CANNABIS PLANT RESIDUE AND USE THEREOF

Abstract

The present disclosure relates to a cannabis plant residue and its use as a prebiotic. The present disclosure also relates to a prebiotic composition comprising a cannabis plant residue and hempseed hull, and its use as a prebiotic. The present disclosure further relates to methods of providing a prebiotic comprising administering a cannabis plant residue of the present disclosure.

Claims

1. A method of providing a prebiotic supplement to a subject in need thereof comprising administering to the subject an effective amount of a cannabis plant residue, the cannabis plant residue having a cannabinoid content of at most 5%.

2. The method of claim 1, wherein the cannabis plant residue is substantially free of cannabinoid.

3. The method of claim 1, wherein the cannabis plant residue is obtained by a treatment process comprising removing cannabinoids from a cannabis plant.

4.-7. (canceled)

8. The method of claim 1, wherein the cannabis plant residue comprises about 15% w/w to about 85% w/w of total dietary fiber.

9. The method of claim 1, wherein the cannabis plant residue comprises about 10% w/w to about 80% w/w of insoluble dietary fiber.

10. The method of claim 1, wherein the cannabis plant residue comprises about 0.5% w/w to about 60% w/w of carbohydrate.

11. The method of claim 1, wherein the cannabis plant residue comprises about 10% w/w to about 30% w/w of protein.

12.-14. (canceled)

15. The method of claim 1, wherein the cannabis plant residue is administered in combination with a probiotic supplement, a parabiotic supplement, a postbiotic supplement, a second prebiotic supplement, and/or one or more cannabinoids.

16. The method of claim 15, wherein the second prebiotic supplement is selected from hempseed hull, fructans, galacto-oligosacharides, starch and/or glucose-derived oligosaccharides, pectin oligosaccharides, non-carbohydrate olligosaccharides and combinations thereof.

17. (canceled)

18. The method of claim 15, wherein the probiotic supplement is microorganisms selected from Lactobacillus species, Bifidobacterium species, Baccilus species, Streptococcus species, Enterococcus species, Saccharomyces species, and combinations thereof.

19.-20. (canceled)

21. A prebiotic composition comprising a cannabis plant residue and hempseed hull, the composition having a cannabinoid content of about 5% or less than 5%.

22. The prebiotic composition of claim 21, wherein the cannabinoid content is about 3% or less than 3%, about 1% or less than 1%, about 0.5% or less than 0.5%, or about 0.1% or less than 0.1%.

23. (canceled)

24. The prebiotic composition of claim 21, wherein the hempseed hull is substantially free of cannabinoids, optionally, the hempseed hull comprising about 40 wt % to about 70 wt % of carbohydrate, about 50 wt % to about 70 wt % of carbohydrate, about 55 wt % to about 65 wt % of carbohydrate, or about 62%.

25.-26. (canceled)

27. The prebiotic composition of claim 21, wherein the composition comprises about 20% w/w to about 99% w/w hempseed hull and about 1% w/w to about 80% w/w cannabis plant residue.

28.-29. (canceled)

30. The prebiotic composition of claim 21, wherein the mass ratio of the cannabis plant residue to the hempseed hull is about 1:20 to about 1:10, about 1:18 to about 1:12, or about 1:16.

31. Method of providing a prebiotic supplement to a subject in need thereof comprising administering to the subject an effective amount of a prebiotic composition as defined in claim 21.

32. The method of claim 31, wherein the prebiotic composition is administered in combination with a probiotic supplement, a parabiotic supplement, a postbiotic supplement, a second prebiotic supplement, and/or one or more cannabinoids.

33. The method of claim 32, wherein the second prebiotic supplement is selected from fructans, galacto-oligosacharides, starch and/or glucose-derived oligosaccharides, pectin oligosaccharides, non-carbohydrate oligosaccharides and combinations thereof.

34. The method of claim 33, where in the second prebiotic supplement is inulin.

35. The method of claim 32, wherein the probiotic supplement is microorganisms selected from Lactobacillus species, Bifidobacterium species, Baccilus species, Streptococcus species, Enterococcus species, Saccharomyces species, and combinations thereof.

36.-39. (canceled)

Description

DRAWINGS

[0019] The embodiments of the disclosure will now be described in greater detail with reference to the attached drawings in which:

[0020] FIG. 1 shows a flowchart of an example of a treatment process to obtain the cannabis plant residue of the present disclosure.

[0021] FIG. 2 shows the growth curve of Bifidobacterium longum when treated with inulin (control), or cannabis plant residue as assessed by OD measurements at 600 nm at 0, 8, and 12 h of fermentation.

[0022] FIG. 3 shows the growth curve of Lactobacillus rhamnosus when treated with inulin (control), or cannabis plant residue as assessed by OD measurements at 600 nm at 0, 8, and 12 h of fermentation.

[0023] Other features and advantages of the present disclosure will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating embodiments of the disclosure, are given by way of illustration only and the scope of the claims should not be limited by these embodiments, but should be given the broadest interpretation consistent with the description as a whole.

DESCRIPTION OF VARIOUS EMBODIMENTS

[0024] I. Definitions

[0025] Unless otherwise indicated, the definitions and embodiments described in this and other sections are intended to be applicable to all embodiments and aspects of the present disclosure herein described for which they are suitable as would be understood by a person skilled in the art.

[0026] The term “and/or” as used herein means that the listed items are present, or used, individually or in combination. In effect, this term means that “at least one of” or “one or more” of the listed items is used or present. The term “and/or” with respect to pharmaceutically acceptable salts and/or solvates thereof means that the compounds of the disclosure exist as individual salts and hydrates, as well as a combination of, for example, a solvate of a salt of a compound of the disclosure.

[0027] As used in the present disclosure, the singular forms “a”, “an” and “the” include plural references unless the content clearly dictates otherwise. For example, an embodiment including “a compound” should be understood to present certain aspects with one compound, or two or more additional compounds.

[0028] In embodiments comprising an “additional” or “second” component, such as an additional or second compound, the second component as used herein is chemically different from the other components or first component. A “third” component is different from the other, first, and second components, and further enumerated or “additional” components are similarly different.

[0029] As used in this disclosure and claim(s), 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 “include” and “includes”) or “containing” (and any form of containing, such as “contain” and “contains”), are inclusive or open-ended and do not exclude additional, unrecited elements or process steps.

[0030] The term “consisting” and its derivatives as used herein are intended to be closed terms that specify the presence of the stated features, elements, components, groups, integers, and/or steps, and also exclude the presence of other unstated features, elements, components, groups, integers and/or steps.

[0031] The terms “about”, “substantially” and “approximately” as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree should be construed as including a deviation of at least ±5% of the modified term if this deviation would not negate the meaning of the word it modifies or unless the context suggests otherwise to a person skilled in the art.

[0032] The term “subject” as used herein includes all members of the animal kingdom including mammals, and suitably refers to humans. Thus, the methods and uses of the present disclosure are applicable to both human therapy and veterinary applications.

[0033] The term “pharmaceutically acceptable” means compatible with the treatment of subjects.

