GB1590507A - Method of controlling fecal output and compositions therefor - Google Patents

Description

(54) METHOD OF CONTROLLING FECAL OUTPUT AND COMPOSITIONS THEREFOR (71) We, SYNTEX (U.S.A.) INC., a Corporation organised under the laws of the State of Delaware, United States of America, of 3401 Hillview Avenue, Palo Alto, California 94304, United States of America, do hereby declare the invention, for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particularly described in and by the following statement: The function and importance of "fiber" in the human diet has been the subject of much discussion and publicity in recent years. Indeed, it has been suggested that large amounts of fiber in the human diet can have beneficial effects on health ranging from prevention or alleviation of constipation and hemorrhoids to possible prevention of 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 average diet in more highly civilized areas of the world contains relatively little fiber. An excellent review of much that is known about dietary fiber at the present time is "Fiber in Human Nutrition" edited by G.A. Spiller and R.J. Amen, Plenum Press, 1976.

The recent interest in "fiber" has resulted in much reevaluation 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 usual sense of the word.

Various alternative terms have been proposed by various investigators (for a summary see for example G.A. Spiller and E.A. Shipley, "New Perspectives on Dietary Fiber", Food Product Development, 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 digested by colonic microflora. The common materials of this type include: cellulose hemi-celluloses pectin lignin gums mucilages associated undigestible plant cell wall factors.

Cellulose is probably the best known of these materials and is a polymer of d-glucose with 1,4-ss linkages having a linear, unbranched structure. Hemicelluloses are more amorphous in structure than cellulose and are usually made up of 150 to 200 sugar units. They may contain a variety of pentose and hexose sugars, many of which are branched monosaccharides and may thus be divided into two broad categories, the pentosans and the non-cellulose hexosans. Pectin consists of unbranched chains of d-galacturonic acid with many of the carboxyl groups esterified as methyl esters or neutralized as their calcium or magnesium salts. Lignin is a non-carbohydrate polymer of the plant cell wall having a molecular weight between about 1,000 and 4,500. Its monomers are linked by carbon to carbon bonds rather than the typical glycoside linkages of other cell wall components. Gums are exudates produced by many plants, often to seal off a damaged section and prevent invasion by microorganisms. Typically the gums are a complex group of highly branched uronic acid-containing polymers with various neutral sugars. Some of the more commonly encountered gums are gum arabic, gum karaya and gum tragacanth. Mucilages, in contrast to gums, are the product of normal plant metabolism and are derived from barks, roots, leaves, seeds and even flowers. Among the more commonly 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 naturally occurring substances, many of which are used for food purposes. Among the common foods which contain substantial amounts of one or more of these materials are fruits, vegetables, legumes and grains. However, the distribution of these materials varygreatly from food type to food type and, even within the same food type, from sample to sample.

Many of these naturally occurring food materials or crude extracts have been used for many years in the treatment of diarrhea and constipation. In particular, the use of fruit as a remedy for diarrhea and dysentery has long been known.

In addition, a variety of commercial products based upon non-purified dietary fiber components have been used as bulk producing laxatives. The great majority of these preparations are derived of agar, gum tragacanth and psyllium seed. However, there are a variety of disadvantages to the use of all of these naturally occurring and commercially 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 difficulty in oral ingestion. Materials derived from certain gums have been known to 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.

Another strong disadvantage to existing natural materials and commercial products derived from natural substances 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 tremendously 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 unpalatable, 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 without the need to otherwise manipulate the normal diet of the person and which would result in a controlled and predictable fecal output.

Combinations of cellulosic substances and various gums (including pectin) are described in U.S. 3,440,065, U.S. 3,573,058, and U.S. 3,574,634. In each of these cases these combinations, usually including other materials, are for purposes other than the control of fecal output or colonic activity.

The present invention concerns a method of controlling fecal output in the human, and compositions therefore. More specifically, the present invention concerns methods and compositions for controlling fecal output in the human involving the administration of a mixture comprising, or consisting essentially of, purified cellulose and pectin as a source of dietary fiber. The term "consisting essentially of" means that the composition consists of the stated ingredients above or with minor amount of non essential ingredients such as impurities.

Still more specifically, the present method involves the administration of such purified cellulose/pectin mixtures such that a daily fecal output of at least 130, preferably at least 150 grams, is achieved, whereby said fecal 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 controlling the transit time of orally ingested materials through the gastrointestinal tract to a desirable reproduceable level of between about 24 to 72 hours, preferably between about 36 and 60 hours. As used in this context, transit time refers to the time interval for 80% of orally ingested radiopaque pellets to appear in the feces.

