Note: Descriptions are shown in the official language in which they were submitted.
109~451
BACKGROUND OF THE INVENTION
The function and importance of 'Ifiber'' in the human
diet has been the subject of much discussion and publicity
in recent years. Indeed, it has been suggested that large
amoun.s o,- fiber in the human diet can have beneficial
effects on health ranging from prevention or alleviation
of cons.ipation and hc~orrhoids to possible prevention o~
colonic carcinoma. While there is no evidence at the present
time establishing any such cause and effect relationship
the public has become more aware of fiber and that the
averase aiet in more highly civilized areas of the world
contai~.s relatively little fiber. An excellent review of
m.uch th~ is '~nown about dietary fiber at the present time
is IlF~ In E~an ~Jutrition1' edited by G.A~ Spiller and
R.J. ~-men, Plenum Press, 1976,
The recent inierest in "fiber" has resulted in much
reeval~a~ion of exactly what constitutes dietary fiber. In
part, the term "fiber" is a misnomer because many substances
normally classified in this category are not fibrous at all
in the usua1 sense of the word. Various alternate terms
have been proposed by various investigators (for a summary
see for example G.A. Spiller and E.A. Shipley, "New Per-
spectives on Dietary Fiber", Food Product Deveiopment,
pp. 54 to 64, October, 1976). For present purposes,~
and in agreement with most of the investigators, the type
of substances which would normally be classified as dietary
fiber include plant derived materials which are not digested
before reaching the ileocecal valve~ but which may possibly
be di~ested by colonic microflora. The common materials of
this type include:
-2
~094~Sl
cellulose
he~i-celluloses
pectin
lignin
3 g~s
mucilzges and
associatod undige3tible plant cell wall factors.
Cellulose is probably the best known of these materials
and is a poly~er of D-glucose with 1,4-~ linkages having a
linear, ul~branched structure~ Hemicelluloses are more
amorphous in structure than cellulose and are usually made
up of 150 to 200 sl~s~r units. They may contain a variety
of pentose and hexose sugars, many of which are branched
monos~cch~-iGe~ and m2y thus be divided into two broad
ca~egori-s, ~;ne pentosans and the non-cellulose hexosans.
Pectin consiats of ur~ranched chains of d-galàcturonic acid
with many o~ the carboxyl groups esterified as methyl esters
or neutralizec as their calcium or magnesium salts. Lignin
is a non-carbo~.ydrate polymer of the plant cell wall having
a molecular ~72isht between about 1,000 and 4,500. Its
monomers 2relinked by carbon to carbon bonds rather than
the typical ~lycoside linkages of other cell wall components~
Gums are exudates produced by many plants, often to seal
off a damaged sec~ion and prevent invasion by microorganisms
Typically t~e gums are a complex group of highly branched
uronic acid-containing polymers with-various neutral sugars.
Some OL tre more co~.monly encountered gums are gum arabic,
gum karaya and gum tragacanth. Mucilages, in contrast to
gums, are thQ product or normal plant metabolism and are
3 derived from barXs, roots, leaves, seeds and even flQwers.
,,
~ -3~
10~ ~5~.
Among the more co~monly encountered mucilages are agar and
carrageenan.
Since the above mentioned components are derived from
plant material they occur in varying amounts and ratios
in many rlaturally occurrins substances, many of which are
used for ~ood purposes. Among the common foods which con-
tain sub~tantial amounts OL one or more of these materials
are fruits, vegetables, leg~mes and grains. However, the
distribution of these materials vary greatly from food
type to ~-ood type and, even within the same food type,'from
sam~le to sam?le.
~'~ny o' thes2 nzturally occurring food materials or
c~ude ~:~tracts have been used for many yeaxs in the treatment
o' cia-rhea ard constipation. In particular, the use of
,ruit as a remedy for diarrhea and dysentery has long been
kno-.in .
