WO2013121411A1 - Fiber supplements and methods for producing and using same - Google Patents

Abstract

An edible composition comprising: (a) dietary fiber as an active ingredient; and (b) a coating of lipid material which is at least 50% digestible (by weight) formulated to retard wetting of said dietary fiber.

Description

FIBER SUPPLEMENTS AND METHODS FOR PRODUCING AND USING SAME RELATED APPLICATIONS

In accord with the provisions of 35 U.S.C. § 119(e) and §363, this application claims the benefit of US 61/ 598,363 filed 14 February 2012 by Carmi RAZ and entitled "FIBER SUPPLEMENTS AND METHODS FOR PRODUCING AND USING SAME", which is fully incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to fiber supplements and their production and use.

BACKGROUND OF THE INVENTION

Obesity is a major health problem in the US and many other western countries. Over

400,000 deaths annually are attributed to excess weight. A majority of the US adult population is considered overweight or obese, when measured by body-mass index (BMI) calculations. Americans and other Westerners consume a relatively high fat diet. In addition, Americans and other Westerners lead a sedentary lifestyle. Either or both of these factors appears to contribute to the obesity problem.

Many different approaches to dealing with obesity have been proposed.

Diet modification and exercise are known to be effective for most of the population, but compliance with diet and exercise regimens in the long term is difficult.

Various medications which reduce appetite have also been proposed. Well known examples are amphetamines and Fen-phen (fenfluramine and phentermine in combination). Each of these drugs has problems associated with it which prevent their widespread use as a viable solution to obesity in a significant percentage of the population. Pharmaceutical products which delay gastric emptying have also been marketed.

SUMMARY OF THE INVENTION

A broad aspect of the invention relates to regulation of absorption of nutrients in the digestive tract. In some exemplary embodiments of the invention, absorption of ingested lipids is reduced. Alternatively or additionally, in some embodiments of the invention absorption of ingested carbohydrates is reduced. In some exemplary embodiments of the invention, absorption is reduced by delivering dietary fiber. Optionally, delivery is to a selected region of the intestine. Some dietary fibers interact with lipids to retard their absorption. Alternatively or additionally, some dietary fibers interact with bile components to interfere with their activity. Alternatively or additionally, some dietary fibers interact with sugars to retard their absorption. Body fat is produced either from ingested lipids or from excess sugar shunted in the glycolysis cycle to fat storage. Thus, various exemplary embodiments of the invention can reduce production of body fat by either mechanism. One aspect of some embodiments of the invention relates to incorporation of dietary fiber into a food product with an acceptably low level of impact on taste and mouth feel of the food product. According to various exemplary embodiments of the invention, the food product is a semi-liquid product (e.g. yogurt or ice cream), a spread (e.g. butter, jam, peanut butter, cream cheese or chocolate spread) or a liquid product (e.g. milk, kefir, milkshake or smoothie). According to these embodiments of the invention, small particles of a composition including dietary fiber associated with lipid material are incorporated into the food product. Optionally, these particles contact the tongue and are perceived as lipids rather than fiber. In some embodiments, perception as lipid contributes to acceptability of flavor and/or mouth feel. In some exemplary embodiments of the invention, dietary fiber is incorporated into solid food compositions with an acceptably low level of impact on taste and mouth feel. Exemplary solid food compositions include energy bars, chocolate, confectionary coatings, pet food and animal feed. According to any of these embodiments (i.e. semi-liquid, liquid, spread or solid), the resultant food product has less biologically available calories than a similar product without the added dietary fiber.

One aspect of some embodiments of the invention relates to a composition containing dietary fiber and associated lipid material. Optionally, the composition is provided as a plurality of fine particles (e.g. less than 1 mm, less than 700 μιη, less than 500 μιη, less than 250 μιη or even less than 100 μιη average diameter. According to various exemplary embodiments of the invention the associated lipid material is at least 50, at least 60, at least 70, at least 80, at least 90, at least 95 or even substantially 100% digestible. In some exemplary embodiments of the invention, the lipid material is associated with the dietary fiber as a plurality of discontinuous droplets. Alternatively or additionally, in some exemplary embodiments of the invention the lipid material is associated with the dietary fiber as a substantially continuous layer or coating surrounding a core containing the dietary fiber. According to various exemplary embodiments of the invention the lipid material retards absorption of moisture by the dietary fiber. Optionally, this retardation contributes to a more "natural" texture when the composition is incorporated into a food preparation. In some exemplary embodiments of the invention, the substantially continuous layer is breached in a desired target area as described below.

In some exemplary embodiments of the invention, the composition and/or particles contain one or more additional ingredients. According to various exemplary embodiments of the invention these additional ingredients include pharmaceutically active compounds and/or nutrients and/or excipients.

Alternatively or additionally, in some embodiments, the associated lipid material is hydrolyzable by at least one intestinal enzyme and/or is capable of interacting with bile acid and/or bile salts (e.g. can be emulsified by bile and/or can bind bile components to retard their activity).

Alternatively or additionally, according to various exemplary embodiments of the invention the associated lipid material includes natural edible oils and/or other lipid materials.

One aspect of some embodiments of the invention relates to release of added dietary fiber at a desired target area in the digestive tract.

In some exemplary embodiments of the invention, the target area is the pylorus. According to these embodiments of the invention gastric lipases act on lipid material associated with dietary fiber to release the dietary fiber in the pyloric region so the fiber is available as it passes into the duodenum.

In some exemplary embodiments of the invention, the target area is the duodenum. According to these embodiments of the invention pancreatic lipases and/or bile salts rapidly act on lipid material associated with dietary fiber to release the dietary fiber soon after it passes from the pyloric region into the duodenum.

In some exemplary embodiments of the invention, the target area is the ileum or jejunum.

According to these embodiments of the invention intestinal pancreatic lipases and/or bile salts act more slowly on lipid material associated with dietary fiber to release the dietary fiber.

According to various exemplary embodiments of the invention the target region in which the dietary fiber becomes available is determined (at least in part) by the type and/or amount of lipid material applied to the fiber. In some exemplary embodiments of the invention, a combination of different formulations is employed so that dietary fiber is released from associated lipid material in two or three or more different target areas. It will be appreciated that although distinct target areas have been described in terms of anatomic landmarks for purposes of illustration, a continuum of targets are actually present.

One aspect of some embodiments of the invention relates to delivery of dietary fiber to a target region without use of protein(s) for targeting.

Another aspect of some embodiments of the invention relates to use of dietary fiber and associated lipid material in the manufacture of a medicament formulated to reduce absorption of dietary fats and/or formulated to reduce blood cholesterol levels and/or formulated to reduce absorption of dietary carbohydrates.

Another aspect of some embodiments of the invention relates to methods of treatment which include oral administration of dietary fiber and associated lipid material to a subject in need thereof to reduce absorption of dietary fats and/or to reduce blood cholesterol levels and/or to reduce absorption of dietary carbohydrates. It will be appreciated that the various aspects described above relate to solution of technical problems associated with weight regulation in humans and/or other mammals

Alternatively or additionally, it will be appreciated that the various aspects described above relate to solution of technical problems related to undesirable side effects of weight reduction medications.

In some exemplary embodiments of the invention, there is provided an edible composition including: (a) dietary fiber as an active ingredient; and (b) a coating of lipid material which is at least 50% digestible (by weight) formulated to retard wetting of the dietary fiber. In some exemplary embodiments of the invention, there is provided a particle including: (a) a core including dietary fiber as an active ingredient; and (b) a coating including lipid material which is at least 50% digestible (by weight) surrounding the core. In some embodiments, the lipid material constitutes between 10 percent and 60 percent by volume of the composition or particle. In some embodiments, a weight of the dietary fiber is at least twice as much as a weight of the lipid material in the composition or particle. Alternatively or additionally, in some embodiments, a weight of the dietary fiber is not more than three times as much as a weight of the lipid material in the composition or particle. Alternatively or additionally, in some embodiments, the composition or particle is characterized by an average transverse cross sectional diameter of 700 micrometer or less. Alternatively or additionally, in some embodiments of the composition or particle the coating is substantially free of protein. Alternatively or additionally, in some embodiments of the composition or particle the lipid material is de-stabilized at a pH > 7.0. Alternatively or additionally, in some embodiments of the composition or particle the lipid material is hydrolyzable by at least one lipase found in the intestine. Alternatively or additionally, in some embodiments of the composition or particle the lipid material is reactive to bile. Alternatively or additionally, in some embodiments of the composition or particle the lipid material includes one or more of at least one natural edible oil and at least one other lipid material. Alternatively or additionally, in some embodiments the composition or particle includes at least one item selected from the group consisting of a viscosifying agent, an emulsifying agent, a plasticizing agent, a stabilizing agent and a firming agent.