As mentioned above, a variety of "fiber" substances have been used to control colonic activity or fecal output 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 of such materials is attendant with many disadvantages. It has now been found that a combination of two specific purified materials (as distinguished from crude extracts) can be used to effectively control fecal output in the human in terms of bulk, moisture, and ease of elimination, and with a controlled, reproduceable transit time through the gastrointestinal tract.

By use of specific combinations of these purified plant fibers, cellulose and pectin, a highly sophisticated and reproduceable system for controlling colonic activity and fecal output may be achieved which could not be achieved with either component alone or with existing therapeutic means. Additionally, the ratio of the substances to one another may be precisely varied to achieve particularly desired effects or to suit individual conditions without necessitating any further manipulation of the gross diet of the person involved.

Furthermore, the mixture of these substances is not damaged in processing (baking, cooking, and the like), while other substances such as wheat bran may be less effective after cooking.

It has been found that, for the practice of the present invention, compositions having a ratio of cellulose to pectin of between 7:3 and 4:1 have superior effects. With a much higher ratio of cellulose to pectin the feces are not sufficiently moist and there is difficulty in elimination. With a ratio much lower than that indicated above there tends to be notable side effects such as cramping and decreased appetite.

In general, the method of the present invention comprises orally administering to a subject a mixture comprising, or consisting essentially of, purified cellulose and pectin in the aforementioned ratio as part of a regular dietary regimen. The total quantity of mixture administered will, of course, depend to a large extent upon the particular subject involved.

However, as a general rule between 140 and 360, most preferably between about 215 and 360 milligrams per kilogram of body weight per day would be administered. For an average adult human subject of about 55 to 70 kilograms this would be between about 10 and 20 grams per day. The dietary composition containing the cellulose/pectin mixture may be administered in unit or divided daily dosages, for example, entirely with one meal, or portionwise, for example, 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 substantial 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 140 microns, most preferably between about 50 and 60 microns.

Examples of commercially available purified cellulose are Solka Floc (Trade Mark of a product of Brown Company) and Avicel (Trade Mark of a product of FMC Corporation).

Pectin that may be used for the present method and composition may be either a highly purified pectin such as pectin NF or a pectin diluted with glucose, sucrose or other standard excipients.

The subject mixtures 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 example, in a glass with a spoon.

A more complete appreciation of the methods and compositions of the present invention may be had by reference to the following specific examples.

Example I Preparation of Purified Cellulose-Pectin Mixtures Purified Cellulose - 99.5% cellulose, essentially free of lignin, food grade, 50-60 (Solka-Floc BW 40, product of Brown Company).

Pectin - Pectin N.F., carbohydrate of purified polygalacturonic acid methyl ester with no less than 6.7% methoxyl content and no less than 74% galacturonic acid content (obtained from Sunkist Co.).

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) (Trade Mark) liquid solid blender until well blended (about eight minutes).

When a flavored powder is desired, the following procedure 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% cornstarch) 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 described 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 alone (6.0 g pectin, other ingredients same as above) or placebo (only flavor, citric acid and sugar as above).

B. Preparation of biscuits: A biscuit containing 20 g. of fiber is prepared from the following ingredients (illustrated for a 70-30 purified cellulose-pectin mixture): Ingredient Weight (g) Egg white solids 7.34 Flour (all purpose) 5.81 Corn meal (yellow degerminated, enriched) 5.81 Brown sugar 25.27 Vegetable shortening 23.91 Sodium Bicarbonate 0.49 Salt mix* 2.49 Dicalcium phosphate 0.614 Pectin N.F. 6.0 Purified Cellulose (Solka Floc BW-40) 14.0 *Mixture of potassium gluconate, 53.6%, tribasic calcium phosphate, 11.15%, sodium chloride, 19.75%, dimagnesium 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 4"C and then baked at 3850F for about 12 minutes. After cooling the biscuits were stored at --15"C until packaging. Prior to packaging, 100 biscuits were selected at random and weighed: mean weight - 26.76 g/biscuit.

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 containing more or less fiber may be prepared by appropriate scale-up or scale-down of the above recipe.

Example 2 Monkey 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 group was fed various plant fibers (as biscuits prepared in a manner similar to Example 1). Each fiber was fed for five weeks with a different intake level each week. All plant fibers were fed at lOg/day the first week and the other four intake levels were randomly assigned to the following four weeks as follows: g/day Fiber Week 1 Week 2 Week 3 Week 4 Week 5 Rice Hulls 10 1 14 7 20 Slippery elm 10 7 1 20 14 Pectin 10 14 1 20 7 Soy Husks 10 1 7 14 20 Oat Straw 10 20 14 1 7 Purified Cellulose 10 7 20 1 14 (Solka-Floc) Locust Bean 10 7 1 14 20 Psyllium Seed Husk 10 14 7 20 1 Feces were collected each day before the morning feeding on each day of the study. They vere weighed, then labeled and frozen for later analysis. The feces were analyzed for fecal et weight, dry weight and moisture.