In a~dition, a variety of com,mercial products based
upon no~-puriLied die~ary fiber components have been used
as bulk producing laxatives. The great majority of these
preparations are derived of agar, gum tragacanth and
psylli~m seed. Ho~ever, there are a variety of disadvantages
to the use of all of these naturally occurring and commer-
cially produced materials. For example~ many of these
materials require the ingestion of substantial quantities
to achieve the desired effect, while products derived from
psyllium seed induce a moist, bulky stool that cannot be
readily controlled or easily modified to fit special needs.
In addition, psyllium seed products tend -to gel in solution
in a short time making for great diEficulty in oral ingestion.
~laterials derived from certain gums h~ve been known to
_~,
~0~4451
cause allergic reactions.
- The gel that rapidly forms with psyllium seed products
leads to difficulty of ingestion and produces a feeling of
excessive fullness in many people causing them to reject
the product. Furthermore, for bowel function control,
there is no need to have tremendous bulk in the upper part
of the gastrointestinal tract; the place where controlled
bulking is needed is in the colon~
Ano.her strong disadvantage to existing natural
materials and commercial products derived from natural
substa~ces is the variability of such material. This is
particularly true in natural foodstuffs themselves. For
example, in wheat bran the amount of "fiber" present in the
bran can vary tremsndously depending upon the milling
process itself, i.e., how much of the outer coating of the
wheat is preserved. -~
Another major disadvantage with present forms of
treatment to control colonic activity (i.e., fecal output)
is the dietary manipulation which is often necessary to
assure that the proper amount of "fiber" is ingested. This
has the effect of forcing people to consume large amounts
of certain foodstuffs which may be otherwise unappealing
or un~alatable, merely to obtain their fiber content.
; It would, therefore, be desirable to have a simple,readily available and inexpensive composition containing a
controlled amount of purified "fiber" substances which
could be consumed as part of a daily dietary regimen with-
out the need to otherwise manipulate the normal diet of
the person and which would result in a controlled and
predictable fecal output.
-5
10944~;1
Prior Art
Co~7 nations of cellulosic substances and various gums
(including pectin) are described in U.S~ 3,440,065, U.S,
3,573,0~8, and U.S. 3,574,634. In each of these cases
these co~bir.ations, usually including other materials,
are for purposes other than the control of fecal output or
colonic activity.
Detailed Description of .he Invention
The p~esent invention concerns a method of controlling
.ecal ou~put in the human, and compositions therefor. More
speci~~c211y, the pre3ent invention concerns methods and
co~pos7t~ons ror controlling fecal output in the human
invol-~7ns th3 ad~inistra_ion of a mixture comprising~ or
con,is'ing ea-sentially of, puriried cellulose and pectin
as z S~ C2 O, dietary fiber.
Still ~ore speci ~5ically ~ the present method involves
the ad~.i?.istration of such purified cellulose/pectin
mixtu_e, such that a daily fecal output of at least 130,
preferably at leas_ 1~0 grams, is achieved, whereby said
recal output has a moisture content of between about 65 and
80%, preferably between about 70 and 75%.
In yet another aspect the present method concerns
1 .
controlling the transit time of orally ingested ~aterials
through 'Ihe gastrointestinal tract to a desirable repro-
25 ` duceable level of bet~een about 24 to 72 hours, preferably
between about 36 and 60 hours~ As used in this context,
transit time refers to ihe time interval for 80% of orally
ingested radiopa~ue pellets to appear in the feces.
As ~entioned above, a variety of `'fiber" substances
have been used to control colonic activity or fecal output
-6-
~944~
in the past but all of the substances are either natural
foodstuffs themselves or non-purified materials obtained
from foods or other natural sources, and the administration
o such materials is attendant with many disadvantages. It
has now been found that a combination OL two specific
puriried materials (as distinguished from crude extracts)
can b^ used to effectively control fecal output in the human
in ~erms or bulk, moisture, and ease of elimination, and
with a controlled, reproduceable tr~nsit time through the
gas~roi ntestinal tract.
