US 2008000326541 US 2008/0003265 Al cs) United States 2) Patent Application Publication (o) pub. No. Casey et al. (43) Pub, Dat Jan. 3, 2008 (1) PROTEIN AND FIBER CONTAINING Publication Classtcation DIETARY SUPPLEMENT ener (76) Inventors: John Francis Casey, Summerfield, aera (2006.01) FL (US; Hans Fisher, Highland (52) US. Ch say Park, NJ (US) 6 ABSTRACT Conespondence Adress ea A dietary supplement, in powder, capsule, pil, or packet SE 120th Loop form, suitable for weight reduction as well as for cholesterol Summerfield, FL 34991 lowering and general colon hell, comprises a sy protein component in ation to a plurality of fiber components 21) Appl Nos MATES Selectad from the group consisting of soy fiber, ost fiber, psylium, sesame flour, flaxseed, barley indigestible dextrin, (2) Filed Jun, 28, 2006 beet fiber, rice bran, guar gum, pectin, and carageenan,US 2008/0003265 Al PROTEIN AND FIBER CONTAINING DIETARY SUPPLEMENT ‘CROSS REFERENCE TO RELATED "APPLICATIONS, [0001] None. FEDERALLY SPONSORED RESEARCH "ANDIOR DEVELOPMENT [0002] None. BACKGROUND OF THE INVENTION [0003] 1. Field ofthe Invention [004] Dict and dietary supplements have become a major ocus of research into overall health, i ight ofthe high and rowing incidence of obesity, particularly in youth and children, Other areas of major concem include high blood. cholesterol, which leads to heart disease, the number one cause of death: early onset diabetes; and increasing cancer rates including colon and ater eancers possibly traceable to poor dietary habits. Tae present iaventon is directed to an Improved ditary supplement comprising a plurality of spe- cifle fibers in combination with a specific proein source, ‘which unique combination provides benefits both in weight contro, digestive health, and lowered blood cholesterol [0005] 2. Background Art [0006] It is well established that high fiber diots are conducive to improved digestive heath, as well as to the control of weight and cholesterol tis knovs tha the typical American det must share inthe blame forthe high incidence of obesity in this country It is further known that ineteased bulk, resulting from an increase in fiber ingestion, contrib- utes to better Taxation, aiding food and the end products of ood digestion to pass through the digestive tract without «dwelling and accumulating in sections of the lower colon, ‘where bacteria may cause the production of toxic substances \hich lead to inflammation such as diverticulitis, or much worse, cancer of the calon. Colon cancer takes the lives of ‘more than 28,000 men each year, and nearly as many ‘women, placing it second only to lung cancer amoag fatal cancers, New studies show that dietary fiber, previously thought to no aid agnnst colon cancer, has a large role inthe prevention thereof. By reducing the dwell time of digesta in the colon, one reduces the development of toxins, conrib- ting appreciably tothe general well-being and health ofthe colon, Fiber also can produce a lowering of blood choles- terol by binding cholesterol and fats inthe digestive tact and preventing them from being absorbed. Still farther, itis known that certain types of soluble and insoluble fiber are beneficial in the prevention and treatment of diabetes and heart disease [0007] As indicated, the use of diet supplements to improve the degree to which fiber and other beneficial clements are ingested is a well-knowa element of nutaition, While itis also Known that many forms of fiber may be ‘employed in such diet supplements, no teachings have been. found which employ 2 combination of multiple fiber com: Ponents, as specified in the present invention, and speci cally combine a plurality of fibers with protein to achieve a synergistic benefit upon overall health. In general, those references that teach the use of dictary fier as dit supple- Jan. 3, 2008 mens avoid the addition of protein tothe diet supplement, ane use only a single fiber to provide bulk 0 aid in avoidance of constipation, [0008] For example, there are many references tothe use of dietary fiber in general for such benefits as cholesterol control, Taxation, and relief of constipation. In addition, a recent posting on the Mayo Clinic website, Mayoelinic.com hhalttiber, entitled “Dietary fiber: An essential part of a healthy diet” by the Mayo Foundation for Medical Educa tion and Research, indicates that dietary fiber, best known {or its ability 1o prevent or relieve constipation, eat also lower the risk of diabetes and heart disease. Dietary fiber, also known as roughage or bulk, is commonly understood 19 ‘include all parts of plant foods thatthe body can't digest oF absorb. Fiber is often classified into