Dietary supplement and method for treating liver conditions

Abstract

A dietary supplement includes a powder extract of Costus igneus leaves which comprises 7% to 10% carbohydrates as measured in sucrose equivalents, 20% to 28% protein as measured in bovine serum albumin (BSA) equivalents, 1 to 3% phenols as measured in gallic acid equivalents, and about 5% to 7.5% flavonoids as measured in amounts of naringin, rutin, apigenin, and hesperidin. The dietary supplement may be used as a treatment for Metabolic dysfunction-associated steatotic liver disease (MASLD).

Description

Electronically Transmitted: March 13, 2026OU 2025-016 PCTDIETARY SUPPLEMENT AND METHOD FOR TREATING LIVER CONDITIONSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application Serial No. 63 / 774,224, filed March 19, 2025. The entirety of the above-referenced patent application(s) are hereby expressly incorporated herein by reference.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

[0002] Not applicable.BACKGROUND

[0003] Metabolic dysfunction-associated steatotic liver disease (MASLD) is a chronic liver disease often linked to obesity and type 2 diabetes mellitus (T2DM). ft is marked by excessive fat accumulation in the liver and progressive insulin resistance. Over the past 30 years, the prevalence of MASLD in the US has risen from 20% to 31.9%, mirroring the increase in obesity, T2MD, and hypertension during the same period. Alarmingly, over 100 million Americans may be affected by some form of MASLD. At diagnosis, MASLD can present as simple steatosis, severe steatohepatitis, or varying degrees of fibrosis. Over time, it can progress to end-stage liver failure and cirrhosis, increasing the risk of hepatocellular carcinoma. Although resmetirom, a thyroid hormone receptor agonist, has been recently approved for advanced stages of fatty liver disease, it is not recommended for chronic preventative use in milder or early forms of MASLD. Additionally, over 900 ongoing or completed clinical trials are exploring other drugs such as elafibranor (PPARa / 5 agonist), obeticholic acid (FXR agonist), selonsertib (ASK1 inhibitor), cenicriviroc (CCR2 / CCR5 antagonist), weightreducing drugs (orlistat and sibutramine), antidiabetics (pioglitazone), GLP1 -agonists (liraglutide and semaglutide) as treatments. The prevailing treatments are often combined with lifestyle changes and diet modifications.

[0004] Experts believe that the complex nature of fatty liver disease is the main reason for the slow progress in treating MASLD. Targeting a single pathway often doesn't address the full range of factors involved in Non-alcoholic fatty liver disease (NAFLD), as suggested by the hypothesis of multiple parallel hits. In this context, polypharmacologic complementarymedicines, such as dietary' supplements, are gaining support. Evidence shows that diseases like MASLD are polygenic or multifactorial, driven by a complex network of factors. Herbal compositions from medicinal plants contain broad-spectrum compounds that interact with multiple molecular targets, helping to stabilize the cellular network. As a result, there is a growing trend towards using alternative herbal products for both the prevention and treatment of fatty liver disorder. For instance, polyphenols (such as curcumin, resveratrol, naringenin, anthocyanin, hesperidin, catechin, silymarin, and genistein) and probiotic are common dietary supplements used to treat MASLD. Given the known role of chronic oxidative stress and reactive oxygen species in MASLD progression, vitamin E and ro-3 fatty7acids are often coconsumed. Vitamin D is also used due to its common deficiency in MASLD / MASH patients. However, the effectiveness of these treatments remains questionable and unproven.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.

[0006] FIG. 1 shows FT-IR of three IPP extracts showing characteristic absorbance peaks, IPP Extract A (upper panel); IPP Extract B (center panel); and IPP Extract C (lower panel).

[0007] FIG. 2 shows Spectrophotometry of ethanolic solution of IPP extract in (A) near UV and (B) visible regions. The scanning was performed in three separate samples of IPP extract dissolved in ethanol.

[0008] FIG. 3 shows HPLC of IPP extract against standard chromatograms of rutin, naringin, hesperidin, and apigenin. Ethanol was used as blank solvent. The chromatograms shown are representatives of three replicates.

[0009] FIG. 4 shows (A) MTT assay for viability of HepG2 cells treated with oleic acid (OA, 500 pM) and different concentrations of IPP extract (500, 250, 100, and 50 pg / mL) for 24 h. The data are the average of three independent biological replicates. (B) Representative LD540 staining of lipid accumulation in HepG2 co-treated with DMSO vehicle (i) or OA±IPP (ii-vi). The fluorescence released by LD540 was captured using a rhodamine filter (Ex / Em: 548 nm / 580 nm, red) and the nuclei were counterstained with DAPI (blue). Images were acquired at 40x magnification (scale bar, 100 pm). (C) LD540 area was quantified by Image J software. The data are show n as mean± SD from two independent experiments.DETAILED DESCRIPTION

[0010] The present disclosure is directed to a dietary supplement product obtained from Costus igneus (C. igneus), a.k.a. and method of its use in modifying the progression of and in treating Metabolic dysfunction-associated steatotic liver disease (MASLD). In a particular (but non-limiting) embodiment, the dietary supplement is an extract of C. igneus wherein the extract (“IPP extract”) comprises 7% to 10% carbohydrates (as measured in sucrose equivalents). 20% to 28% protein (as measured in BSA equivalents), 1 to 3% phenols (as measured in gallic acid equivalents), and about 5% to 7.5% flavonoids (e.g., naringin, rutin, apigenin, and hesperidin).

[0011] C. igneus (syn. Costus pictus), a perennial plant native to South and Central America, has been used in traditional medicine and is commonly known as the insulin plant (IP). Recently, it has gained popularity as a complementary botanical, with claims that consuming its leaves, stem, or rhizome can reduce blood glucose levels in T2DM. The leaves of C. igneus are rich in proteins, iron, and antioxidants such as ascorbic acid, a-tocopherol, P-carotene, terpenoids, steroids, and flavonoids. The pharmacologic principles isolated in plant extracts include quercetin, -L-arabinopyranose methyl glycoside, lupeol. corosolic acid, stigmasterol, and diosgenin. The typical recommended daily dose of the extract of C. igneus is contained in four size 0 capsules.

[0012] The present disclosure describes a method of purifying and concentrating the C. igneus leaf extract so that a recommended daily dose can be contained in a single size 0 capsule loaded with the dried extract, thereby making it much easier and more palatable for a user to consume an entire daily dose in a single swallow, rather than having to consume a daily dose by up to four separate swallows. The resulting “single capsule” product is called IPP+.