By use of specific combinations of these purified
plan~ ibers, cellulos2 and pectin~ a highly sophisticated
and re~-oduceable system for controlling colonic acti~ity
and fec~l ou-put may be achieved which could not be
achieved with either component alone or with existing
thera~e~_ic means. Additionally, the ratio o the sub-
stances to one another may be precisely varied to achieve
par~icularly desired effects or to suit individual condi-
tions ~ hout necessitating any further manipulation of
the gross diet of the person involved. Furthermore, the
mixture of these substances is not damaged in processing
(bakins,cooking, and the like), whiLe other substances such
as wheat bran may be less effective after cooking.
It has been Lound that, for the practice of the present
invention, compositions having a ratio of cellulose to
pectin of between about 1:1 and 8.5:1.5 and most preferably
between about 7;3 and 4:1 have superior effects. ~lith a
; higher ratio of cellulose to pectin the feces are not
sufficiently moist and there is difficulty in elimination.
With a ratio lower than that indicated above there tends to
-7~
.
1094451
be notable side effects such as cramping and decreased
appetite.
In gen~ral, the method of the present invention com-
prises orally administering to a subject a mixture com-
prising, or consisting essentially of~ purified cellulose
and pectin in the aforementioned ratio as part of a regular
dietary reg~msn. The total quantity of mixture administered
will, of course, depend to a large extent upon the particular
subject invol-~ed. Ho~ever, as a general rule between about
140 and 36~, most preferably between about 215 and 360
milligræms per kilogram of body weight per day would be
administerea. For an average adult human subject of about
55 to 70 kilosrams this would be between about 10 and 20
græ~s se- day. The dietart~ com?osition containin~ the
cellulos_/p-c~in mixture may be administered in unit or
divided aaily dosages, for example, entirely with one meal~
or portion.~ise, for eYam~le, with each meal~
Of course, the particular effect on any given subject
will depend to a certain extent upon the total dietary
composition, so that the method hereof achieves more
predictable and reproduceable results when the composition
hereof is substantially the sole source of dietary fiber.
If the diet includes a substan~ial amount of one or more
fiber components in addition to that being administered
in accordance with the method hereof~ the beneficial effects
of the subject method may be altered. However, one major
advantage of the present invention is the avoidance of
dietary manipulation to insure the proper amount and proper
mix of fiber in the diet. ~_
-8
The cellulose/pectin composition as described above
may be administered by itself, for example by suspension
in water (with optional addition of a flavoring agent) or
may be combined with other dietary components such as
protein sources, lipids, carbohydrates, vitamins, minerals,
and the like. The cellulose/pectin mixture can be utilized
as a convenient pre-mix for the preparation of baked
goods such as breads, cakes, cookies, muffins, and
the like. It may also be combined into other foods, for
example, puddings and beverages, or it may be conveniently
used as a sprinkle-on additive to prepared foods.
The cellulose-pectin mixture has good dispersability
and suspension stability, is moderately soluble in water
at room temperature, and has an acceptable viscosity. It
is also acceptable in terms of flavor, odor, mouth feel
and appearance. In fact, in terms of the above properties,
the subject composition is superior to either cellulose
or pectin alone. In comparison to other commonly used
products, such as those derived from mucilages, the subject
composition is equal to or superior with respect to both
physical and organoleptic properties.
Cellulose utilized for the present composition and
method should be of high purity, at least 90 percent,
and is preferably utilized as a finely divided powder or
crystalline form of between about 20 and 40 microns, most
preferably between 50 and 60 microns. Examples of
commercially available purified cellulose are Solka Floc*
(product of Brown Company) and Avicel* (product of FMC
Corporation).
Pectin that may be used for the present method and
` *trademarks 9
,,
. , ~
10~45~
composition may be either a highly purified pectin such as
pectin ~iF or a pectin diluted with glucose, sucrose or other
standard excipients.
