FIELD OF THE INVENTION

The current invention relates to psyllium-fiber-containing food products. More specifically, the invention relates to high-fiber-nutritional-supplement compositions, such as chocolate bars, comprising high amounts of psyllium fiber and having positive organoleptic properties for aiding in dietary matters; methods of producing such products; and uses of such products.

BACKGROUND OF THE INVENTION

The benefits of consuming dietary fiber are well known. Dietary fiber or “roughage” is derived from plant parts that the digestive system is unable to break down fully. As such, dietary fiber passes through the body and is excreted in a largely unchanged form.

There are two types of dietary fiber: soluble and insoluble fiber. Soluble fiber is dissolvable in water. As soluble fiber travels through the digestive system it typically absorbs water, forming a gel-like substance. As the fiber gel travels through the digestive tract, it binds and softens digestive waste making it easier to pass. The soluble dietary fiber gel also binds to glucose and cholesterol and slows or even prevents the absorption of these compounds into the bloodstream. Hence, the consumption of soluble fiber is linked to a lower risk of heart disease through the reduction of cholesterol and blood sugar levels. Soluble fiber is found in common foods, including oat bran, barley, beans, and peas.

Research has shown that the intake of both types of dietary fiber is imperative to a well-balanced and healthy diet. However, while the American Heart Association recommends that an average adult in the U.S. ingest 25-30 grams of total dietary fiber per day from food sources, the average adult typically only receives about 15 grams of fiber per day from food. Based on the cardiovascular and other health benefits arising from dietary fiber intake, e.g., reduction of risks of heart disease, stroke, obesity, type 2 diabetes, and related ailments, individuals are often advised to consume, or independently seek out for incorporation into their diet, fiber supplements for a quick, easy, and/or satisfying way to augment their daily fiber intake. Psyllium is one of the sources of fiber that has been approved by the US FDA as a dietary fiber for such purposes.

Psyllium is a type of soluble fiber material derived from the husk and seeds of thePlantago ovataplant. As a soluble fiber, psyllium promotes regularity by absorbing water, forming a sticky gel, and swelling, resulting in the formation of bulkier stools that are easier to pass. The soluble fiber of Psyllium forms a viscous gel, which is not absorbed by the small intestine. More specifically, psyllium mucilage (plant-derived gel) absorbs excess water while stimulating normal bowel elimination. Thus, psyllium can be considered a dietary fiber with bulk laxative properties and, accordingly, it is a product that is often used to avoid or treat constipation. Psyllium also has been associated with a diet that aids in the maintenance of optimal health, and even the prevention and treatment of certain health conditions, including diarrhea, irritable bowel syndrome, heart disease/heart health, overeating/obesity (e.g., by acting as an appetite suppressant), type 2 diabetes (by, e.g., lowering glucose levels), and high blood cholesterol/hypercholesterolemia (by, e.g., blocking cholesterol absorption).

Psyllium has been used for thousands of years as a traditional health medicine and supplement, especially in India. In 1934 Metamucil® was introduced into the U.S. market by G. D. Searle & Company, which marketed Metamucil® brand psyllium products from 1934 until 1985, at which time the brand was acquired by Procter and Gamble, which still markets several psyllium products under the Metamucil® brand. While initially and primarily marketed as a powder mixed with water, Metamucil® products and other psyllium products in the market have expanded to include tablets, capsules, and, more recently, fiber thin “cookies,” including chocolate-flavored fiber thins, sometimes referred to as wafers, for both adults and children.

Metamucil powder and many other psyllium products have for several years been flavored. Such flavoring reflects the fact that psyllium is unappetizing in flavor, thus reducing consistent use, adoption, and compliance associated with the use of such products with treatment plans, recommended dietary regimens, and the like.