[0034] The term “cannabinoid” as used herein refers to C21 or C22 terpenophenolic compounds, their carboxylic acids, analogs and transformation products, and endo- and artificial compounds that bind to cannabinoid receptors. For example, when the cannabinoid naturally occurs in a plant such as Cannabis sativa plant, the cannabinoid is understood to be a phytocannabinoid.

[0035] The term “cannabis plant” as used herein refers to a plant of the species Cannabis sativa.

[0036] II. Cannabis Plant Residue and Prebiotic Composition of the Present Disclosure

[0037] In one aspect, the present disclosure relates to a cannabis plant residue.

[0038] The cannabis plant residue of the present disclosure is prepared by removing cannabinoids from a cannabis plant that has a non-negligible level of cannabinoids. In some embodiments, the cannabis plant residue has a cannabinoid content of at most 5%. In some embodiments, the cannabis plant residue has a cannabinoid content of at most 3%, at most 1%, or at most 0.5%. In some embodiments, the cannabis plant residue has a cannabinoid content of at most 0.5% or 0.1%. In some embodiments, the cannabis plant residue has a cannabinoid content of about 5% or less than 5%. In some embodiments, the cannabis plant residue has a cannabinoid content of about 3% or less than 3%, about 1% or less than 1%, about 0.5% or less than 0.5%. In some embodiments, the cannabis plant residue is substantially free of cannabinoids.

[0039] In some embodiments, the cannabis plant residue is obtained by removing at least 95%, 96%, 97, 98%, or 99% of cannabinoids from a cannabis plant. For example, the cannabis plant residue is obtained by removing about 95%, about 96%, about 97%, about 98% or about 99% of cannabinoid from a cannabis plant. For example, the cannabis plant residue is obtained by removing at least 99.5%, 99.7%, 99.8% or 99.9% of cannabinoids from the cannabis plant. For example, the cannabis plant residue is obtained by removing about 99.5%, 99.7%, 99.8% or 99.9% of cannabinoid from the cannabis plant.

[0040] In some embodiments, the cannabis plant residue is obtained by a treatment process comprising removing cannabinoids from a cannabis plant. In some embodiments, the removing of cannabinoids from the cannabis plant is by super critical CO.sub.2 extraction, by ethanol extraction, by CO.sub.2 extraction, and/or by ethanol/CO.sub.2 extraction. In some embodiments, the removing of cannabinoids from the cannabis plant is by super critical CO.sub.2 extraction and ethanol extraction. In some embodiments, the removing of cannabinoids from the cannabis plant is by super critical CO.sub.2 extraction followed by a secondary ethanol extraction.

[0041] In some embodiments, the cannabis plant comprises one or more dried cannabis plant parts selected from flower, sugar leaves and stems. For example, the cannabis plant comprises any part of the plant that is above ground.

[0042] In some embodiments, the treatment process further comprises milling the cannabis plant.

[0043] In some embodiments, the treatment process further comprises decarboxylating the cannabis plant.

[0044] In some embodiments, the super critical CO.sub.2 extraction or the ethanol extraction is performed at a temperature of about 30° C. to about 90° C.

[0045] In some embodiments, the super critical CO.sub.2 extraction or the ethanol extraction is performed at a pressure of about 1500 PSI to about 5000 PSI.

[0046] In some embodiments, the treatment process does not comprise fermentation of the cannabis plant.

[0047] In some embodiments, the cannabis plant residue is micronized. In some embodiments, the cannabis plant residue is not micronized. It is appreciated by a person skilled in the art that micronization can be performed with any suitable technique in the art. For example, jet micronization can be used. Micronized cannabis plant residue can have an average particle size of about 1 micron to about 10 microns.

[0048] In some embodiments, the cannabis plant residue comprises about 15% w/w to about 85% w/w of total dietary fiber. In some embodiments, the cannabis plant residue comprises about 20% w/w to about 80% w/w of total dietary fiber. In some embodiments, the cannabis plant residue comprises about 60% w/w to about 70% w/w of total dietary fiber.

[0049] In some embodiments, the cannabis plant residue comprises about 10% w/w to about 80% w/w of insoluble dietary fiber. In some embodiments, the cannabis plant residue comprises about 55% w/w to about 75% w/w of insoluble dietary fiber. In some embodiments, the cannabis plant residue comprises about 65% w/w of insoluble dietary fiber.

[0050] In some embodiments, the cannabis plant residue comprises about 0.5% w/w to about 60% w/w of carbohydrate. In some embodiments, the cannabis plant residue comprises about 1% w/w to about 3% w/w of carbohydrate. In some embodiments, the cannabis plant residue comprises about 2.5% w/w of carbohydrate.

[0051] In some embodiments, the cannabis plant residue comprises about 10% w/w to about 30% w/w of protein. In some embodiments, the cannabis plant residue comprises about 15% w/w to about 22% w/w of protein. In some embodiments, the cannabis plant residue comprises about 18% w/w of protein.

[0052] In another aspect, the present disclosure includes the cannabis plant residue of the present disclosure for use as a prebiotic dietary supplement.

[0053] In some embodiments, the cannabis plant residue is formulated for use in a unit dose of about 0.1 g to about 1.5 g. In some embodiments, the cannabis plant residue is formulated for use in the unit dose of about 0.3 g to about 1 g. In some embodiments, the cannabis plant residue is formulated for use in the unit dose of about 0.5 g to about 0.7 g. In some embodiments, the cannabis plant residue is formulated for use in the unit dose of about 0.5 g.

[0054] In some embodiments, the cannabis plant residue is used 2 or 3 times per day. In some embodiments, the cannabis plant residue is used 3 times per day.

[0055] In some embodiments, the cannabis plant residue is formulated for use in an amount of about 0.5 g to about 50 g per day, about 1 g to about 40 g per day, or about 10 g to about 30 g per day. In some embodiments, the cannabis plant residue is formulated for use in the amount of about 0.5 g to about 3 g per day. In some embodiments, the cannabis plant residue is formulated for use in the amount of about 1.5 g to about 3 g per day. In some embodiments, the cannabis plant residue is formulated for use in the amount of about 1.5 g per day. In some embodiments, the cannabis plant residue is formulated for use in an amount of at least 1.5 g per day.

[0056] In some embodiments, the cannabis plant residue is used in combination with a probiotic supplement, a parabiotic supplement, a postbiotic supplement, a second prebiotic supplement, and/or one or more cannabinoids.

[0057] In some embodiments, the second prebiotic supplement is selected from hempseed hull, fructans, galacto-oligosacharides, starch and/or glucose-derived oligosaccharides, pectin oligosaccharides, non-carbohydrate oligosaccharides, and combinations thereof. In some embodiments, the second prebiotic is selected from inulin, hempseed hull and combinations thereof. In some embodiments, the second prebiotic is hempseed hull. In some embodiments, the second prebiotic supplement is inulin.

[0058] In some embodiments, the probiotic supplement is microorganisms selected from Lactobacillus species, Bifidobacterium species, Baccilus species, Streptococcus species, Enterococcus species, Saccharomyces species, and combinations thereof.