The subject mixtu-res may be prepared by any of the
normal procedures for blending solid components of this
type intended for oral human consumption, for example, a
household blender or shaker, or by simple stirring, for
exampl~, in a glass with a spoonr
A more comple'e appreciation of the methods and compo-
sitions Oc the present invention may be had by reference
to the ollowing specific ex2mples. These examples are
- illus-~rat_~e only and should not be construed as limitative
os t he scope or spirit of the present invention,
:
--10--
`` ~.0~ 51
EXAMPLE 1
Preparation of Purified Cellulose-Pectin Mixtures
Purified Cellulose - 99.5% cellulose, essentially free
of lignin, food grade, 50-60p (Solka-Floc BW 40, product
of Brown Company)~
Pectin - Pectin N.F.*, carbohydrate of purified poly-
galacturonicacid methyl ester with no less than 6.7%
methoxyl content and no less than 74~ galacturonic acid
content (obtained from Sunkist Co.).
10. A. A powder mixture of 70% purified cellulose - 30%
pectin is prepared as follows:
70 g. of purified cellulose and 30 g. of pectin are
mixed in a Patterson Kelly (P-K)* liquid solid blender until
well blended (about eight minutes).
When a flavored powder is desired, the following pro-
cedure is utilized (illustrated for lemon flavor):
0.3 g of natural lemon flavor and
0.8 g of citric acid are mixed well and
24.0 g of powdered sucrose (with 3% co~nstarch) is
added and mixed in a P-K blender until well blended
(about eight minutes).
The above mixture is added to 20 g. of the above des-
cribed fiber mixture and mixed in a P-K blender until well
blended (about 15 minutes).
Other flavored powders may be prepared in the same
- manner for
purified cellulose alone (14.0 g. cellulose, other
ingredients same as above,
pectin NF along (6.0 g. pectin, other ingredients same
as above) or
*trademarks 11
~09~451
placebo (only flavor, citric acid and sugar as above).
B. Preparation of biscuits: ~
A biscuit containing 20 g. of fiber is prepared from
the ~ollowing ingredients ~llustrated for a 70-30 purified
cellulose-pectin mixture):
Ingredient weight (g)
Egs white solids 7.34
Flour (all purpose) 5.81
Corn m~al (yellow degerminated, enriched) 5.81
Brown susar 25.27
Vesetable shortening 23,91
Sodi--~ Bicarbonate 0,49
Salt mix~ 2.49
Dicalcium phos?hate 0.614
Pectin N.F. ~ 6.0
Purified Cellulose (Solka Floc BW-40) 14.0
*i1ixture of potassium gluconate, 53.6got tribasic calcium
; phosphate, ll.lS~o~ sodium chloride, 19.75%,
di~agnesium phosphate, 13.35~ and calcium citrate, 2.15
All dry ingredients (except purified cellulose) were
blended in a Hobart mixer for five minutes. Shortening
was creamed in and allowed to mix for about 5 minutes.
Purified cellulose was then added to the batch requiring
it and blended for 5 minutes. The dough was then rolled,
cut and adjusted to the desired wet dough weight of 30.4 g.
The dough was stored at 4C and then baked at 385F for
about 12 minutes. Ater cooling the biscuits were stored
at -15 C until packaging. Prior to packaginy, 100 biscuits
were selected at random and weighed: mean weight - 26.76
g/biscuit.
-12-
1()9~4Sl
A placebo biscuit may be prepared by replacing the
purified cellulose and pectin by 20 g. corn syrup solids.
Biscuits containing other fibers or fiber mixtures may be
prepared in an identical fashion to the above by replacing
purified cellulose and pectin by the same weight (20 g~ of
the desired fiber~ Biscuits con~aining more or less fiber
may be prepared by appropriate scale-up or scale-down o~.
the above recipe.
,
, . . .
.,1
.,
-
' ~
-13-
- .
