas, SFC, citrus albedo, pineapple core bulking
agent and sugar beet pulp bulking agent were able to
completely control (i.e., eliminate) polysaccharide
and/or polyol~induced diarrhea.
Soy fiber concentrate is the material obtained
by deoiling dehulled soybeans followed by water
extracting the deoiled material. Soy fiber con-
centrate is essentially the cell wall material re-
maining after soybeans have been dehulled and the
oil, protein and soluble carbohydrates have been
extracted.
Citrus albedo is the whitish inner portion of
the rind of citrus fruit that is commonly regarded
as a source of pectin, and typically contains on the
order of 40% pectin and 27% cellulose by weight.
The crude albedo is preferably extracted with water
to remove soluble carbohydrates and may also be
extracted with isopropyl alcohol to remove any
off-colors and off-flavors. Such treatment will
yield a material which can be dried and ground to
produce a bland-tasting, fiber-containing albedo
flour which is useful as a low-caloric bulk filler.
Pineapple core is a waste by product of the
pineapple canning industry. The pineapple core is
coarsely ground or shreaded, extracted with water to
remove soluble carbohydrates and may also be ex-
tracted with isopropyl alcohol to remove any off-
flavors and off-colors. After drying and grinding,
the pineapple core bulking agent thus produced is a
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bland, decolorized, fiber-containing material which
is low in calories and which is useful as a bulk
filler. The pineapple core bulking agent contains
approximately 5 to 10% total pectin, approximately
05 35% cellulose and approximately 30% hemicellulose on
a dry weight basis. --
Sugar beet pulp is a waste by product of thesugar industry. The sugar beet pulp, usually in the
form of sugar beet cossettes can be collected from a
sugar beet processing plant and placed in a solution
of sodium metabisulphite to prevent darkening of the
pulp due to polyphenol oxidase activity. The Sugar
beet pulp can be drained and further processed or
frozen stored. The sugar beet pulp material is
coarsely ground or sliced, water washed to remove
soluble carbohydrates and may also be extracted with
isopropyl alcohol to remove any off-colors and
off-flavors. When the material is dried and ground
a whitish, bland-tasting, fiber-containing bulk
filler is produced which contains approximately 25
to 30% cellulose, 15% hemicellulose and 15 to 20%
pectin on a dry weight basis.
Materials such as polysaccharide and polyol are
believed to induce diarrhea because they are not
metabolized or otherwise broken down in the stomach
or small intestine and move rapidly into the colon.
It is further speculated that because of an osmotic
and metabolic effect of the fermentation products of
polysaccharides, and polyols large amounts of water
are pulled into the colon where bacterial fermenta-
tion rapidly occurs. A high water and gas level
will facilitate adverse activity within the colon
and produce a diarrheal condition.
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Fiber material has been generally thought of as
a means to decrease transit times and increase fecal
output, or, in other words, to promote a favorable
laxation, stool softening and bulking effect. It
05 was, therefore, surprising to discover that selected
naturally-occurring fiber materials are able to
control and/or alleviate polysaccharide and/or
polyol-induced diarrhea.
Best Mode For Carrying Out The Invention
The present invention will be applicable to
low-calorie food products which contain in excess of
10% by weight (dry basis) of polysaccharides and/or
polyols. For purpose of this invention, the term
"low-calorie food" is used to represent foods having
a caloric cbntent of 50% or less of the caloric
value of corresponding ordinary food. Thus, a
low-calorie cake is one that has only half or less
than half of the calories of the same type of cake
prepared with standard ingredients. Typically, the
low-calorie food products of this invention will
have a calorie content of less than about 2 calories
per gram. The products of this invention will
preferably contain a level of polysaccharides and/or
polyols of at least 20% by weight (dry basis) and
may reach levels as high as 60% or more by weight
(dry basis). The amount of dietary fiber composi-
tion which is present in the products of this inven-
tion will range from 1/4 to 2 times the combined
level of polysaccharides and polyols contained in
the product, and preferably will be at from l/2 to
about 1.5 times this level, and typically will be
about 1.0 times this level.
When soluble polysaccharides are employed, they
will, as recognized by those skilled in the art,
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typically be utilized in combination with artificial
or other intensive sweeteners as replacements for
natural sugars. Polyols which are soluble and
possess varying levels of sweetness may also be
05 utilized as sugar replacements, either alone or in
- combination with intensive sweeteners. Insoluble
polysaccharides will typically be used as a replace-
ment for flour.
