Animal food supplement, methods of use thereof and methods of making
A dry powder animal supplement with biotic and antimicrobial components addresses the rapid ingestion and brushing challenges in canine oral health, effectively reducing plaque and tartar, and enhancing oral health by inhibiting bacteria and improving gum health.
Patent Information
- Application Number
- PCT/US2025/025037
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-04-16
- Filing Date
- 2025-04-16
- Publication Date
- 2025-10-23
AI Technical Summary
The challenge in addressing canine oral health is the rapid ingestion time of orally consumed actives, limited oral residence time, and the lack of routine tooth brushing, which hinders the effectiveness of improving oral health and reducing biofilm formation and subsequent systemic infections.
A dry powder animal supplement composition comprising biotic components, such as probiotics and Ascophyllum nodosum, along with an antimicrobial component like rosemary leaf extract, is designed to inhibit bacteria, reduce plaque and tartar formation, and enhance oral residence time.
The supplement effectively reduces bacterial plaque, tartar, and gingivitis, while improving gum health and overall oral microbiome balance, thereby minimizing the risk of systemic infections.
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Figure US2025025037_23102025_PF_FP_ABST
Abstract
Description
ANIMAL FOOD SUPPLEMENT, METHODS OF USE THEREOF AND METHODS OF MAKINGCROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims benefit of and priority to U.S. Provisional Patent Application No. 63 / 634,724, filed April 16, 2024, which is incorporated by reference herein in its entirety.BACKGROUND
[0002] Oral health in dogs is especially challenging compared to human oral health given the lack of routine tooth brushing. This presents a unique challenge to pet owners in the care of their pet.
[0003] The oral cavity is home to its own microbiome environment with a unique composition of microbiota. The canine oral microbiome is generally considered different from the human oral microbiome. Ruparell et al. (2020) found microbiota differences in supragingival plaque (hard tissue surfaces), buccal and tongue dorsum mucosa (soft tissue surfaces), and saliva. Within supragingival plaque, the following operational taxonomic units (OTUs) were most often present: Bergeyella, Capnocytophaga, Lachnospiroceae, Peptostreptococcaceae, and proteocatella. Buccal mucosa OTUs most prevalent were: Bergeyella, Capnocytophaga, Lachnospiroceae, Porphyromonas cangingivalis, and unclassified Porphyromonas sp. For the tongue mucosa, the most common OTUs were: Bergeyella, unclassified Frederiksenia sp., unclassified Pasteur ellaceae sp., Streptococcus sp. COT-297, Moraxella sp. FOT-35, an unclassified Fusobacterium sp., Porphyromonas cangingivalis, Conchioformibius sp. COT-286 and an unclassified Conchiformibius sp. For saliva, there were no common OTUs identified in all samples.
[0004] The bacterial composition of the oral microbiome influences plaque formation since not all bacteria species have the same ability to produce plaque. Perhaps most concerning are the supragingival plaque OTUs as these bacteria form the basis of the plaque which leads to tartar which then leads to gingivitis which then increases the risk of oral bacteria translocating into the blood stream. Once bacteria enter the blood stream, the risk for increased infection of other areas of the body such as the kidneys, liver, or joints increases. This, in turn, creates life threatening risk for systemic bacterial infection which can lead to other organ infection and ultimately death of the animal.
[0005] The core of poor oral health in a canine is the growth of unwanted bacteria in the oral cavity. Bacteria that attach to the surface of the tooth can produce a biofilm. The biofilm serves to protect the bacteria from competitors and conditions in their environment which threaten their existence. Heavy biofilm formation is visible to the naked eye and is called plaque. Plaque then tends to attract calcium ions from the surrounding environment which turns into tartar. Tartar is a hard, cement-like substance that adheres to the tooth. When tartar, otherwise known as calculus, comes in contact with the gingiva surrounding the tooth, it can cause irritation. Irritated gingiva tends to recede and under extended conditions results in bleeding, breaks in the gingival defense barrier, and an associated immune response. Reduced gingival defense barrier results in the possibility of oral bacteria translocating from the oral cavity into the bloodstream. Bacteria in the bloodstream are undesirable as they pose health risks to infecting systemic locations such as joints and(or) internal organs such as the kidneys or liver. Sepsis and other infections of the organs and so forth can result in death of the pet.