Furthermore, psyllium products known to date continue to be associated with other organoleptic/mouthfeel sensation problems which reduce adoption and consistent use of such products, or compliance in using such products as part of a recommended or prescribed health plan. Leading psyllium products are known by consumers to be associated with slimy gelling, which can make swallowing such products unpleasant if not difficult. See, e.g., Thomas Easley et al., The Modern Herbal Dispensatory, 2016, p. 52, https://books.google.com/books/about/The_Modern_Herbal_Dispensatory.html ?id=NY2xCwAAQBAJ (“Psyllium rapidly absorbs water, turning into a slimy gelatinous mass that is not very appealing.”); Steve Taylor, Ed. Advances in Food and Nutrition Research, Vol. 55, 2008, p. 195, https://www.google.com/books/edition/Advances_in_Food_and_Nutrition_Rese arch/KN7ZBkLzwRoC?hl=en&gbpv=1&dq=advances+in+food+and+nutrition+research+acadennic+press+2008&printsec=frontcover (describing psyllium products as being associated with an “unpleasant slimy mouth feeling”); and The Encyclopedia of Food Chemistry; Vol. 1; Peter Veralis, Laurence Melton, and Fereidoon Shahidi Eds., Elsevier; 2018; p. 67; available at https://books.google.com/books?id=MTV8DwAAQBAJ&source=gbs_navlinks_s (reporting an “unpleasant slimy nnouthfeel and undesirable flavor characteristics” associated with psyllium products).

The problem of psyllium taste and texture has led others to develop alternative forms of bulking/dietary fibers, such as inulin (a popular alternative fiber and prebiotic found in many types of plants), dextrin, and methylcellulose. Another alternative approach has been to propose mixtures of such alternative fibers with psyllium to reduce the negative properties of psyllium.

Psyllium wafers offer yet another means of psyllium supplementation. Psyllium wafers provide an added benefit of yielding a hunger satiation effect, as the consumption of a wafer offers a snack-like experience and provides calories from ingredients not found in pills, capsules, tablets, or powder forms. While wafers may provide a more positive consumption experience as compared to a powdered formulation or a pill/capsule/tablet, exposure to water during mastication and swallowing causes swelling and gelling in the mouth/throat. Further, the wafers often require the ingestion of multiple wafers per day, causing individuals to repeatedly endure the uncomfortable slimy feeling in their mouth and throat.

Another proposed approach to overcoming the organoleptic challenges associated with psyllium has been to combine the product with highly desirable foods, such as chocolate or sugar. Examples of proposed psyllium nutritional products described in patent disclosures that seek to address one or more of the shortcomings of psyllium products in such a way include those in U.S. Pat. No. 4,766,004 to Moskowitz and 4,568,557 to Becker (each and collectively describing a broad range of psyllium-rich coated and flavored compositions); U.S. Patent Publication Nos. 2002016844 (Mody), 20050238694 (Gerhardt), and 20050186306A1 (Sonneveld) (mostly describing similar coated psyllium products); and U.S. Patent Publication 20050271600 to Coleman (describing high concentration psyllium gummy chews containing an amount of a confectionary base). Despite the existence of such several attempts to propose such products in the patent literature, there are no associated chocolate-flavored psyllium products in the market that have addressed the issues reported above in association with psyllium products.

U.S. Patent Application 2011/0287134 (Ervin '134) similarly describes homogeneous blends of a high concentration of fiber (at least 20%, such as 20-59%, and preferably at least 40%), preferably composed of a blend of psyllium and inulin, with a high amount of chocolate (between 40% and 79%, with examples of actual embodiments of the alleged invention containing about 75% chocolate), along with a substantial amount of oil and added sugar. The Ervin '134 application discloses application and related know-how and was originally assigned to Antioxidant Superfoods, Inc. (“AOS”), of Naples, Fla., USA, but was subsequently assigned to the applicant, Lang Pharma Nutrition of Middletown, R.I., USA (“Lang”).

After acquiring the Ervin '134 application, Lang sought to promptly commercialize products according to the Ervin '134 application. However, after attempting to scale up production of compositions according to the Ervin '134 application, Lang determined that such did not actually overcome the shortcomings of the prior art and failed to allow for economical mass production of a product suitable for the dietary supplement/nutrition market.

These facts demonstrate that despite the numerous prior proposals for developing chocolate-associated psyllium products in the art, the development of a psyllium-rich, chocolate flavored composition that is suitable for regular use by significant numbers of consumers requires a level of ingenuity that goes beyond any mere attempt to optimize these ingredients.

Principles of Construction

The following principles govern interpretation of this disclosure unless explicitly contradicted or clearly contradicted by context or plausibility.

All headings (e.g., “Principles of Construction”) are used for convenience only and should not be construed as limiting the invention.