In some exemplary embodiments of the invention, there is provided an oral dosage form including a composition as described hereinabove and/or a plurality of particles according to as described hereinabove. In some embodiments, the oral dosage form includes one or more additional active ingredients. Alternatively or additionally, in some embodiments the oral dosage form is provided as a tablet. Optionally, the tablet includes an external coating. Alternatively or additionally, in some embodiments the oral dosage form is provided as a capsule or gel-cap including an external capsule. Optionally, the external capsule includes one or more gelling agents.

In some exemplary embodiments of the invention, there is provided a preparation including a composition as described hereinabove and/or or a plurality of particles as described hereinabove incorporated into a food or beverage. In some embodiments, the particles and/or composition are characterized by an average moisture content of less than 50%.

In some exemplary embodiments of the invention, there is provided a manufacturing method including: (a) dispersing dietary fiber in a gas stream; (b) spraying lipid material which is at least 50% digestible (by weight) onto the fiber; and (c) cooling the lipid material so that it adheres to the fiber. In some embodiments, the method includes granulating the dietary fiber. Alternatively or additionally, in some embodiments the lipid material has a volume of 10 to 60% of the coated dietary fiber. Alternatively or additionally, in some embodiments, a weight of the dietary fiber is at least twice as much as a weight of the lipid material. Alternatively or additionally, in some embodiments, a weight of the dietary fiber is not more than three times as much as a weight of the lipid material. Alternatively or additionally, in some embodiments the method includes incorporating the lipid material adhered to the fiber into a food or beverage. Alternatively or additionally, in some embodiments the method includes compressing the lipid material adhered to the fiber to produce tablets. Alternatively or additionally, in some embodiments the method includes coating the tablets. Alternatively or additionally, in some embodiments the method includes encapsulating the lipid material adhered to the fiber in an external capsule. Alternatively or additionally, in some embodiments the method includes granulating the lipid material adhered to the fiber and using the resultant granules in the dispersing.

Some exemplary embodiments of the invention relate to use of lipid material which is at least 50% digestible (by weight) and substantially free of protein to coat dietary fiber in a food preparation. Alternatively or additionally, some exemplary embodiments of the invention relate to use of lipid material which is at least 50% digestible (by weight) in preparation of a medicament formulated to reduce digestive absorption of dietary fats. Alternatively or additionally, some exemplary embodiments of the invention relate to use of lipid material which is at least 50% digestible (by weight) in preparation of a medicament formulated to reduce blood cholesterol levels. Alternatively or additionally, some exemplary embodiments of the invention relate to use of lipid material which is at least 50% digestible (by weight) in preparation of a medicament formulated to reduce digestive absorption of dietary carbohydrates. According to various exemplary embodiments of the invention one or more of these medicaments is formulated as a food or beverage. Alternatively or additionally, in some embodiments one or more of these medicaments includes particles including dietary fiber with the lipid material adhered to the fiber. Alternatively or additionally, in some embodiments one or more of these medicaments includes particles including a core including dietary fiber as an active ingredient and a coating including the lipid material surrounding the core. Alternatively or additionally, in some embodiments the coating is substantially free of protein. Alternatively or additionally, in some embodiments the lipid material in one or more of these medicaments includes one or more of at least one natural edible oil and at least one other lipid material.

In some exemplary embodiments of the invention, there is provided a treatment method including: (a) providing a composition as described hereinabove, or a plurality of particles as described hereinabove; (b) administering a physiologically effective amount of the composition and/or particles to a subject in need thereof to alter the subject's metabolism. In some embodiments, the administering alters the subject's metabolism by reducing digestive absorption of dietary fats. Alternatively or additionally, in some embodiments the administering alters the subject's metabolism by reducing blood cholesterol levels. Alternatively or additionally, in some embodiments the administering alters the subject's metabolism by reducing digestive absorption of dietary carbohydrates.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although suitable methods and materials are described below, methods and materials similar or equivalent to those described herein can be used in the practice of the present invention. In case of conflict, the patent specification, including definitions, will control. All materials, methods, and examples are illustrative only and are not intended to be limiting.

As used herein, the terms "comprising" and "including" or grammatical variants thereof are to be taken as specifying inclusion of the stated features, integers, actions or components without precluding the addition of one or more additional features, integers, actions, components or groups thereof. This term is broader than, and includes the terms "consisting of" and "consisting essentially of" as defined by the Manual of Patent Examination Procedure of the United States Patent and Trademark Office.

The phrase "adapted to" as used in this specification and the accompanying claims imposes additional structural limitations on a previously recited component.

The term "method" refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of architecture and/or computer science. Percentages (%) of chemicals and other components are WAV (weight per weight) unless otherwise indicated.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying figures. In the figures, identical and similar structures, elements or parts thereof that appear in more than one figure are generally labeled with the same or similar references in the figures in which they appear. Dimensions of components and features shown in the figures are chosen primarily for convenience and clarity of presentation and are not necessarily to scale. The attached figures are:

FIG. la is a schematic view of an edible composition including dietary fiber associated with lipid material according to some exemplary embodiments of the invention;

FIG. lb is a schematic view of a relatively ordered array of edible composition dietary fibers associated with lipid material as depicted in Fig. la according to some exemplary embodiments of the invention;

FIG. lc is a schematic view of a relatively disordered array of edible composition dietary fibers associated with lipid material as depicted in Fig. la according to some exemplary embodiments of the invention;

FIG. 2a is a schematic transverse cross-sectional view of a particle including a core of dietary fiber as an active ingredient and a coating of lipid material according to some exemplary embodiments of the invention;

FIG. 2b is a schematic transverse cross-sectional view of a particle similar to that of Fig 2a except that the dietary fiber in the core includes an edible composition as depicted in Fig. la;

FIG. 3 is a schematic transverse cross-sectional view of a particle similar to that depicted in Figs. 2a and/or 2b with an optional dispersing agent and/or an optional additional active ingredient as it disperses the core following interruption of the coating;

FIG. 4a is a schematic transverse cross-sectional view of an oral dosage form according to some embodiments of the invention including an edible composition as depicted in Fig lb surrounded by an external coating or capsule;

FIG. 4b is a schematic transverse cross-sectional view of an oral dosage form according to some embodiments of the invention including particles as depicted in Fig 2a and/or Fig. 2b surrounded by an external coating or capsule;

Fig. 5 is a simplified flow diagram of methods of manufacture according to some exemplary embodiments of the invention; and Fig. 6 is a simplified flow diagram of methods of treatment according to some exemplary embodiments of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Various exemplary embodiments of the invention relate to compositions or particles including dietary fiber in conjunction with lipid material that is at least 50% digestible, foods or beverages containing the compositions or particles, methods of making the compositions or particles, oral dosage forms including the compositions or particles and treatment methods which employ the compositions or particles.

Some exemplary embodiments of the invention, relate to use of lipid material which is at least 50% digestible (by weight) to coat dietary food fiber and/or to prepare medicaments. According to various exemplary embodiments of the invention the medicaments are formulated to reduce digestive absorption of dietary fats and/or to reduce blood cholesterol levels and/or to reduce digestive absorption of dietary carbohydrates. Alternatively or additionally, according to various exemplary embodiments of the invention the medicament is formulated as a food, a beverage or an oral dosage form (e.g. tablet or capsule).