[0006] The microbiome of the oral cavity may be altered by the presence of probiotics, prebiotics, synbiotics and other microbiome altering tools such as postbiotics. Using this principle, it is desirable to design a product that lessens the risk of biofilm formation which is the basis of plaque and the subsequent sequelae that leads to systemic infections.
[0007] The challenge in addressing the oral microbiome is that the oral residence time of anything ingested by a dog is limited. Typical dog feeding behavior is extremely quick and thus limits the residence time of orally consumed actives. Further, brushing of a dog’s teeth is very uncommon by canine owners which prevents the normal approach to improving oral health as done in humans.
[0008] Thus, there is still a need in the art to reduce the threat of oral microorganisms and improve the residence time of oral actives to change the potential for oral biofilm formation in the canine.SUMMARY
[0009] In a first aspect, a dry powder animal supplement composition is provided that comprises a biotic component and Ascophyllum nodosum. In certain embodiments, the biotic component is a probiotic component. In certain embodiments, the biotic component is a synbiotic component. In certain embodiments, the dry powder animal supplement composition further comprises an antimicrobial component. In certain embodiments, the dry powder animal supplement composition further comprises sodium hexametaphosphate.
[0010] In a second aspect, a dry powder animal supplement composition is provided that comprises an oral residence time enhancer. In certain embodiments, the dry powder animal supplement composition is a dry powder animal supplement composition of the present disclosure.
[0011] In a third aspect, a kit is provided comprising a dry powder animal supplement and a dry food affinity enhancer. In certain embodiments, the dry powder animal supplement composition is a dry powder animal supplement composition of the present disclosure. In certain embodiments, the dry powder animal supplement further comprises the dry food affinity enhancer. In certain embodiments, a composition comprises a dry animal feed, a dry powder animal supplement, and a dry food affinity enhancer.
[0012] In a fourth aspect, a dry powder animal supplement composition is provided that comprises a saliva-inducing component. In certain embodiments, the dry powder animal supplement composition is a dry powder animal supplement composition of the present disclosure.
[0013] In a fifth aspect, a delivery device comprising a dry powder animal supplement is provided, wherein the delivery device comprises a tube configured to contain the dry powder animal supplement and to slow consumption by an animal subject. In certain embodiments, a tube comprising a dry powder animal supplement of the present disclosure is provided.
[0014] In another aspect, a method is provided that comprises the step of providing a dry powder animal supplement of the present disclosure for consumption by an animal subject; and allowing the animal subject to consume the dry powder animal supplement. In certain embodiments, the dry powder animal supplement is combined with a wet or dry animal feed prior to providing the dry powder animal supplement for consumption. In certain embodiments, the method is a method for reducing bacterial plaque and / or dental calculus, improving gum health, reducing inflammation, treating halitosis, improving the oral microbiome or whitening teeth in the animal subject.
[0015] In another aspect, a method for increasing the oral residence time of a dry powder animal supplement is provided comprising the step of combining the dry powder animal supplement with an oral residence time enhancer.
[0016] In another aspect, a method for increasing the affinity of a dry powder animal supplement for dry food is provided comprising the step of combining the dry powder animal supplement, a dry food affinity enhancer and the dry food.
[0017] In another aspect, a method for inducing saliva producing in an animal subject is provided comprising the step of combining a dry powder animal supplement with a salivainducing component.
[0018] In another aspect, a method for improving quality of life of an animal subject is provided comprising providing a dry powder animal supplement of the present disclosure to the animal subject for consumption and allowing the animal subject to consume the dry powder animal supplement.
[0019] In another aspect, a method for slowing consumption of a dry powder animal supplement is provided comprising the step of providing the dry powder animal supplement in a container configured to slow consumption of the powder.BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Fig. 1 provides a depiction of the process flow for development of gingivitis from the output of oral bacteria and the impact of various of the active ingredients of the dry powder animal supplements of the present disclosure.