The terms “a,” “an,” and “the” and similar referents cover both singular and the plural forms of the referred element unless otherwise indicated herein or clearly contradicted by context (e.g., “a lipid” means “one or more lipids” and “the lipid” means “the one or more lipids”). Similarly, the use of an element or component in the singular is to be understood as also providing simultaneous disclosure and support for a plurality of the element or component. For example, discussion of a psyllium compound in one context should be understood as providing support for one, two, or more psyllium compounds unless clearly contradicted by context or an express contradictory statement. The converse also will be understood by those of ordinary skill in the art in reading this disclosure. In other words, the singular is intended to convey the plural and vice versa herein.

The recitation of ranges of values in this document is intended to serve as a shorthand method of referring individually to each separate value falling within the range within an order of magnitude of the order of the recited range, including the endpoints. For example, a recited range of 1-2 should be interpreted as providing support for 1.0, 1.1, 1.2, 1.3, . . . 1.9, and 2.0 and a recited range of 10-20 is to be interpreted as providing support for 10, 11, 12, 13, . . . 19, and 20). Unless otherwise indicated, each such separate value is incorporated into the specification as if it were explicitly individually recited herein. All ranges provided herein include the endpoints of the provided range, unless the exclusion of such endpoints is clearly stated or clearly indicated, regardless of the terminology used to describe the range. Unless otherwise stated, all exact values provided herein are representative of corresponding approximate values and vice versa (e.g., all exact exemplary values provided concerning a particular factor or measurement can also be considered to provide a corresponding approximate measurement, modified by “about,” where appropriate; e.g., disclosure of “about 10” is to be understood as also providing support for 10 exactly as well as values of about 10).

Terms of approximation, such as “about” and “approximately” are used herein where measurements are understood to vary due to measurement limitation(s) or variability in populations, such as results of technical/scientific studies. The scope of such terms will depend on the context of the element at issue and the understanding of those skilled in the art. In the absence of such guidance in the art, through relevant teachings or examples, the term “about” should be understood as meaning +/−10% of the indicated value(s).

The term “also” means “also or alternatively.”

Use of the term “or” herein is not meant to imply that alternatives are mutually exclusive unless clearly stated or clearly contradicted by context. Thus, in this disclosure, the use of “or” means “and/or” unless expressly stated or understood by one skilled in the art. In the context of any listed aspects of the invention written as depending on two or more other listed aspects, the use of “or” will be understood as referring to any of the referenced aspects. A “/” symbol between terms can signify an “or” or alternative names for an element or step, as will be clear from the disclosure/art.

All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context or plausibility. Unless clearly indicated or contradicted by context or plausibility, the elements of a composition disclosed herein (e.g., a pharmaceutical formulation) can be formulated in any suitable manner and by any suitable method. Unless otherwise explicitly stated or clearly contradicted by context, any combination of the various elements, steps, components, or features of the aspects of the invention described herein, and all possible variations thereof, is to be considered encompassed by the invention.

Numerous examples and aspects are provided in this disclosure to better illuminate the invention. No example, aspect, or combination or pattern thereof is intended to pose a limitation on the scope of the invention unless otherwise indicated. No language in the specification should be construed as indicating any element is essential to the practice of the invention unless as much is explicitly stated. Any of the exemplary embodiments should not limit the breadth and scope of the invention.

No claim or aspect of this document is intended to be interpreted as limited to “means-plus-function” construction unless such intent is clearly indicated by use of the terms “means for” or “step for.” In particular, the use of the terms “configured to” or “adapted to” are not intended to suggest a “means-plus-function” interpretation, but, rather, suggest that the relevant component, composition, device, or element has been configured to, designed to, selected to, or adapted to achieve a particular referenced performance, characteristic, property, or the like.

Terms such as “including,” “having,” “containing,” and “comprising” herein mean “including, without limitation.” The description herein of any aspect or embodiment of the invention using terms such as “comprising,” “having,” “including,” or “containing” an element simultaneously implicitly provides support for corresponding aspects wherein the aspect or embodiment “consists of,” “consists essentially of,” “sizably comprises,” “predominantly comprises,” and “essentially consists of,” that particular element, unless otherwise stated or clearly contradicted by context.