[0013] Before further describing various embodiments of the present disclosure in more detail by way of exemplary description, examples, and results, it is to be understood that the compounds, compositions, and methods of present disclosure are not limited in application to the details of specific embodiments and examples as set forth in the following description. The description provided herein is intended for purposes of illustration only and is not intended to be construed in a limiting sense. As such, the language used herein is intended to be given the broadest possible scope and meaning; and the embodiments and examples are meant to be exemplary, not exhaustive. 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 unless otherwise indicated as so. Moreover, in the following detailed description, numerous specific details are set forth in order to provide a more thorough understanding of the present disclosure. However, it will be apparent to a person having ordinary skill in the art that the presentdisclosure may be practiced without these specific details. In other instances, features which are well known to persons of ordinary skill in the art have not been described in detail to avoid unnecessary complication of the description. It is intended that all alternatives, substitutions, modifications and equivalents apparent to those having ordinary skill in the art are included within the scope of the present disclosure. All of the compounds, compositions, and methods and application and uses thereof disclosed herein can be made and executed without undue experimentation in light of the present disclosure. Thus, while the compounds, compositions, and methods of the present disclosure have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the compounds, compositions, and methods and in the steps or in the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the inventive concepts.

[0014] All patents, published patent applications, and non-patent publications including published articles mentioned in the specification or referenced in any portion of this application are herein expressly incorporated by reference in their entirety to the same extent as if each individual patent or publication was specifically and individually indicated to be incorporated by reference.

[0015] The term “pharmaceutically acceptable” refers to compounds and compositions which are suitable for administration to humans and / or animals without undue adverse side effects such as toxicity, irritation and / or allergic response commensurate with a reasonable benefit / risk ratio. The compounds or conjugates of the present disclosure may be combined with one or more pharmaceutically-acceptable excipients, including carriers, vehicles, diluents, and adjuvants which may improve solubility, deliverability', dispersion, stability, and / or conformational integrity of the compounds or conjugates thereof.

[0016] As used herein, “pure” or “substantially pure” means an object species is the predominant species present (i.e., on a molar basis it is more abundant than any other object species in the composition thereof), and particularly a substantially purified fraction is a composition wherein the object species comprises at least about 50 percent (on a molar basis) of all macromolecular species present. Generally, a substantially pure composition will comprise more than about 80% of all macromolecular species present in the composition, more particularly more than about 85%, more than about 90%, more than about 95%, or more than about 99%. The term “pure” or “substantially pure” also refers to preparations where the object species is at least 60% (w / w) pure, or at least 70% (w / w) pure, or at least 75% (w / w) pure, or at least 80% (w / w) pure, or at least 85% (w / w) pure, or at least 90% (w / w) pure, or at least 92%(w / w) pure, or at least 95% (w / w) pure, or at least 96% (w / w) pure, or at least 97% (w / w) pure, or at least 98% (w / w) pure, or at least 99% (w / w) pure, or 100% (w / w) pure.

[0017] Non-limiting examples of animals within the scope and meaning of this term include dogs, cats, rats, mice, guinea pigs, chinchillas, horses, goats, cattle, sheep, zoo animals, Old and New World monkeys, non-human primates, and humans.

[0018] “Treatment” refers to therapeutic treatments. “Prevention” refers to prophylactic or preventative treatment measures or reducing the onset of a condition or disease. The term “treating” refers to administering the active agent to a subject for therapeutic purposes and / or for prevention. Non-limiting examples of modes of administration include oral, topical, retrobulbar, subconjunctival, transdermal, parenteral, subcutaneous, intranasal, intramuscular, intraperitoneal, intravitreal. and intravenous routes, including both local and systemic applications. In addition, the active agent of the present disclosure may be designed to provide delayed, controlled, extended, and / or sustained release using formulation techniques which are well known in the art.

[0019] The term “dietary supplement” refers to an active agent-containing composition that may be administered to a subject by any method known in the art or otherwise contemplated herein, wherein administration of the composition brings about a therapeutic effect as described elsewhere herein. In addition, the compositions of the present disclosure may be designed to provide delayed, controlled, extended, and / or sustained release using formulation techniques which are well known in the art.

[0020] The term “effective amount” refers to an amount of the active agent which is sufficient to exhibit a detectable therapeutic or treatment effect in a subject without excessive adverse side effects (such as substantial toxicity, irritation and allergic response) commensurate with a reasonable benefit / risk ratio when used in the manner of the present disclosure. The effective amount for a subject will depend upon the subject’s type, size and health, the nature and severity of the condition to be treated, the method of administration, the duration of treatment, the nature of concurrent therapy (if any), the specific formulations employed, and the like. Thus, it is not possible to specify an exact effective amount in advance. However, the effective amount for a given situation can be determined by one of ordinary skill in the art using routine experimentation based on the information provided herein.

[0021] The term “ameliorate” means a detectable or measurable improvement in a subject’s condition or symptom thereof. A detectable or measurable improvement includes a subjective or objective decrease, reduction, inhibition, suppression, limit or control in the occurrence, frequency, severity, progression, or duration of the condition, or an improvement in a symptomor an underlying cause or a consequence of the condition, or a reversal of the condition. A successful treatment outcome can lead to a “therapeutic effect” or “benefit” of ameliorating, decreasing, reducing, inhibiting, suppressing, limiting, controlling, or preventing the occurrence, frequency, severity, progression, or duration of a condition, or consequences of the condition in a subject.

[0022] A decrease or reduction in worsening, such as stabilizing the condition, is also a successful treatment outcome. A therapeutic benefit therefore need not be complete ablation or reversal of the condition, or any one, most or all adverse symptoms, complications, consequences or underlying causes associated with the condition. Thus, a satisfactory endpoint may be achieved when there is an incremental improvement such as a partial decrease, reduction, inhibition, suppression, limit, control or prevention in the occurrence, frequency, severity, progression, or duration, or inhibition or reversal of the condition (e.g, stabilizing), over a short or long duration of time (e.g., seconds, minutes, hours).

[0023] Unless otherwise defined herein, scientific and technical terms used in connection with the present disclosure shall have the meanings that are commonly understood by those having ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular. Where used herein, the specific term “single” is limited to only “one.”

[0024] As utilized in accordance with the methods, compounds, and compositions of the present disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings.