10~44S~
EX~'~PLE 2
~lonkey Study
A study on the effect of different plant fibers fed at
several levels of intake on fecal bulk and moisture was carried
out using pig-tailed monkeys (Macaca nemestrina) as subjects
The monkeys were divided into groups of four and each
grou~ was fed- various plant fibers (as biscuits prepared in
a mar.ner s~miiar to Example 1). Each fiber was fed for five
weeks, with a diCferent ~ntake level each week. All plant
fibars were fed at 10 g/d~y the first week and the other
four intake levels were randomly assigned to the following
four T~a~'~a as fOllo-~a:
g/day
Fibe ~ee~ eek 2 Weak 3 ~leek 4 Week 5
.
Ric2 Eulls 10 1 14 7 20
Sli~ lm 10 7 1 20 14
Pec~in 10 14 1 20 7
Soy ~us~s 10 1 7 14 20
Oat St-aw 10 20 14 1 7
Purified Cellulose 10 7 20- 1 14
(Solka-Floc)
Locust ~ean 10 7 1 14 20
Psylliu~ Seed Husk 10 14 7 20
~eces were collecied each day before the morning feedins
on each day o the study. They were weighed, then labeled
and frozen for later analysis. The feces were analyzed for
fecal net ~eight, dry weight and moisture.
The results are as rollows with the exact intake for
each fiber and each level indicated;
-14-
1094~Sl
Intake Mean Total Mean
Fiber (g/day) - Weight (g/day) Moisture
Pectin .94 10.5 70
6.6 13.5 72
13 11.0 67
19.8 12.5 72
Locust Bean .85 10.0 72.5
5.8 9.5 72.5
9,3 15.0 69.0
15.3 11.0 72.5
Slippery Elm 1 9.5 60.0
7 18.0 61.5
14 25.0 5~,~
27.0 50.0
Rice ;~ulls ,97 12.0 62.0
6.72 18.5 57.0
13 23.0 57.0
16~5 34 0 57.5
Oat S'raw 1 12.0 67.5
5.9 21.0 64.0
11~6 25.0 63.5
15.4 32.5 57.5
Soy Husks 1 12.0 64.0
7 16.0 ~6.0
14 21.5 62.0
34.0 57.0
Purified Cellulose .84 12.5 57.5
7 19.0 56.0
14 35.5 60.0
52 54.0
Psyllium Seed 1 25.0 72.5
6.8 35.0 78.0
12.7 35.0 82.
18.4 51.5 82.
109~
Analysis of the results indicate that although pectin
did not increase fecal bulk, it did increase fecal moisture
at all le~-els cf plant fiber intake, i.e., it acts
as a fecal so~tener. Purified cellulose, on the other hand,
increases fecal bulk ~rith a minimal effect on fecal moisture
Thes~ ~indinss are in contrast to psyllium seed ~rhich
increa~s2d both fecalbulk and recal moisture, ~ut in an
apparently uncontrolled fashion.
-16-
10944~;~
EXAMPLE 3
A human study was carried out in order to compare the
effects of ingesting purified cellulose, pectin, and mixtures
thereof, on fecal output and frequency, fecal transit time,
fec21 com osition and subjects' subjective feelings.
The fi~ers involved, fed as biscuitsr were:
1. purified cellulose (Solka-Floc BW-40)
2. pectin N.F.
3. 70~ purified cellulose~ 30~ pectin, and
~. ~0~ purified cellulose, 50% pectin.
The s tudy was a double-blind study. Volunteers were
presc~e~n2d to ascertain physical condition and acceptance
of biscuits s~milar to those used in the study.
~.ie~ y-eig~t subjects were divided into four treatment
groups~ They ~;ere asked to make no changes in their normal
diets, but to observe certain restrictions during the
treatment with respect to use of drugs (including laxatives
and an~i-diarrheal agents), moderation in consumption of
cer.ain bever2ges, and no "summer type" fruits or dry fruits
On days 1-7, subjects were given placebo biscuits
containing r.o plant fiber (see Example 1). Feces were
collected for the baseline period with radiopaque pellets
being administered on day 1 (the appearance of 80~ of these
pellets in the feces is the transit time)~
On days 8-21 each group was given biscuits containing
a total of 20 g. of plant f-iber. Feces wexe ~ollected daily.