two categories: that which doesn’t dissolve in water (insoluble fiber) and that whieh does (soluble fiber) The insoluble fiber is beneficial ane necessary for movement of material through the diges- tive system, while the soluble fiber helps lower blood cholesterol and glucose levels. It s recommended that one include a wide varity of high fiber foods in ones ‘obiain the greatest health benefit [0009] In addition, Li et al, in “Effects of fiber intake on the blood pressure lipids, and heart rate in Goto Kavizaki sats", Nuttin, 2004 Nav-Dee: 20 (11-12): 1003-7, cou clude that high fiber intake has beneficial effects on systolic blood pressure and blood lipid levels, and that fiber intake should be increased by individuals who have diabetes mel- Tus. [0010] Further, many studies ofthe effect of specific fiber sources on health have been published, including the fol- Towing. Panlasigui et al, in “Blood cholesterol and lipid- lowering effects of carageenan on human volunteers", Asia Pae J Chie Nur. 2003:12(2):200-14 indicate thatthe regular inclusion of carageenan in the diet may result in redoced blood cholesterol aad lipid levels in human subjects. ball et al, in “Comparison of Homane and Glucose Responses ‘of Overweight Women to Barley and Oats", JAm Coll Nutr June 2005; 24(3), 182-8, show both oat and barley meals reduced glyeemic responses; the high soluble fer content ofthe barley appeared to bea factor inthe greater eduction jobserved. The same authors, in an earlier published anicle, “Lipids Significantly Reduced by Diets Coatainiag Burley in Moderately Hypercholesterolemic Men, J m Colt Nur Febuary 2004; 23(1): 55-62, concluded that increasing soluble fiber through consumption of barley ina health diet can reduce cardiovascular risk factors. In “Reduced glyce- ric response to beet-fibre meal in noa-insulin-dependent iabeties and its relation to plasma levels of panereatc and gastrointestinal hormones.” Diabetes Res. Febuary 1986; 3(2): 91-6, Hagander etal observe that diminished glycemic response afler bootfiber ingestion is associated with an increased response of somatostatin, giving a reduced glu- cose absorption and a delayed gastrointestinal transit time. Similarly, Overton etal, in “The effects of dietary sugat-beet fibre and guar gum on fipid metabolism in Wistar rats,” Br J Nut. Seplember 1994; 723)385.95, indicate that guar exer its hypocholesterlemic effect via intraluminal bile ‘acid binding and loss of cholesterol frm increased fecal bile acid excretion. Oat bran is discussed in “Oat-bran cereal Jowers serum total and LDL cholesterol in hypercholester- olemic mea”, Am J Clin Nutr. September 1990, 523) 495-9, where Anderson et al conchude that ready-to-eat oat ‘bran cereal provides a practical means to incoeporate solubleUS 2008/0003265 Al fiber into the diet to lower serum cholesterol. En “Longe-term cholesterol-lowering effets of psylium a an adjunct to diet therapy in the treatment of hypercholesterolemia", Am J Clin Nutr. une 2000; 71(6}: 1433-8, Anderson etal teach that ueatment with 5.1 g psyllium wwiee daily produces significant net reduction in serum total and LDL-cholesterol concentrations in men and women with primary hypercho- lesterolemia, providing an alterative to drug therapy for some patients. Rice bran i discussed in “Full-Fat Rice Bran ‘and Oat Bran Similarly Reduce Hypercholesterolemia in Humans", J Nutr. May 1998; 128(5): 865-9, by Gerhardt ot al Sesame is similarly discussed in *Sesamin, a Sesame LLignia, isa Potent Inducer af Hepatic Fatty Acid Oxidation in the Rat", Metabolism. October 1999; 48(10): 1303-13, by Ashakumary et al [0011] | OF course, protein is a wellestblished necessity in the human diet, and may be obtained in @ number of forms, Sourees of animal protein include meas, egy albumin, whey, ‘and caseinates. Other sources of peotein include plant mate- rial, such as sunflower, linseed, saflower, peanut, almond, ‘walnut, cottonseed, and sesame seed, The preferred protein for-use in the present invention is, however, soy protein, Which is readily available, and a known ingredient of food. supplements and dietary supplements. However, as previ- ously stated, no previous food supplements have employed say protein in combination witha plurality of fiber sources tas set forth herein. Even those diet supplements designed specifically for weight loss, which commonly employ a protein source, fail 10 recognize o utilize the advantage of ‘uultiple fibers in combination with protein in their compo- {0012| The benefit of soy protein in the diet rather than ‘animal protein is discussed by Anderson et al, in *Meta- analysis of the Elfects of Soy Protein Intake on