[0059] In some embodiments, the second prebiotic supplement is inulin, and the inulin is formulated for use in a unit dose of about 1 g to about 3 g, about 1.5 g to about 2.5 g, or about 2 g. In some embodiments, the second prebiotic supplement is inulin, and the inulin is used in an amount of about 2 g to about 10 g per day, about 5 g to about 8 g per day, about 6 g to about 7 g per day, or about 6 g per day.

[0060] In some embodiments, the second prebiotic is hempseed hull. For example, the hempseed hull used in combination with the cannabis plant residue of the presentation disclosure can be particularly suitable for use as a prebiotic. For example, the hempseed hull of the present disclosure can have a high content of carbohydrate. For instance, the carbohydrate of the hempseed hull of the present disclosure can comprise predominantly polysaccharides including pectin, cellulose and/or xylan. In some embodiments, the hempseed hull of the present disclosure comprises about 45 wt %, about 50 wt %, about 55 wt %, about 60 wt %, about 62 wt %, or about 65 wt % of carbohydrate. In some embodiments, the hempseed hull comprises above 40 wt %, above 50 wt %, above 55 wt %, or above 60 wt % of carbohydrate. In some embodiments, the hempseed hull of the present disclosure comprises about 45 wt % to about 70 wt %, about 50 wt % to about 70 wt %, about 55 wt % to about 68 wt %, about 45 wt % to about 55 wt %, about 50 wt % to about 65 wt % of carbohydrate.

[0061] In some embodiments, cannabis plant residue is formulated for oral use.

[0062] In some embodiments, the cannabis plant residue is used contemporaneously with, prior to or subsequent to food in-take.

[0063] In some embodiments, the cannabis plant residue is formulated for use in a tablet, a capsule, a powder or a soft chewable tablet.

[0064] In some embodiments, the cannabis plant residue of the disclosure is orally administered, for example, with an inert diluent or with an assimilable edible carrier, or it is enclosed in hard or soft shell gelatin capsules, or it is compressed into tablets, or it is incorporated directly with the food of the diet. In some embodiments, the cannabis plant residue is incorporated with excipient and used in the form of ingestible tablets, buccal tablets, troches, capsules, caplets, pellets, granules, lozenges, chewing gum, powders, syrups, elixirs, wafers, aqueous solutions and suspensions, and the like. In the case of tablets, carriers that are used include lactose, corn starch, sodium citrate and salts of phosphoric acid. Pharmaceutically acceptable excipients include binding agents (e.g., pregelatinized maize starch, polyvinylpyrrolidone or hydroxypropyl methylcellulose); fillers (e.g., lactose, microcrystalline cellulose or calcium phosphate); lubricants (e.g., magnesium stearate, talc or silica); disintegrants (e.g., potato starch or sodium starch glycolate); or wetting agents (e.g., sodium lauryl sulphate). In embodiments, the tablets are coated by methods well known in the art. In the case of tablets, capsules, caplets, pellets or granules for oral administration, pH sensitive enteric coatings, such as Eudragits™ designed to control the release of active ingredients are optionally used. Oral dosage forms also include modified release, for example immediate release and timed-release, formulations. Examples of modified-release formulations include, for example, sustained-release (SR), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), or continuous-release (CR or Contin), employed, for example, in the form of a coated tablet, an osmotic delivery device, a coated capsule, a microencapsulated microsphere, an agglomerated particle, e.g., as of molecular sieving type particles, or, a fine hollow permeable fiber bundle, or chopped hollow permeable fibers, agglomerated or held in a fibrous packet. Timed-release compositions are formulated, for example as liposomes or those wherein the active compound is protected with differentially degradable coatings, such as by microencapsulation, multiple coatings, etc. Liposome delivery systems include, for example, small unilamellar vesicles, large unilamellar vesicles and multilamellar vesicles. In some embodiments, liposomes are formed from a variety of phospholipids, such as cholesterol, stearylamine or phosphatidylcholines. For oral administration in a capsule form, useful carriers or diluents include lactose and dried corn starch.

[0065] In some embodiments, liquid preparations for oral administration take the form of, for example, solutions, syrups or suspensions, or they are suitably presented as a dry product for constitution with water or other suitable vehicle before use. When aqueous suspensions and/or emulsions are administered orally, the cannabis plant residue of the disclosure is suitably suspended or dissolved in an oily phase that is combined with emulsifying and/or suspending agents. If desired, certain sweetening and/or flavoring and/or coloring agents are added. Such liquid preparations for oral administration are prepared by conventional means with pharmaceutically acceptable additives such as suspending agents (e.g., sorbitol syrup, methyl cellulose or hydrogenated edible fats); emulsifying agents (e.g., lecithin or acacia); non-aqueous vehicles (e.g., almond oil, oily esters or ethyl alcohol); and preservatives (e.g., methyl or propyl p-hydroxybenzoates or sorbic acid). Useful diluents include lactose and high molecular weight polyethylene glycols.

[0066] Examples of excipients that can be used with the cannabis plant residue and compositions of the present disclosure include for example Methocel K-100-M™, Methodcel E-4-M™, leucine powder, silicified microcrystalline cellulose, calcium undecylenate, magnesium laurate, calcium laurate, silicone dioxide (e.g. AEROSIL 200 PHARMA, SIPERNAT 22™) powdered cellulose, citric acid, microcrystalline cellulose, medium chain triglyceride (MCT) oil, carboxymethylcellulose gum (e.g. Ticalose 6000™)

[0067] In another aspect, the present disclosure includes a prebiotic composition comprising a cannabis plant residue and hempseed hull, the composition having a cannabinoid content of about 5% or less than 5%. In some embodiments, the prebiotic composition of the present disclosure has a cannabinoid content of at most 5%.

[0068] In another aspect, the present disclosure includes a prebiotic of the present disclosure for use as a prebiotic dietary supplement.

[0069] In some embodiments, the cannabis plant residue is the cannabis plant residue of the present disclosure.

[0070] In some embodiments, the cannabinoid content is at most 3%, at most 1%, at most 0.5%, or at most 0.1%. In some embodiments, the cannabinoid content is about 3% or less than 3%, about 1% or less than 1%, about 0.5% or less than 0.5%, or about 0.1% or less than 0.1%.

[0071] In some embodiments, the hempseed hull is substantially free of cannabinoids, optionally, the hempseed hull comprising about 40 wt % to about 70 wt % of carbohydrate, about 50 wt % to about 70 wt % of carbohydrate, about 55 wt % to about 65 wt % of carbohydrate, or about 62%.

[0072] In some embodiments, the hempseed hull is untreated hempseed hull. In some embodiments, the hempseed hull is ground, pulverized and/or milled.

[0073] The hempseed hull can be obtained from for example hulling whole hempseeds using methods known in the art. For example, whole hempseeds can be inputted in a hopper, and de-hulled. After the de-hulling process, the hull and the hulled hempseeds can be separated. Further processing can be performed on the hempseed hull including but is not limited to pulverizing, grinding, milling, filtering, and/or being pressed into a cake.

[0074] The hempseed hull may be in the form of meal or powder, such as a meal or a powder suitable for formulation in dietary items or supplements.

[0075] In some embodiments, the prebiotic composition further comprises one or more of carrier, excipient, flavouring agent, or diluent.