[0025] The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and / or the specification may mean “one,” but it is also consistent with the meaning of “one or more.” “at least one,” and “one or more than one.” The use of the term “or” in the claims is used to mean “and / or” unless explicitly indicated to refer to alternatives only or when the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and / or.” The use of the term “at least one” will be understood to include one as well as any quantity more than one, including but not limited to, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 100, or any integer inclusive therein. The term “at least one” may extend up to 100 or 1000 or more, depending on the term to which it is attached; in addition, the quantities of 100 / 1000 are not to be considered limiting, as higher limits may also produce satisfactory results. In addition, the use of the term “at least one of X, Y, and Z” will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y, and Z.

[0026] As used herein, all numerical values or ranges include fractions of the values and integers within such ranges and fractions of the integers within such ranges unless the context clearly indicates otherwise. Thus, to illustrate, reference to a numerical range, such as 1-10 includes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, as well as 1.1, 1.2, 1.3, 1.4, 1.5, etc., and so forth. Reference to a range of 1-50 therefore includes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, etc., up to and including 50, as well as 1.1. 1.2, 1.3, 1.4, 1.5. etc., 2.1, 2.2. 2.3, 2.4, 2.5, etc., and so forth. Reference to a series of ranges includes ranges which combine the values of the boundaries of different ranges within the series. Thus, to illustrate reference to a series of ranges, for example, of 1-10, 10-20, 20-30, 30-40, 40-50, 50-60, 60-75, 75-100, 100-150, 150-200, 200-250, 250-300, 300-400, 400-500, 500-750, 750-1,000, includes ranges of 1-20, 10-50, 50-100, 100-500. and 500-1.000, for example. Reference to an integer with more (greater) or less than includes any number greater or less than the reference number, respectively. Thus, for example, reference to less than 100 includes 99, 98, 97, etc. all the way dow n to the number one (1); and less than 10 includes 9, 8, 7, etc., all the way down to the number one (1).

[0027] As used in this specification and claims, the words ‘"comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0028] The term “or combinations thereof’ as used herein refers to all permutations and combinations of the listed items preceding the term. For example, “A, B, C, or combinations thereof’ is intended to include at least one of: A, B, C, AB, AC, BC, or ABC, and if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, expressly included are combinations that contain repeats of one or more item or term, such as BB, AAA, AAB, BBC, AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context.

[0029] Throughout this application, the terms “about” or “approximately” are used to indicate that a value includes the inherent variation of error for the composition, the method used to administer the active agent or composition, or the variation that exists among the study subjects. As used herein the qualifiers “about” or “approximately” are intended to include not only the exact value, amount, degree, orientation, or other qualified characteristic or value, but are intended to include some slight variations due to measuring error, manufacturing tolerances, stress exerted on various parts or components, observer error, wear and tear, andcombinations thereof, for example. The term “about’' or “approximately,’" where used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass, for example, variations of ± 20%, or ± 10%, or ± 5%, or ± 1%, or ± 0.1% from the specified value, as such variations are appropriate to perform the disclosed methods and as understood by persons having ordinary7skill in the art. As used herein, the term “substantially” means that the subsequently described event or circumstance completely occurs or that the subsequently described event or circumstance occurs to a great extent or degree. For example, the term “substantially” means that the subsequently described event or circumstance occurs at least 90% of the time, or at least 95% of the time, or at least 98% of the time.

[0030] As used herein any reference to “one embodiment” or “an embodiment” means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment and may be included in other embodiments. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment and are not necessarily limited to a single or particular embodiment. Further, all references to one or more embodiments or examples are to be construed as non-limiting to the claims.

[0031] By “biologically active” is meant the ability of the active agent to modify the physiological system of an organism without reference to how the active agent has its phy siological effects

[0032] Effectiveness of a method or use. such as a treatment that provides a potential therapeutic benefit or improvement of a condition or disease, can be ascertained by various methods and testing assays.

[0033] Use of the word “we,” “us,” and / or “our” as a pronoun in the present disclosure refers generally to laboratory personnel, technicians, or other contributors who assisted in laboratory procedures and data collection and is not intended to represent an inventorship role by said laboratory personnel, technicians, or other contributors in any subject matter disclosed herein.

[0034] Suitable carriers, vehicles, and other components that may be included in the formulation are described, for example, in Remington: The Science and Practice of Pharmacy, 2P{Ed. and 22ndEd. The term “pharmaceutically acceptable” means that the carrier is a nontoxic material that does not interfere with the effectiveness of the biological activity of the active agent. The characteristics of the carrier will depend on various factors, including but not limited to, the route of administration. For example, but not by way of limitation, the active agent may be dissolved in a physiologically acceptable pharmaceutical carrier or diluent andadministered as either a solution or a suspension. Non-limiting examples of suitable pharmaceutically acceptable carriers include water, saline, dextrose solutions, fructose solutions, ethanol, or oils of animal, vegetative, or synthetic origin, or any combination thereof. A sterile diluent, which may contain materials generally recognized for approximating physiological conditions and / or as required by governmental regulations, may be employed as the pharmaceutically acceptable carrier. In this respect, the sterile diluent may contain a buffering agent to obtain a physiologically acceptable pH, such as (but not limited to) sodium chloride, saline, phosphate-buffered saline, and / or other substances which are physiologically acceptable and / or safe for use.

[0035] The dietary supplements of the present disclosure may also contain one or more additional components in addition to the active agent and pharmaceutically acceptable carrier(s) (and other additional therapeutically active agent(s), if present). Examples of additional components that may be present include, but are not limited to, diluents, fillers, salts, buffers, preservatives, stabilizers, solubilizers, and other materials well known in the art. Another particular non-limiting example of an additional component that may be present in the dietary supplements is a delivery agent, as discussed in further detail herein below.

[0036] Other non-limiting embodiments of the dietary supplements of the present disclosure may include the incorporation or entrapment of the active agent in various ty pes of delivery7systems that function to provide controlled release and / or increased half-life to the active agent. For example, but not by way of limitation, it is possible to entrap the active agent in microcapsules prepared by coacervation techniques or by interfacial polymerization (for example, hydroxymethylcellulose or gelatin-microcapsules and poly-(methylmethacylate) microcapsules, respectively). It is also possible to entrap the active agent in macroemulsions or colloidal drug delivery systems (such as but not limited to, liposomes, albumin microspheres, microemulsions, nanoparticles, nanocapsules, and the like). Such techniques are well known to persons having ordinary skill in the art, and thus no further description thereof is deemed necessary.