Serum Lipids” N Engl J Med, August 1995 3:333(5}:276-82, in hich itis concluded that the consumption of soy protein rather than animal protein significantly decreased serum concentrations of total cholesterol, LDL cholesterol, and triglycerides withou significantly affecting serum HDL cho- Iesterl concentrations. Carol, in “Review of clinical stud- ies on cholesterl-lowering response to soy protein, J Am Diet Assoc. July 1991; 91(7)820-7, relates that soybean protein has hypocholesterolemie and ant-aherogenic prop- erties BRIEF SUMMARY OF THE INVENTION [0013] The present invention relates to ingestible dietary supplements foe the purpose of providing appropriate utri- tional clements to the human diet. More paniculary, this invention relates 1 8 unique composition comprising a specific combination of both protein and a plurality of dietary fibers. The specifi selection ofthe components of the inventive composition is based upon obtaining an opti- ‘mal choice and conceatraton of amino acid profiles in the protein component, and the best balance of fibers for overall elfect. The fibers are chosen so as (0 obtain an optimal balance ofthe most eflective percentages of soluble fiber for influencing cholesterol levels, and soluble, semi-soluble or insoluble fiber for overall colon heath, For example sesame seed and soy proteins complement each otber in so far as their respective amino acid profiles are concemed. While soy is high in lysine, sesame is low in lysine. Conversely, Jan. 3, 2008 sesame’s higher level of tryptophan compensates for the lower level of this amino acid in soy protein DETAILED DESCRIPTION OF THE INVENTION [0014] The present invention is directed to an ingestible ood supplement s0 formulated as to have the maximum ‘beneficial results First, the formulation is designed to pro- vide © mixture of fibers in combination with protein in a ‘convenient form w be ingested shorly prior to or as pact of a meal, which will produce early satiety in one consuming the product and thereby enable the individual to reduce his orler food intake during the meal. further beneficial elect of the composition is to prevent the absorption of dietary cholesterol and fats from the meal, thereby denying the liver the fats that serve as precursors of cholesterol. Still further, the ditary fibers employed are believa to be beneficial in the possible prevention of colon cancer, andi reducing the risk of diabetes, intestinal problems, and heart disease Moreover, by combining these fibers with the specified protein employed in the present invention, one obtains an ‘optimal combination of protein and amino acid profiles for overall health [0015] Satiety is dependent upon two principal physi- ological needs that are best satisted simultaneously. The fist ofthese is the need for ealoric intake; the second isthe ced for bulk. If one provides a high density, high calorie dict, a8 for example with a low fiber, high fat diet, one inevitably tends to overeat beyond the need for calories in order to Satisfy the noed for bulk. I is helioved that many Americans become obese because of the tendeney to follow this dietary tread of eating foods low in fiber and high in ft Itis, of course, also possible to eat a det so high in fiber oF bulk as to prevent the ingestion of sulicient calories to meet the calorie needs, although this sekdom happens in Wester society. Under those conditions, the person will eventually suffer fom malauition, The importance of bulk ia coa- junction with adequate caloric intake results fom the fact ‘that digestion is facilitated through the activation of nerve endings in the walls of the intestine, brought about through pressure ftom the inside ofthe intestine resulting from the volume of food mixed with moisture, Thus, the more fiber in the diet the more readily the volume will increase and produce pressure against the intestinal walls, which tiggers nerve endings to canse movement of the digestive tract. This movement, refed to as peristalsis, is responsible for the propulsion ofthe food through the digestive system, leading tothe completion of the digestive process andthe absorption of the nutrients, Moreover, fiber, through its bulkiness, contributes to better laxation which means that food and the end peoduets of food digestion pass through the digestive tract without accumulating. in sections of the lower bowel, where bacteria ean act on them and peeduce harmful toxins that can cause inflammation such as diverticulitis, or much worse, cancer of the colon [0016] Tis well Known that dietary fibers are considered fan essential part of a healhy dit, providing many health benefits. The term dietary fiber is