[0076] In some embodiments, excipients can be added. For example, excipients can be added to the hempseed hull and/or to the prebiotic composition. The excipients may have functions including aid in suspension or dispersion, improving stability, preventing caking and/or modifying flavour.

[0077] It can be appreciated that the hempseed hull and the cannabis plant residue of the present disclosure may be combined by methods known in the art. For example, the hempseed hull and the cannabis plant residue of the present disclosure may be mixed, combined, or blended to homogenize the two ingredients such as to obtain a homogenous mixture. For example, the mixing, combining or blending can be carried with a ribbon blender, V blender, and or high-shear mixer. It can be appreciated that the choice of equipment may be based on volume of the material being blended, and or their chemical and physical properties.

[0078] It is envisioned that in preparing the prebiotic composition, the hempseed hull and the cannabis plant residue of the present disclosure may be combined first, prior to the addition of other components if present, such as excipients, carriers, flavouring agents, diluents, and/or preservatives. However, it is also envisioned that each of hempseed hull and the cannabis plant residue of the present disclosure may be individually mixed with one or more of the other components if present prior to being combined. Further, it is also envisioned that all components of the prebiotic composition may be combined at the same time.

[0079] In some embodiments, the composition comprises about 20% w/w to about 99% w/w hempseed hull and about 1% w/w to about 80% w/w cannabis plant residue. In some embodiments, the composition comprises about 40% to about 97% hempseed hull and about 3% w/w to about 60% w/w of the cannabis plant residue. In some embodiments, the composition comprises about 30% to about 60% hempseed hull and about 70% w/w to about 40% w/w cannabis plant residue. In some embodiments, the composition comprises about 40% w/w to about 55% w/w hempseed hull and about 45% w/w to about 60% w/w cannabis plant residue. In some embodiments, the composition comprises about 80% w/w to about 99% w/w of hempseed hull and about 1% w/w to about 20% w/w of the cannabis plant residue. In some embodiments, the composition comprises about 85% w/w to about 97% w/w of hempseed hull, and about 3% w/w to about 15% w/w of the cannabis plant residue. In some embodiments, the composition comprises about 90% w/w to about 97% w/w hempseed hull and about 3% w/w to about 10% w/w cannabis plant residue. In some embodiments, the composition comprises about 20% w/w to about 40% w/w of hempseed hull and about 80% w/w to about 60% w/w cannabis plant residue. In some embodiments, the composition comprises about 30% w/w to about 40% w/w of hempseed hull and about 70% w/w to about 60% w/w cannabis plant residue.

[0080] In some embodiments, the composition comprises about 30% w/w, about 35% w/w, about 40% w/w, about 45% w/w, about 50% w/w, about 55% w/w, or about 60% w/w of hempseed hull. In some embodiments, the composition comprises about 65% w/w, about 60% w/w, about 55% w/w, about 50% w/w, about 45% w/w, or about 40% w/w of the cannabis plant residue.

[0081] In some embodiments, the composition comprises about 80% w/w, about 85% w/w, about 90% w/w, about 95% w/w, or about 99% w/w of hempseed hull. In some embodiments, the composition comprises about 20% w/w, about 15% w/w, about 10% w/w, about 5% w/w, or about 1% w/w of the cannabis plant residue.

[0082] In some embodiments, the composition comprises about 94% w/w to about 96% w/w of hempseed hull and about 4% w/w to about 6% w/w of cannabis plant residue.

[0083] In some embodiments, the composition comprises about 20% w/w, about 25% w/w, about 30% w/w, about 35% w/w, or about 40% w/w of hempseed hull. In some embodiments, the composition comprises about 80% w/w, about 75% w/w, about 70% w/w, about 65% w/w, or about 60% w/w of the cannabis plant residue.

[0084] In some embodiments, the mass ratio of the cannabis plant residue to the hempseed hull is about 1:20 to about 1:10, about 1:18 to about 1:12, or about 1:16. In some embodiments, the mass ratio of the cannabis plant residue to the hempseed hull is about 20:1 to about 10:1, about 18:1 to about 12:1, or about 16:1. In some embodiments, the mass ratio of the cannabis plant residue to the hempseed hull is about 2:1 to about 1:2, about 1.5:1 to about 1:1.5, or about 1:1.

[0085] III. Methods and Uses of the Disclosure

[0086] In another aspect, the present disclosure includes a use of a cannabis plant residue of the present disclosure in the preparation of a prebiotic dietary supplement.

[0087] In another aspect, the present disclosure includes a use of a cannabis plant residue of the present disclosure as a prebiotic dietary supplement in a subject in need thereof.

[0088] In another aspect, the present disclosure includes a method of providing a prebiotic supplement to a subject in need thereof comprising administering to the subject an effective amount of a cannabis plant residue of the present disclosure.

[0089] In another aspect, the present disclosure includes a method of providing a prebiotic supplement to a subject in need thereof comprising administering to the subject an effective amount of prebiotic composition of the present disclosure.

[0090] In another aspect, the present disclosure includes a use of a prebiotic composition of the present disclosure in the preparation of a prebiotic dietary supplement.

[0091] In another aspect, the present disclosure includes a use of a prebiotic composition of the present disclosure as a prebiotic dietary supplement in a subject in need thereof.

[0092] In some embodiments, the cannabis plant residue is administered or used in a unit dose of about 0.1 g to about 1.5 g. In some embodiments, the cannabis plant residue is administered or used in the unit dose of about 0.3 g to about 1 g. In some embodiments, the cannabis plant residue is administered or used in the unit dose of about 0.5 g to about 0.7 g. In some embodiments, the cannabis plant residue is administered or used in the unit dose of about 0.5 g.

[0093] In some embodiments, the cannabis plant residue is administered or used 2 or 3 times per day. In some embodiments, the cannabis plant residue is administered or used 3 times per day.

[0094] In some embodiments, the cannabis plant residue is administered or used in an amount of about 0.5 g to about 50 g per day, about 1 g to about 40 g per day, or about 10 g to about 30 g per day. In some embodiments, the cannabis plant residue is administered or used in the amount of about 0.5 g to about 3 g per day. In some embodiments, the cannabis plant residue is administered or used in the amount of about 1.5 g to about 3 g per day. In some embodiments, the cannabis plant residue is administered or used in the amount of about 1.5 g per day. In some embodiments, the cannabis plant residue is administered or used in an amount of at least 1.5 g per day.

[0095] In some embodiments, the cannabis plant residue is administered or used in combination with a probiotic supplement, a parabiotic supplement, a postbiotic supplement, a second prebiotic supplement, and/or one or more cannabinoids.

[0096] In some embodiments, the prebiotic composition is administered or used in combination with a probiotic supplement, a parabiotic supplement, a postbiotic supplement, a second prebiotic supplement, and/or one or more cannabinoids.

[0097] In some embodiments, the second prebiotic supplement is selected from hempseed hull, fructans, galacto-oligosaccharides, starch and/or glucose-derived oligosaccharides, pectin oligosaccharides, non-carbohydrate oligosaccharides, and combinations thereof. In some embodiments, the second prebiotic is selected from hempseed hull, inulin, and combinations thereof. In some embodiments, the second prebiotic is the hempseed hull. In some embodiments, the hempseed hull is as described herein. In some embodiments, the second prebiotic supplement is inulin.