[0021] Fig. 2 provides a depiction of the incidence of “other” smells during study progression in Example 2.
[0022] Fig. 3 provides a depiction of the incidence of “no smell” during study progression in Example 2.
[0023] Fig. 4 provides a depiction of improvement of tartar during study progression in Example 2.
[0024] Fig. 5 provides a depiction of mood during study progression in Example 2.
[0025] Fig. 6 provides a depiction of sleep during study progression in Example 2.
[0026] Fig. 7 provides a depiction of relationships during study progression inExample 2.
[0027] Fig. 8 provides a depiction of habits during study progression in Example 2.
[0028] Fig. 9 provides a depiction of mood + sleep + pain during study progression inExample 2.
[0029] Fig. 10 provides a depiction of mood + sleep during study progression in Example 2.
[0030] Fig. 11 provides a depiction of mood + pain during study progression in Example 2.
[0031] Fig. 12 provides a depiction of sleep + relationships during study progression in Example 2.
[0032] Fig. 13 provides a depiction of sleep + habits during study progression in Example 2.
[0033] Fig. 14 provides a depiction of sleep + habits + relationships during study progression in Example 2.
[0034] Fig. 15 provides a depiction of mood + habits during study progression in Example 2.
[0035] Fig. 16 provides a depiction of mood + relationships during study progression in Example 2.
[0036] Fig. 17 provides a depiction of mood + sleep + habits + relationships during study progression in Example 2.
[0037] Fig. 18 provides the absolute change in plaque index at 60 and 90 days after receiving the Test or Control articles in Example 3.
[0038] Fig. 19 provides the precent change in plaque index at 60 and 90 days after receiving the Test or Control articles in Example 3.DETAILED DESCRIPTIONDefinitions
[0039] Unless otherwise defined, all terms of art, notations and other scientific terminology used herein are intended to have the meanings commonly understood by those of skill in the art to which this disclosure. In some cases, terms with commonly understood meanings are defined herein for clarity and / or for ready reference. The inclusion of such definitions herein should not necessarily be construed to represent a difference over what is generally understood in the art. The techniques and procedures described or referenced herein are generally well understood and commonly employed using conventional methodologies by those skilled in the art.
[0040] As used herein, the singular forms “a,” “an,” and “the” include the plural referents unless the context clearly indicates otherwise.
[0041] The term “about” indicates and encompasses an indicated value and a range above and below that value. In certain embodiments, the term “about” indicates the designated value + / - 10%, + / - 5%, or + / - 1%.
[0042] It should be understood that “dry powder animal supplement” and “dry powder animal supplement composition” are used interchangeably herein.
[0043] The term “combinations thereof’ includes every possible combination of elements to which the term refers to.
[0044] The term “dry powder animal supplement” refers to a composition that is suitable for addition to an animal feed and / or to be consumed itself and is in the form of a dry powder.
[0045] The term “biotic” or “biotic component” refers to a compositions that can include prebiotics, probiotics, and / or synbiotics. It should be understood that the biotic component can also include components of or produced by a live microorganism or live microorganisms and / or substrate upon which the live microorganism(s) are grown.
[0046] The term “probiotic” refers to a live microorganism or live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. It should be understood that the term “probiotic” can include formerly alive probiotic microorganisms. Thus, in some embodiments, the probiotic can include a live microorganism or live microorganisms. In some embodiments, the probiotic can include a formerly alive microorganism(s). In some embodiments, the probiotic can include both live microorganism(s) and formerly alive microorganism(s).
[0047] The term “prebiotic” refers to a substrate that is selectively utilized by host microorganisms conferring a health benefit.
[0048] The term “synbiotic” refers to a mixture of live microorganisms and substrate(s) selectively utilized by host microorganisms that confers a health benefit on the host.