yeneric term given 10 indigestible fractions ia foods, which human digestive enzymes cannot digest. Detar fibers, now considered an important aspect of diet, are found in fruits, vegetables, ‘whole grains, and legumes, and are probably best known for their ability to prevent or relieve constipation. But dietary fibers can provide other important health benefits as wel,US 2008/0003265 Al such a contbuting to the overall health ofthe eolon, and lowering one’s risk of diabetes and heart disease. As set forth in the present invention, we have found it beneficial to provide a mixture of soluble dietary fiber and insoluble dietary Her 10 achieve an optimal mix of fShers 1 be ingested. Dietary fibers are believed to have a number of health benefits, perhaps the best known of which sto lower serum cholesterol level. This eft, however, is not uni fomly found forall types of itary fies, due wo dierent physiological properties and cliffering_ physicochemical Properties, dependent upon the sources of the dietary ers Geran types of fiber bind dietary cholesterol inthe dges- tive tact, thus preventing it from being absorbed, while orhers bind bile sais. Many studies have showa other benefits of fher as well, such as reduction of the risk of diabetes. In this disease, fibers such as guar gum, caog- ena, or pectin bring about a much slower rate of sugar absorption, thus producing 2 much saullerstimulaon of insulin secretion, thereby helping the diabetic patient ts ako believed that intestinal problems, such a8 the risk of diverticulitis, a condition suffered by half of Americans over the age of 60, canbe substantially redvced by the eonsump- tion ofa high-fiber diet. Moreover, a recent Harvaed study, {or example, found that over a six-year period the men who ate the mst fiber (averaging 28.9 grams a day) had 41% fewerhear attacks compared with the men who ate the lest. Dietary fiber is generally obi fom plant foods, and consists ofthat portion of the plant not digested by man While the sugars and starches are broken don into simpler nutints andar absorbed by our intestine, the cel walls re not digested and go on to fom an important component of the stol. An example of dietary fiber is celulose anda food high in fiber is wheat bran, Dietary fiber, also refered to as roughage oe bulk iachids all pats of plant fod thatthe body cant digest ar absorb. ibe is often lasted into two categories: those that don't dissolve in water (insoluble fiber) and those that do (Soluble fiber). Insoluble fiber inereases the movement of material through the digestive system and increases stool bulk, so it ean be of benefit 10 those who strggle with constipation or iepular stool. Wholesvheat flour, wheat bran, nuts and many vegetables axe good sources of insoluble fiber. Soluble fiber dissolves in Water to foma a gel-like material. It ean help lower blood coesterl and glucose levels. Generous quantities of soluble fiber are found in oats, peas, beans, apples, citrus fru, caro, barley and psylium {0017} Thus, there is much to be gained by ingesting Gvtary fiber, But to get the most bene, iis important provide a good mix ofhigsfber fds. Fiber is found in sundance in vegetable products such as the bran of whale sins, the leaves and stems of plants, an nuts, seed rts, and vegetables. However the normal dit of most adults is deficient is some oral of these pets, Als, i is known that recommended diy dosages for fhe are often relatively high, requiring the patient to ingest the fiber composition several times daily. Patient compliance is aso a problem ‘when the composition hasan unpleasant tase alerste, or arity mouth feel. Accordingly, 2 goal of the resent inven- fon is to provide tothe consumer an easily and readily ingested procuet that wll provide a proper Balance of the best fibers, and additonal protein, to atin the aforemen- tioned benefits, and atthe same ime provide tool to contol \weiht and cholesterol. The addition of fiber to the diet for \wejght contol is known, a fiber generally provides few it Jan. 3, 2008 any calories othe dt, while proving satiety However i js not generally recognized by the public that low calorie diets may result in a breakdown of protein inthe body, partculaly from the digestive wat, and a coresponding Joss of potassium asociated with cll nucleus protein os Potassium loss is known to result in cardi issues, as wel as general heath problems. Accordingly, 0 protet the digs tract and to prevent possible protein breakdown, 18 have found it appropiate to provide a source of prosin in combination with the fibers provided in the present dietary supplement {0018} To achieve an optimal produc, it has been deter mined hat