[0098] In some embodiments, the probiotic supplement is microorganisms selected from Lactobacillus species, Bifidobacterium species, Baccilus species, Streptococcus species, Enterococcus species, Saccharomyces species, and combinations thereof.

[0099] In some embodiments, the second prebiotic supplement is inulin, and the inulin is administered or used in a unit dose of about 1 g to about 3 g, about 1.5 g to about 2.5 g, or about 2 g. In some embodiments, the second prebiotic supplement is inulin, and the inulin is administered or used in an amount of about 2 g to about 10 g per day, about 5 g to about 8 g per day, about 6 g to about 7 g per day, or about 6 g per day.

[0100] In some embodiments, cannabis plant residue is administered or used orally.

[0101] In some embodiments, the cannabis plant residue is administered or used contemporaneously with, prior to or subsequent to food in-take.

[0102] In some embodiments, the cannabis plant residue is formulated in a tablet, a capsule, a powder or a soft chewable tablet.

[0103] In some embodiments, the cannabis plant residue is comprised in a dietary item.

[0104] In some embodiments, the prebiotic composition is administered or used in a unit dose of about 1 g to about 40 g, about 2 g to about 30 g, about 5 g to about 25 g, about 10 g to about 20 g, about 1 g to about 10 g, about 5 g to about 15 g, about 15 g to about 25 g, about 25 g to about 35 g, about 35 g to about 40 g, about 1 g, about 3 g, about 5 g, about 7 g, about 9 g, about 10 g, about 12 g, about 15 g, about 18 g, about 20 g, about 22 g, about 25 g, about 27 g, about 30 g, about 32 g, about 35 g, about 37 g, or about 40 g.

[0105] In some embodiments, the prebiotic composition is administered or used 1, 2 or 3 times per day.

[0106] In some embodiments, the prebiotic composition is administered or used in an amount of about 1 g to about 120 g per day, about 2 g to about 90 g per day, about 5 g to about 75 g per day, about 10 g to about 60 g per day, about 1 g to about 30 g per day, about 5 g to about 45 g per day, about 15 g to about 75 g per day, about 25 g to about 105 g per day, about 35 g to about 120 g per day, about 1 g per day, about 2 g per day, about 3 g per day, about 5 g per day, about 6 g per day, about 7 g per day, about 9 g per day, about 10 g per day, about 12 g per day, about 14 g per day, about 15 g per day, about 18 g per day, about 20 g per day, about 21 g per day, about 22 g per day, about 24 g per day, about 25 g per day, about 27 g per day, about 27 g per day, about 30 g per day, about 32 g per day, about 35 g per day, about 36 g per day, about 37 g per day, about 40 g per day, about 44 g per day, about 45 g per day, about 50 g per day, about 54 g per day, about 60 g per day, about 64 g per day, about 66 g per day, about 70 g per day, about 74 g per day, about 75 g per day, about 80 g per day, about 81 g per day, about 90 g per day, about 96 g per day, about 105 g per day, about 111 g per day, about 120 g per day.

[0107] In some embodiments, the prebiotic composition is administered or used orally.

[0108] In some embodiments, the prebiotic composition is administered or used contemporaneously with, prior to, or subsequent to food intake.

[0109] In some embodiments, the prebiotic composition is formulated in a tablet, a capsule, a powder or a soft chewable tablet.

[0110] In some embodiments, the prebiotic composition is formulated in a dietary item.

[0111] In some embodiments, the dietary item is selected from a smoothie, a salad-dressing, a beverage, a protein bar, a chocolate bar, a meal replacement, a powder-form seasoning, a liquid-form seasoning, a spreadable condiment, a powder-form beverage mix, a cereal, a bread, a yogurt, a fermented food, and a pasta.

[0112] The dosage of a cannabis plant residue or the prebiotic composition of the disclosure varies depending on many factors such as the pharmacodynamic properties of the cannabis plant residue, the mode of administration, the age, health and weight of the recipient, the nature and extent of the symptoms, the frequency of the treatment and the type of concurrent treatment, if any, and the clearance rate of the cannabis plant residue in the subject to be treated.

EXAMPLES

[0113] The following non-limiting examples are illustrative of the present disclosure.

Example 1 Illustrative Example of Preparation of Cannabis Plant Residue

[0114] The cannabis plant residue of the present disclosure can be prepared for example according to the following general process. It is appreciated by a person skilled in the art that some aspects of the general process can be adjusted and modified without affecting the resulting cannabis plant residue.

[0115] Dried Cannabis sativa plant parts (e.g. flower, sugar leaves, and stems) were milled by a grinder. Confirmatory identification (botanical plant identification of Cannabis sativa) was performed on the milled, dried product using an NIR Multipurpose Analyzer. The milled plant parts were subjected to decarboxylation to convert acidic forms of cannabinoids.

[0116] The decarboxylated plant parts were extracted using super critical CO.sub.2 extraction with a Waters Bio-Botanical™ Extraction System (BBES). For example, the super critical CO.sub.2 extraction can be conducted at about 30° C. to about 90° C., and at a pressure of around 1500 PSI to 5000 PSI. The cannabis oil extracted from the plant parts contains the majority of cannabinoids and can be used for other purposes. The residual plant material forms the cannabis plant residue. Optionally, the residual plant material from the super critical CO.sub.2 extraction can be subjected to a secondary extraction by for example ethanol/CO.sub.2 extraction. The cannabis plant residue thus prepared was analysed for its cannabinoid content. The results are shown in Table 1.

TABLE-US-00001 TABLE 1 Cannabinoid Level Analysis Value (% w/w) Post Supple- Cannabis Plant Lab Extract mental Residue Lower Reporting Recorded Upper Upper Analytes Limit Limit Values Limit Limit Delta 9- 0 0.05 <0.05 0.05 1.1 Tetrahydrocannabinol (Delta 9-THC) Delta 9- 0 0.05 <0.05 0.05 1.1 Tetrahydrocannabinolic Acid (Delta 9-THCA) Cannabidiol (CBD) 0 0.05  0.16 0.3 3.1 Cannabidiolic Acid 0 0.05  0.79 0.9 2.1 (CBDA) Cannabigerol (CBG) 0 0.05 <0.05 0.05 1.1 Cannabigerolic Acid 0 0.05  0.09 0.2 1.1 (CBGA) Cannabinol (CBN) 0 0.05 <0.05 0.05 1.1 Cannabichromene 0 0.05 <0.05 0.05 1 .1 (CBC) Total Delta 9- 0 0.07 <0.07 0.07 1.1 Tetrahydrocannabinol (Delta 9-THC) Total Cannabidiol 0 0.07  0.85 1 2.1 (CBD) Total Cannabigerol 0 0.07  0.08 0.2 1.1 (CBG)

Example 2 Proximate Analysis of Cannabis Plant Residue

[0117] A sample of the cannabis plant residue prepared according to Example 1 was characterized by proximate analysis for its fiber, carbohydrate, protein, and hydration contents. The results are shown in Table 2. The cannabis plant residue contains a high level of dietary fiber. Further, the majority of the dietary fiber was shown to be insoluble dietary fiber.