[0037] In one particular, non-limiting example, the dietary supplements may include a liposome in which the active agent is disposed. In addition to other pharmaceutically acceptable carrier(s), the liposome may contain amphipathic agents such as lipids which exist in an aggregated form as micelles, insoluble monolayers, liquid crystals, or lamellar layers in aqueous solution. Suitable lipids for liposomal formulation include, but are not limited to, monoglycerides, diglycerides, sulfatides, lysolecithin, phospholipids, saponin, bile acids, combinations thereof, and the like. Preparation of such liposomal formulations is well withinthe level of ordinary skill in the art, as disclosed, for example, in U.S. Patent No. 4,235,871; U.S. Patent No. 4.501,728; U.S. Patent No. 4.837,028; and U.S. Patent No. 4,737,323; the entire contents of each of which are incorporated herein by reference.

[0038] In other non-limiting examples, the active agent of the present disclosure may be incorporated into particles of one or more polymeric materials, as this ty pe of incorporation can be useful in controlling the duration of action of the active agent by allowing for controlled release from the preparations, thus increasing the half-life thereof. Non-limiting examples of polymeric materials that may be utilized in this manner include polyesters, polyamides, polyamino acids, hydrogels, poly(lactic acid), ethylene vinylacetate copolymers, copolymer micelles of, for example, PEG and poly(l-aspartamide), and combinations thereof.

[0039] The dietary supplements of the present disclosure may be formulated for administration by any other method known or otherwise contemplated in the art, as long as the route of administration allows for delivery' of the active agent so that the compounds can function in accordance with the present disclosure. Examples of routes of administration include, but are not limited to, oral, topical, and suppository.

[0040] The amount of the active agent that is effective in the treatment described herein can be determined by the attending diagnostician, as one of ordinary skill in the art, by the use of conventional techniques and by observing results obtained under analogous circumstances. In determining the therapeutically effective dose, a number of factors may be considered by the attending diagnostician, including, but not limited to: the species of the subject; its size, age, and general health; the specific diseases or other conditions involved; the degree, involvement, and / or severity of the diseases or conditions; the response of the individual subject; the particular active agent administered; the mode of administration; the bioavailability characteristics of the preparation administered; the dose regimen selected; the use of concomitant medication; and other relevant circumstances. A therapeutically effective amount of an active agent of the present disclosure also refers to an amount of the active agent which is effective in controlling, reducing, or ameliorating the condition to be treated.

[0041] Practice of the method of the present disclosure may include administering to a subject a therapeutically effective amount of the dietary supplements (containing the active agent in any suitable systemic and / or local formulation, in an amount effective to deliver the dosages listed above. The dosage can be administered, for example, but not by way of limitation, on a one-time basis, or administered at multiple times (for example, but not by way of limitation, from one to five times per day, or once or twice per week). The dietarysupplements may be administered either alone or in combination with other therapies, in accordance with the inventive concepts disclosed herein.

[0042] The dietary supplements of the present disclosure can be administered in a single dose treatment or in multiple dose treatments on a schedule and over a time period appropriate to the age, weight, and condition of the subject, the particular composition used, and the route of administration. In one non-limiting embodiment, a single dose of the composition according to the disclosure is administered. In other non-limiting embodiments, multiple doses are administered. The frequency of administration can vary depending on any of a variety of factors, e.g., severity' of the symptoms, or whether the composition is used for prophylactic or curative purposes. For example, in certain non-limiting embodiments, the composition is administered once per month, twice per month, three times per month, every other week, once per week, twice per week, three times per week. four times per week, five times per week, six times per week, every other day, daily, twice a day, or three times a day. The duration of treatment, e.g., the period of time over which the dietary supplements is administered, can vary', depending on any of a variety of factors, e.g., subject response. For example, the composition can be administered over a period of time ranging from about one day to about one week, from about two weeks to about four w eeks, from about one month to about two months, from about tw o months to about four months, from about four months to about six months, from about six months to about eight months, from about eight months to about 1 year, from about 1 year to about 2 years, or from about 2 years to about 4 years, or more.

[0043] As noted above, the dietary supplements can be combined with a pharmaceutically acceptable carrier (excipient) or vehicle. Pharmaceutically acceptable carriers and excipients can contain a physiologically acceptable compound that acts to, e.g., stabilize, or increase or decrease the absorption or clearance rates of the dietary supplements. Physiologically acceptable carriers and vehicles can include, for example, carbohydrates, such as glucose, sucrose, or dextrans, antioxidants, such as ascorbic acid or glutathione, chelating agents, low molecular w eight proteins, detergents, liposomal carriers, aloe vera, curcumin, flavonoids such as hesperidin, or other natural or synthetic excipients or other stabilizers and / or buffers. Other physiologically acceptable compounds, carriers, and vehicles include wetting agents, emulsifying agents, dispersing agents or preservatives. The pharmaceutically acceptable carriers and excipients may be added to the extract material to accelerate or enhance the dry ing and removal of ethanol from the extract material to produce the IPP extract. The carriers and excipients may comprise from 1% to 30% of the extract material prior to the drying process to produce the IPP extract.

[0044] When administered orally, the present compositions may be protected from digestion. This can be accomplished either by complexing the active agent with a composition to render it resistant to acidic and enzymatic hydrolysis or by packaging active agent in an appropriately resistant carrier such as a liposome, e.g., such as shown in U.S. Pat. No.5,391,377.