mixture of upto about ten specifi ber sources should be combined with a foefied protein source. While atemative protein sources are avalable, soy protein is considered the best protein fo the preset invention, Ii a be noted that various forms of soy protein ae available. For example, soy Hour comprises about $0 pereet proicin, ‘while soy concentrate compises from about 700 72 percent proicin, and soy isolate comprises from about 83 10 92 percent protein, Such sources of soy protein are commenly extracted using the solvent hexane, but the prefered soy fsolte for use in the preseat invention is extracted with ‘water and ult firation. OF course, the prefered forifed soy solute protein, in combination wit eer than te bers willprovie a benefits well although the maximum benefit Js achioved dough the seat lest four and preferably sx, oF the fiber components, each of which adds a speciic benefit to the mixture of components. While the present composition wil provide beneficial resus with as few 28 one oF two fibers, fr superor results are obtained through the use of at least four fibers. However, as one adds xktinal fiver components ess ofeach, an thus less ofthe specitic benefit of cach individual fiber component, is attained. {0019} The fod supplement ofthe present invention takes Into consideration he fact that chest and blood cholesterol ane inextricably interwoven, and the present invention com- prises & meal supplement concentrate, rater than @ meal replacement. Intended to aid in both weight ad cholesterol cont, itis Fomulated with plurality of natura ingredi- ens, each available from a leading food processor. The optimal product i produced without the use of solvents oF aukttves of any kind, is fine grate, and may be conveniently packaged in pill or capsule fen, oF in pockets cor pouches, for individual use prior toa meal as an adition to liquid carrer, or, altematvely, may be added toa food product asa supplemeat theta in the preparation threo. Further, the pct may be made avaiable as an emulsion {or addition to igid containing foods, and may be Davored or neutral. As a fine granulate, the product i readily dis- prsible in any liquid, hot or eld o¢ can he used in cooking or baking withont compromising effectiveness, oF may be provided as small Mavored nuggets (fom 2 to 35 mm in diameter, for example) for various applications such 28 cereals (preferably hot), tition bars, and confectionary items. The product may be produced foe consumption with water, juices, sport dink, applesauce, sauces, salad dress jogs, gravis, pling, yoru, et, athe users option, a ‘well asan additive toomelets, hamburger patties, hamburger helper. or other foods, or may be baked ino o inched in bread, ols, cookies, pretzls, meat lof, pancakes, or sini- Jar pres. The prefered formulation Was developed with such applications and uses in mind, and thst conform orUS 2008/0003265 Al harmonize with such applications. The preset invention is specifically directed to a dietary supplement preferably in the form of pills, capsules, or packets, fo be taken a specific ‘number of times daly for the desired benef. [0020] The product comprises about 26 to 36 percent (by \weight) soy protein, preferably in the form of soy protein ‘solute, the balance comprising a plurality of fibers, with up ‘w about 2 percent avoring anor coloring agents tis aso to be noted that there are significant amounts of protein in some of the fiber components utilized, Specifically there are protein components present in psyllium, soy fiber, sesame, ‘and flax, which are additive tothe soy protein isolate, The preferred harmonious blend of soy protein and up to about 10 specifi fibers, with soluble and insoluble fractions, was based upon a careful consideration of the amino ac profile and the physiological characterises of the ingredients, to achieve the greatest posible degre of success in cholesterol reduction and overall colon health. However, the synergistic elfect ofthe combination of fibers suggested isnot sufiient in and of itself and the user should follow a recommended regimen of consuming a least 4 glasses of water daly, and slowly introduce moderate improvements in dietary prac- tices. The use of three doses daily of the present invent prior to meals is beneficial to those marginally overweight or entering into Ievels of serum cholesterol above normal, buts not intended for those who are pathologically obese oF suffering from hyperipidemi. The proposed daly dosage of ‘bout 30 grams, whea combined with the fiber in an average diet, should be ideal for most normal consumers, enabling them to reap the benefits of a realistic and moderate program that will lead them