Alternatively or additionally, some embodiments of the invention can be used to mask the flavor and/or texture of dietary fiber in foods and/or beverages.

The principles and operation of compositions and/or particles and/or methods and/or uses according to exemplary embodiments of the invention may be better understood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

Overview

According to various exemplary embodiments of the invention lipid matter is associated with dietary fiber. According to various exemplary embodiments of the invention lipid matter 120 is associated directly with fibers 110 (Figs, la and 2b) and/or is used as a coating 220 applied to cores 210 containing the fiber (Figs. 2a and 2b).

In some embodiments, this association allows a significant amount of dietary fiber to be incorporated into a food product or beverage without significantly altering the perceived texture or flavor of the food/beverage. Incorporation of dietary fiber into foods and/or beverages presents at least two problems in terms of flavor/texture. One problem is that dietary fiber can absorb water so that the fiber tends to draw water out of high moisture products and impart a gummy or soggy texture to the product. Another problem is that dry dietary fiber in a food product can impart a gritty texture which is often perceived as objectionable. Various exemplary embodiments of the invention address one or both of these problems as described in greater detail hereinbelow.

Alternatively or additionally, in some embodiments an amount of fiber 110 included in a formulation has the capacity to affect metabolism of a much greater quantity of lipid than that present in droplets 120 and/or coating 220. In some embodiments, consumers are willing to ingest physiologically effective amounts of fiber because presence of the fiber is masked by associated lipids 120 and/or 220. Exemplary physiologic effects of some embodiments of the invention include, but are not limited to, reduced fat metabolism, reduced carbohydrate metabolism and reduced blood cholesterol levels.

Exemplary structural units

Fig la depicts a coated fiber according to some embodiments of the invention indicated generally as 100. Coated fiber 100 includes dietary fiber 110 with a plurality of droplets of lipid material 120 adsorbed or adhered thereto.

Fig. 2a depicts a particle indicated generally as 200 with a core 210 including dietary fiber 110 as an active ingredient and a coating 220 including lipid material surrounding core 210.

Fig. 2b depicts a particle indicated generally as 201 with a core 210 including coated fibers 100 as an active ingredient and a coating 220 including lipid material surrounding core 210.

In some embodiments, a core of a single particle includes both coated fibers 100 and uncoated fibers 110 (see Fig. 3). Alternatively or additionally, in some embodiments, a single particle includes coated fibers 100 coated with different types of lipid droplets 120.

In some exemplary embodiments of the invention, lipid droplets 120 and/or coating 220 serve to retard wetting of fiber 110. Optionally, this retardation of wetting can help to reduce a change of texture of a food or beverage in which coated fibers 100 and/or particles 200 have been incorporated between preparation of the food/beverage and its consumption.

Alternatively or additionally, this retardation of wetting can help to impart targeting function to fibers 110 so that they are wetted in a desired portion of the digestive tract.

Alternatively or additionally, droplets 120 and/or coating 220 mask the perceived gritty texture of fibers 110 by serving as an intervening layer between the fibers and the tongue during ingestion. In some exemplary embodiments of the invention, contact of lipids (120 and/or 220) with the tongue is perceived favorably (e.g. as creamy, rich or smooth).

Exemplary compositions Fig. la depicts an edible composition 100 including dietary fiber 110 as an active ingredient and a coating of lipid material 120 which is at least 50% digestible (by weight) formulated to retard wetting of dietary fiber 110. According to various exemplary embodiments of the invention the coating of lipid material 120 is formulated to retard wetting of fiber 110 after 5 ingestion as composition 100 passes through the mouth, esophagus and stomach. Alternatively or additionally, coating of lipid material 120 (Fig. la) is formulated to retard wetting of fiber 110 after incorporation into a moist food product/beverage (e.g. yogurt, ice cream, cottage cheese, milk, and kefir) and the time the food/beverage is consumed.

According to various exemplary embodiments of the invention coating of lipid material 10 120 is formulated to retard wetting of fiber 110 so that fiber 110 absorbs less than 50, 25, 10, 5 or even less than 1% or intermediate percentages of its weight in water between the time it is incorporated into a food product/beverage and the latest "use by" date indicated on the package.

Alternatively or additionally, according to various exemplary embodiments of the invention coating of lipid material 120 is formulated to retard wetting of fiber 110 so that fiber 15 110 absorbs less than 50, 25, 10, 5 or even less than 1% or intermediate percentages of its weight in water between its ingestion and its passage through the pylorus into the intestine.

According to various exemplary embodiments of the invention the rate of wetting of fiber 110 is controlled by adjusting one or more of a composition of lipids in droplets 120 and/or a relative amount of droplets 120 to fiber 110 and/or selection of fiber 110 with appropriate 20 wetting properties.

Fig. lb depicts an aggregate 102 of coated fibers 100 in which fibers 110 are relatively organized with respect to one another. Optionally, composition of lipids in droplets 120 contributes to this organization.

Fig. lc depicts an aggregate 104 of coated fibers 100 in which fibers 110 are relatively 25 disorganized with respect to one another. Optionally, composition of lipids in droplets 120 contributes to this disorganization.

Exemplary particles

Fig. 2a depicts an ingestible particle indicated generally as particle 200. Depicted exemplary particle 200 includes a core 210 including dietary fiber 110 as an active ingredient 30 and a coating 220 comprising lipid material which is at least 50% digestible (by weight) surrounding core 210.

Fig. 2b depicts an ingestible particle indicated generally as particle 201. Depicted exemplary particle 201 is similar to particle 200 except that fibers 110 are provided as composition 100 of Fig. la (described hereinabove). In other exemplary embodiments of the invention, a single core 210 contains a mixture of uncoated fiber 110 and coated fiber of composition 100 (see Fig. 3).

According to various exemplary embodiments of the invention coating 220 of lipid material is formulated to retard wetting of fiber 110 so that fiber 110 absorbs less than 50, 25, 10, 5 or even less than 1 % or intermediate percentages of its weight in water between the time it is incorporated into a food product/beverage and the latest "use by" date indicated on the package.

Alternatively or additionally, according to various exemplary embodiments of the invention coating 220 of lipid material is formulated to retard wetting of fiber 110 so that fiber 110 absorbs less than 50, 25, 10, 5 or even less than 1% or intermediate percentages of its weight in water between its ingestion and its passage through the pylorus into the intestine.

According to various exemplary embodiments of the invention the rate of wetting of fiber 110 is controlled by adjusting one or more of a composition of lipids in droplets 120 and/or a relative amount of droplets 120 to fiber 110 and/or selection of fiber 110 with appropriate wetting properties.

Considerations for formulation to control rate of wetting are similar to those discussed hereinabove. In addition, additive and/or synergistic effects between coating 220 and lipid droplets 120 on fiber 110 of composition 100 included in core 210 can contribute to retardation of wetting of fibers 110.

Exemplary dietary fibers

According to various exemplary embodiments of the invention dietary fibers 110 include cellulose and/or hemicellulose and/or lignin and/or pectin and/or dextrin and/or gums and/or polyfructoses.

Alternatively or additionally, dietary fibers 110 can be provided as, or derived from bran (e.g. oat bran, wheat bran, rice bran), grain husks (e.g. wheat chaff, rice hulls) psyllium (i.e. husks and/or seeds of Plantago spp.), carambola insoluble fiber and chitosan.

Exemplary lipid materials

According to various exemplary embodiments of the invention the lipid material employed in droplets 120 and/or coating 220 includes natural edible oils and/or other lipid materials.

Natural edible oils include, but are not limited to, vegetable oil (e.g. rapeseed oil, canola oil, soybean oil, corn oil), coconut oil, cocoa butter, palm oil, olive oil, avocado oil (from pits and/or fruit), peanut oil, nut oils (e.g. walnut oil, hazelnut oil, brazil nut oil, macadamia nut oil), cashew oil, sesame oil and fish oils.

