Cellulose/carboxymethyl cellulose mixtures useful for controlling fecal output, and methods employing them

Methods of controlling fecal output and of appetite control, and compositions therefor, employing a fiber-containing mixture of cellulose with CMC, are described.

BACKGROUND OF THE INVENTION 
Control of fecal output in human beings has become problematical with the 
increase in processed foods in the diet. The present invention concerns a 
fiber-containing bulking mixture to effect such control. 
The proper function of the human large bowel (colon) depends greatly on the 
amount of plant fibers in the diet. Many minor disorders, as well as major 
diseases, may be due to lack of sufficient plant fiber intake, a typical 
situation in western European and American diets, which are high in animal 
products and refined carbohydrates. An excellent review of what is known 
at present about dietary fiber, and the requirements therefor, is Fiber in 
Human Nutrition edited by G. A. Spiller and R. J. Amen, Pleman Press, 
1976. 
In the context of "dietary fiber", the term "fiber" is somewhat misleading, 
because many substances normally classified in this category are not 
fiberous in the common sense of the word. Various alternate terms have 
been proposed; see for example, G. A. Spiller and E. A. Shipley "New 
Prospectives in Dietary Fiber", Food Product Development, pages 54-64, 
October 1976. For present purposes, and in agreement with most 
investigators, substances which will be termed "dietary fiber" include 
plant derived material, such as cellulose, pectin, lignin; and various 
gums and semi-synthetic materials such as, for example, 
carboxymethylcellulose, which are not digested before reaching the 
ileocecal valve, but which may possibly be digested by the colonic 
microflora. 
The most common of the "minor disorders" resulting from a lack of dietary 
fiber is constipation, a problem that plagues a large portion of the 
population in industrial countries. Laxatives are in widespread use in 
western Europe and the United States, indicating the desire of people to 
relieve this condition. Of the laxatives presently known, the only truly 
physiological ones are the so-called bulk laxatives, which employ an agent 
which increases the volume of fecal matter in the large intestine by 
virtue of its own bulk and/or by virtue of its ability to absorb water. 
The most common ingredient in such preparations is an extract of psyllium 
seed. There are many disadvantages associated with this material, such as 
the requirement for the ingestion of substantial quantities to achieve the 
desired effect, a bulky stool that cannot be readily controlled or easily 
modified, tendencies of the extract to gel in solution in a short time, 
making for difficulty in oral ingestion, and problems with allergic 
reactions. 
All natural extracts have the following disadvantages: 
(a) They are subject to inconstant composition due to natural variation; 
this is clearly true of natural foodstuffs themselves. For example, in 
wheat bran, the amount of "fiber" present in the bran can vary 
tremendously depending on the milling process, that is, how much of the 
outer coating of the wheat is preserved. Even in unprocessed fruits and 
vegetables the composition is affected by degree of ripening and length of 
storage. 
(b) They require dietary manipulation 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 they may otherwise be 
unwilling to consume simply to obtain their fiber content. 
The present invention offers a controllable and known mixture of pure 
materials, such that the proper amount of "fiber" intake can be carefully 
regulated. In addition, this preparation has properties which permit it to 
be included in foods normally consumed by the individual, as well as being 
palatable when taken alone. 
It is known that a specified mixture of cellulose with the natural produce 
pectin can offer a controlled amount of fiber. See, for example, Belgian 
Patent 867,088, issued May 16, 1978. 
The present invention relates to mixtures of cellulose and 
carboxymethylcellulose (CMC) useful for fecal output control, which are 
thus also antidiarrheal regulatory of colon function, and control 
appetite. 
SUMMARY OF THE INVENTION 
In one aspect, the invention concerns methods of controlling fecal output 
in a human subject and of controlling appetite, which method comprises 
administering orally to said subject, a daily dosage of between about 50 
and 300 milligrams per kilogram body weight of a composition comprising or 
consisting essentially of purified cellulose and CMC in a weight ratio of 
between about 2:1 and 10:1. 
In another aspect the invention concerns a dietary composition for 
controlling fecal output or for controlling appetite in a human subject 
which comprises or consists essentially of an effective amount of a 
mixture of purified cellulose and CMC in a relative weight ratio of 
between 2:1 and 10:1. 
DETAILED DESCRIPTION OF THE INVENTION 
The essence of the present invention is a composition comprising or 
consisting essentially of purified cellulose and purified carboxymethyl 
cellulose in a defined ratio as part of the 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 about 50 and 300, most preferably between about 85 and 225 
milligrams per kilogram of body weight per day would be administered. For 
an average adult human subject of about 70 kilograms this would be between 
about 4 and 21, preferably between about 6 and 16 grams per day. The 
dietary composition containing the cellulose/CMC 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 extend upon the total dietary composition, so that the method 
achieves more predictable and reproduceable results when the said 
cellulose/CMC composition 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 herein, 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/CMC 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/CMC 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, 
hamburger, casseroles or puddings and beverages, or it may be conveniently 
used as a sprinkle-on additive to prepared foods. It may also be combined 
with carbohydrate material, commonly sucrose, to form granules, which may 
be simply swallowed as is, washed down with water, or dispersed in water. 