The term “appreciable” and “appreciably” when used in relation to an amount of an ingredient/element in relation to a second, larger amount or whole (e.g., as in an amount of a composition or ingredient comprising “a sizable amount of” element A), means making up at least about 2% of the second, larger amount or whole (e.g., at least 5%, 7.5%, or 10%).

The terms “sizable” and “sizably” when used in relation to an amount of an ingredient/element in relation to a second, larger amount or whole (e.g., as in an amount of a composition or ingredient comprising “a sizable amount of” element A), means making up at least about 15% of the second, larger amount or whole (e.g., at least 20%, 25%, or 33%).

The terms “predominate” and “predominately” describe elements/ingredients that make up at least 50% of a larger amount or whole.

Similarly, use of terms such as “substantially”, “in substantial amount”, “materially,” “in material amount,” and the like with respect to an amount in relation to a larger amount/whole means that the amount makes up at least about 65% of the larger amount/whole (e.g., at least about 70%, at least about 75%, at least about 80%, or at least about 85% of the second amount or whole).

The phrases “consists essentially of” or “consisting essentially of” means that any step/element that maintains the fundamental features of the referenced element/step or retains the desired function of such element/step. The fundamental features & functions of elements and steps will be clear from the disclosure or the art. For ingredients, where features & functions are not clear, any such phrase should be interpreted as meaning “essentially all,” as described in the following paragraph.

Terms such as “essentially all,” “essentially entirely,” or “essentially comprise” when used in connection with a referenced amount and a larger amount/whole mean that the smaller referenced amount makes up at least about 90% of a larger amount/whole (e.g., at least about 91%, 92%, 93%, 95%, 96%, 97%, 98%, or at least about 99% of the larger amount or whole).

Changes to tense or presentation of phrases defined herein (e.g., using “comprises predominately” instead of “predominately comprises”) do not modify the meaning of the defined phrase.

The terms “significantly” or “significant” refer to results that are statistically significant using an appropriate statistical test (e.g., p≤0.05/0.01).

Any reference to “combination” or “combinations” of listed elements means combination(s) of any or all thereof.

All references, including publications, patent applications, and patents, cited herein, including the patents and patent applications cited above, are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein. Accordingly, the reader should review and consider such references in understanding the full content of this disclosure. For example, unless clearly contradicted by context or explicit statement, the disclosure of such documents relating to formulations, methods of production, and methods of use of compositions and devices can be combined with the teachings provided herein to provide additional useful compositions and applications. However, the citation and incorporation of patent documents herein is limited to the technical disclosure of such patent documents and does not reflect any view of the validity, patentability, or enforceability of any such patent applications or patents or the validity of such references as prior art.

The term “here” means “in this disclosure.” The abbreviation “OTI” means “of the invention.” The abbreviation “ITA” means “in the art.”

No part of this disclosure should be construed as indicating any element/step is essential to the practice of the invention.

Unless clearly indicated, the scope of any aspect or embodiment of the invention is not limited to any exemplary processes, compositions, or methodologies described here. The terminology used in the description is to describe versions or embodiments only and is not intended to limit the scope of the invention. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Any methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, the methods, devices, and materials described herein.

Scope and Meaning of Terms Specific to this Disclosure

Because certain terms specific to this disclosure may be used differently in the art, provided here is guidance concerning the scope and meaning of a selection of such terms.

Use of the abbreviation “NC” means “nutritional composition” and can refer to any one or more compositions of the invention.

The term “component” in this disclosure (e.g., a lipid component) typically refers an ingredient or collection of ingredients incorporated into a nutritional composition, which is defined by one or more characteristics. Each “component” described here can contain several different ingredients and such ingredients can comprise a mixture of other ingredients (e.g., a lipid component can contain cocoa butter and coconut oil and a chocolate component can contain a dark chocolate ingredient or a milk chocolate ingredient, each of which can contain other components such as milk fats, cocoa butter, sugar, emulsifier(s), and cocoa/cacao). When a composition is in its finished/ready state (i.e., ready for consumption), most, at least materially all, or at least essentially all, of the components are blended or otherwise mixed, as described below. However, because the amount and characteristics of the components and ingredients provide functional properties to the composition, they are used to describe the compositions of the invention, as are the overall (total) characteristics of the compositions.