Another set of transit markers were administered on day 14.
The biscuits utilized (see Example 1) were divided
so that the 20 g. of plant fiber was contained in 4-6
biscuits. Subjects were as~ed to consume the biscuits at
-17-
10~4~;1
breakfast, lunch and dinner together with fluids.
The results were as follows:
Code -
?urirle~ Cellulose - U
Pectin - J
70/30 - X
50/50 - Q
Frea1lency o_ Elimination_(dailY avera~e)
U Q ~ X
~eek 1 0.898 0.918 1.020 1.061
2 1.020 1.000 1.~65 1.531
3 1.000 0.~93 l.Z04 1.367
Fecal ~ransit Time (da~s)
U Q ~ X
Placebo 3.71 3.86 2.71 4.71
Treatment 2.52 3.29 2.57 3.86
Wet r~Jeights ~daily average)
U ~ J X
~eek.l 108.22 91.93 96.50 93.48
2 152.79 126.53 140.25 121.64
3 1~0.53 144.1~ 147.93 122.45
-18-
10944~;~
Personal Reactions
General Ease of
TreatmentSide EffectsElimination Ranking
(U) Purified some Increasea least Fair (3)
Cellulose
(J) Pectinmany Increased good Poor (4)
(Q) 50/50negligible Increased good - OK (2)
(X) 70~30negligible Increased most OK (l)
(side effec~s = headache, nausea, cramping, decreased
appetlte, etc.)
-19
~- 10~5~
EXAMPLE 4
A human study was carried out in order to compare the
effects of ingesting various plant fibers or mixtures
thereof on fecal output, fecal transit time, fecal compo-
sition and subjects' subjective feelings. The fibers
tested were a 70:30 mixture of purified cellulose (Solka-
Floc BW-40) and pectin N.F., and a psyllium hydrophilic
mucilloid 50% - dextrose 50~ (Metamucil*, Searle Laboratories.)
These were compared to a placebo. Both powder and
biscuit form were utilized.
The study was a parallel double-blindstudy consisting
of 56 healthy human volunteers. The subjects were required
to follow a modified low-residue diet beginning with day 1
and continuing through the last day of the study. Body
weights, blood pressures and blood samples were taken on
day 15 or 16 during the baseline period and days 37 or 38
during the experimental period. Subjects were requested
to maintain a record of their food intake and gastro-
intestinal feelings throughout the entire study. The
entire study lasted for 38 days; the baseline period
consisted of days 1-15 and the treatment period consisted
of days 17-38 with a two day pause between the baseline and
treatment periods to allow time for subject treatment
assignment and treatment labeling.
Beginning on day 8 and ending on day 15, and again
starting on day 31 and ending on day 38, all subjects
collected feces daily. Radiopaque transit markers were
administered on days 8 and 31 and their appearance in the
feces were noted for the following 7 days (the appearance
*trademark 20
,, .
10~44~1
o~ 80~6 of the markers was designated as the transit time).
Subjects were statistically assigned the various treatments
on the ~asis of transit time and fecal output. Each day
the feces were X-rayed for transit markers and then weighed
before storage at 4C~ Combined 7-day homogenates were
prepared and analyzed for fecal dry matter and moisture.
The treatments were as follows:
~O Total
Subiec.s Treatment FormLevel/dayBasal Diet
8 70/30 powder20 g modified
low residue
8 70/30 biscuit 20 g modified
low residue
12 psyllium seed powder 20 g low residue
6 placebo po~;der 20 g modified
- low residue
6 placebo biscuit 20 g - mo2ified
low residue
The results were as follows:
Fecal Weight (g)
. .