Other lipid materials include fats, fatty acids, triglycerides, triglycerides, monoglycerides, omega-3 fatty acids and phospholipids. Fats includes, but is not limited to, milk fat (e.g. butter or cream), animal fat (e.g. beef fat, lamb fat, chicken fat, pork fat, duck fat and whale blubber) and vegetable fat (e.g. margarine or shortening).

In some exemplary embodiments of the invention, the other lipid materials include controlled amounts of indigestible oils. Indigestible oils include linseed oil, castor bean oil and tung oil.

According to various exemplary embodiments of the invention the associated lipid material is used "as is", is partially hydrogenated, or is fully hydrogenated. Alternatively or additionally, the associated lipid material optionally includes a viscosifying agent(s) and/or an emulsifying agent(s) and/or a plasticizing agent(s) and/or a stabilizing agent(s) and/or a firming agent.

Exemplary formulation considerations

According to various exemplary embodiments of the invention lipid material present in droplets 120 and/or coating 220 constitutes between 10 percent and 60 percent by volume of composition 100 or particle 200 or particle 201. Alternatively or additionally, in some embodiments a weight of dietary fiber 110 is at least twice as much as a weight of lipid material in droplets 120 and/or coating 220. Alternatively or additionally, in some embodiments a weight of dietary fiber 110 is not more than three times as much as a weight of lipid material a weight of lipid material in droplets 120 and/or coating 220. Alternatively or additionally, in some embodiments a single coated fiber or a particle 200 or 201 characterized by an average transverse cross sectional diameter of 700, 600, 500, 400, 200 or even 100 μιη or smaller or intermediate diameters. Alternatively or additionally, droplets 120 and/or coating 220 are provided substantially free of protein. Alternatively or additionally, lipid material in droplets 120 and/or coating 220 is de-stabilized at a pH > 7.0. As used here "destabilized" means disrupted and/or dissociated from fibers 110 and/or core 210.

Alternatively or additionally, lipid material in droplets 120 and/or coating 220 is hydrolyzable by at least one lipase found in the intestine. Alternatively or additionally, lipid material in droplets 120 and/or coating 220 is reactive to bile. In some embodiments, reactivity to bile includes emulsification and/or dispersion by bile or its components. Alternatively or additionally, lipid material in droplets 120 and/or coating includes one or more of at least one natural edible oil and at least one other lipid material. Alternatively or additionally, composition 100 and/or particle 200 or 201 include a viscosifying agent and/or an emulsifying agent and/or a plasticizing agent and/or a stabilizing agent and/or a firming agent.

Exemplary additional ingredients

In some exemplary embodiments of the invention, the composition and/or particles contain one or more additional ingredients. According to various exemplary embodiments of the invention these additional ingredients can be adsorbed to fibers 110 and/or associated with lipid droplets 120 and/or incorporated into core 210 and/or incorporated into coating 220.

According to various exemplary embodiments of the invention these additional ingredients include additional active ingredients (in addition to fibers 110) and/or inactive ingredients. Additional active ingredients include, but are not limited to, pharmaceutically active compounds and/or nutrients. In active ingredients include, but are not limited to excipients and fillers.

Exemplary pharmaceutically active compounds include, but are not limited to, hormones (e.g. insulin), analgesics, antidepressants, antibiotics, antivirals, probiotics, enzymes, oncolytics, and immune regulators (e.g. immuno-modulators, immunogens, vaccines and antibodies).

Exemplary nutrients include, but are not limited to, vitamins, minerals, growth factors, nutritional fatty acids (e.g. omega-3 fatty acids), antioxidants and nutraceuticals (e.g. persopolis, phytohormones, plant extracts and animal extracts).

Exemplary excipients include, but are not limited to, antioxidants, dispersing agents, disintegrating agents, anti-caking agents, emulsifiers and fillers.

Exemplary release mechanism

Fig. 3 depicts a particle, indicated generally as 300, according to some exemplary embodiments of the invention as it interacts with intestinal contents in a target area of the intestine. Reference numerals used in previous figures indicate corresponding structures in Fig. 3.

In the depicted exemplary embodiment, interaction with the intestinal contents causes formation of pores 310 in lipid coating 220 surrounding core 210. Pores 310 allow dietary fiber 110 and/or coated fibers 100 to exit the particle into the intestinal lumen. Although two pores 310 are depicted for simplicity, a much greater number may actually be present. Alternatively or additionally, in some embodiments coating 220 is completely dissolved and/or thoroughly disrupted so that the entire contents of core 210 are free to interact with the contents of the intestinal lumen.

In the depicted exemplary embodiment, particle 300 includes dispersing agent(s) 350 in core 210 to improve dispersion of fibers 110 and/or coated fibers 110 from the particle. Alternatively or additionally, in some embodiments particle 300 includes additional active ingredient(s) 360 which it delivers to the intestinal lumen when coating 220 is disrupted.

In the depicted exemplary embodiment, delivery of contents of core 210 to the intestinal lumen has at least two effects.

One effect is that uncoated fibers 110 are substantially immediately available to interact with contents of the intestinal lumen. Potential interactions include, but are not limited to, absorption of water, binding of lipids, binding of bile components and binding of carbohydrates. In some exemplary embodiments of the invention, absorption of water by fibers 110 contributes to an increase in viscosity of the intestinal contents. This increase in viscosity can, in turn, contribute to a slow-down in enzymatic kinetics by making it more difficult for enzymes to find their targets. Such a slow-down, if it occurs, would be expected to reduce digestion of ingested food, and reduce absorption through the intestinal wall by a corresponding degree.

Alternatively or additionally, in some embodiments binding of lipids by fibers 110 contributes to a reduction in availability of those lipids to lipase and/or bile. This reduction in availability, in turn, contributes to reduction in lipid digestion. Such a reduction in lipid digestion, if it occurs, would be expected to reduce absorption of lipids through the intestinal wall by a corresponding degree.

Alternatively or additionally, in some embodiments binding of bile components by fibers 110 contributes to a reduction in bile activity. Such a reduction in bile activity, if it occurs, would be expected to reduce digestion of lipids and their subsequent absorption through the intestinal wall.

Alternatively or additionally, in some embodiments binding of carbohydrates by fibers

110 contributes to a reduction in carbohydrate digestion and/or absorption. Such a reduction, if it occurs, would be expected to reduce lipid formation through the glycolytic cycle.

Regardless of the exact type or types of interaction of fibers 110 with the intestinal contents, it is expected that the percentage of ingested calories which are digested and absorbed will decrease as a result of ingestion of composition 100 and/or particles 200 and/or 201. Alternatively or additionally, circulating lipid levels and/or blood cholesterol levels are expected to decrease as a result of ingestion of composition 100 and/or particles 200 and/or 201.

Another effect is that coated fibers 100 are available to interact with contents of the intestinal lumen. Interaction of coated fibers 100 will begin with disruption of lipid droplets 120 (see Fig. la). This will cause a time delay, after which previously coated fibers 100 will become available for the range of interactions described above as fibers 100.

In some embodiments, incorporation of uncoated fibers 110 and coated fibers 100 into a single particle (e.g. 300 in Fig. 3) contributes to an ability to distribute active fibers through a broader target zone in the intestine.

Exemplary oral dosage forms

In some exemplary embodiments of the invention, compositions 100 and/or particles 200 and/or 201 are provided as oral dosage forms.

Fig. 4a depicts an oral dosage form, indicated generally as 400, including composition 100 as described hereinabove. Fig. 4b depicts an oral dosage form, indicated generally as 402, including particles 200 and/or 201 as described hereinabove.

In other exemplary embodiments of the invention, particles 300 as described hereinabove are incorporated into an oral dosage form of type 400 and/or 402 (not depicted).

As used in this specification and the accompanying claims the term "oral dosage form" includes tablets, capsules, gel-caps, syrups, suspensions, powders, granules, dragees and elixirs. In some embodiments, oral dosage form 400 and/or 402 includes one or more additional active ingredients (see 360 in Fig. 3). In some exemplary embodiments of the invention, the additional active ingredients are incorporated into cores 210 of particles 200 and/or 201 as described above. In other exemplary embodiments of the invention, the additional active ingredients are incorporated into, or provided with, composition 100.