Terms such as “fat” and “lipid” may, in some fields of art, be used synonymously. Here, the term “lipid” here is used to describe substances that are insoluble in water and soluble in nonpolar solvents, such as alcohol, ether, and chloroform, are safe for human consumption, and can be nutritious. Typically, lipids are predominately, essentially, or entirely composed of hydrocarbons and in aspects are predominately, essentially, or entirely composed of fatty acids.

A lipid ingredient typically can be at least predominately, at least materially, at least essentially, or is entirely composed of lipids (e.g., is at least 65%, at least 75%, at least 85%, at least 95%, at least 97%, or at least 99% or 100% composed of lipids). Many lipid ingredients, such as coconut oil, typically entirely consist of lipids due to separation/purification of lipids from other source materials.

The terms “fats” and “oils” are used here to describe classes of lipids. A “fat” in this disclosure means a lipid that is predominately, essentially, or entirely solid at room temperature and normal atmospheric conditions. The term “oil” here is used to refer to any edible lipid that is predominately, essentially, or entirely liquid under such conditions.

Typically, fats sizably comprise, predominately comprise, materially comprise, essentially comprise, or consist of saturated fatty acids, particularly triglycerides. Typically, oils sizably comprise, predominately comprise, materially comprise, essentially comprise, or consist of unsaturated fatty acids. Given their difference in composition and chemistry, saturated fatty acids and unsaturated fatty acids exhibit significantly different nutritional and compositional properties.

Fat ingredients can be ingredients which are typically solid at room temperature (“RT”) but which can in aspects be comprised of both saturated lipids (or fats, typically solid at RT) and unsaturated lipids (or oils, typically liquid at RT). Cocoa butter and coconut oil are examples of such fat ingredients. Any description of the state of an ingredient or component at RT implicitly also means at normal/typical atmospheric conditions (about 1 atm/about 14.7 psi). An “oil” also may contain some amount of fat, but an oil will at least predominately, materially, or essentially be composed of lipids, usually unsaturated lipids, that are liquid at RT.

In some aspects, the terms “lipid,” “oil,” and “fats” can also be used to refer to nutritional ingredients, that are at least predominately, materially, or essentially composed of lipid, oil, or fat, respectively, but may contain other components. Thus, e.g., cocoa butter herein is classified as a fat because it is a composition that is at least predominately lipid in composition and is solid at room temperature and normal pressure.

The term “dietary fiber” means any fiber that the US Food and Drug Administration or corresponding international regulatory body has recognized as dietary fiber as of the date of this disclosure. References to fiber herein implicitly mean fiber that would be recognized as dietary fiber by such regulatory authorities.

The terms “user” and “consumer” both refer to a person that consume nutritional products of the invention.

SUMMARY OF THE INVENTION

This disclose describes new and inventive soluble fiber and lipid rich flavored nutritional compositions that are useful in, among other things, the management of appetite, regularity, glucose control, and other dietary fiber-related health matters including, e.g., reducing risk of heart health/disease, stroke, obesity, or type 2 diabetes, and related ailments.

Nutritional compositions of the invention (“nutritional compositions” or “NCs”) comprise (a) a fiber component comprising one or more soluble dietary fiber ingredients comprising psyllium or a soluble dietary fiber that has similar water absorption characteristics as psyllium (e.g., in terms of swelling and gelling and negative organoleptic properties), (b) a lipid component comprising one or more fats, and (c) a flavoring component (e.g., a chocolate component defining the primary flavor of the composition, commonly defining a base for the composition). The amounts and characteristics/composition of these components, alone or in combination with other components/ingredients, provide measurably or significantly improved characteristics over similar currently on-market and previously proposed psyllium compositions, including with respect to measurably or significantly improving organoleptic properties, consumer adoption and/or sustained use, or ease of commercial production.