progressively toward modest weight loss ane maintenance, cholesterol control, and general colon health, [021] Based upon a recommended wsage of 30 grams per ay ofthe dietary supplement, to be taken before each meal in individual servings of 10 grams, the product may be conveniently provided in the form of pills, capsules, or tablets, or may be packaged in 10-gram packets of powder. Its to be noted thatthe invention isnot intended to replace ‘any meals, but asa meal supplement, and the consumer is encouraged to consume a normal dietary’ regimen of three ‘meals dily. The packets may be any of those known in the fa as being suitable for food grade packaging, and may be hheat-saled to protect the product. Shelf life of the product is highly extended, as it contains less than 5 peroent mois- ture, The individval serving packets may be packaged in larger packages for convenience and sale to the consumer, With informational and instructional materials included as appropriate, or ready available tothe consumer through an. internet web site, or by other means. The pills, capsules, or ‘ablets may be prepared in conventional manner, and may be packaged in conventional packaging for the convenience of the consumer. For example, individual 10 voring sen 6 fasUS 2008/0003265 Al EXAMPLE I [0041] As atest formulation of the invention, » mixture of the following components was prepared: T Soy pti concaate (50 Pre) aR You ba us 5. Barey be 08 4 Soy her eo 5 Rie 10 6 Bos er a 4. Pei fier a Lec io [0042] I is to be noted thatthe soy protein employed in this test was a concentrate, rather than an isolate (88% protein) which isthe preferred fom of protein, and thatthe mix contained no coloring or flavoring agents, but did contain lecithin, a wetting agent. This formulation was administered toa group consisting of 30 randomly selected emale individuals, ranging in age from 27 10 65 years, for f period of 3 weeks, All rwcoived an orientation at the commencement of the study, which included a basic com- ‘mentary on nutrition and dieting, and emphasized that an objective ofthe program was to demonstrate that one could Jose @ moderate amount of weight by staying within one's ‘normal eating patterns, while ang a supplement prior to each meal. In the context of this stu, a maximum weekly ‘weightloss of 2 pounds was sought, The participants kept a siary of foods consumed during the study, including snacks ‘and beverages, were weighed on a weekly basis, and refinined from any other dietary efforts to acelerate weight loss. tthe end of this period, a large majority ofthe subjects indicated feeling comforable, with improved overall well being while taking the product. While weight loss vatied among the test subjects, almost all registred a weight loss At the conclusion ofthe study, the results of 4 persons were considered invalid fora variety of reasons. Of the remaining Paricipans, 3.8% lost 8 pounds, $0.0% lost from 6 to 7.5 pounds, 30.8% lost from 3.5 to 5.25 pounds, and 3.8% lost 2 pounds, while 3.8% gained 1.6 pounds, 38% gained 1.25 pounds, and 3.8% remained the sume weight. Of the 30 brginal participants, 28 signed up for anaditional 3 wook eyele, which was not monitored. Informal reports indicated. similar results, with satisfaction ofthe participants shown by esi to purchase the product for continued use. This study validated the expectations of the inventors, and led to further refinement of the formulation to improve flavor, palatability, ‘and overall balance of te ingredients, leading wo the ranges sot forth in the table above EXAMPLE Il [0043] After further experimentation, sample of the jvention was prepared in accordance with the preferred ormulaton st forth inthe table above. Fortis experiment, ‘an isolated soy protein was employed, permitting the for: ‘ulation to contin less ofthe protein, and thus more iber. Since rice bran was found to be less efficacious, alternative fibers were employed. A coloring agent was employed to provide a more visually attractive product, and a flavoring ‘agent was employed to mask the lavor imparted by the soy protein. In addition, a finer granvlar dispersion of the components was achieved, permitting the elimination of Jan. 3, 2008 lecithin a8 a wetting agent. This formulation comprised the following ingredients, in the stated concentrations based ‘upon the weight of the total mixture Say Fibrin 120) (Ot iter i) Pym 40 mss) Fnsed evn Indgsible sexi ber 2) Gue NT 308 Pein 198) (Cangeeas (Loetasin DX 2018) Gin Acid ashy) Cin sme DRE Yellow #6 Alm Lake 35-4 ao [0044] Upon analysis, this Formulation is found to eom- prise (on a per serving basis) 27.8% protein, 46.2% fiber (16.5% soluble, 