. ~
Placebo Psyllium seed 70/30
~ = . . .
Baseline 58.1656~34 61.
Treatment 63.11 101.68 104.45
Difference +4.95 ~45.34 +42.68
Transit Time (days)
-
Group Means
Placebo Psyllium seed 70/30
Baseline 4.464.20 3.97
Treatmen~ 3.88 3.80 2.66 ~_
Difference -0.58 -0.40 -1.31
--21--
-
109~5~
1 Fecal Weight (g) Transit Time (days)
Means Means
Placebo70/30 Placebo 70/30
Biscuit - Baseline55.2159.65 4.75 4.0
- Treatment57.09108.74 4.5~ 2.9
Powder - Baseline 61.1163.91 4.17 3.9
- Treatment69.12100.23 3.17 2.4
Analysis of the results of this study indicate the
ingestion of either the 70/30 purified cellulose-pectin
mixture or the pysllium seed hydrocolloid product increased
the mean fecal output compared to the placebo. Mean
transit times decreased for all treatment groups/ and the
proportion decrease was most notable for the 70/30 mixture
than for either the pysllium seed product or the placebo. :~
The study also demonstrated that the biscuit (baked)
and powder forms of the 70/30 mixture had similar effects
in mean transit times and mean fecal output, thus allowing
for much more versatility for this mixture as compared to
the pysllium seed product which is only available in a
powder form.
- 22 -
X
'
~094~S~
.
EX~lPLE 5
A. Pnysical and organoleptic properties of purified
cellulose, pectin and mixtures,
A study was made of various physical and organoleptic
properties of purified cellulose (Solka-Floc BW-40),
pectin N~ and a mixture thereof (70/30), indicating that
the mixture nas advantages over either com.ponent by itself.
109~4Sl
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109~145~
Purified cellulose in solution by itself settles
rapidly while a mixture does not settle appreciably within
an hour. Pectin is insoluble at room temperature at levels
above 5~ and must first be moistened with either alcohol or
glycerol in oxder to go into solution. However, if there
is some puriried cellulose present, no wetting agent is
needed b-cau3e the cellulose appears to separate the pectin
particles so they can be easily hydrated. In addition high
concentr2tions of pectin in solution are very viscous and
~hus difficult to drink, and high concentrations of purified
cellulose are very chalky, while a mixture of the two sub-
stances gives an accep-able product in solution.
B. ~hysical and organoleptic properties of puri~ied
c211 ulose/p~ctin mixture (70/30) and psyllium seed product.
~ s_udy was made of various physical and organoleptic
prop_rtiea o_ a purified cellulose (Solka-Floc BW-40) pectin
~J.F. mi~.u~- (70/30) and a psyllium hydrophilic mucilloid
(Metamucil, Searle Laboratories) indicating the advantages
of the former over the latter.
Property 70/30 Mix~ture Psyllium Seed
Physical- Dispersability Good Good
Suspension Good Poor
Stability
Solubility Partially Partially soluble
Soluble
Viscosity Acceptable 0-5 min: acceptable
5+ min: unacceptably
- high
-25-
.
109445~
1 Property 70/30 Mixture Pysllium Seed
Orgànoleptic- FlavorMarginally Marginally
Acceptable Acceptable
OdorAcceptable Acceptable
Mouthfeel Acceptable: Marginally
slightly chalky Acceptable:
and mucilagenous very
mucilagenous
Appearance good, milky translucent
white color solution with
brown particles
Evaluations based on solution, equivalent to 20 g. fiber in
10 oz. water (6.7% solution).
A significant finding was that after 5 minutes the
pysllium seed product became so viscous it was unacceptable
and difficult, if not impossible, to drink while the 70/30
mixture retains its acceptability for an indefinite period
of time. In addition the 70/30 mixture, when mixed with
water has a milky white color with a good appearance when
compared to the pysllium seed product which gives a trans-
lucent solution containing brown particles and therefore
has a somewhat undesirable appearance.
