Balanced fiber composition

A nutritional fiber composition which comprises approximately 30 to 48.5% fiber, based on the weight of the entire composition, derived from the fruit and vegetable groups, approximately 30 to 48.5% fiber derived from the cereal group and approximately 3 to 40% fiber from sources other then the fruit, vegetable and cereal groups, wherein at least 10% of the total dietary fiber in the entire composition is soluble dietary fiber.

FIELD OF THE INVENTION 
The present invention relates to a novel nutritional composition of matter 
comprising a balanced formulation of dietary fibers. This composition 
contains a preferred ratio of soluble dietary fiber to insoluble dietary 
fiber and includes a balance of fiber sources from the main food groups. 
BACKGROUND OF THE INVENTION 
The need for an appropriate balance of crude fiber in the diet of mammalian 
organisms has been recognized. For many years nutritionists have noted the 
crude fiber content of foods and the need for this fiber in a balanced 
diet. However, crude fiber is only part of what is generally referred to 
as "dietary fiber". In a general sense dietary fiber can be thought of as 
the undigestible portion of the foods we eat. A more precise definition is 
that it consists of the parts of plant cells that are not easily broken-up 
by the digestive enzymes of man. Specifically, dietary fiber may be 
defined as the sum of the polysaccharides and lignin which are not 
digested by the endogenous secretions of the human gastrointestinal tract. 
Thus, dietary fiber is not a single substance but it is composed of at 
least five different and complex materials including lignin, cellulose, 
hemicelluloses, pectins, gums and mucilages. 
The individual components of dietary fiber may be conveniently divided into 
two major groups, soluble dietary fiber and insoluble dietary fiber. 
Insoluble dietary fiber is made up of lignin, cellulose and 
hemicelluloses. Soluble dietary fibers are substances like pectins, gums 
and mucilages as well as some hemicelluloses which are not "fibrous" in 
their physical form but which fit the definition of dietary fiber. 
Together the soluble and insoluble groups make up Total Dietary Fiber. 
One reason for thinking of dietary fiber in terms of its soluble and 
insoluble components has to do with differences in physiological activity. 
Although the picture is still far from complete and much research remains 
to be done, certain things appear to be fairly well established. In 
general, the insoluble components of dietary fiber are associated with 
decreased gastrointestinal transit times and increased fecal bulk while 
the soluble components tend to decrease gastric emptying times and 
influence nutrient absorption. Thus, insoluble components are thought to 
be associated with a reduced tendency toward bowel disorders. Soluble 
dietary fiber, on the other hand, is associated primarily with a reduction 
in low density lipoproteins and serum cholesterol as well as improved 
glucose tolerance at least in the short term. 
In addition, a further advantage of dietary fiber is that a higher intake 
of dietary fiber may aid in weight reduction through "caloric dilution" 
and an increased sense of fullness because of bulk. Unfortunately, the 
benefits of increased fiber intake are not without risks. It is 
particularly critical to keep in mind that very large amounts of fiber may 
interfere with the absorption of other nutrients. However, there does not 
appear to be a problem with modest levels of fiber intake in conjunction 
with good mineral nutrition. Thus, a proper balance must be found among 
the types of fiber available to maximize the benefits of fiber at only 
modest levels of intake. 
Because of the complexity of dietary fiber and the difficulty of 
establishing its effects, no definite recommendations have been set for 
adequate intake of dietary fiber. It has been estimated that Western diets 
provide roughly 10-20 grams per day of total dietary fiber. Nutritional 
experts have suggested that as much as 25-40 grams per day of fiber could 
be beneficial in the human diet. At the present time, the Canadian Expert 
Advisory Committee on Dietary Fiber is recommending to increase the intake 
of dietary fiber to 32 grams per day. Unfortunately, even in view of these 
seemingly specific recommendations of experts in the field of nutrition, 
up through the present time no specific recommendations have been promoted 
as to the preferred types or balance of fiber products. 