The soluble fiber component (“fiber component’) of NCs is at least predominately, at least materially, or at least essentially composed of one or more sources of soluble dietary fiber. In aspects, the fiber component is at least predominantly composed of, at least materially composed of, or at least essentially composed of (e.g., is at least about 95% composed of), or is entirely composed of psyllium. In aspects, NCs comprise about 8.5 wt. % to about 18.5 wt. % psyllium, such as about 10-18.5 wt. % psyllium, e.g., about 11-18 wt. % psyllium, e.g., about 12-17 wt. %, about 13-17 wt. %, or 13-16 wt. % psyllium fiber). In aspects, compositions of the invention can be characterized by lacking significant amounts (e.g., 5% or more, 2% or more, 1% or more, 0.5% or more, or 0.1% or more) of soluble/dietary fiber sources other than psyllium, such as inulin. In aspects, compositions described herein lack any detectable amounts of soluble/dietary fiber sources other than psyllium, such as inulin. In aspects, some, most, materially most, e.g., at least about 50%, at least about 60%, at least about 80%, at least about 90%, at least about 95%, or at least about 99% of psyllium in the composition has a mesh size of at least 33. In aspects, the average mesh size of psyllium in the composition also or alternatively is between about 40-60.

The lipid content of NCs is typically at least sizably or at least predominately composed of saturated lipids. In aspects, compositions comprise about 15-25 wt. % total saturated lipid, such as about 16-21 wt. % saturated lipid (e.g., about 16-19 wt. % saturated lipid). In some respects, the amount of saturated lipid content of NC's is less than 20 wt. %.

In aspects, the amount of oil used in making the compositions, such as for example canola oil, is less than about 2.5 wt. %, such as less than about 2.4 wt. %, less than about 2.3 wt. %, less than about 2.2 wt. %, or less than about 2.1 wt. %, such as less than about 2.05 wt. %.

In aspects, the ingredients of the NC comprise between 10-18 wt. % (e.g., 11 wt. %-15 wt. %, or 12-14 wt. %) unsaturated lipids. Thus, e.g., the invention provides nutritional compositions comprising 10-18.5 wt. % psyllium fiber, 10 wt. %-18 wt. % unsaturated oil, 16-21 wt. % saturated lipid, the saturated lipid to unsaturated lipid/oil ratio optionally being more than 1.

In aspects, NCs comprise a texturizing element that further enhances the organoleptic or nutritional properties of the NC. In aspects, the texturizing element can comprise a non-soluble fiber. In aspects, NCs comprise at least 5 wt. %, at least 6 wt. %, or at least 7 wt. % of a texturizing element (e.g., about 5-15 wt. % of a texturing element, or about 5-15 wt. % of a texturizing element), such as a rice crisp, protein crisp, a combination thereof, or similar texturizing element. In certain embodiments, the texturizing element will sizably, predominately, materially, essentially entirely, or entirely be composed of a material having a density of at least about 0.1 g/cm3(g/cc). As with all aspects described herein, this aspect can be combined with any other aspect of this disclosure. For example, the invention provides compositions comprising 10-18.5 wt. % psyllium, 50-75 wt. % chocolate, 10-18 wt. % (e.g., 10 wt. %-15 wt. %) unsaturated lipid, 16 wt. %-25 wt. % saturated lipid (e.g., 16 wt. %-21 wt. % saturated lipid, or 16-19 wt. % saturated lipid), and at least about 5 wt. % of a texturizing element (e.g., at least about 7 wt. % of a texturizing element), which texturizing element has a density of at least about 0.1 g/cm3and commonly has a density of at least about 0.2 g per cubic cm.

In aspects, NCs are not formed from extrusion (i.e., are non-extruded compositions). In aspects, NCs also are not coated (e.g., the compositions lack any chocolate coating or coating of any coating layer). In aspects, the chocolate component is the predominate, materially only, essentially only, or only flavoring (e.g., the NC lacks any other flavoring component). In aspects, less than about 5 wt. %, less than about 2.5 wt. %, less than about 1 wt. %, less than about 0.5 wt. %, or less than about 0.25 wt. % of the composition is made up of flavoring agents (flavorants) that are separate from the chocolate component. An NC also typically lacks any chocolate flavoring; such as any chocolate flavoring, not meeting a regulatory authority definition of “chocolate”, e.g., as defined by US FDA. NCs also are typically substantially homogeneous in composition. NCs also typically comprise no detectable amount of water, e.g., less than 1 wt. % water. Any one or more of these characteristics of the nutritional compositions of the invention can be applied to any of the aspects described elsewhere herein.