TABLE-US-00002 TABLE 2 Proximate analysis of cannabis plant residue Hydration properties Water Hydration Capacity (WHC g/g) 6.43 ± 0.22  Water Solubility Index (WSI %) 0.08 ± 0.004 Dietary fiber analysis (%) Total Dietary Fiber 69.24 Insoluble Dietary Fiber 65.58 Soluble Dietary Fiber  3.73 Proximate analysis Total Carbohydrate (% w/w) 2.39 ± 0.12  Soluble Protein (mg/g)  3.7 ± 0.01  Crude Protein (% w/w) 18.1 

Example 3 Effect of Cannabis Plant Residue on Growth of Intestinal Microorganisms

General Methodology

[0118] Inulin from dahlia tubers was obtained from Sigma-Aldrich. Growth media was prepared according to Tzounis et al. (British Journal of Nutrition, 2008, 99:782-7922008) using 2 g/L proteose peptone, 2 g/L yeast extract, 0.1 g/L NaCl, 0.04 g/L K.sub.2HPO.sub.4, 0.04 g/L KH.sub.2PO.sub.4, 2 g/L NaHCO.sub.3, 0.01 g/L MgSO.sub.4.Math.7H.sub.2O, 0.01 g/L CaCl.sub.2.Math.6H.sub.2O, 2 mL/L Tween 80, 0.05 g/L Hemin, 10 μL/L MEM vitamin solution, 0.5 g/L L-cysteine, 0.5 g/L bile salts, 0.001 g/L resazurin and autoclaved dH.sub.2O.

Batch Fermentation

[0119] Simulation of GI conditions was done using a dynamic computer-controlled model that utilizes several 250 mL independent fermentation vessels run in parallel. All vessels were maintained under anaerobic conditions by purging with oxygen-free nitrogen gas. Vessel contents were continuously stirred using magnetic stirrers and maintained at 37° C. using heated double-jacketed beakers. The pH monitoring and regulation of each vessel during enzymatic digestion and fermentation was done using python coding of a Raspberri Pi™ microprocessor (ver. 1B) with an embedded EZO™ pH circuit (Altas Scientific, NY, USA). Addition of 0.5 M NaOH or 0.5 M HCl was carried out to maintain pH using computer-controlled peristaltic pumps (Gaisawat et al., Nutrients., 2019, 11(9). pii: E2007. doi: 10.3390/nu11092007).

[0120] In vitro digestion was adapted from Miranda et al. (Food and Function, 2013, 4, 1595-1601). Vessels contained either inulin (control) or cannabis plant residue as prepared in Example 1. One gram of each treatment was added to their respective autoclaved vessel along with 100 mL of phosphate buffered saline. To each vessel, 2 mL of amylase (707.83 mg α-amylase/1.5 mL water) were added and the pH was manually adjusted to 7 (±0.2), using NaOH (0.5 M or 0.1 M), and incubated for 15 minutes, to simulate oral digestion. Gastric digestion was then initiated by adjusting the pH to 2 (±0.2) and adding 2 mL pepsin (1.167 g pepsin/1.5 mL) and incubating for 90 minutes. The pH was then raised to 8 (±0.2) and 30 mL of pancreatic juice (12 g/L of NaHCO.sub.3, 6 g/L of bile extracts/salts, 0.9 g/L of pancreatin were added, and the vessels incubated for 120 minutes to simulate small intestinal digestion.

[0121] Stock solutions of Lactobacillus rhamnosus GG or Bifidobacterium longum BB536® (LifeExtension®) were prepared in autoclaved saline and used to inoculate each vessel (1 mL), along with 50 mL of growth medium at 37° C., for a final concentration of 108 CFU/vessel. Time 0 indicates the addition of the bacterial solution and growth medium. Five mL Samples were withdrawn from each vessel at times 0, 8, and 12 h for microbial growth assessment. Three independent experiments were conducted.

Microbial Growth Assessment

[0122] Bacterial growth was monitored via OD measurements at 600 nm using a spectrophotometer. Bacterial suspensions were mixed by vortexing for 10 seconds prior to measurement and assessed in duplicate. Values were converted into fold-change from values at time 0 and combined with fold-change values obtained in the first round of fermentations performed in March-April 2018, for a total of 5 independent experiments. Results were analyzed via two-way ANOVA using JMP 14.1.0 (SAS Institute Inc.). A p-value <0.05 was considered significant.

[0123] The growth curves of the intestinal microorganisms used are shown in FIG. 2 for L. rhamnosus and in FIG. 3 for B. longum. The resulting data of in-vitro gastrointestinal simulation modeling showed a statistically significant increase in growth in cultures treated with the cannabis plant residue in comparison to Inulin. This demonstrates that the cannabis plant residue can be used as an effective prebiotic.

Example 4 Prebiotic Composition of Cannabis Plant Residue and Hempseed Hull

[0124] The hempseed hull used for some embodiments of the compositions of the present disclosure was analyzed for its compositional properties, which are shown in Tables 3 to 7.

[0125] Ash content was measured using Official Methods of Analysis of AOAC INTERNATIONAL, 18th Ed., Method 923.03, AOAC INTERNATIONAL, Gaithersburg, Md., USA, (2005). (Modified)

[0126] Bromide content was measured using methods reported in: [0127] Community Reference Laboratory for Single Residue Methods, CVUA, Stuttgart, Schaglandstr 3/2, 70736 Fellbach, Germany [0128] T. Stijve, Gas Chromatographic Determination of Inorganic Bromide Residues—a Simplified Procedure, Dtsch. Lebenm Rundsch 77 99-101 (1981). [0129] Deutsche Forschungsgeneinschaft (DFG), Manual of Pesticide Residue Analysis, Volume I by Verlag Chemie, 1987 ISBN 3-527-27010-8.

[0130] Carbohydrate content was measured using methods in United States Department of Agriculture, “Energy Value of Foods”, Agriculture Handbook No. 74, pp. 2-11, (1973).

[0131] Fat by acid hydrolysis was measured using methods reported in: [0132] Food Products that are not Dairy, Egg or Cheese Products: Official Methods of Analysis of AOAC INTERNATIONAL (2005) 18TH Ed., AOAC, INTERNATIONAL, Gaithersburg, Md., USA, Official Methods 922.06 and 954.02. (Modified) [0133] Cheese and Cheese Products: Official Methods of Analysis of AOAC INTERNATIONAL (2005) 18th Ed., AOAC INTERNATIONAL, Gaithersburg, Md., USA, Official Method 933.05. (Modified) [0134] Egg, Egg Products, and Mayonnaise: Official Methods of Analysis of AOAC INTERNATIONAL (2005) 18th Ed., AOAC INTERNATIONAL, Gaithersburg, Md., USA, Official Method 925.32. (Modified).

[0135] Moisture content was measured using M100_T100 (M100T100_S) Official Methods of Analysis of AOAC INTERNATIONAL, 18th Ed., Methods 925.09 and 926.08, AOAC INTERNATIONAL, Gaithersburg, Md., USA, (2005). (Modified).