[0045] The following non-limiting example describes an extraction and purification process that is used to make the powder for the presently disclosed treatment.EXAMPLES

[0046] Examples are provided hereinbelow. However, the present disclosure is to be understood to not be limited in its application to the specific experimentation, results, and laboratory procedures disclosed herein after. Rather, the Examples are simply provided as one of various embodiments and are meant to be exemplary, not exhaustive.Example 1METHODS

[0047] Extract Preparation:1. Provide a quantity of commerci ally-available C. igneus dry raw leaf powder (50-80 mesh).2. Macerate the raw leaf powder with a solvent, such as an 80% ethanol (1-part powder + 6-part ethanol), at 80 °C while stirring for approximately 3 h, producing a macerated mixture. The solvent may be any suitable solvent used in the extraction of substances from plants for use in dietary supplements including, but not limited to, methanol, hexane, acetone, ethyl acetate, and propylene glycol.3. Filter the mixture to collect the solvent extract as fdtrate.4. Evaporate excess solvent from the filtrate to obtain a thick concentrated extract. The solvent can be collected for reuse or recycling.5. Weigh the thick concentrated extract and subject it to drying to remove residual solvent and moisture. To assist complete removal of the solvent(s) or moisture from the extract material, a carrier or excipient in a powder form may be added to enhance or expedite the complete drying of the extract material to form the 1PP extract. The earner or excipient will be mixed with the thick concentrate of the extract material and dried in open air or a tray dryer (temp < ~50 °C).6. The dried mass is milled to a mesh size 80, or size suitable for capsulation in a size 0 capsule. The expected yield of the dry extract (referred to below as the IPP extract") from 50 kg of raw dry powder input is approximately 15 kg.7. Conduct appropriate standard analytical tests that are performed on herbal products, which optionally include (a) Organoleptic character (appearance, color, and texture); (b) Particle size; (c) Solubility in water (slightly soluble, freely soluble, insoluble, etc.); (d) Solubility in ethanol (slightly soluble, freely soluble, insoluble, etc.); (e) Toxic heavy metal, e.g. Pb, As, and Hg; (f) Total plate count; (g) Total yeast / mold; (h) E. coir. (i) Salmonella, (j) Staphylococcus,' (k) Moisture content; (1) Loss on drying: (m) Residual Solvent (ethanol).ANALYSIS OF IPP EXTRACT

[0048] The IPP extracts produced by the above methods were analyzed using the methods below.Phytochemistry of IPP extract:

[0049] To phytochemically characterize IPP, 100 mg of dry powder extract was solubilized in 10 mL ethanol (95% v / v). The solubilization process was promoted by three 2-min ultrasound cycles. The resulting solution was filtered through 0.45 pm and 0.22 pm membrane filters.Fourier transform-infrared (FT-IR) spectroscopy:

[0050] FT-IR spectroscopy is a valuable non-destructive analytical method for identifying the functional groups of chemical constituents. Its ease of use, quick and highly reproducible results, and low cost make it particularly beneficial for assessing herbal quality control. The objectives of FT-IR spectroscopy were to establish a baseline qualify control parameter for batch-to-batch comparison and to determine the differences in spectra of the IPP extracts from two other experimental extractions, B and C as compared to that produced originally (A). IPP extract B was produced using tray-drying at 50 °C to produce the dry ethanolic extract powder whereas IPP extract C was produced using a standard high temperature spray-drying condition (exit temperature 80 °C). For FTIR analysis, approximately 10 mg of each IPP extract was suspended in 0.2 mL of ethanol. The suspension was sonicated for 15-20 seconds and then centrifuged to separate the insoluble material. About 25 pL of the supernatant was placed on the probe of a Nicolet Summit X FTIR Spectrometer (Thermo Fisher Scientific, Pittsburgh, PA). The sample was allowed to evaporate, and the dried residue was scanned in the region between 4000 and 400 cm"1. The resultant data were then baseline corrected.UV-visible spectrophotometry:

[0051] A Genesys® 150 UV -Visible spectrophotometer equipped with Exacta Optec quartz cuvettes was used (Thermo Fisher Scientific). Suitable calibration curves were obtained from solutions of determined concentration to (r2>0.99). All analyses were conducted in triplicate with suitable dilution and blank for each protocol applied. When possible, scanning in a wide range of wavelength (A = 190 - 700 nm) was performed to detect main peaks. Sensitivity was set to medium level with detection every 1 nm.Carbohydrate content:

[0052] To determine sugar content, a phenol-sulfuric acid assay was performed. Briefly, 500 pL of a diluted sample (1:5) was added to 1.25 mL of concentrated sulfuric acid and 250 pL of a 5% (w / v) phenol solution. The mixture was vortexed for 30 seconds, incubated on ice for 20 minutes, and absorbance was measured at 490 nm. A sucrose standard (concentration range: 18.75 to 150 ppm) was used to create a calibration curve.

[0053] Fructose was selectively quantified using the Seliwanoff reagent (0.1% resorcinol in hydrochloric acid). The test sample (1 mL) was mixed with 4 mL of Seliwanoff reagent. After incubating at 70°C for 30 minutes, the reaction tubes were placed on ice for 2 minutes to stop the reaction. Samples were then read using a UV-Vis spectrophotometer at 484 nm, with fructose standards used for the calibration curve.Protein content:

[0054] Protein content was determined using both the Bradford assay and the Bicinchoninic acid (BCA) assay. For the Bradford assay. 2 pL of the sample was added to the Bradford reagent, which was diluted 1:5 with water. After a 30-minute reaction period, absorbance was measured at 595 nm. For the BCA assay, 50 pL of the sample was added to 1 mL of working reagent (prepared by mixing 8 mL of reagent A with 160 pL of reagent B; Sigma- Aldrich, St. Louis, MO). The mixture was incubated at 37 °C for 30 minutes, and absorbance was measured at 562 nm. In both assays, BSA (2 to 16 ppm) was used to create a calibration plot.Total phenolic content:

[0055] Total phenolic content w as determined using the Folin-Ciocalteu method. Briefly, 50 pL of the sample was added to 250 pL of Folin-Ciocalteu phenol reagent and vortexed for 30 seconds. After a 5-minute incubation at room temperature, 500 pL of 5% (w / v) sodiumcarbonate was added, followed by a 25-minute incubation at room temperature, protected from light. Absorbance at 760 nm was measured immediately after the incubation. Gallic acid was used as the reference standard for the calibration curve (0.1 to 0.5 mg / mL). Results were expressed as milligrams of gallic acid equivalents per rnL of extract (mg GAE / mL).