According to embodiments, NCs contain a limited amount of one or more emulsifiers, such as lecithin (outside of the chocolate component, in total, or both). In aspects, other than in any chocolate ingredients, NCs comprise about 0.25 wt. % or less of an emulsifier (e.g., a lecithin). In aspects, NCs comprise between about 0.05 wt. % and 0.2 wt. % lecithin outside of any chocolate component, such as 0.05 wt. %-0.175 wt. % or 0.05 wt. % and 0.125 wt. % of a lecithin (e.g., soy or sunflower lecithin). Again exemplifying how all aspects of this disclosure can be combined, the invention provides NCs comprising 10-18.5 wt. % psyllium, 50-75 wt. % of a chocolate component, at least about 28 wt. % total lipid (e.g., 16-21 wt. % saturated lipid or 10-15 wt. % unsaturated lipid) at least a sizable amount of which is contained in the chocolate component and the rest in a lipid component; at least 5% of a texturizing element (e.g., at least about 7 wt. % of a texturizing element), wherein (a) optionally no more than about 2.1 wt. % of the composition is attributable to any oil ingredient(s), (b) optionally at least about 5 wt. % (e.g., at least 6 or 7 wt. %) of the NC is attributable to a solid lipid (a fat), and (c) the NCs contains about 0.05 wt. %-about 0.2 wt. % lecithin, such as 0.05 wt. %-0.175 wt. % lecithin in the composition, outside of the chocolate component.

The nutritional products of the invention can exhibit measurably or significantly improved organoleptic properties (e.g., the flavor, texture, or mouthfeel, as experienced by the typical consumer) (e.g., with respect to currently available psyllium products, such as Metamucil® wafer products or products described in the above-referenced prior art), which can lead to better rates of adoption and sustained use, while maintaining the benefits of a high psyllium fiber diet such as reduced constipation, caloric management, etc.

The invention also provides methods comprising administering nutritional compositions of the invention, such as any of the above-described compositions, to individuals/consumers (e.g., to dieters). In one aspect, the invention provides a method of supplementing a diet comprising administering to an individual about between 5 g, about 7.5 g, or about 10 g (e.g., 12 g, 15 g, 20 g, 24 g, or 25 g) and about 50 g, about 70 g, about 80 g, about 90 g, or about 100 g of the nutritional composition (e.g., about 5-150 g, about 7.5 g-125 g, about 10 g-100 g, or about 12-96 g of such a composition), e.g., per intake or per day. According to embodiments, such a method also or alternatively can be characterized in providing between about 2 g, about 2.5 g, or about 3 g, such as at least between about 3.1 g or at least about 3.2 g and about 10 g, about 12 g, about 12.5 g, about 13 g, about 14 g, about 15 g, about 20 g psyllium, or about 25 g of psyllium to the individual, e.g., per intake or per day. Thus, for example, the invention provides methods that comprise administering between about 10 g-about 100 g of a nutritional composition comprising about 8.5-18.5 wt. % psyllium, about 50-75 wt. % chocolate, at least about 28 wt. % lipid (e.g., about 28-38 wt. % lipid, which optionally is predominately saturated lipid, which optionally comprises 16-21 wt. % saturated lipid or 10-15 wt. % unsaturated lipid), optionally about 5-15% of a texturizing element (optionally that has a density of at least about 0.1 g/cubic cm and commonly a density of at least about 0.2 g/cm3), to the individual, for one or more days. Such amounts of the composition can be provided to the individual in units (“administrations” or “servings”) of about 5 g-50 g, such as about 7.5 g-about 35 g, e.g., about 10 g-about 30 g (e.g., 12-24 g). Servings can correspond with meals, snacks, or a combination thereof. In some aspects, supplementation with the compositions described herein comprises a method of escalating amounts (e.g., in escalating “doses”) from a first time period (e.g., about 2-14 days, e.g., 3-10 days, 4-8 days, or about a week) to at least a second period (which can be indefinite), such as for example to allow the body of the consumer to become accustomed to a composition before increasing the amount of composition(s).