As will be recognized by those skilled in the
art, the presence of the fiber component within the
formulations contemplated by this invention might
render such formulations undesirable for certain
products in which the consumer would not readily
accept a fiber component. The formulations of this
invention are, however, suitable for use in a wide
range of low-calorie foodstuffs, including baked
goods, (e.g., breads, cakes, etc.) puddings, confec-
tions, pastas, noodles, jams, toppings, sauces and
dressings. The determination of the levels of
various standard food ingredients to be used in
formulating the low-calorie products of this inven-
tion can be readily made by those skilled in the
art. Standard manufacturing procedures can be
applied to the production of these products.
Animal studies employing young adult male
Sprague Dawley rats have demonstrated the effective-
ness of adding dietary fiber to diets which contain
high levels of modified polydextrose and/or polyols.
In this experiment, the animals were fed with a
standardized diet containing on a weight basis 18%
casein, 10% water, 8% corn oil, 4% salt, 1% vitamin
mix and 59% cornstarch and were allowed 150 grams of
diet each week. The animals exhibited no diarrhea
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on this diet. Test diets were formulated by substi-
tuting modified polydextrose (MPD), polyol and/or
fiber material for an equal weight of the corn-
starch. The animals' feces was observed each day
05 and rated according to the following laxation fecal
scoring scale: ;
-1 - no feces
0 - no diarrhea
1 - mild diarrhea, soft formed stool but
stringy or irregular
2 - moderate diarrhea, very soft stools,
mounded
3 - severe diarrhea, liquid stools
Test diets were fed for 14 days and each animal was
given a diarrheic score which was the sum of its 14
daily scores. The median diarrheic score of the
animal group was used in evaluating the respective
test diets and the results set forth in Table I were
obtained.
TABLE I
Weight % of this diet medium diarrheic score
10% Xylitol 9
10% Xylitol, 5% Wheat Bran 4.5
10% Xylitol, 10% Wheat Bran 4.5
25 30% Xylitol 2'
30% Xylitol, 5% Wheat Bran 19
30% Xylitol, 10% Wheat Bran 16.5
10% Modified Polydextrose (MPD) 36
10% MPD, 5% Wheat Bran 19
10% MPD, 10% Wheat Bran 7
20% MPD 38
20% MPD, 5% Wheat Bran 35
20% MPD, 10% Wheat Bran 26
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As can be seen from the above results, both
xylitol and MPD are capable, at sufficient levels in
the diet, of producing a diarrhea condition and that
the addition of wheat bran to the diet is able to
05 reduce the severity of the diarrhea condition.
An additional study to assess the laxati~on
effects of various levels of dietary fiber was made
using male Sprague Dawley rats (201 to 225 gms.)
which were fed ad libitum for 14 days. During this
time, the fecal output for each of the various rat
diets were scored according to the following laxa-
tion fecal scoring scale:
0 - small, hard, well-formed pellets
Acceptable l - larger, hard, well-formed pellets
Laxation 2 - large, soft, elongated pellets
with tapered ends
UnacceptablP 3 - very soft pile of feces
Diarrheal 4 - no form, very loose stools
5 - watery propulsive diarrhea
The average 14 daily fecal scores for the test
population are set forth in Table II which shows the
laxation effects of various dietary fibers fed at
various levels in the aforementioned standard casein
diet.
TABLE II
% Fiber by Wt. Average Daily
Diet in Diet Fecal Score
Control (18% casein) 0 0.21
Orange Albedo Flour 5 - 0.32
(sample #l) 10 0.47
0.80
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% Fiber by Wt. Average Daily
Diet in Diet Fecal Score
Orange Albedo Flour 10 0.42
(sample #2) 20 0.76
05 Alpha Cellulose 10 1.10
1.60
Soy Fiber Concentrate 5 0.25
0.36
0.77
10 Corn Hull Flour 5 0.70
1.01
1.10
Wheat Bran 10 1.00
1.00
Hemi-Cellulose 10 1.35
(extracted from Corn)
MPD 10 2~96
4.00
The effect of these same dietary fibers in
controlling diarrhea induced by the standard casein
diet containing 20% by weight of MPD is set forth in
Table III. The treatment period was again 14 days
and the fecal score value was arrived at in the
manner of Table II.