[0056] Within phenolics, the flavonoid content in the extract was quantified using an aluminum chloride colorimetric method. In brief, 1 mL of the diluted sample was mixed with 60 pL of sodium nitrite solution (5% w / v) and allowed to react for 5 minutes. Subsequently, 120 pL of aluminum chloride solution (10% w / v) was added, vortexed, and incubated for another 5 minutes. Finally, 0.40 mL of sodium hydroxide (1 M) was added to neutralize the pH, and the final volume was adjusted to 2 rnL with water. The sample was then scanned for absorbance between 200 and 600 nm. Specific peaks and wavelengths were selected based on standard flavonoids, including naringin, apigenin, hesperidin, and rutin. Solutions of these flavonoids were prepared in a DMSO-ethanol mixture (1:1 v / v). A suitable calibration curve was plotted using the absorbance values of a mixture containing naringin, rutin, apigenin, and hesperidin in 1:1:1:1 weight ratio (y = 0.0153 x + 0.0615; r2=0.994).Antioxidant activity:

[0057] The antioxidant activity of the extract was assessed using a colorimetric assay based on its ability to inhibit the free radical 2,2-diphenyl-l-picrylhydrazyl (DPPH). In brief, 50 pL of the extract was mixed with 5 mL of 0.004% (w / v) methanolic DPPH solution, vortexed, and incubated in the dark for 30 minutes at room temperature. The absorbance of the mixture was then measured at 518 nm. An 80% (v / v) methanol solution served as the blank, while a DPPH solution was used as the negative control. L-ascorbic acid (5 mg / mL) was used as the positive control. The percentage of DPPH inhibition was calculated using the formula: I(%) = [(Ao -Al) / Ao] x 100, where Ao is the absorbance of the negative control and Al is the absorbance of the extracts or standards.High-performance liquid chromatography (HPLC):

[0058] For HPLC analysis, 20 pL of the samples were injected onto an Acclaim® 120 reverse phase 5 pm C18 column (100 mm x 4.6 mm) and eluted with a gradient mobile phase consisting of 10 mM phosphoric acid and acetonitrile. The column temperature was maintained at 25 °C, the detector was set to 340-350 nm, and the method duration was 20 minutes. The HPLC apparatus included a Vanquish System Base VC- S01-A-02 equipped with a VC-P20-A-01 quaternary pump, a VC-A13-A-02 split sampler, a VC- C10-A-03 column compartment, and a VF-D40-A UV / VIS variable wavelength detector, all controlled by Chromeleon® software version 7.2 (Thermo Fisher Scientific, Rosano, MI, Italy). Peak identification was performed by comparing the retention times wi th those of standard solutions of rutin, naringin, hesperidin, and apigenin. Calibration curves (0.0625 mg / mL to 1 mg / mL; r2> 0.998) were used to identify the flavonoids present in the samples. For further characterization, the sample extract was next subjected to a liquid chromatography separation followed by a high-resolution mass spectrometry analysis (ESI-MS). The separation conditions were the same as those described above. Heated electrospray ionization (HESI) in negative polarity was used in all analyses. High-purity nitrogen was used as sheath gas (30 arb units) and auxiliary gas (10 arb units). The compound characterization was based on the corresponding HRMS spectra, accurate masses, characteristic fragmentations, and retention times.In vitro Biological ExperimentsCell viability:

[0059] HepG2 cells were purchased from the American Type Culture Collection (Manassas, VA, USA). The cells were cultured and maintained in Minimum Essential Medium (MEM, Coming 10-009-CV) supplemented with 10% Fetal Bovine Serum (SIAL-FBS), penicillin (100 U / mL). and streptomycin (100 pg / mL) in a humidified incubator (95% O2. 5% CO2) at 37 °C.To evaluate the effects of the IPP extracts on cell viability, HepG2 cells (1 x 104cells in 100 pL) were seeded in a 96-well cell culture plate and allowed to grow for 24 h. The cells were then treated with IPP extract (50, 100, 250, and 500 pg / mL). Cell viability assay was performed after 24 h using the MTT (3-[4,5-dimethylthiazol-2-yl]-2,5 diphenyl tetrazolium bromide). Briefly, MTT solution (Sigma Aldrich, St. Louis, MO, USA) at the concentration of 5 mg / mL was added to each well and incubated at 37 °C for 2 h. The supernatants were removed and replaced with 100 pL of dimethyl sulfoxide. The optical density was measured at 570 nm.Intracellular lipid content:

[0060] After 24 h of seeding, HepG2 cells were co-treated for 24 h with different concentrations of IPP extract (50, 100, 250, and 500 pg / mL) and 500 pM oleic acid (OA) conjugated to 1% BSA. Intracellular neutral fat content was visualized by a lipophilic dye LD540. Briefly, HepG2 cells were seeded in a coverslip at a densify of 2 x io5cells / well in 6-well plates. After treatment, the cells were washed with PBS, and fixed with 4% paraformaldehyde for 10 min. Intracellular lipids were stained for 10 minutes with 0.1 pg / mLLD540 at 37 °C in dark. Cell nuclei were stained with 4',6-diamidino-2-phenylindole (DAPI) for 10 min. All steps were carried out at room temperature while protecting samples from light. Images were acquired with a Leica DM4 B Upright Microscope (Leica Microsystems). The LD540-stained area was normalized to the number of D API-stained nuclei and quantified using ImageJ software (v.l.52h, NIH).RESULTS FT-IR overall characteristics:

[0061] The absorption spectra of dried IPP extracts are illustrated in FIG. 1. The spectra of IPP extracts A and B were similar within the range of 4000 to 400 cm '. but IPP extract C (which was dried at a higher temperature than A or B) showed significant differences. The spectra of IPP extracts A and B featured a broad peak at 3357 cm and two sharp peaks at 2929 and 2857 cm1in the single bond region, three sharp peaks at 1732, 1657, and 1525 cm1in the double bond region, and five peaks at 1457, 1379, 1204, and 1064 cm1in the fingerprint region. In contrast, the spectrum of extract C lacked or had subdued versions of these peaks, except for those at 2929 and 2857 cm indicating significant degradation of molecular entities at the high temperature (~80 °C) employed to dry extract C.