[0136] Protein (N×6.25) content was measured using the Dumas method (DGEN_S) Official Methods of Analysis of AOAC INTERNATIONAL, 18th Ed., Methods 968.06 and 992.15, AOAC INTERNATIONAL, Gaithersburg, Md., USA, (2005). (Modified).

[0137] Total Content of Dithiocarbamates (DTCs) expressed as CS2 per USP <561> (DTC_PKG) was measured using methods reported in Hayama, T. and Takada, M., “Simple and Rapid method for the determination of Ethylenebisdithiocarbamate Fungicides in Fruits and Vegetables Using Liquid Chromatography with Tandem Mass Spectrometry,” Anal. Bioanal. Chem., 392:969-976 (2008).

[0138] Total dietary fiber content was measured using Official Methods of Analysis of AOAC INTERNATIONAL 18th Ed., Method 991.43, AOAC INTERNATIONAL, Gaithersburg, Md., USA, (2005). (Modified).

[0139] USP pesticides contents were measured using methods below: [0140] Official Methods of Analysis, AOAC Official Method 2007.01, Pesticide Residues in Foods by Acetonitrile Extraction and Partitioning with Magnesium Sulfate, AOAC INTERNATIONAL (modified). [0141] CEN Standard Method EN 15662: Food of plant origin—Determination of pesticide residues using GC-MS and/or LC-MS/MS following acetonitrile extraction/partitioning and clean-up by dispersive SPE—QuEChERS method. [0142] EP Chapter 2.8.13 Pesticide Residues, The European Pharmacopoeia [0143] USP Chapter <561> Articles of Botanical Origin, The United States Pharmacopeia.

TABLE-US-00003 TABLE 3 Compositional Analysis of Hempseed Hull Analysis Result Fat by Acid Hydrolysis Fat 12.6% Carbohydrates Total Carbohydrates 61.6% Total Dietary Fiber Total Dietary Fiber 62.0% Protein (N × 6.25) Dumas Method Protein 13.2% Ash Ash 3.09% Moisture by M100_T100 Moisture 9.39%

TABLE-US-00004 TABLE 4 Compositional Analysis of Hempseed Hull Pass/ Analysis Limit Result Fail Bromide per USP <561> Bromide, 125 mg/kg <125 mg/kg Pass inorganic (calculated as Bromide lon) Total Content of Dithiocarbamates (DTCs) expressed as CS2 per USP <561> Total Content of 2 mg/kg <2 mg/kg Pass Dithiocarbamates (DTCs) expressed as CS2 USP <561> Pesticides Acephate 0.1 mg/kg <0.1 mg/kg Pass Alachlor 0.05 mg/kg <0.05 mg/kg Pass Aldrin and 0.05 mg/kg <0.05 mg/kg Pass dieldrin (sum of) Azinphos-ethyl 0.1 mg/kg <0.1 mg/kg Pass Azinphos-methyl 1 mg/kg <1 mg/kg Pass Bromophos-ethyl 0.05 mg/kg <0.05 mg/kg Pass Bromophos- 0.05 mg/kg <0.05 mg/kg Pass methyl Bromopropylate 3 mg/kg <3 mg/kg Pass Chlordane 0.05 mg/kg <0.05 mg/kg Pass (sum of cis- and trans- isomers and oxychlordane) Chlorfenvinphos 0.5 mg/kg <0.5 mg/kg Pass

TABLE-US-00005 TABLE 5 Compositional Analysis of Hempseed Hull Pass/ Analysis Limit Result Fail USP <561> Pesticides Chlorpyrifos- 0.2 mg/kg <0.2 mg/kg Pass ethyl Chlorpyrifos- 0.1 mg/kg <0.1 mg/kg Pass methyl Chlorthal- 0.01 mg/kg <0.01 mg/kg Pass dimethyl Cyfluthrin 0.1 mg/kg <0.1 mg/kg Pass (sum of isomers) Cyhalothrin, 1 mg/kg <1 mg/kg Pass lambda- Cypermethrin 1 mg/kg <1 mg/kg Pass (sum of isomers) DDT (sum of 1 mg/kg <1 mg/kg Pass o,p′-DDT, p,p′-DDT, o,p′-DDE, p,p′-DDE, o,p′-DDD, and p,p′-DDD) Deltamethrin 0.5 mg/kg <0.5 mg/kg Pass Diazinon 0.5 mg/kg <0.5 mg/kg Pass Dichlofluanid 0.1 mg/kg <0.1 mg/kg Pass Dichlorvos 1 mg/kg <1 mg/kg Pass Dicofol 0.5 mg/kg <0.5 mg/kg Pass Dimethoate 0.1 mg/kg <0.1 mg/kg Pass and omethoate (sum of) Endosulfan 3 mg/kg <3 mg/kg Pass (sum of isomers and endosulfan sulfate) Endrin 0.05 mg/kg <0.05 mg/kg Pass Ethion 2 mg/kg <2 mg/kg Pass Etrimphos 0.05 mg/kg <0.05 mg/kg Pass Fenchlorphos 0.1 mg/kg <0.1 mg/kg Pass (sum of fenchlorphos and fenchlorphos- oxon) Fenitrothion 0.5 mg/kg <0.5 mg/kg Pass Fenpropathrin 0.03 mg/kg <0.03 mg/kg Pass Fensulfothion 0.05 mg/kg <0.05 mg/kg Pass (sum of fensulfothion, fensulfothion- oxon, fensulfothion- oxon sulfone and fensulfothion sulfone) Fenthion 0.05 mg/kg <0.05 mg/kg Pass (sum of fenthion, fenthion-oxon, fenthion-oxon sulfone, fenthion-oxon sulfoxide, fenthion sulfone and fenthion sulfoxide) Fenvalerate 1.5 mg/kg <1.5 mg/kg Pass Flucythrinate 0.05 mg/kg <0.05 mg/kg Pass

TABLE-US-00006 TABLE 6 Compositional Analysis of Hempseed Hull Pass/ Analysis Limit Result Fail USP <561> Pesticides Fluvalinate, 0.05 mg/kg <0.05 mg/kg Pass tau- Fonofos 0.05 mg/kg <0.05 mg/kg Pass Heptachlor 0.05 mg/kg <0.05 mg/kg Pass (sum of heptachlor and cis- and trans- heptachlor epoxides) Hexachloro- 0.1 mg/kg <0.1 mg/kg Pass benzene Hexachloro- 0.3 mg/kg <0.3 mg/kg Pass cyclohexane isomers (other than gamma) Lindane 0.6 mg/kg <0.6 mg/kg Pass (gamma- hexachloroc yclohexane) Malathion and 1 mg/kg <1 mg/kg Pass malaoxon (sum of) Mecarbam 0.05 mg/kg <0.05 mg/kg Pass Methacriphos 0.05 mg/kg <0.05 mg/kg Pass Meth- 0.05 mg/kg <0.05 mg/kg Pass amidophos Methidathion 0.2 mg/kg <0.2 mg/kg Pass Methoxychlor 0.05 mg/kg <0.05 mg/kg Pass Mirex 0.01 mg/kg <0.01 mg/kg Pass Mono- 0.1 mg/kg <0.1 mg/kg Pass crotophas Parathion- 0.5 mg/kg <0.5 mg/kg Pass ethyl and paraoxon- ethyl (sum of) Parathion- 0.2 mg/kg <0.2 mg/kg Pass methyl and paraoxon- methyl (sum of) Pendimethalin 0.1 mg/kg <0.1 mg/kg Pass Penta- 0.01 mg/kg <0.01 mg/kg Pass chloranisol Permethrin 1 mg/kg <1 mg/kg Pass (sum of isomers) Phosalone 0.1 mg/kg <0.1 mg/kg Pass Phosmet 0.05 mg/kg <0.05 mg/kg Pass Piperonyl 3 mg/kg <3 mg/kg Pass butoxide Pirimiphos- 0.05 mg/kg <0.05 mg/kg Pass ethyl Pirimiphos- 4 mg/kg <4 mg/kg Pass methyl (sum of pirimiphos- methyl and N-desethyl- pirimiphos- methyl) Procymidone 0.1 mg/kg <0.1 mg/kg Pass Profenophos 0.1 mg/kg <0.1 mg/kg Pass Prothiophos 0.05 mg/kg <0.05 mg/kg Pass