The results are as follows with the exact intake for each fiber and each level indicated: 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 54.0 20 27.0 50.0 Rice Hulls .97 12.0 62.0 6.72 18.5 57.0 13 23.0 57.0 16.5 34.0 57.5 Oat Straw 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 66.0 14 21.5 62.0 20 34.0 57.0 Purified Cellulose .84 12.5 57.5 7 19.0 56.0 14 35.5 60.0 20 52 54.0 Psyllium Seed 1 25.0 72.5 6.8 35.0 78.0 12.7 35.0 82.0 18.4 51.5 82.5 Analysis of the results indicate that although pectin did not increase fecal bulk, it did crease fecal moisture at all levels of plant fiber intake, i.e., it acts as a fecal softener.

Purified cellulose, on the other hand, increases fecal bulk with a minimal effect on fecal moisture. These findings are in contrast to psyllium seed which increased both fecal bulk and fecal moisture, but in an apparently uncontrolled fashion.

Example 3 A human study was carried out in order to compare the effect of ingesting purified cellulose, pectin, and mixtures thereof, on fecal output and frequency, fecal transmit time, fecal composition and subjects' subjective feelings.

The fibers involved, fed as biscuits, were: 1. purified cellulose (Solka-Floc BW-40) 2. pectin N.F.

3. 70% purified cellulose, 30% pectin, and 4. 50% purified cellulose, 50% pectin.

The study was a double-blind study. Volunteers were prescreened to ascertain physical condition and acceptance of biscuits similar to those used in the study.

Twenty-eight subjects were divided into four treatment groups. They were asked to make no change in their normal diets, but to observe certain restrictions during the treatment with respect to use of drugs (including laxatives and anti-diarrheal agents), moderation in consumption of certain beverages, and no "summer type" fruits or dry fruits.

On days 1-7, subjects were given placebo biscuits containing no 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 transmit time).

On days 8-21 each group was given biscuits containing a total of 20 g. of plant fiber. Feces were collected 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 asked to consume the biscuits at breakfast, lunch and dinner together with fluids.

The results were as follows: Code Purified Cellulose - U Pectin - J 70/30 - X 50/50 - Q Frequency of Elimination (daily average) U Q J X Week 1 0.898 0.918 1.020 1.061 2 1.020 1.000 1.265 1.531 3 1.000 0.898 1.204 1.367 Fecal Transit time (days) U Q J X Placebo 3.71 3.86 2.71 4.71 Treatment 2.52 3.29 2.57 3.86 Wet Weights (daily average) U Q J X Week 1 108.22 91.93 96.50 93.84 2 152.79 126.53 140.25 121.64 3 140.53 144.19 147.93 122.45 Personal Reactions General Ease of Treatment Side Effects Elimination Ranking (U) Purified some Increased least Fair (3) Cellulose (J) Pectin many Increased good Poor (4) (Q) 50/50 negligible Increased good OK (2) (X) 70/30 negligible Increased most OK (1) (side effects = headache, nausea, cramping, decreased appetite, etc.) 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 transmit time, fecal composition 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-blind study 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 gastrointestinal 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 of 80% of the markers was designated as the transit time). Subjects were statistically assigned the various treatments on the basis of transit time and fecal output.

Each day the feces were X-rayed for transit markers and then weighed before storage at 4"C. Combined 7-day homogenates were prepared and analyzed for fecal dry matter and moisture.

The treatments were as follows: No. Total Subjects Treatment Form Level/day Basal Diet 8 70/30 powder 20 g modified low residue 8 70/30 biscuit 20 g modified low residue 12 psyllium seed powder 20 g modified low residue 6 placebo powder 20 g modified low residue 6 placebo biscuit 20 g modified low residue The results were as follows: Fecal Weight (g) Group Means Placebo Psyllium seed 70/30 Baseline 58.16 56.34 61.77 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 4.46 4.20 3.97 Treatment 3.88 3.80 2.66 Difference -0.58 -0.40 -1.31 Fecal Weight (g) Transit Time (days) Means Means Placebo 70/30 Placebo 70/30 Biscuit - Baseline 55.21 59.65 4.75 4.0 - Treatment 57.09 108.74 4.58 2.9 Powder - Baseline 61.11 63.91 4.17 3.9 - Treatment 69.12 100.23 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 psyllium 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 psyllium 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 psyllium seed product which is only available in a powder form.

