CA1094451A - Method of controlling fecal output and compositions therefor - Google Patents

Method of controlling fecal output and compositions therefor

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Publication number
CA1094451A
CA1094451A CA303,512A CA303512A CA1094451A CA 1094451 A CA1094451 A CA 1094451A CA 303512 A CA303512 A CA 303512A CA 1094451 A CA1094451 A CA 1094451A
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Prior art keywords
pectin
cellulose
mixture
purified cellulose
purified
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French (fr)
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Gene A. Spiller
Myron A. Beigler
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Syntex USA LLC
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Syntex USA LLC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A21BAKING; EDIBLE DOUGHS
    • A21DTREATMENT, e.g. PRESERVATION, OF FLOUR OR DOUGH, e.g. BY ADDITION OF MATERIALS; BAKING; BAKERY PRODUCTS; PRESERVATION THEREOF
    • A21D13/00Finished or partly finished bakery products
    • A21D13/02Products made from whole meal; Products containing bran or rough-ground grain
    • AHUMAN NECESSITIES
    • A21BAKING; EDIBLE DOUGHS
    • A21DTREATMENT, e.g. PRESERVATION, OF FLOUR OR DOUGH, e.g. BY ADDITION OF MATERIALS; BAKING; BAKERY PRODUCTS; PRESERVATION THEREOF
    • A21D2/00Treatment of flour or dough by adding materials thereto before or during baking
    • A21D2/08Treatment of flour or dough by adding materials thereto before or during baking by adding organic substances
    • A21D2/14Organic oxygen compounds
    • A21D2/18Carbohydrates
    • A21D2/183Natural gums
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21Addition of substantially indigestible substances, e.g. dietary fibres

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  • Health & Medical Sciences (AREA)
  • Food Science & Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Mycology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nutrition Science (AREA)
  • Polymers & Plastics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Seeds, Soups, And Other Foods (AREA)
  • Jellies, Jams, And Syrups (AREA)

Abstract

ABSTRACT OF THE DISCLOSURE
A method of controlling fecal output in humans involving the administration of controlled quantities of a mixture of purified cellulose and pectin is described me result of this method is the physiologically desirable increase of fecal output in humans to at least 130 g/day with an easy to eliminate stool having a moisture content of between about 65 and 80 percent and with a transit time through the gastrointestinal tract of between 24 and 72 hours Dietary composition containing specified ratios of Purified cellulose and pectin suitable for the above method are described.

Description

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.

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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.

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 ~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~

.

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. ~_ 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, :

`` ~.0~ 51 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.

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.

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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;

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.

10944~;~

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 10~4~;1 breakfast, lunch and dinner together with fluids.
The results were as follows:

Code -?urirle~ Cellulose - U
Pectin - J

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 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.) ~- 10~5~

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 -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.

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.

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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 .

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.

-`` 10~4451 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 ` ' ! ; . ~ . .

.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.

.

~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.

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 -' ' ' ~ .

Claims (5)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PRO-PERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A dietary composition for controlling fecal output in a human subject which comprises an effective amount of a mixture of purified cellulose and purified pectin in a relative weight ratio of between about 7:3 and 4:1.
2. The composition of claim 1 which is a pre-mix for incorporation as an ingredient in food products for human consumption.
3. A dietary composition for controlling fecal output in a human subject which consists essentially of an effective amount of a mixture of purified cellulose and purified pectin in a relative weight ratio of between about 7:3 and 4:1.
4. The composition of claims 1, 2 or 3, wherein the purified cellulose has a purity of at least 90%.
5. The composition of claims 1, 2 or 3, wherein the purified cellulose is a crystalline powder of 20-140, preferably 50-60 microns.
CA303,512A 1977-05-20 1978-05-16 Method of controlling fecal output and compositions therefor Expired CA1094451A (en)

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US4444761A (en) * 1981-05-04 1984-04-24 Syntex (U.S.A.) Inc. Cellulose/carboxymethyl cellulose mixtures useful for controlling fecal output, and methods employing them

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DE2919449C2 (en) * 1979-05-15 1981-08-06 Kowalsky, Horst, Dr.med., 5000 Köln Dietary agent for natural digestive regulation
DE3148810A1 (en) * 1981-12-10 1983-06-16 Bruno 7957 Schemmerhofen Gerster LOW-CALORIES FOOD AND METHOD FOR THE PRODUCTION THEREOF
GB2145103B (en) * 1983-08-11 1987-04-29 Procter & Gamble Absorbent vegetable material and process for making same
US5009916A (en) * 1983-12-12 1991-04-23 The Procter & Gamble Company Psyllium mucilloid fiber food products
DE3479630D1 (en) * 1983-12-12 1989-10-12 Procter & Gamble Psyllium mucilloid products
AU624065B2 (en) * 1987-09-08 1992-06-04 Kabushiki Kaisha Yakult Honsha Liquid food
US5095008A (en) * 1987-09-14 1992-03-10 The Procter & Gamble Company Cookies containing psyllium
US4950140A (en) * 1987-09-14 1990-08-21 The Procter & Gamble Company Cookies containing psyllium
US5126150A (en) * 1990-10-01 1992-06-30 The Procter & Gamble Company Compositions containing psyllium
FR2673360A1 (en) * 1991-03-01 1992-09-04 Ard Sa Composition based on dietary fibres, food containing this composition and preparation method
US5258181A (en) * 1992-03-02 1993-11-02 The Procter & Gamble Company Compositions containing psyllium
AU3812893A (en) * 1992-03-20 1993-10-21 Procter & Gamble Company, The Anion exchange resin compositions
US5955123A (en) * 1996-10-21 1999-09-21 The Procter & Gamble Company Baked compositions comprising psyllium
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US1495789A (en) * 1923-07-28 1924-05-27 Heinz Co H J Food product
US2145016A (en) * 1934-02-20 1939-01-24 George R Gould Process of incorporating pectin in bakery products
US2043204A (en) * 1934-02-20 1936-06-02 George R Gould Laxative composition
NZ183356A (en) * 1976-03-03 1980-03-05 Kay Cantrell Kitchens Ltd Food base composition for simulated food products, containing fibrous cellulose particles
FR2351662A1 (en) * 1976-05-18 1977-12-16 Pharmacologie Pharmacocinetiqu Laxative compsn. contg. cereal bran and cereal germ - together with cholagogues, pectin and opt. magnesium or cobalt salt

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4444761A (en) * 1981-05-04 1984-04-24 Syntex (U.S.A.) Inc. Cellulose/carboxymethyl cellulose mixtures useful for controlling fecal output, and methods employing them

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