TABLE-US-00007 TABLE 7 Compositional Analysis of Hempseed Hull Analysis Limit Result Pass/Fail USP <561> Pesticides Pyrethrum 3 mg/kg <3 mg/kg Pass (sum of cinerin I, cinerin II, jasmolin I, jasmolin II, pyrethrin I, and pyrethrin II) Quinalphos 0.05 mg/kg <0.05 mg/kg Pass Quintozene 1 mg/kg <1 mg/kg Pass (sum of quintozene, pentachloro- aniline and methyl pentachloro- phenyl sulfide) S-421 0.02 mg/kg <0.02 mg/kg Pass Tecnazene 0.05 mg/kg <0.05 mg/kg Pass Tetradifon 0.3 mg/kg <0.3 mg/kg Pass Vinclozolin 0.4 mg/kg <0.4 mg/kg Pass

[0144] The hempseed hull was also analyzed for its cannabinoid content by HPLC. Various cannabinoids have been assessed, the results of which are shown in Table 8.

[0145] The chromatographic conditions are shown below: [0146] Method: ATM-815-0300 [0147] Column: AP270 Kinetex 2.6 μm C18 100A (150×4.6 mm) [0148] Temperature: 30° C. [0149] Flow rate: 1 mL/min [0150] Injection volume: 5 μL [0151] UV detection: 228 nm [0152] Mobile phase: 0.1% formic acid in water; 0.1% Formic acid in methanol:acetonitrile (75:25) [0153] Instrument: Alliance™_1

[0154] Sample preparation: Transferred approximately 125 mg of sample to a 25 mL volumetric flask and filled to volume with methanol. Vortexed 30 seconds and sonicated 15 minutes at room temperature. Filtered through 0.2 pm syringe filter. Transferred into HPLC vial for analysis.

[0155] Cannabinoids were not detected in the hempseed hull sample.

TABLE-US-00008 TABLE 8 Cannabinoid Content of Hempseed Hull Ret. Prep Prep Average Time 1 2 Average Dried Basis (min) Compound Name (%) (%) (%) (%) Specification Result 3.4 Cannabidivarin (CBDV) ND ND ND ND Report Only N/A 4.1 Cannabidivarinic Acid (CBDVA) ND ND ND ND Report Only N/A 5.5 Cannabidiol (CBD) ND ND ND ND Report Only N/A 5.6 Cannabigerol (CBG) ND ND ND ND Report Only N/A 6.2 Tetrahydrocannabidivarin (THCV) ND ND ND ND Report Only N/A 6.8 Cannabidiolic Acid (CBDA) ND ND ND ND Report Only N/A 9.5 Cannabigerolic Acid (CBGA) ND ND ND ND Report Only N/A 9.8 Cannabinol (CBN) ND ND ND ND Report Only N/A 11.0 Δ.sup.9-Tetrahydrocannabinol (Δ.sup.9-THC) ND ND ND ND Report Only N/A 11.5 Δ.sup.8-Tetrahydrocannabinol (Δ.sup.4-THC) ND ND ND ND Report Only N/A 13.2 Cannabichromene (CBC) ND ND ND ND Report Only N/A 14.8 Δ.sup.9-Tetrahydrocannabinolic Acid A (THCA-A) ND ND ND ND Report Only N/A Total THC (Δ.sup.9-THC + 0.877 THCA-A) ND ND ND ND Report Only N/A Total cannabinoids ND ND ND ND Report Only N/A

[0156] The hempseed hull was also analyzed for its mycotoxin content, the results of which are shown in Table 9.

TABLE-US-00009 TABLE 9 Mycotoxin Content in Hempseed Hull   Analysis Performed Specification Result Aflatoxin B1 <2ppb Negative Total Aflatoxins <4ppb Negative

[0157] The hempseed hull was also analyzed for its heavy metal content by inductively coupled plasma (ICP) mass spectrometry, the results of which are shown in Table 10.

TABLE-US-00010 TABLE 10 Hempseed Hull ICP Analysis Date Result Analysis Spec Element Tested (ng/g = ppb) (ug/g = ppm) (pm) As 11/30/20 16.8087 0.0 <1.5 ppm Cd 11/30/20 30.3140 0.0 <0.5 ppm Pb 11/30/20 15.2240 0.0 ≤0.6 ppm Hg 11/30/20 3.2473 0.0 ≤1.5 ppm

[0158] The hempseed hull was also analyzed for microbiological content, the results of which are shown in Table 11.

TABLE-US-00011 TABLE 11 Microbiological Testing Data of Hempseed Hull Microbiological Test Specifications Results SOP# Total Viable Count <10,000 cfu/g 141,400 cfu/g 00103 Yeast & Mold <100 cfu/g 5,600 cfu/g 00088 Coliform <100 cfu/g *ND@10 cfu/g 00097 E. coli Absent in 10 g Absent in 10 g 00100 Salmonella Absent in 10 g Absent in 10 g 00078 S. aureus Absent in 10 g Absent in 10 g 00099

[0159] As shown above, the hempseed hull of the present disclosure has a high carbohydrate content of over 60%. A significant portion of the carbohydrate content of the hempseed hull is present in polysaccharide forms such as xylan and pectin. As such, it can be appreciated that the hempseed hull of the present disclosure can be used as a source of prebiotic, for example in combination with the cannabis plant residue of the present disclosure.

[0160] For example, the hempseed hull can be combined with the cannabis plant residue of the present disclosure in a mass ratio of about 20:1 to about 10:1, about 18:1 to 12:1, or about 16:1. It can be expected that given the prebiotic activity of the cannabis plant residue of the present disclosure as shown herein and the high carbohydrate content of the hempseed hull of the present disclosure, the resulting composition would be useful as a prebiotic supplement.

[0161] While the present disclosure has been described with reference to examples, it is to be understood that the scope of the claims should not be limited by the embodiments set forth in the examples, but should be given the broadest interpretation consistent with the description as a whole.

[0162] All publications, patents and patent applications are herein incorporated by reference in their entirety to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference in its entirety. Where a term in the present disclosure is found to be defined differently in a document incorporated herein by reference, the definition provided herein is to serve as the definition for the term.