Example 5 A. Physical 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 NF and a mixture thereof (70/30), indicating that the mixture has advantages over either component by itself.

Purified Cellulose/Pectin Property Pectin Purified Cellulose Mixture (70/30) Physical Dispersability poor good good Suspension poor-clear serum stability good in hour good Solubility Insoluble above Insoluble Partially soluble 5% at r.t.

Viscosity Judged Low, unacceptably high acceptable Acceptable Organoleptic Flavor Sour-acidic bland Marginally acceptable marginally acceptable Odor Acceptable Acceptable Acceptable Mouthfeel Mucilagenous but chalky, mealy Acceptable acceptable Appearance Translucent solution Suspension of Milky-white solution white particles Evaluations are based on solutions equivalent to 20 g. fiber in 10 oz. water (6.7% solution).

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 order to go into solution.

However, if there is some purified cellulose present, no wetting agent is needed because the cellulose appears to separate the pectin particles so they can be easily hydrated. In addition high concentrations of pectin in solution are very viscous and thus difficult to drink, and high concentrations of purified cellulose are very chalky, while a mixture of the two substances gives an acceptable product in solution.

B. Physical and organoleptic properties of purified cellulose/pectin mixure (70/30) and psyllium seed product.

A study was made of various physical and organoleptic properties of a purified cellulose Solka-Floc BW-40) pectin N.F. mixture (70/30) and a psyllium hydrophilic mucilloid Metamucil, Searle Laboratories) indicating the advantages of the former over the latter.

Property 70/30 Mixture 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 Property 70/30 Mixture Psyllium Seed Organoleptic- Flavor Marginally Marginally Acceptable Acceptable Odor Acceptable Acceptable Mouthfeel Acceptable: Marginally slightly chalky Acceptable: and mucilagenous very mucilagenous Appearance good, milky translucent solution white color 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 psyllium 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 psyllium seed product which gives a translucent solution containing brown particles and therefore has a somewhat undesirable appearance.

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. For 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 mixtures 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 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%) 00%) 15 Treatment Period Consistency Score Formed Soft Watery Total 2 g Pectin 13(87%) 2(13%) 0(0%) 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 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 21-220C. The results were as follows: CELLULOSE IN SUSPENSION Viscosity Quantity of Pectin 1.5 Hours 2 Hours 6 Hours (Centipoise) 6 g yes yes yes 300 4 g yes yes yes 200 2.8 g yes yes yes 100 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.

Claims (10)

WHAT WE CLAIM IS:

1. A method of controlling fecal output in a human subject such that a daily fecal output of at least 130 grams per day is achieved, said fecal output having an average moisture content of between 65 and 80 percent, with an average transit time through the gastrointestinal tract of between 24 and 72 hours, which method comprises orally administering to said subject, a daily dosage of between 140 and 360 milligrams per kilogram body weight of a composition comprising purified cellulose and purified pectin in a weight ratio of between about 7:3 and 4:1.

2. A method of controlling fecal output in a human subject such that a daily fecal output of at least 130 grams per day is achieved, said fecal output having an average moisture content of between 65 and 80 percent, with an average transit time through the gastrointestinal tract of between 24 and 72 hours, which method comprises orally administering to said subject a daily dosage of between 140 and 360 milligrams per kilogram body weight of a composition consisting essentially of (as hereinbefore defined) purified cellulose and pectin in a weight ratio of between 7:3 and 4:1.

3. A dietary composition for controlling fecal output in a human subject which comprises a mixture of purified cellulose and purified pectin in a relative weight ratio of between 7:3 and 4:1.

4. The composition of Claim 3, which is a pre-mix for incorporation as an ingredient in food products for human consumption.

5. A dietary composition for controlling fecal output in a human subject which consists essentially of (as hereinbefore defined) a mixture of purified cellulose and purified pectin in a relative weight ratio of between 7:3 and 4:1.

6. A method or composition according to any one of the preceding claims, wherein the purified cellulose has a purity of at least 90%.

7. A method or composition according to any one of the preceding claims wherein the purified cellulose is a crystalline powder of 20 to 140 microns.

8. A method or composition of claim 7 wherein the purified cellulose is a crystalline powder of 50 to 60 microns.

9. A method of controlling fecal output in humans, substantially as described herein.

10. A dietary composition for controlling fecal output, substantially as exemplified herein.