[0062] The broad peak in the 3650-3200 cm1region indicates symmetric and asymmetric stretching of polymeric hydroxyl groups (O-H) and H-bonded stretching, characteristic of polyphenolic compounds. The absorbance at 3300-3280 cm1can also indicate the presence of N-H stretching in polypeptides or proteins, with peaks at 1657 and 1525 cm1typically associated with protein structures. The peaks at 2929 and 2857 cm1signify the presence of aliphatic compounds with - CH, -CH2, and -CH3stretching vibrations, derived from carbohydrates and sugars in dried herbal extracts. The stretching of the C-H and C=C-C aromatic bond in the 1615-1580 cm1region indicates the presence of one or more aromatic rings in the chemical structure. Additionally, the phenolic C-0 stretching at around 1200 cm1is likely due to the C-0 of pyran, typical of flavonoid C-rings.UV-Visible spectrum:

[0063] The ethanolic IPP extract solution exhibited a distinct peak at 665 nm, indicative of chlorophyll (FIG. 2, Panel A). Additionally, other notable peaks were observed at 270. 315, and 415 nm, likely corresponding to organic nitrates and polyphenols, including flavones and flavonoids (FIG. 2, Panel B).Carbohydrate content:

[0064] The IPP extract solution contained 0.864 ± 0.022 mg / mL of carbohydrates (sucrose equivalents), accounting for nearly 8.6% of the solubilized extract (Table 1). However, a fructose-specific Seliwanoff colorimetric assay did not yield a characteristic peak for fructose at 484 nm (data not shown). This indicates that the sugars in the extract are soluble fibers or carbohydrate monomers conjugated to other macromolecules, such as flavonoids (e.g., rutinose linked to rutin).

[0065] In at least certain embodiments, after drying, the IPP powder extract contains less than 10% by wt of insoluble fiber, or less than 5% by wt of insoluble fiber, or less than 1% by wt of insoluble fiber, or less than .9% by wt of insoluble fiber, or less than .8% by wt of insoluble fiber, or less than .7% by wt of insoluble fiber, or less than .6% by wt of insoluble fiber, or less than .5% by wt of insoluble fiber, or less than .4% by wt of insoluble fiber, or less than .3% by wt of insoluble fiber, or less than .2% by wt of insoluble fiber, or less than .1% by wt of insoluble fiber, or less than .05% by wt of insoluble fiber, or less than .01% by wt of insoluble fiber.Protein content:

[0066] The protein content of the extract was determined using two colorimetric assays commonly employed for herbal extracts containing complex mixture of various interfering factors. The Bradford assay indicated that the IPP solution had a protein concentration of 2.46 ± 0.294 mg / mL (BSA equivalents). Similarly, the BCA assay detected a protein concentration of 2.32 ± 0.012 mg / mL (BSA equivalents). These results indicate that the extract powder likely contains 23.2-24.6% (w / w) protein (Table 1).Total phenolic content:

[0067] The presence of phenolic and polyphenolic compounds in IPP was measured as gallic acid equivalents (GAE) using Folin-Ciocalteu’s reagent. The ethanolic solution of IPP contained 0.1661 ± 0.012 mg / mL GAE, accounting for approximately 1.66% w / w of the extract powder (Table 1). Among phenolic compounds, flavonoids were the most abundant group found in herbal extracts. Using a flavonoid-specific aluminum chloride colorimetric method, we detected an average flavonoid content of 0.637 ± 0.006 mg / mL, which corresponds to 6.37% w / w of the powder extract (Table 1).Antioxidant activity:

[0068] The antioxidant activity of the IPP extract was measured using an assay that compared its potency to ascorbic acid, which was set at 100%. The IPP extract demonstrated an antioxidant capacity of 18.76 ± 0.5% (Table 1).Table 1: Phytochemical evaluation of IPP extract.Parameter Value in 10 mg / mL extract solution Percent in extract (mean ± SD, n=3) powder Carbohydrates 0.864 ± 0.22 mg / mL as sucrose equivalents 8.6%Fructose Not detected Not presentProtein 2.46 ± 0.294 mg / mL (Bradford) and 23.2 to 24.6%2.32 ± 0.012 mg / mL (BCA) as BSAequivalentsPhenols 0.1661 ± 0.012 mg / mL gallic acid 1.7%equivalentsFlavonoids 0.637 ± 0.006 mg / mL as naringin, rutin, 6.37%apigenin, and hesperidinAntioxidant activity 18.76 ± 0.502% inhibition of ascorbic acid N / AHigh-performance liquid chromatography (HPLC):

[0069] The IPP extract was analyzed using an HPLC method that can distinguish between different flavonoids present in the extract. The analysis revealed the presence of the following flavonoids: rutin (retention time = 7.06 min. 0.0121 mg / mL), naringin (retention time = 11.58 min, 0.0051 mg / mL), and apigenin (retention time = 17.8 min, 0.0006 mg / mL). Hesperidin was not detected in the extract sample (FIG. 3). ESI-MS analysis indicated a major peak at 17.5 min in addition to more water-soluble compounds eluting early in the void volume at 1.10 min; other peaks were detected at retention times of 18.7 min and 22-23 min. The mass of the compound eluting at 17.5 min was identified as kaempferol-3-O-robinoside.IPP extract reduces fat accumulation in HepG2:

[0070] First, we studied the cytotoxicity of IPP extract (50 to 500 pg / mL) by treating HepG2 cells for 24 h. As shown in FIG. 4, Panel A, IPP extract treatment did not affect the cell viability of HepG2 cells. To study the effect of IPP extract on lipid metabolism in vitro, we treated HepG2 cells with 500 pM OA with or without IPP extract (50-500 pg / mL). The LD540 stainingshowed a significant increase in lipid deposition in OA-stimulated HepG2 cells compared w ith untreated cells (Control), indicating that OA treatment induces steatosis in cultured cells (FIG.4, Panel B(ii). Co-treatment with IPP extract significantly attenuated lipid accumulation in HepG2 cells (FIG. 4, Panel B(iii-vi)). How ever, the reduction in fat accumulation was doseindependent and there was no significant difference in the efficacy of various concentrations of IPP extract (FIG. 4, Panel C).DISCUSSION

[0071] Considering the liver’s vital role in anabolic, catabolic, and detoxification processes, preserving its structural and functional integrity is crucial for overall health. Additionally, the liver is integral to biochemical processes such as growth, nutrient provision, energy supply, and reproduction. Using disease prevalence as a measure, MASLD is the leading cause of liver dysfunction and may initially present as a diabetic condition. It encompasses simple fatty infiltration, known as steatotic liver disease (a benign condition), and metabolic dysfunction-associated steatohepatitis (MASH), a less common but clinically significant progression of the disease. Regrettably, most patients remain asymptomatic until severe consequences occur. Even those with cirrhosis due to MASH may not display the usual signs of liver disease, leading to delayed clinical intervention. Furthermore, the available treatment options are suboptimal.