In some exemplary embodiments of the invention, the oral dosage form is provided as a tablet. Tablets can be prepared by compressing composition 100 and/or particles 200 and/or 201. Optionally, a binder or filler is added during compression. In some exemplary embodiments of the invention, compression produces an ordered array 102 (Fig. lb). In other exemplary embodiments of the invention, compression produces a disordered array 104 (Fig. lc).

In some embodiments, an oral dosage form provided as a tablet includes an external coating 410 or 412.

In some embodiments, the oral dosage form is provided as a capsule or gel-cap comprising an external capsule 410 or 412. According to various exemplary embodiments of the invention external capsule 410 or 412 includes one or more gelling agents (e.g. proteins such as gelatin and/or polysaccharides (e.g. carrageenans) and/or modified starches and/or cellulose). Alternatively or additionally, external capsule 410 or 412 includes plasticizers (e.g. sorbitol and/or glycerin) and/or disintegrants and/or lubricants.

Exemplary preparations

In some exemplary embodiments of the invention, compositions 100 and/or particles 200 and/or 201 are incorporated into a food or beverage. Thus, some embodiments of the invention relate to a preparation including a composition 100 or a plurality of particles 200 or 201 incorporated into a food or beverage.

According to various exemplary embodiments of the invention composition 100 or a plurality of particles 200 or 201 is/are incorporated into yogurt and/or ice cream and/or mayonnaise and/or salad dressing and/or peanut butter and/or chocolate spread and/or dulce de leche and/or margarine and/or butter and/or jam and/or sausage and/or cheese and/or an energy bar and/or a granola bar and/or frosting and/or a confectionary coating and/or a pastry filling. In other exemplary embodiments of the invention, composition 100 or a plurality of particles 200 or 201 is/are incorporated into a beverage such as a sports drink and/or an energy drink and/or kefir and/or milk and/or chocolate milk and/or iced coffee and/or a milk shake and/or a fruit smoothie.

In other exemplary embodiments of the invention, composition 100 or a plurality of particles 200 or 201 is/are incorporated into pet foods and/or animal feeds.

In some exemplary embodiments of the invention, composition 100 or a plurality of particles 200 or 201 incorporated into a food/beverage are characterized by an average moisture content of less than 50, 40, 30, 20, 10, 5, 2 or even 1% or intermediate or lower degrees of moisture.

Although composition 100 or a plurality of particles 200 or 201 is/are amenable to incorporation into a wide range of products, the masking effect described above is optionally enhance if such incorporation is performed in a way that lipid droplets 120 and/or coating 220 are not melted. While the exact melting temperature may vary with the specific lipid composition employed, about 70 °C may be a theoretical limit. In some exemplary embodiments of the invention, manufacture of foods/beverages incorporating composition 100 or a plurality of particles 200 or 201 on an industrial scale should is planned accordingly.

For example, incorporation of composition 100 or a plurality of particles 200 or 201 into a cake is more easily accomplished by adding the composition/particle to the icing than to the cake batter.

As another example, incorporation of composition 100 or a plurality of particles 200 or 201 into jam can optionally be done after the jam is partially cooled.

Exemplary methods of manufacture

Fig. 5 is a simplified flow diagram of methods of manufacture according to various exemplary embodiments of the invention indicated generally as method 500. Depicted exemplary method 500 includes dispersing 510 dietary fiber in a gas stream, spraying 520 lipid material which is at least 50% digestible (by weight) onto the fiber; and cooling 530 the lipid material so that it adheres to the fiber. In the depicted exemplary embodiment, this produces coated fibers 532.

In those embodiments of the invention in which untreated fibers are dispersed (510), coated fibers 532 will be of the type depicted as 100 in Fig. la.

In some embodiments, the gas stream is maintained at a temperature that keeps the lipid material in a liquid state. Alternatively or additionally, in some embodiments of the invention, cooling 530 causes gelling or solidification of the lipid material. In some exemplary embodiments of the invention, method 500 includes granulating 508 the dietary fiber. Granulation produces small pellets which can serve as cores 210 of particle 200. In those embodiments of the invention in which granulated fibers are dispersed (510), coated fibers 532 will be in the form of particles 200 in Fig. 2a. In some embodiments, the fibers 5 are micronized prior to granulation.

According to various exemplary embodiments of the invention the composition of coated fibers 532 is controlled in terms of the ratio of lipid to dietary fiber in order to achieve desired properties between formulation and use and/or in the mouth and/or in the stomach/intestines. In some exemplary embodiments of the invention, the lipid material has a volume of 10 to 60% of 10 the dietary fiber. Alternatively or additionally, in some embodiments, a weight of the dietary fiber is at least twice as much as a weight of the lipid material. Alternatively or additionally, in some embodiments, a weight of the dietary fiber is not more than three times as much as a weight of the lipid material.

According to various exemplary embodiments of the invention, coated fibers 532 are 15 further processed in different ways.

In some embodiments, coated fibers 532 are granulated 509 and introduced into method 500 at dispersing 510. If only fibers granulated at 509 are employed in the method, the resultant coated fibers 532 will be particles 201 (Fig. 2a). If granulation 508 and granulation 509 are conducted in parallel with all granules proceeding to dispersing 510, a mixture of particles 200 20 and 201 will result. In other exemplary embodiments of the invention, untreated dietary fiber and coated fibers 532 are granulated together (indicated by double headed arrow between 508 and 509) to produce mixed cores. Subsequent spraying 520 and cooling 530 of these mixed cores produces coated fibers 532 in the form of particles 300 (Fig. 3).

In some exemplary embodiments of the invention, method 500 includes incorporating 25 540 the lipid material adhered to the fiber (coated fibers 532) into a food or beverage. Various foods/beverages produced by incorporation 540 are described above.

In some exemplary embodiments of the invention, method 500 includes compressing 550 said lipid material, adhered to said fiber (coated fibers 532) ,to produce tablets 552. Optionally, method 500 includes coating 555 tablets 552 to produce coated tablets 556. Coated tablets 556 30 are an oral dosage form as described hereinabove (e.g. 400 or 402, depending on what form of dietary fiber was input at dispersing 510).

In some exemplary embodiments of the invention, method 500 includes encapsulating 560 said lipid material adhered to said fiber (coated fibers 532) in an external capsule to produce an oral dosage form (capsules 562).

35 Exemplary industrial uses Various exemplary embodiments of the invention relate to new uses of known materials in manufacturing or production processes.

Some exemplary embodiments of the invention, relate to use of lipid material which is at least 50% digestible (by weight) and substantially free of protein to coat dietary fiber in a food preparation. Optionally, the coating forms particles. Various foods resulting from this use are described hereinabove.

Some exemplary embodiments of the invention, relate to use of lipid material which is at least 50% digestible (by weight) in preparation of a medicament formulated to reduce digestive absorption of dietary fats. Optionally, the lipid is associated with dietary fiber as described hereinabove.

Some exemplary embodiments of the invention, relate to use of lipid material which is at least 50% digestible (by weight) in preparation of a medicament formulated to reduce blood cholesterol levels. Optionally, the lipid is associated with dietary fiber as described hereinabove. In some exemplary embodiments of the invention, the lipid material is characterized by a high degree of saturation (e.g. beef fat, butter, cocoa butter or palm oil). Optionally, the lipid is associated with dietary fiber as described hereinabove.

Some exemplary embodiments of the invention, relate to use of lipid material which is at least 50% digestible (by weight) in preparation of a medicament formulated to reduce digestive absorption of dietary carbohydrates. Optionally, the lipid is associated with dietary fiber as described hereinabove.

In some exemplary embodiments of the invention, the various medicaments described above are formulated as a food or beverage. Alternatively or additionally, in some embodiments, the medicament contains particles (e.g. 200 and/or 201 and/or 300) including dietary fiber with the lipid material adhered to the fiber. In some of these embodiments, the medicament contains particles including a core including dietary fiber as an active ingredient and a coating including the lipid material surrounding the core. Alternatively or additionally, in some embodiments the coating is substantially free of protein. Alternatively or additionally, in some embodiments the lipid material includes one or more of at least one natural edible oil and at least one other lipid material.