- 26 -
-`` 10~4451
1 EXAMPLE 6
A human study was carried out in order to compare the
effects of two different ratios of purified cellulose to
pectin on fecal output, fecal consistency and frequency of
elimination. The mixtures were a 70:30 mixture of purified
cellulose (Solka Floc BW-40) and pectin NF and an 87.5:12.5
mixture of these materials. The amount of purified cellulose
was fixed at 14 g. per day. Eor the 70:30 mixture each
subject ingested 20 g. of mixture per day (14 g. of purified
cellulose plus 6 g. pectin) and for the 87.5:12.5 mixture
each subject ingested 16 g. of mixture per day (14 g.
purified cellulose plus 2 g. pectin). The treatment mixr
tures were administered as flavored powders, prepared
essentially as described in Example 1. Each daily dose
contained 14 g. purified cellulose, either 2 g. or 6 g.
pectin, plus flavoring which consisted of 24 g. confectioners
sugar, 0.8 g. citric acid and 0.3 g. lemon flavor. The
treatment mixture was taken once per day in the evening
dissolved in 8-12 ounces of water.
The study was a parallel double blind study with 30
healthy human volunteers. The subjects were required to
follow a modified low-residue diet beginning with day one and
continuing through the last day of the study. The study
consisted of a baseline period of days 1-12, day 13 for
assigning treatment groups and a treatment period of days
14-24. Beginning with day 7 and ending on day 11 of the
baseline period each subject collected feces daily. During
the treatment period each subject, randomly assigned to one
of the two treatment groups, ingested one of the fiber
mixtures as described above. On days 19-23 of the treatment
- 27 -
` ' ! ; . ~ . .
.09~4S~
1- period each subject collected feces daily.
The results were as follows:
DAILY FECAL WET WEIGHT (g)
GROUP MEANS
2 g Pectin 6 g Pectin
Baseline 43.49 47-35
Treatment 91.90 88.20
Difference ~48.41 +40.85
FREQUENCY OF ELIMINATION PER COLLECTION PERIOD
GROUP MEANS :
2 g Pectin 6 g Pectin
Baseline 3.0 3.1
Treatment 4.7 4.1
Difference +1.7 +1.0
FECAL CONSISTENCY (mean for collection period)
Baseline Period Consistency Score
Formed Soft Watery Total
2 g Pectin 14 (93%) 1(7%) 0(0%) 15
6 g Pectin 14 (93%) 1(7~ ` 0(0%) 15
Treatment Period Consistency Score
Formed Soft Watery Total
2 g Pectin 13(87%) 2(13%) o(o%) 15
6 g Pectin 9(60%) 6(40%) 0(0%) 15
The conclusions are as follows:
1. The two treatment groups showed comparable increases
in mean daily fecal wet weight from baseline to treatment.
- 28 -
.
~o~ s~
1 2. The two treatment groups showed comparable increases
in frequency of elimination.
3. Significantly more subjects in the 6 g pectin
treatment group had soft stools compared to the 2 g pectin
treatment group during the treatment collection period.
EXAMPLE 7
A study was made of certain physical properties of
solutions containing a fixed amount of purified cellulose
and varying amounts of pectin. For each solution 14 g. of
purified cellulose ~Solka Floc BW-40) and from 2 to 6 g. of
pectin NF was dissolved in 300 ml of water. Observations
were made at 1.5, 2 and 6 hours for cellulose settling.
Viscosity was measured at 21-22C. The results were as
follows:
_ELLULOSE IN SUSPENSION
Viscosity
Quantity of Pectin 1.5 Hours 2 Hours 6 Hours (Centipoise~
6 g yes yes yes300
4 g yes yes yes200
2.8 g yes yes yes100
2.5 g yes no no 50
2 g no no no 25
It is clear that a viscosity of about 50 centipoise or
greater is needed to have desirable suspension stability.
_ 29 -
' ' ' ~ .