The cellulose/CMC 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 terms of the above properties, the subject composition is 
superior to either cellulose or CMC alone. 
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 (product of Brown Company) and 
Avicel (product of FMC Corporation). 
CMC used for the present method and composition must also be highly 
purified; however commercially available CMC is of sufficient purity to 
satisfy this requirement. 
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. 
PREFERRED EMBODIMENTS 
Biologically effective mixtures consisting essentially of cellulose and 
carboxymethyl cellulose can be prepared in the range of about 2:1 to 10:1, 
cellulose to CMC ratio. However, in terms of acceptability in taste and of 
compatibility with other ingredients, it is preferred that the ratio be 
between 5:1 7:1l, 9:1, cellulose to CMC; most preferably 7:1, 
cellulose/CMC. 
The composition can be administered in amounts within the range of 50 to 
300 milligrams per kilogram of body per day, however, it is preferred that 
this range be between 85 and 225 milligrams per kilogram of body weight. 
If the composition is to be used for controlling fecal output, any of the 
modes of administration described herein is satisfactory as a suspension, 
of a powdered or granule form, included in recipes for ordinary foods, 
chewable or swallowable granules, etc. However, if it is to be used for 
appetite control, it is preferable that the composition be administered as 
granules or as a suspension, about 0.5 hours to 1 hour before meals.

A more complete appreciation of the methods and compositions of the present 
invention may be had by reference to the following specific examples. 
These examples are illustrative only and should not be construed as 
limitative of the scope or spirit of the present invention. 
EXAMPLE 1 
Preparation of Purified Cellulose-CMC Mixtures for Administration 
Purified Cellulose--99.5% cellulose, essentially free of lignin, food 
grade, 50-60.mu. (Solka-Floc BW 40, product of Brown Company). 
CMC--commercial grade CMC is obtained from Hercules Powder Company. 
A powder mixture of the cellulose/CMC is prepared as follows: 
87.5 g. of purified cellulose and 12.5 g. of CMC 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 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). 
EXAMPLE 2 
Illustrative Recipes Incorporating the Composition as a Premix 
Quiche Lorraine: 5 g. Cellulose/CMC/Serving 
308 Calories/Serving 537 mg/Serving 
1/2 lb. bacon, chopped into 1 inch pieces, cooked and drained 
2 large eggs 
1/4 tsp. salt 
1/4 tsp. dry onion 
1/4 tsp. nutmeg 
1 cup milk 
1/2 cup cellulose/CMC 
1 cup grated Cheddar cheese 
1 9" frozen pie crust 
Beat eggs, salt, onion and nutmeg. Add milk, then cellulose/CMC. Beat well. 
Place bacon, then cheese, then egg mixture into crust. Bake at 375.degree. 
F. for 40 min. or until brown. Makes 6 servings. 
Asparagus-Cauliflower Au Gratin 
5 g Cellulose/CMC/Serving 384 Calories/Serving 
10 oz. asparagus--cooked and drained 
10 oz. cauliflower--cooked and drained 
2 cups grated cheddar cheese 
1 can cream of celery soup 
1/2 cup milk 
1/4 tsp. dry mustard 
2 tbsp. margarine 
1/3 cup cellulose/CMC 
Blend cheese, soup, milk, mustard and margarine. Stir in cellulose/CMC. 
Place vegetables in baking dish. Pour cheese mixture over them. Bake at 
325.degree. for 25 min. Makes 4 servings. 
Sloppy Joes: 541 Calories/Serving 10 g Cellulose/CMC 
1 lb. ground beef 
4 tbsp. chopped green pepper 
4 tsp. dry onion 
1 tsp. salt 
4 cups tomato sauce 
2/3 cup cellulose/CMC 
Brown meat, pepper and onion. Mix tomato sauce, salt, and cellulose/CMC. 
Add to meat mixture and heat until bubbly. Serve on hamburger rolls. 
Serves 4. 
Pizza (Deep Dish): 
240 Calories/Serving 17.5 g Cellulose/Serving 
1 pkg. Appian Way Pizza Mix-Regular 
3/4 cup warm water 
1/3 cup cellulose/CMC 
1/2 cup chopped green pepper 
2 tsp. dry onion 
2 cups grated mozzarella cheese 
4 oz. can whole peeled tomatoes w/sauce-diced 
1/4 cup cellulose/CMC 
Combine, water, dough mix, and 1/3 cup cellulose/CMC. Placed in greaded 
9".times.9" sq. pan. Bake crust at 425.degree. for 10 min. 