Many researchers in the field of dietary fiber have recognized in a very 
general way, the importance of a wide variety of fiber sources in the 
diet. Because of the differences in types of dietary fiber and because of 
individual metabolic differences it seems reasonable to obtain fiber from 
a variety of sources in order to obtain a more balanced intake of all 
dietary fiber components. However, no composition has yet been formulated 
which provides an appropriate balance of fiber which takes full advantage 
of the nutritional aspects of fiber and attempts to develop a balanced 
formulation. Furthermore, no such fiber composition has been made 
available which offers not only a balanced formulation but the convenience 
of unit-of-use administration. 
OBJECTS OF THE INVENTION 
An object of the present invention is to provide a unique fiber supplement 
composition which provides an appropriate balance of fiber while avoiding 
the disadvantages associated with fiber intake, and thus without serious 
risk of inducing disorders in the organism. 
It is a further object of the present invention to formulate a select fiber 
composition which contains a preferred ratio of soluble dietary fiber to 
insoluble dietary fiber and includes a balance of fiber sources from the 
main food groups. 
Thus, an object of the present invention is to provide a good balance of 
fiber sources modeled after the basic food group approach to sound 
nutrition. 
It is another object of the present invention to prepare a unit-of-use form 
of a dietary fiber product which is convenient, easy to administer and 
provides a beneficial total dietary fiber balance. 
Typically, the fiber components of the invention are further associated 
with a non-toxic therapeutically or nutritionally acceptable inert carrier 
or carriers therefor. 
Additional objects of the invention will appear from a reading of the 
specification and claims which follow. 
SUMMARY OF THE INVENTION 
Surprisingly, it has been discovered that a novel composition of fibers can 
be advantageously formulated into a novel nutritional composition and 
administered to mammals, especially humans, to provide a balanced intake 
of dietary fiber. 
The nutritional fiber composition is formulated so as to comprise 
approximately 30 to 48.5% fiber of the entire amount of fiber derived from 
the fruit and vegetable groups based on the total weight of fiber in the 
composition, approximately 30 to 48.5% fiber derived from the cereal group 
and approximately 3 to 40% fiber from fiber sources other than the fruit, 
vegetable and cereal groups, wherein at least 10% of the total dietary 
fiber is soluble dietary fiber.

DETAILED DESCRIPTION OF THE INVENTION 
Most of the fiber of the food we eat comes from the fruit, vegetable and 
cereal groups. Small amounts come from the protein group, mainly from 
beans, nuts, seeds, etc. Thus, the balance of the fiber sources in the 
unique fiber composition of the present invention is such that 
approximately 30 to 48.5% of the fiber source is derived from the fruit 
and vegetable groups based on the total weight of fiber in the 
composition, approximately 30 to 48.5% from the cereal group and 
approximately 3 to 40% from additional fiber sources. The total amount of 
fiber from each source totals 100%. Preferably, approximately 40% of the 
fiber sources is derived from the fruit and vegetable groups, 
approximately 40% is from the cereal groups and approximately 20% is 
derived from other fiber sources. 
Each of the members of these basic food groups were carefully selected to 
provide the desired nutritional benefit. To this end, lemon, acerola and 
carrot were preferably selected to represent the fruit and vegetable 
fibers. Corn, barley and oat brans preferably provide the cereal fibers. 
And preferably, soybean bran, psyllium seed husk and guar gum are members 
of the third group. 
High fiber diets generally contain about one-fifth or more of the total 
dietary fiber as soluble dietary fiber. Furthermore, certain components of 
dietary fiber such as lignin and cellulose often occur in roughly the same 
relative proportions. Thus, the nutritional fiber composition of the 
present invention was developed to supply both the soluble and insoluble 
forms of dietary fiber wherein at least 10% of the total dietary fiber in 
the entire composition is soluble dietary fiber and preferably, at least 
15% is soluble distary fiber. This ratio was evaluated in light of the 
relative proportions of the individual fiber components. Thus, three 
preferred fibers were selected for each group and the preferred balance of 
each fiber type was determined. The variety of different fiber components 
were selected to obtain a balanced fiber composition. A balanced fiber 
composition generally has a good variety or range of types of fiber. 