29.7% insoluble), and 5.8% Lat (0.9% saturated, 49% unsaturated). The product was given to a ocus group for evaluation, in 1D gram serving pouebes, 10 be used as a supplement to each of three meals dil, over ‘period of 21 days. The focus group comprised 18 indi viduals, 10 female and 8 male, fom 24 to 32 years in age ‘The announced objective ofthe study was to determine any ‘weight or cholesterol changes afer three weeks use of the supplement. Participants were urged to not change their ‘oral eating habits, merely to add the supplement t their ‘normal dit aad to consume at least 4 glasses of water daly, sot counting any other beverages consumed. The partici pants were asked to avoid taking any other measures to influence their Weight of cholesterol count. The orientation included a fill product deseripton so that each participant new exactly what was being consumed. Subjects were jnstucted to take the product once daly for the first week, preferably 15 minutes before their largest meal ofthe day For the secon and third weeks, they Were asked to take the product twice daily, preferably one before breakfast, and the other hefore the lngest mel of the day. The product could be consumed by string into a glass of water, juice, or other ‘beverages, andthe orientation included other suggestions for use, such as with yogurt or applesauce. If water was use, it ‘was to be included in their daily allotment of four glasses Participants took their first dose of the product during the orientation mecting. The participants were weighed, and received a Total Cholesterol reading. LDL and HDL were not determined [0045] The dominant reaction of the subjects was new feeling of comfor, or well-being, in the abdomen (not the stomach). While not fully understood tis believed that this feeling of well-being results from the product eliminating from the body, or otherwise neutralizing, substances that could cause toxicity of discomfort, a view generally sup- ported in the extensive literature on the individual ingredi- cents contained ia the product. There were no reports of iscomfor, gas, or blosting. The group also reported higher degree of satiety than in Example I, probably result ing from the use of an isolate of protein rather than a concentrate, and fom a more synergistic selection of fibers Reactions tothe most pleasant way to consume the productUS 2008/0003265 Al wer almost alike that taking the prodict with beverage or food as sampled at the orientation was prefered. Speci cally, § paicipants reported no strong preference fr ether using water or anoter beverage or food, while 14 prefered juice, beverage, ora food/snack ten. {0046} The incividval pouch serving was mentioned as an important convenience. The taste (oF lack there), coor, parle size and dispensiily ofthe product were review, With no changes suggested, although some soggesed other product forms, such as tablets, inclusion in has, ee: {0047} Laxation improved for S participants, who reported ‘ecasional constipation, andl most noted an increased fre quency of bawel movements, but ao lose sto! or dara, and no discomfors were reported. One peren rsportd cvcasinal “ry tool, but did admit some carelessness in consuming fil 4 plasses of water daily. The results of ttl cholesterol measurements showed that 3 participants exib- ited no chang, 7 showed decrease of fom 5 to 7.5%, and 6 showed a decrease of from 8 10 11%. Two participants did not appear atthe inal meeting foe Weighing and cholesterol testing, In adltion, 2 paricipans showesl no weight los, ‘while persons lost from 3t 3.3 pounds, and 9 persons lost from 3.5 to 5 pounds. Ths weightloss i consistent with reconimiendations of not exceeding weight los of 2 pounds per week, to avoid deprivation, Lit loss, if any, was registered during the fst week, reflecting tat the pret was added to an unchanged diet in stages, and i's effect ‘upon sates and appetite are not quickly note {0048} The invention being this deserbod, it will be ‘obvious thatthe invention may be Varied in numerous Ways Such variations are aot to he considera departure om the spirit and scope of the present invention, and all such ‘modifications are intended tobe inluded within the seopeot the following claims. 1. A dietary supplement consisting essentially of 3 uni fora mixture of protein and plurality’ of dctary fibers. 2. The supplement of claim 1, wherein said plurality of dietary fibers are selete from the group consisting of soy fier, oat fiber, plum, sesame fous, faseod, barley, indigestbledexin fiber, beet fhe, sce bran, uae gun, postin, and caragcenan 3. The supplement of elsim 2, wherein ssid pro‘ein is selected fom the group consisting of oy, whey, cseinats, saflower, sunflower linseed, almond, peanut, walt, cot- tonseed, and sesame proteins. 