Exemplary treatment methods

Fig. 6 is a simplified flow diagram of methods of treatment according to some exemplary embodiments of the invention indicated generally as method 600. Depicted exemplary method 600 includes providing 610 a composition (100) or a plurality of particles (e.g. 200 and/or 201 and/or 300) as described hereinabove. According to various exemplary embodiments of the invention the provided composition/particles can be in the form of a food preparation or an oral dosage form as described hereinabove.

Depicted method 600 includes administering 620 a physiologically effective amount of the particles or the preparation to a subject in need thereof to alter 630 the subject's metabolism. An initial estimate of a physiologically effective dose can be made by determining the subject's current condition, reported eating habits and metabolic goals. Monitoring of relevant metabolic parameters during treatment will allow dosage adjustment if needed.

In some exemplary embodiments of the invention, administering 620 alters the subject's metabolism by reducing digestive absorption of dietary fats. Alternatively or additionally, in some exemplary embodiments of the invention, administering 620 alters the subject's metabolism by reducing blood cholesterol levels. Alternatively or additionally, in some exemplary embodiments of the invention, administering 620 alters the subject's metabolism by reducing digestive absorption of dietary carbohydrates.

It is expected that during the life of this patent many lipid and/or fiber types will be characterized and the scope of the invention is intended to include all such new materials a priori.

As used herein the term "about" refers to ± 10 %.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

Specifically, a variety of numerical indicators have been utilized. It should be understood that these numerical indicators could vary even further based upon a variety of engineering principles, materials, intended use and designs incorporated into the various embodiments of the invention. Additionally, components and/or actions ascribed to exemplary embodiments of the invention and depicted as a single unit may be divided into subunits. Conversely, components and/or actions ascribed to exemplary embodiments of the invention and depicted as sub- units/individual actions may be combined into a single unit/action with the described/depicted function.

Alternatively, or additionally, features used to describe a method can be used to characterize an apparatus and features used to describe an apparatus can be used to characterize a method.

It should be further understood that the individual features described hereinabove can be combined in all possible combinations and sub-combinations to produce additional embodiments of the invention. The examples given above are exemplary in nature and are not intended to limit the scope of the invention which is defined solely by the following claims. Specifically, the invention has been described in the context of the general population but might also be used in subjects with various metabolic disorders that cause obesity.

All publications, references, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

The terms "include", and "have" and their conjugates as used herein mean "including but not necessarily limited to".

Additional objects, advantages, and novel features of various embodiments of the invention will become apparent to one ordinarily skilled in the art upon examination of the following examples, which are not intended to be limiting. Additionally, each of the various embodiments and aspects of the present invention as delineated hereinabove and as claimed in the claims section below finds experimental support in the following examples.

EXAMPLES

Reference is now made to the following exemplary formulations and use scenarios which, together with the above descriptions, illustrate the invention in a non- limiting fashion.

It is stressed that all of these formulations are hypothetical and have not yet been actually prepared or tested in animal or human subjects to determine actual physiologic efficacy.

EXAMPLE 1:

Mayonnaise

In order to present exemplary advantages of some embodiments of the invention in a more concrete fashion an exemplary use scenario is presented in which a composition 100 or particles 200 according to an exemplary embodiment of the invention is/are introduced into mayonnaise.

Table 1 summarizes composition data for a well known commercially available full fat mayonnaise and mayonnaise prepared according to four exemplary embodiments of the invention indicated as Ml to M4 respectively.

Calories are presented based upon predicted calorimetric data (lipids = 9 cal/gram; carbohydrates = 4 cal/gram) as well as predicted metabolizable calories. Dietary fiber, although it is a carbohydrate, is substantially indigestible so that it contributes 4 cal/gram to calorimetric calories, and zero calories/gram to metabolizable calories.

Results presented in table 1 indicate formulation Ml would probably be deemed acceptable by most consumers, despite the fact that it has only one fifth the fat of full fat mayonnaise. One reason for this may be that organization of the lipids around fibers gives a high ratio of lipid surface area per gram of lipid so that the sensory mechanism in the tongue is deceived. Alternatively or additionally, results presented in table 1 indicate formulation Ml would probably be deemed acceptable by most consumers, despite the fact that it has 38% dietary fiber. Again, the organization of the lipids around fibers masks the presence of fibers and the sensory mechanism in the tongue is deceived.

Assuming that each gram of dietary fiber can prevent absorption of 7.5 grams of dietary fat into the body, the predicted metabolizable calories for Ml are near zero. This is because the dietary fiber itself is substantially indigestible and the presence of the fiber interferes with digestion and/or absorption of fat present in the mayonnaise so that substantially none of it is absorbed.

In the described exemplary embodiments, each gram of the dietary fiber has the capacity to interfere with digestion and/or absorption of 7.5 grams of fat (e.g. chitosan). This means that a one tablespoon serving of mayonnaise Ml has a predicted metabolic fat impact of -35.5 grams. In other words, consumption of the mayonnaise concurrently with another food containing fat can interfere with digestion and/or absorption of an additional 35.5 grams of fat in the other food.

Table 1: Mayonnaise formulations

* When consumed as part of a meal including other sources of dietary fat.

†Of the 10 grams, about 0.5 grams is associated with dietary fiber; the remaining fat is in an emulsion with water as in regular mayonnaise. Turning now to exemplary embodiment M2, it is formulated to contain 3.5 grams of fat and 7 grams of fiber in a 1 tablespoon serving. This is about one third the fat present in commercial full fat mayonnaise. It is believed that this formulation would be perceived as rich by most subjects consuming the product and that that would rate it as roughly equivalent in terms of flavor and mouth feel to commercially available full fat mayonnaise. Reasons for this are as discussed above in the context of Ml.

M2, like Ml, has nearly zero metabolizable calories. Surprisingly, M2 has a metabolic fat impact of -49 grams per serving (13.5 grams better than Ml). This is despite the fact that M2 contains 1.5 additional grams of fat per serving relative to Ml.

M3 is presented to illustrate practical limitations associated with practice of some embodiments of the invention. For very high fat foods such as mayonnaise, it may be difficult to achieve the "normal" fat content of the food product using only fat formulated according to an embodiment of the invention. M3 is formulated by beginning with 10 grams of fat per tablespoon (as in commercially available mayonnaise). Embodiments Ml and M2 each have more than two grams of fiber per gram of fat. However, there is not sufficient space in a 1 tablespoon serving to preserve this ratio in M3, so a 1 : 1 ratio of fiber: fat is employed. This still gives a 1 tablespoon serving a weight of 20 grams, as opposed to 13 grams for commercial full fat mayonnaise. It is anticipated that this formulation would have a significantly higher viscosity than regular mayonnaise and would be perceived by most subjects as "too rich". This is despite the fact that M3 contains 50% fiber. The predicted metabolic fat impact of M3 is an impressive - 65 grams per 1 tablespoon serving. In some embodiments, M3 could be mixed with other ingredients to increase palatability. For example, M3 could be mixed with lemon juice or vinegar and used in preparation of tuna salad, chicken salad or ham salad. Alternatively or additionally, M3 could be mixed with mustard and used as a condiment for French fried potatoes. Alternatively or additionally, M3 could be mixed with ketchup/diced pickles to make "French/thousand island" dressing for salads.

M4 is presented to illustrate an exemplary way to overcome practical limitations encountered in preparation of M3. M4 contains 10 grams of fat per serving, like M3 and commercial full fat mayonnaise. However, only 0.5 grams of this fat is associated with the 1.33 grams of dietary fiber provided in the M3 formulation. The remaining 9.5 grams of fat is present as an emulsion as in regular mayonnaise. This formulation returns the weight of a 1 tablespoon serving to 13 grams (relative to the 20 grams of M3) and provides a user perception of "rich". This user perception is not surprising since M4 is 95% commercial full fat mayonnaise. What is surprising is that the predicted metabolic fat impact of a product that is 95% full fat mayonnaise is zero. Results summarized in table 1 illustrate that it will be possible to formulate food products so that they have an acceptable flavor and texture and a negative metabolic fat impact by incorporating dietary fat into the product as compositions 100 and/or particles 200 or 201 as described hereinabove.