The end result of the foregoing development was a fiber composition having 
the fiber sources and composition (given in weight % of the total amount 
of fiber in the composition) presented in Table I. The total amount of 
fiber from each fiber source equals 100%. 
TABLE I 
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Composition 
(%) Preferred 
Individual Group 
Fiber Source 
Value Range (%) Range (%) 
______________________________________ 
Acerola Pulp 
12.2 1-20 
Powder 
Carrot Pulp 
5.0 1-20 30-48.5 
Powder 
Lemon Pulp 
22.5 1-30 
Powder 
Corn Bran 19.5 1-30 
Oat Bran 8.5 1-20 30-48.5 
Barley Bran 
12.0 1-20 
Soy Bran 11.0 1-20 
Psyllium Seed 
5.5 1-15 3-40 
Husk 
Guar Gum 3.8 1-15 
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In the preferred composition identified under the heading "Composition (%) 
Preferred Value" in Table I, the various fiber types were determined and 
are now identified under the heading "Composition (%)" in Table II. Table 
II is based on the nine fibers identified in Table I and does not take 
into consideration the optional presence of fiber excipients. 
TABLE II 
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Fiber Composition of the Preferred Formula 
Suitable 
Parameter Composition (%) 
Range (%) 
______________________________________ 
Crude Fiber 18.55 15-20 
Neutral Detergent Fiber 
47.84 40-50 
Hemicellulose 24.35 20-30 
Lignin 4.20 1-5 
Cellulose 20.47 15-25 
Total Dietary Fiber (TDF) 
69.86 40-90 
Soluble Dietary Fiber (SDF) 
14.30 10-20 
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Thus, in the preferred dietary fiber composition, the relative amounts of 
total dietary fiber, crude fiber, cellulose and lignin were selected in an 
attempt to achieve the optimum high-fiber diet. As previously stated, at 
least 10% of the total dietary fiber in the entire composition is soluble 
dietary fiber, and preferably, at least 15% is soluble dietary fiber. In 
the fiber composition of the preferred formula set forth in Table II, more 
than 20% of the total dietary fiber is present as soluble dietary fiber. 
The novel fiber composition of the present invention is uniquely formulated 
to approximate the fiber composition found in a balanced diet containing 
the recommended portions of carbohydrates, proteins and fats. Since each 
basic fiber classification is represented by three fibers, this variety of 
fiber sources allows the unique dietary fiber composition of the present 
invention to comprise an excellent adjunct to a diet. 
Generally, the primary adverse impact of administering dietary fiber 
compositions to a mammalian organism is that large amounts of fiber may 
interfere with the absorption of other nutrients. However, the unique 
composition of the present invention was specifically designed to provide 
a balanced composition and thus minimize any problems associated with the 
use of fiber. 
The compositions of the present invention are intended only for oral 
administration. Typically, the active ingredients of the compositions of 
the present invention are further associated with a non-toxic 
therapeutically acceptable inert carrier material. Such carrier materials 
are well known to those skilled in the art of nutritional formulations. In 
this regard, reference is made to the text entitled, "REMINGTON'S 
PHARMACEUTICAL SCIENCES" (Fourteenth Edition), 1970. For instance, 
suitable oral non-toxic acceptable inert carriers may include lactose, 
starch (pharmaceutical grade), dicalcium phosphate, calcium sulfate, 
kaolin, mannitol and powdered sugar. Additionally, when required, suitable 
binders, lubricants, disintegrating agents and coloring agents can also be 
included. Typical binders include starch, gelatin, sugars such as sucrose, 
molasses and lactose, natural and synthetic gums such as acacia, sodium 
alginate, extract of Irish moss, carboxymethylcellulose, methylcellulose, 
polyvinylpyrrolidone, polyethylene glycol. ethylcellulose and waxes. The 
preferred binder is acacia gum. Typical lubricants for use in these dosage 
forms can include, without limitation, magnesium stearate, stearic acid, 
hydrogenated vegetable oil, monoglycerides, diglycerides, sucrose fatty 
acids or any combination thereof. Suitable disintegrators can include, 
without limitation, starch, methylcellulose, agar, bentonite, cellulose, 
alginic acid, guar gum, citrus pulp, carboxymethylcellulose and sodium 
lauryl sulfate. The preferred disintegrator is microcrystalline cellulose. 