[0072] The IPP extract of the present disclosure showed significant concentrations of flavonoids. Generally considered nontoxic for humans, flavonoids include flavones, isoflavones, flavanones, flavonols, flavanonols and anthocyanins. They not only can exhibit direct pharmacological effects, but also display indirect effects by modulating the activity of xenobiotic-metabolizing enzymes, particularly phase I enzy mes. The IPP extract showed the presence of at least three flavonoids- rutin, naringin, and apigenin. Without wishing to be bound by theory, it is believed that the observed anti-oxidative effect of IPP extract is attributable to the presence of flavonoids acting via their anti-oxidative mechanism. Rutin is a glycoside comprising of flavonol quercetin aglycone and rutinose disaccharide. Quercetin is a known hepatoprotective compound by virtue of its ability to activate antioxidant nuclear factor-erythroid 2-related factor 2 (Nrf2) and heme oxygenase (HO-1) pathway. Interestingly, in a model of CCI4-mduced liver injury', rutin was more effective in activating the Nrf2 / HO-l pathw ay as compared to quercetin. On the other hand, quercetin was found to be more potent in suppressing the expression of transforming growth factor-[31 (TGF-[31) than rutin. In a mouse model of high-cholesterol diet, rutin and quercetin were found to attenuate the expression ofredox sensitive transcription factor NF-KB and inflammatory' markers CRP and TNF-a. The presence of quercetin in C. igneus and related plants has been previously reported.

[0073] Like rutin, naringenin (a flavanone) also possesses anti-oxidative and antiinflammatory properties. In mice on high-fat diet, naringenin restored hepatic triglycerides and normalized the expression of PGCla, CPTla, and SREBP-lc. Earlier, naringenin was found to exert antifibrogenic effects by directly or indirectly down-regulating SMAD3 protein expression and phosphorylation through TGF-0 signaling. Apigenin was the third flavonoid detected in IPP extract. It can occur as free aglycone or in a glycoside form. Recently, Ji et al showed that apigenin alleviates liver fibrosis in CCh-induced liver injury by inhibiting hepatic stellate cell activation and autophagy via TGF- / il / Smad3 and p38 / PPARa pathways. We also found that treatment of HepG2 cells with the IPP extract reduced phospho- AKT in a dosedependent manner (data not shown).

[0074] It will be understood from the foregoing description that various modifications and changes may be made in the various embodiments of the present disclosure without departing from their true spirit. The description provided herein is intended for purposes of illustration only and is not intended to be construed in a limiting sense, except where specifically indicated. Thus, while the present disclosure has been described herein in connection with certain nonlimiting embodiments so that aspects thereof may be more fully understood and appreciated, it is not intended that the present disclosure be limited to these particular embodiments. On the contrary, it is intended that all alternatives, modifications, and equivalents are included within the scope of the present disclosure as defined herein. Thus the examples described above, which include particular embodiments, will serve to illustrate the practice of the present disclosure, it being understood that the particulars shown are by way of example and for purposes of illustrative discussion of particular embodiments only and are presented in the cause of providing what is believed to be a useful and readily understood description of procedures as well as of the principles and conceptual aspects of the inventive concepts. Changes may be made in the formulation of the various components, compounds, and compositions described herein, the methods described herein, or in the steps or the sequence of steps of the methods described herein, without departing from the spirit and scope of the present disclosure.

Claims

What is claimed is:

1. A method of treating Metabolic dysfunction-associated steatotic liver disease (MASLD) in a subject in need of such treatment, comprising:administering to the subject a dietary supplement comprising a powder extract of Costus igneus leaves.

2. The method of claim 1 , wherein the powder extract comprises:7% to 10% carbohydrates as measured in sucrose equivalents,20% to 28% protein as measured in bovine serum albumin (BSA) equivalents, 1 to 3% phenols as measured in gallic acid equivalents, andabout 5% to 7.5% flavonoids as measured in amounts of naringin, rutin, apigenin, and hesperidin.

3. The method of claim 1, wherein the dietary supplement comprises a size 0 capsule loaded with an amount of the powder extract.

4. The method of claim 3, wherein a daily treatment dosage comprises one or more loaded capsules.

5. The method of claim 1 , wherein the dietary supplement comprising the powder extract is formed into a dosage form selected from the group consisting of at least one capsule, at least one pill, at least one tablet, at least one sachet, and at least one lozenge.

6. A dietary supplement, comprising:a dry powder extract of Costus igneus leaves which comprises:7% to 10% carbohydrates as measured in sucrose equivalents, 20% to 28% protein as measured in bovine serum albumin (BSA) equivalents, 1 to 3% phenols as measured in gallic acid equivalents, andabout 5% to 7.5% flavonoids as measured in amounts of naringin, rutin, apigenin, and hesperidin.

7. The dietary supplement of claim 6, comprising a size 0 capsule loaded with the dry powder extract of Costus igneus leaves.

8. The dietary supplement of claim 7. wherein a daily dosage comprises one or more loaded capsules.

9. The dietary supplement of claim 7, wherein a daily dosage consists essentially of one loaded capsule.

10. The dietary supplement of claim 6, comprising the ry powder extract formed into a dosage form selected from the group consisting of at least one capsule, at least one pill, at least one tablet, at least one sachet, and at least one lozenge.

11. A kit or package, comprising:a plurality of the dietary supplements of claim 6 disposed in a sealed container.

12. A kit or package, comprising:a plurality of the loaded capsules of claim 7 disposed in one or more sealed containers.

13. A method of producing a dietary' supplement comprising:mascerating a quantity of Coslus igneus leaves;treating the mascerated quantity of Costus igneus leaves with a solvent to form a solvent extract;removing the solvent from the solvent extract to form a dry powder extract, wherein the dry powder extract comprises 7% to 10% carbohydrates as measured in sucrose equivalents, 20% to 28% protein as measured in bovine serum albumin (BSA) equivalents, 1% to 3% phenols as measured in gallic acid equivalents, and about 5% to 7.5% flavonoids as measured in amounts of naringin, rutin, apigenin, and hesperidin; andforming the dry’ powder extract into a dosage form to produce the dietary supplement.

14. The method of claim 13, wherein the dosage form is a size 0 capsule loaded with the dry powder extract.

15. The method of claim 14, wherein a daily treatment dosage of the dietary supplement comprises at least one size 0 capsule loaded with the dry powder extract.

16. The method of claim 13. wherein the dosage form comprising the dry powder extract is selected from the group consisting of at least one capsule, at least one pill, at least one tablet, at least one sachet, and at least one lozenge.

17. The method of claim 13, wherein the solvent is ethanol.

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