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TABLE III
% Fiber by Wt. Average Daily
Diet (with 20% MPD) in Diet Fecal Score
MPD Control 0 4.0
05 Orange Albedo Flour 10 1.7
(sample #1) 20 1.55
Orange Albedo Flour 10 2.0
(sample #2) 20 1.75
Alpha Cellulose 10 2.66
2.22
Soy Fiber Concentrate 10 2.47
1.75
Corn Hull Flour 10 3.85
2.95
Wheat Bran 10 3.02
2.51
Hemi-CeIlulose 10 4.05
4.15
As can be seen from the data in Table III, all
of the tested dietary fibers with the exception of
hemi-cellulose were able to effect a reduction in
MPD-induced diarrhea. Additionally, both orange
albedo flour samples and soy fiber concentrate are
able to completely control ~i.e., reduced fecal
score to 2.0 or less) MPD-induced diarrhea.
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Using the same scoring system employed to
obtain the results of Tables II and III, tests were
conducted to show the effect of several of the same
dietary fibers in controlling diarrhea acutely
05 induced by orally dosing animals with 1.0 ml of an
aqueous solution containing 28% by weight x-ylitol.
The results of this study is set forth in Table IV.
TABL~ IV
Diet (challenged with % Fiber by Wt. Average Daily
280 mg of xylitol) in Diet Fecal Score
Control (18% casein) 0 4.0
Orange Albedo Flour 10 2.5
(sample #1) 20 2.05
Orange Albedo Flour 10 3.0
(sample #2) 20 1.6
Soy Fiber Concentrate 10 1.15
1.75
Corn Hull Fiber 10 3.0
2.1
20 Wheat Bran 10 1.0
1.0
As can be seen from the data in Table IV, all
of the tested fibers were able to effect a reduction
in xylitol-induced diarrhea and several fibers were
able to completely control xylitol-induced diarrhea.
The following tests (See Tables V and VI) which
utilize the same procedure and laxation fecal
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scoring scale employed to obtain the results in
Tables II and III have demonstrated the effective-
ness of pineapple core bulking agent and sugar beet
pulp bulking agent in the control of diarrhea in-
05 duced by modified polydextrose. It is believed thatthese two additional fiber sources will prove effec-
tive in controlling polyol-induced diarrhea as well.
The laxation effects of various dietary fibers
are set forth in Table V. The results obtained from
this experiment which was conducted utilizing the
same scientific method as was previously discussed
to obtain the results listed in Table II, clearly
shows that when the fiber sources are fed alone at
the levels indicated they all significantly in-
creased the fecal scores, or produce an acceptableand favorable laxation/bulking effect. The average
fecal score results produced by feeding orange
albedo flour, pineapple core or sugar beet pulp
sources in the diet are clearly less than that of
alpha cellulose ~fecal score of 1.15), and yet
greater than that of the control diet (fecal score
of 0) in this study.
TABLE V
% Fiber by Wt. Average Daily
25 Diet in Diet Fecal Score
Control (18% casein) 0
Alpha Cellulose 20 1.15
Orange Albedo Flour 20 0.79
(sample #3)
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% Fiber by Wt. Average Daily
Diet in Diet Fecal Score
Sugar Beet Pulp 10 0.19
Bulking Agent 20 0~43
05 Pineapple Core 10 0.21
Bulking Agent ~ 20 0.54
The effect of orange albedo flour, pineapple
core bulking agent and sugar beet pulp bulking agent
in controlling diarrhea induced by the standard
casein diet containing 20% by weight of MPD is set
forth in Table VI. The treatment period was again
14 days and the fecal score value was arrived at by
the same manner explained in Table III.
Results in Table VI clearly show that with 20%
MPD in the diet, all three fiber sources fed signi-
ficantly reduce the severity of the average fecal
scores. Addition of either 10 or 20% levels of
orange albedo flour, sugar beet pulp or pineapple
core samples are able to completely control (i.e.,
reduce or maintain average fecal scores to 2.0 or
less) MPD-induced diarrhea.
TABLE VI
% Fiber by Average daily
Diet (with 20% MPD)Weight in Diet fecal scores
MPD control 0 3.95 ~ O.01
Orange Albedo Flour 10 1.57 ~ 0.04
(sample #3) 20 1.48 $ 0.10
Sugar Beet Pulp 10 1.70 ~ 0.09
(6909-56) 20 1.65 ~ 0.13
Pineapple Core 10 1.07 ~ 0.08
(6909-57) 20 0.87 ~ 0.05
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As will be recognized by those skilled in the
art, the present invention will permit the formula-
tion of low-caloric foodstuffs which contain higher
levels of po:Lysaccharides and/or polyols than could
05 previously be contemplated. Thus, an additional
degree of flexibility is given to manufacturers of
low-caloric foodstuffs.