If desired, a conventional pharmaceutically acceptable dye can be 
incorporated into the dosage unit form, i.e., any of the standard FD&C 
dyes. Sweetening and flavoring agents and preservatives can also be 
included, particularly when a liquid dosage form is formulated, e.g., an 
elixir, suspension or syrup. 
Table I identifies the preferred fiber composition of the present invention 
and does not identify any additives or excipients generally associated 
with its administration. The preferred fiber composition may comprise 
about 40 to 80 weight % based on the weight of one tablet for 
administration. Thus, about 20-60% of the composition may comprise 
miscellaneous excipients. Preferably, about 40 to 50 weight % of the 
tablet comprises the preferred fiber composition. 
Miscellaneous fibers may be used as excipients as identified above. The 
preferred tablet of the present invention contains a variety of excipients 
including two fiber excipients. These fiber excipients are acacia gum and 
microcrystalline cellulose. Acacia gum is a soluble fiber which is used as 
a granulating aid and to improve the compressibility of a tablet. Acacia 
gum may comprise about 1 to about 5 weight % of the total tablet, 
preferably about 2.77 weight %. Microcrystalline cellulose is an insoluble 
fiber which is also used to improve the compressibility of the tablet. 
Microcrystalline cellulose may comprise about 2 to about 10 weight % of 
the entire tablet preferably about 6.54 weight %. However, it should be 
appreciated that at least 10% of the total dietary fiber in the entire 
composition including additives and excipients is soluble dietary fiber. 
Various other materials may be present as coatings or to otherwise modify 
the physical form of the dosage unit. For instance, tablets, pills, or 
capsules may be coated with shellac, sugar or both. It is also 
particularly relevant to note that the fiber composition may readily be 
prepared in the form of a bulk powder or granules. The composition may be 
prepared such that approximately 2 grams of fiber in bulk powder form may 
be mixed with a liquid food product such as milk or orange juice to aid in 
ease of administration. Alternatively, the powder or granules may be 
sprinkled on a salad or a breakfast food to aid in ease of administration. 
The novel nutritional fiber composition of the present invention is 
preferably available in unit-of-use administration form. In the 
unit-of-use system of administration, each unit is prepared as one unit 
for administration. For example, one capsule, one tablet, one capful of a 
bulk powder or granules or the like is consistent with the concept of 
unit-of-use administration. Thus, one or more units of the dosage form is 
taken at each administration. All the fiber necessary for a daily diet may 
be obtained by administering one or several of the unit-of-use nutritional 
fiber compositions of the present invention. The amount of fiber contained 
within each unit of administration may vary. A typical amount of fiber in 
each unit for administration may range from about 0.5 gram to about 5 
grams. More preferably, there is about 1 to about 3 grams of fiber in each 
unit for administration. Thus, the frequencv of recommended administration 
may range from one to four times a day. 
The compositions of the present invention should contain at least 0.1% of 
fiber components; generally, the fiber components will comprise between 
about 2% to about 85% of each dosage unit for administration. Preferably, 
the fiber composition comprises about 40 to 80 weight % of fiber based on 
the weight of one dosage unit of administration. 
The preferred dosage form is a tablet or bulk powder. The tablet is most 
preferably designed to be administered either by chewing or swallowing. 
The chewable tablet form contains the necessary flavoring agents to allow 
a pleasant taste sensation. The chewable tablet is designed to be chewed 
for a brief period of time and then swallowed preferably with water or a 
liquid beverage. 
From the foregoing description, one of ordinary skill in the art can easily 
ascertain the essential characteristics of the instant invention, and 
without departing from the spirit and scope thereof, can make various 
change and/or modifications of the invention to adapt it to various usages 
and conditions. As such, these changes and/or modifications are properly, 
equitably and intended to be, within the full range of equivalence of the 
following claims.