Alternatively or additionally, results summarized in table 1 illustrate that it will be possible to formulate high fat food products so that they have an acceptable flavor and texture and a metabolic fat impact near zero by incorporating dietary fat into the product as compositions 100 and/or particles 200 or 201 as described hereinabove.

EXAMPLE 2:

Mayonnaise according to embodiment M2

as part of a high fat meal

In order to illustrate how the "predicted metabolic impact" from Example 1 might be used advantageously in a real life setting, a hypothetical fast food meal from McDonald's^® is presented and the effect of adding commercially available full fat mayonnaise or mayonnaise according to embodiment M2 as described in Example 1 is considered.

Table 2 summarizes fat content for a meal including standard McDonald's^® menu items as well as the metabolic impact of adding mayonnaise to such a meal.

Data on fat content of McDonald's^® menu items are taken from:

http://nutritionDOTmcdonaldsDOTcom/getnutrition/nutritionfacts.pdf

on February 9. 2012.

Results presented in table 2 (below) show that the fast food meal of three standard menu items contains 91 grams of fat. Presumably, substantially all of this fat is metabolizable.

Table 2: Impact of added mayonnaise on a typical fast food meal

McDonald's^® Meal

Food item Fat content

(grams)

Double quarter 42

pounder^® with cheese

Large Fries 154 gram 25

Chocolate McCafe 24 Mayonnaise added

shake 22 oz.

Total fat in meal 91 commercial full fat Embodiment M2

Mayonnaise serving size 1 Tbsp. 2 Tbsp. 1 Tbsp. 2 Tbsp.

Predicted metabolic fat impact +10 +20 -49 -98

from mayonnaise

Predicted metabolizable fat from 101 111 42 zero

meal consumed with mayonnaise As would be expected, adding commercial full fat mayonnaise increases the metabolizable fat content by 10 grams/tablespoon of mayonnaise.

However, adding 1 tablespoon of mayonnaise according to embodiment M2 from Example 1 interferes with digestion and/or absorption of more than half of the fat in the meal. This corresponds to a reduction of 440 metabolized calories.

If two tablespoons of mayonnaise according to embodiment M2 from Example 1 are added, they interfere with digestion and/or absorption of substantially all of the fat in the meal. This corresponds to a reduction of 880 metabolized calories.

Results presented in table 2 illustrate how exemplary embodiments of the invention might help people who are unwilling and/or unable to comply with sensible dietary regimens control their weight.

Alternatively or additionally, this example illustrates how fat in foods prepared at relatively high temperatures (e.g. Hamburger and French fries) can be handled by post preparation application of a composition 100 and/or particles 200 or 201 according to exemplary embodiments of the invention.

EXAMPLE 3:

Two component products

Example 2 dealt with addition of a food prepared according to an exemplary embodiment of the invention, to a high fat meal in order to interfere with digestion and/or absorption of fats in the meal. However, in order to effectively neutralize the fat in the meal, the hypothetical fast food customer would need to be aware of the amount of fat in the meal and use an appropriate amount of the exemplary M2 mayonnaise.

This example deals with a prepared product with two components. According to this example one component (e.g. yogurt) is formulated as an exemplary embodiment of the invention and the other component (e.g. granola) is prepared according to a standard recipe. Predicted metabolic fat impact in this example is based upon each gram of the dietary fiber in the yogurt having the capacity to interfere with digestion and/or absorption of 4.0 grams of fat (Significantly lower than in examples 1 and 2).

According to this example, the food manufacturer adjusts formulation of the first component to compensate for fats present in the second component. Embodiments of this type at least partially shift the burden of awareness of fat content from consumer to manufacturer. Table 3: Interaction between components in an exemplary two component product

formulated according to an exemplary embodiment of the invention

* When consumed with other sources of dietary fat such as the granola.

* *When consumed with the yogurt

Results presented in table 3 indicate that the serving of Yl full fat yogurt formulated according to an exemplary embodiment of the invention is more than sufficient to interfere with digestion and/or absorption of all the fat in the granola. This is despite the fact that the fibers used in the preparation of the yogurt were presumed to have a much lower capacity to interfere with digestion and/or absorption of fat than what was presumed in Examples 1 and 2. As a result, the total metabolizable calories of the yogurt plus granola are only 342. This is significantly less than the amount of metabolizable calories in the granola consumed without the yogurt.

Table 3 also illustrates that the predicted metabolic fat impact of the serving of Yl yogurt is sufficient to offset the fat content of a large latte or cappuccino containing as much as 400 ml of whole milk.

This example illustrates that food manufacturers can formulate products which retain palatability while being significantly less fattening.

Alternatively or additionally, this example shows how to deal with dietary fats in a product (i.e. the granola) prepared at relatively high temperatures.

EXAMPLE 4:

Products for children

Obesity among children is a significant cultural problem. Many products marketed specifically to children are high in dietary fat. One product category marketed primarily to children is snack cakes. Perhaps the most well known snack cake in the United States is the Twinkie^® (Hostess brands). Although a single Twinkie is only 150 calories, it contains only 1 gram of protein, substantially no dietary fiber and is high in sugars and fat.

Table 3 summarizes composition data for Hostess Twinkies^® and a similar snack cake (Tl) prepared according to an exemplary embodiment of the invention. The dietary fiber introduced into Tl can be incorporated into the shortening based vanilla flavored creme filling of the cake as a composition 100 and/or particles 200 or 201 as described hereinabove. Incorporation of the fiber into the filling spares it from baking temperature which might be problematic. Predicted metabolic fat impact in this example is based upon each gram of the dietary fiber in the snack cake having the capacity to interfere with digestion and/or absorption of 6.0 grams of fat.

Table 4: snack cake and similar cake according to exemplary embodiment of the invention

formulated according to an exemplary embodiment of the invention

* When consumed with a meal including other sources of dietary fat.

Results presented in table 4 show that it is relatively easy to incorporate sufficient dietary fiber into a snack cake to interfere with digestion and/or absorption of all the fat in the snake cake itself. In fact, the predicted metabolic impact of -49.5 is sufficient to interfere with digestion and/or absorption of all the fat in nearly 1.5 liters of whole milk (3.5% fat). This is relevant because children are often encouraged to consume milk with snacks in order to make the snack "more healthy".

This example illustrates that food manufacturers can formulate products which remain appealing to children while being significantly less fattening.

Alternatively or additionally, this example shows how to deal with dietary fats in a product (i.e. snack cake) prepared at relatively high temperatures by introducing a composition 100 and/or particles 200 or 201 to the product at a later stage of manufacturing.

EXAMPLE 5:

Sprinkle on granules

In order to allow people to eat a wide range of foods with high fat content, it may be desirable to provide particles 200 and/or 201 as granules which can be applied to food at the table. Such granules can be formulated with highly saturated fats so that they have a melting temperature of 65 to 70° C.

Formulation with highly saturated fats would make the granules amenable to application to any foods below that melting temperature. Alternatively or additionally, granules could be applied to cold food items (e.g. bread or salad) being consumed with a hot dish which is high in fat.

As demonstrated by examples 1 to 4, the granules can be formulated to have varying degrees of metabolic fat impact, and labeled accordingly. In some embodiments, granules with a high metabolic fat impact are provided for people that want to lose weight. In other exemplary embodiments of the invention, granules with a lower metabolic fat impact are provided for people that want to eat a high fat meal without gaining weight.

In some exemplary embodiments of the invention, granules according to an exemplary embodiment of the invention are provided in a container with a measuring device, or even in a container with a metered dose dispenser.