4. The supplement of elim 3, wherein said dietary fiber comprises a mixture of at last 4 fibers 5. The supplemeat of claim 4, wherein sid mixture of dietary fiber includes soy fiber, ot fiber, pslium, and guar um 6. The supplement of claim 3, wherein said protein i a soy protein isolate 7. The supplement of elim 6, wherein sad mixture etary bers includes soy fiber, oat ber, sium and guar gum, 8. The supploment of claim 3, futher comprising up to about 3.0 percent Mavoring agent, and up to about 1.0 percent coloring agen 9. A dictry supplement consisting essentially of «nie form mixture of from about 26 to about 36 weit percent protein selected fom the group consisting of soy, whey, cascinats, sallower, sunower,lnsed, almond, pean, ‘walnut, cotonsed, and sesame proicins, the balanee com- prising a plrality of fibers selected from the group cons Jan. 3, 2008 Jing of sy fiber oat fiber, plum, sesame flour flaxseed, barley, indigestible dextrin fiber, beet fiber, rice ban, guar sum, peta, and carageenan, 10. dietary supplement as set forth in claim 9, wherein tho fers comprise from about 8 to shout 20 weight percent soy fhe, fom about 8 to about 20 weight perent oat ier, from about 8 to about 20 weight percent psylium, from about 4 to about 8 weight pereent sesame flour, from about to about 14 weight percent axsee, rom about 4 9 about 8 weight percent barley, from about 8 to about 18 weight percent indigestible dextein ier, from about 8 to about 18 ‘weight percent bet fiber, from about 3 to about 9 weight percent rice bran, fom about Oto about $ weight percent ar gum, fom about Oto about $ weight percent pectin, and {rom about 0 to about S weit percent carageenan. 11 The supplement of cam 19, wherein sid etary fiber comprises a mixture of atleast 4 fibers 12. dietary supplement asset forth in clio 1, furer comprising upto about 3.0 weight perent coloring agent, and upto aboot 1.0 weight percent favoring agent 13. dietary supplement set forth in elim 12, wherein said protein comprises a soy protein isolate, and said fiber comprises soy her, oat fiber, plum, and guar gum. 14. etary supplement a et forth in csim 10, wherein said dietary fiber comprises a mixture of fom about $1 about & fibers, further comprising up to about 1.0 weight percent coloring agent, and up to about 1.0 weight percent Alavoring agent 18. A ditary supplement comprising about 32 weight ereent isolated soy pron, about 12 percent soy fiber, about 125 percent oat fiber, about 10 percent pslium, about 10 pereat flaxseed, about 10 percent indigestible dextrin, about percent sesame ur, about 2 percent guar trum, about 2 percent pectin, about 2 percent carpeeman, about 2 percent favoring, and coloring agent 16..\ composition of mater comprising uniform mix- ture consisting essentially of from about 26 to about 36 ‘weight protein, from about 64 10 about 74 weight percent Aietary ther comprising a paraty ober, and upto about 1 percent each of coloring agents and favoring gents. 17. A composition of matter as set fr in claim 16, ‘wherein sid proteins selected from the group consisting of soy, whey, caseinats, sallower sunflower, linseed mond, peanut, walnut, cottonseed, and sesame proteins, and sid Gietary fiber comprises fibers selected from the gxoup con- sisting of soy fiber, oat fiber, pallu, sesame flour, fax seed, arly, indigestible dextrin fiber, beet fiber, ice bran, star gum, pectin, and carageenan 18. A composition of matter as set fork in claim 17, ‘wherein sid protein comprises isolated soy protein, and said Givtary fiber comprises a mixture of soy fiber, oat fiber, psu, and guar gum. 19. A composition of matter as set forth in claim 18 comprising fom about 30 to about 34 weight percent fsolated soy protein, from about 10 to about 15 weight percent soy fiber, from about 10 to about 15 weight percent cat fiber fom about 100 about 15 weight percent psiium,US 2008/0003265 Al tibout Ito about 3 weight percent guar gum, ad rom about 18 weight percent to about 39 weight percent xiitional fibets selected from the group consisting of beet fiber, indigestible dextrin, flaxseed, sesame lor, barley, rice bran, Pectin, and caragecnan. 20./A composition of matter as set forth in claim 16 comprising about 32 weight percent isolated soy protein, bout 12 percent soy fiber, about 125 percent at fiber, about Jan. 3, 2008 10 percent psium, about 10 peeent flaxseed, about 10 percent indigestible dextrin, about 5 percent sesame fous, about 2 percent guar gum, about 2 percent pectin, about 2 peeentcargeenan, about? percent Bavoring and coloring agent