For example, in one embodiment the invention provides a method of dietary regulation that comprises (a) 1-3 servings of a nutritional composition with a mass of about 20-35 g, e.g., about 25 g (such as 24 g), taken in association with a meal, such as before a meal, for a total of, e.g., about 20 g-about 100 g and (b) 1-6 snack servings, such as 2-4 snacks, of servings of about 25-75%, such as 33-66%, such as about 50% of the meal serving, e.g., about 2.5 g-15 g, such as about 5 g-14 g, such as about 7.5 g-12.5 g, e.g., about 10 g, 11 g, or 12 g. Packages of the nutritional composition can be provided in a manner that facilitates such administration, e.g., by scoring ½, ⅓rd, or ¼th servings, and by being provided in recommended serving sizes, e.g., of about 20 g-about 30 g, such as about 24 g, each serving providing at least 3 g, and preferably at least 3.15 g, such as at least 3.2 g of psyllium fiber. In aspects, a recommended serving size can comprise multiple, individually wrapped final products, such as for example each individually wrapped final product representative of about ½ a serving size. For example, a serving size can be approximately 24 g of a nutritional composition, provided to the consumer as 2 individually wrapped about 12 g products, each individually wrapped product providing about ½ of the total amount of psyllium fiber per serving, for a total amount of psyllium per serving of at least about 3 g, for example about 3.2 g or about 3.3 g, or about 3.4 g, or about 3.5 g or about 3.6 g.

Some NCs can be characterized by requiring less water for comfortable consumption or to ensure the safety of the individual as compared to currently marketed psyllium products. For example, in one embodiment, the invention provides methods, such as those described above, wherein a method comprising consumption of an NC product comprises the individual co-consuming less than 8 oz of water per every at least 3 g, at least 3.1 g, at least 3.2 g, at least 4 g, or at least 5 g of psyllium, on a serving, snack, or daily basis. In one embodiment, a method is provided that comprises an initial minimum amount of water to be co-consumed with the psyllium-containing composition, which is reduced over a period of recommended consumption (as part of a diet plan of at least about 5 days, at least about 1 week, at least about 10 days, at least about 2 weeks, at least about 3 weeks, at least about 1 month, or longer).

Methods of the invention can, in aspects, be used to promote health in any of the various ways that psyllium products are known to be useful, such as those described in the Background of this disclosure and elsewhere herein (e.g., in regulating excessive caloric intake, constipation/assuring regularity in bowel movements, in managing high cholesterol, or in assisting with a combination of any or all thereof).

According to one embodiment, the individual using nutritional compositions/products of the invention in a method of the invention is an individual that has previously received a recommendation for, or attempted adoption of, a fiber-rich or more specifically a psyllium-rich diet or health plan, but has failed to maintain the regimen consistently, wherein the individual's adoption of the product is greater, the individual's compliance with using the product is greater, or both. Thus, for example, in an aspect, the invention provides a method of supplementing fiber in the diet comprising administering about 10 g-100 g, such as about 50 g-100 g, e.g., about 70 g-90 g of a nutritional product comprising about 10-18.5 wt. % psyllium, about 50-75 wt. % chocolate, and about 25-40 wt. %, such as about 25-37.5 wt. %, or such as about 28-35 wt. % total lipid (which optionally is sizably or predominately saturated lipid, such as in comprising about 16-21 wt. % saturated lipid), optionally comprising about 5-15 wt. % texturizing material, and optionally comprising less than about 0.2 wt. %, such as less than about 0.1 wt. % of lecithin attributable to any ingredient other than the chocolate, in serving/snack sizes of 2-6 times, e.g., 3-5 times or 3-4 times per day, over a period of one week or longer, two weeks or longer, wherein optionally the method is associated with consumption of a lower minimum amount of water than currently recommended for Metamucil® products, optionally where the individual has improved compliance in using the product on a recommended basis than in previous experience with psyllium products or where the product is recommended to a person that has previously failed to have a positive experience with psyllium products.

Such embodiments and additional aspects and features of the invention will be described further in the following Detailed Description of the Invention. To aid the reader, parts of the Detailed Description will focus on particular elements of the inventive compositions or methods. However, unless otherwise indicated any aspect, feature, embodiment, component (ingredient), step, or method of the invention can be combined with any other such aspect, feature, embodiment, component (ingredient), step, or method, and the focus on the particulars of any aspect should not be interpreted as a limitation of any aspect, but, rather, as providing possible details for any such element, feature, step, etc., that can be combined with the various descriptions of inventive compositions and methods provided herein, unless otherwise explicitly stated or clearly contradicted by context.