Combine topping mix, 1/4 cup cellulose/CMC, and tomatoes. Spread on cooked 
crust. Sprinkle cheese, onions, and green pepper over sauce. Bake at 
425.degree. for 15 min. Makes 2 servings. 
Oatmeal-Applesauce Cookies: 100 Calories/Cookie 
1.5 g Cellulose/CMC/Cookie 153 mg/Serving 
7 tbsp. margarine 
3/4 cup brown sugar 
1 egg 
1/4 cup applesauce 
1 cup flour 
3/4 tsp. baking soda 
1 tsp. baking powder 
1/4 tsp. salt 
2 tsp. cinnamon 
2 tsp. nutmeg 
1/2 cup cellulose/CMC 
1/2 cup oatmeal 
1/2 cup raisins 
Cream together margarine and sugar. Add egg and applesause. Sift together 
dry ingredients. Add to creamed mixture. Stir in cellulose/CMC, then oats, 
then raisins. Place by teaspoonsful onto greased cookie sheet. Bake at 
375.degree. F. for 25 minutes. Makes 20 large cookies. 
EXAMPLE 3 
Comparison of Physical and Organoleptic Properties of Cellulose/CMC 
Compositions 
______________________________________ 
Purified Cellulose 
Purified CMC Mixture 
Property CMC Cellulose (7:1) 
______________________________________ 
Physical 
Dispersability 
poor good good 
Suspension 
good poor-clear good 
stability serum in 
1/2 hour 
Solubility 
soluble Insoluble Partially soluble 
Viscosity Judged Low, Acceptable 
unacceptably 
acceptable 
high 
Organoleptic 
Flavor Bland Bland Acceptable 
Odor Acceptable Acceptable Acceptable 
Mouthfeel Mucilagenous 
Chalky, Acceptable 
but mealy 
acceptable 
Appearance 
Translucent 
Suspension Milky-white 
solution of white solution 
particles 
______________________________________ 
Evaluations are based on solutions equivalent to 20 g. fiber in 10 oz. 
water (6.7% solution) 
EXAMPLE 4 
Granule Formulation 
The following formulation results in sugar coated granules which can be 
simply popped into the mouth like candy, and either swallowed as such, or 
washed down with water or juice. 
A sugar syrup is made by dissolving 25% to 50% by weight of sucrose in 
water. About 100 g of the cellulose:CMC mixture (7:1) as prepared in 
Example 1 is dissolved in a minimum quantity of syrup--about 100 g mixture 
to 30 g syrup. 
The mixture is then placed in appropriate granulating equipment, such as a 
coating pan or a disc pelletizer. The resulting granules contains about 
15% sugar (after the water has evaporated). 
The granules may also be compressed into wafers or tablets, of varying 
sizes, e.g., 2 grams. 
EXAMPLE 5 
Efficacy Studies of the Cellulose/CMC Composition 
Protocol: 
Forty human subjects were divided into 5 groups of 8 subjects each. All 
subjects were required to eat a low residue diet prepared by the diet 
kitchen throughout a 20-day period wherein calories were adjusted to 
maintain the weight of each subject. In addition, as part of the total 
dietary intake, each subject received one of the five compositions listed 
in the results chart below. Each subject received one of these 
compositions for the first 10 days, and another of these compositions for 
the second 10 days. Fecal collections were made only on each of the last 5 
days of each 10 day test period. Results were measured in terms of average 
fecal wet weight (g/day) and of transit time (days). Transit time was 
measured by the method of Hinton J. M. et al, Gut, Vol. 10, 842 (1969). 
The cellulose/pectin composition listed below and used for comparison was a 
mixture of 70 g cellulose to 30 g pectin flavored with lemon extract, 
prepared essentially in the manner described for the cellulose/CMC 
mixtures in Example 1. The cellulose/CMC mixtures were prepared as 
described in Example 1, using the lemon flavored alternative. 
Results: 
Stools were collected from each of the subjects, on the last 5 days of each 
10 day period, as indicated above. The following average results were 
obtained: 
______________________________________ 
Average Transit 
Fecal Wt. Time 
Composition Amount (g/day) (Days) 
______________________________________ 
Sucrose 10.7 g/day 64.8 4.3 
Cellulose/Pectin 
18 g/day 114.5 3.1 
Cellulose/CMC 
16 g/day 110.5 3.3 
Cellulose/CMC 
10.7 g/day 106.9 3.3 
Cellulose/CMC 
5.3 g/day 89.2 3.2 
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