Use of granules according to this example will be more effective if the user has at least a rough idea of how much fat is in the meal to be eaten. Current trends in the United States encourage restaurants to provide nutrition information for menu items. In some cases, commercial restaurant chains provide such information on the Internet. Widespread use of smart- phones and tablet devices means that this information is available to restaurant patrons as they dine. Optionally, the time spent looking up nutritional information allows food to cool sufficiently so that granules can be applied without melting.

One advantage of the granules described in this example is that they can be easily incorporated into virtually any type of food presented. EXAMPLE 6:

Oral dosage formulations

In some embodiments, compositions 100 and/or particles 200 or 201 are provided as oral dosage forms 400 or 401.

Table 5 summarizes exemplary oral dosage formulations which have a 1 : 1 ratio dietary fiber to lipid material and varying capacities to interfere with lipid metabolism and predicts their metabolic fat impact and shows the smallest number of oral dosage units need to completely interfere with digestion and/or absorption of 90 grams of dietary fat.

Table 5: Exemplary oral dosage form formulations

*to interfere with digestion and/or absorption of dietary fat

grams

In contrast to the previous examples, this example deals with pills or capsules to be taken with a meal. The potential advantage of this approach is that dosages are premeasured and can be taken without waiting for food to cool. The potential disadvantage is that the number of pills or capsules to be swallowed and/or the size of the individual pills/capsules may be a deterrent to subject compliance.

Data presented in table 5 shows that by using dietary fiber with a high capacity to interfere with digestion and/or absorption of dietary fat a 90 gram portion of dietary fat can be completely "cancelled" by ingesting 4 to 5 pills/capsules (formulations 21, 18 and 15). However, these formulations based upon a 750 mg of dietary fiber, and an additional 750 mg of associated lipid material may be objectionably large in the eyes of some subjects. Similar effects may be achieved by consuming 5 slightly smaller tablets/capsules (formulation 20) containing 500 mg each of fiber and lipid material.

In many cases, a much smaller number of pills/capsules may be sufficient. The 90 gram figure is taken from the exemplary fast food meal discussed in example 2. Such a meal is general considered as excessive. A meal containing a more modest amount of fat, say 40 to 50 grams, could be handled by 2 dosage units according to formula 21.

Alternatively or additionally, for some subjects it may not be necessary to prevent absorption of all the fat in a meal. For these subjects a correspondingly smaller number of dosage units may be appropriate.

In summary, these examples demonstrate that it is theoretically feasible to provide dietary fiber coated with lipid material as a way to interfere with metabolism and/or absorption of other ingested lipid material. In some exemplary embodiments of the invention, the dietary fiber coated with lipid material is provided as a food product or condiment. In other exemplary embodiments of the invention, the dietary fiber coated with lipid material is provided separately (e.g. as granules or in an oral dosage form).

Claims

CLAIMS:

1. An edible composition comprising:

(a) a dietary fiber as an active ingredient; and

(b) a coating comprising lipid material which is at least 50% digestible (by weight) formulated to retard wetting of said dietary fiber.

2. A particle comprising:

(a) a core comprising a dietary fiber as an active ingredient; and

(b) a coating comprising lipid material which is at least 50% digestible (by weight) surrounding said core.

3. A composition according to claim 1 or a particle according to claim 2, wherein said lipid material constitutes between 10 percent and 60 percent by volume of said composition or said particle

4. A composition according to claim 1 or a particle according to claim 2, wherein a weight of said dietary fiber is at least twice as much as a weight of said lipid material.

5. A composition according to claim 1 or a particle according to claim 2, wherein a weight of said dietary fiber is not more than three times as much as a weight of said lipid material.

6. A particle according to claim 1 or a particle according to claim 2, characterized by an average transverse cross sectional diameter of 700 micrometer or less.

7. A composition according to claim 1 or a particle according to claim 2, wherein said coating is substantially free of protein.

8. A composition according to claim 1 or a particle according to claim 2, wherein said lipid material is de-stabilized at a pH > 7.0.

9. A composition according to claim 1 or a particle according to claim 2, wherein said lipid material is hydrolyzable by at least one lipase found in the intestine.

10. A composition according to claim 1 or clam 2, wherein said lipid material is reactive to bile.

11. A composition according to claim 1 or clam 2, wherein said lipid material includes one or more of at least one natural edible oil and at least one other lipid material.

12. A composition according to claim 1 or clam 2, comprising at least one item selected from the group consisting of a viscosifying agent, an emulsifying agent, a plasticizing agent, a stabilizing agent and a firming agent.

13. An oral dosage form comprising a composition according to claim 1.

14. An oral dosage form comprising a plurality of particles according to claim 2.

15. An oral dosage form according to claim 13 or claim 14, comprising one or more additional active ingredients.

16. An oral dosage form according to claim 13 or claim 14, provided as a tablet.

17. An oral dosage form according to claim 16, wherein said tablet comprises an external coating.

18. An oral dosage form according to claim 13 or claim 14, provided as a capsule or gel-cap comprising an external capsule.

19. An oral dosage form according to claim 18, wherein said external capsule comprises one or more gelling agents.

20. A preparation comprising:

a composition according to claim 1 or a plurality of particles according to claim 2 incorporated into a food or beverage.

21. A preparation according to claim 20, wherein said particles/composition are characterized by an average moisture content of less than 50%.

22. A manufacturing method comprising:

(a) dispersing dietary fiber in a gas stream;

(b) spraying lipid material which is at least 50% digestible (by weight) onto said fiber to form a coating thereon; and

(c) cooling said lipid material so that it adheres to said fiber.

23. A method according to claim 22, comprising:

granulating said dietary fiber.

24. A method according to claim 22, wherein said lipid material has a volume of 10 to 60% of said coated dietary fiber.

25. A method according to claim 22, wherein a weight of said dietary fiber is at least twice as much as a weight of said lipid material.

26. A method according to claim 22, wherein a weight of said dietary fiber is not more than three times as much as a weight of said lipid material.

27. A method according to claim 22, comprising incorporating said lipid material adhered to said fiber into a food or beverage.

28. A method according to claim 22, comprising compressing said lipid material adhered to said fiber to produce tablets.

29. A method according to claim 28 comprising coating said tablets.

30. A method according to claim 22, comprising encapsulating said lipid material adhered to said fiber in an external capsule.

31. A method according to claim 22, comprising granulating said lipid material adhered to said fiber and using the resultant granules in said dispersing.

32. Use of lipid material which is at least 50% digestible (by weight) and substantially free of protein to coat dietary fiber in a food preparation.

33. Use of lipid material which is at least 50% digestible (by weight) in preparation of a medicament formulated to reduce digestive absorption of dietary fats.

34. Use of lipid material which is at least 50% digestible (by weight) in preparation of a medicament formulated to reduce blood cholesterol levels.

35. Use of lipid material which is at least 50% digestible (by weight) in preparation of a medicament formulated to reduce digestive absorption of dietary carbohydrates.

36. Use according to any one of claims 33 to 35, wherein said medicament is formulated as a food or beverage.

37. Use according to any one of claims 33 to 36, wherein said medicament comprises particles including dietary fiber with said lipid material adhered to said fiber.

38. Use according to any one of claims 33 to 36, wherein said medicament comprises particles including a core including dietary fiber as an active ingredient and a coating comprising said lipid material surrounding said core.

39. Use according to claim 38, wherein said coating is substantially free of protein.

40. Use according to any one of claims 32 to 35, wherein said lipid material includes one or more of at least one natural edible oil and at least one other lipid material.

41. A treatment method comprising:

(a) providing a composition according to claim 1, or a plurality of particles according to claim 2;

(b) administering a physiologically effective amount of said composition and/or particles to a subject in need thereof to alter the subject's metabolism.

42. A method according to 41, wherein the administering alters the subject's metabolism by reducing digestive absorption of dietary fats.

43. A method according to 41, wherein the administering alters the subject's metabolism by reducing blood cholesterol levels.

44. A method according to 41, wherein the administering alters the subject's metabolism by reducing digestive absorption of dietary carbohydrates.