[0049] It should be understood that ingredients of the dry powder animal supplement compositions disclosed herein are important to the function of the compositions. It should be further understood that the compositions disclosed herein, including the dry powder animal supplement compositions, can be provided with the same ingredients but in any suitable form for administration, including but not limting to, a paste, liquid suspension, or any other suitable form.Dry Powder Animal Supplement Compositions
[0050] In some embodiments, a dry powder animal supplement composition is provided that comprises a biotic component and Ascophyllum nodosum. In certain embodiments, the biotic component is a probiotic component. In certain embodiments, the biotic component is a synbiotic component. In certain embodiments, the dry powder animal supplement does not comprise an essential oil. In certain embodiments, the dry powder animal supplement does not comprise an enzyme derived from plant material. In certainembodiments, the dry powder animal supplement does not comprise a proteinase derived from plant material.
[0051] As shown in Fig. 1, various active ingredients that can be present in a dry powder animal supplement of the present disclosure can have an impact either directly or indirectly on bacteria, including volatile sulfur compound (VSC) bacteria and the downstream effects of such bacteria on oral health. VSC bacteria represent a subset of total bacteria in the oral cavity, both of which can adhere to teeth to enable residence, followed by biofilm formation as a bacterial defense, followed by plaque formation with an increase in biofilm and food particles, followed by tartar formation from calcium present in saliva, followed by gingivitis characteried by gum swelling due to inflammation and increased risk of bacterial translocation. Asocphyllum nodosum can inhibit VSC and other bacteria and reduce plaque formation as well as gingivitis. Probiotic components can inhibit total bacteria by either competing with such bacteria, killing them or lessening VSC bacteria and can also lessen inflammation due to gingivitis. Rosemary leaf extract can also inhibit VSC bacteria as well as inhibit biofilm formation and provide antioxidants to reduce inflammation due to gingivitis. Green tea extract can also exert an antibacterial effect, including by antibacterial peroxidases. Sodium hexametaphosphate can inhibit tartar formation by competing for calcium and weakening existing tartar. The foregoing activities are presented as expected activities without being bound to theory.
[0052] It should be understood that all amounts of ingredients in the dry powder animal supplement represent daily doses and can be formulated at different concentrations to ensure daily dosing even if multiple unit doses are administered. It should be further understood that the dry powder animal supplement compositions as claimed can refer to a unit dose that is present in a larger quantity of the composition such as, by way of example but not limitation, a unit dose of 0.25 g, 0.5 g, 0.75 g, 1 g, 1.5 g, 2 g, 2.5 g, 3 g, 3.5 g, 4 g or more. For example, a package or kit may contain multiple unit doses of the dry powder animal supplement composition in combination, such as a 100 g package that contains 40 2.5 g unit doses as one dry powder, where each unit dose comprises the amounts of components recited herein.Biotic Component
[0053] In certain embodiments, the biotic component comprises one or more strains of bacteria or yeast. In certain embodiments, the biotic component comprises one, two, three, four, five, six, seven, eight, nine, ten or more strains of bacteria or yeast. In certainembodiments, the one or more strains of bacteria or yeast can be in any suitable form. In certain embodiments, the one or more strains of bacteria or yeast can be live, freeze dried, spray-dried or otherwise formulated for delivery in the dry powder animal supplement composition. In certain embodiments, the biotic component is a probiotic or synbiotic. In certain embodiments, the biotic component comprises one or more prebiotics. In certain embodiments, the biotic component is a probiotic component. In some embodiments, the biotic component is a synbiotic component.
[0054] In certain embodiments, the one or more strains of bacteria or yeast can comprise non-spore forming bacterial or yeast strains, spore-forming bacterial or yeast strains, or a combination thereof. In certain embodiments, the one or more strains of bacteria or yeast can comprise non-spore-forming bacterial or yeast strains. In certain embodiments, the one or more strains of bacteria or yeast can comprise spore-forming bacterial or yeast strains. In certain embodiments, the one or more strains of bacteria or yeast can comprise a combination of non-spore-forming bacterial or yeast strains and spore-forming bacterial or yeast strains.
[0055] In certain embodiments, the non-spore-forming bacterial or yeast strains can comprise one or more strains selected from the group consisting of Bifidobacterium animalis. Bifidobacterium longum, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus rhamnosus, Lactiplantibacillus plantarum, Pediococcus pentosaceus, Enterococcus faecium, Saccharomyces cerevisiae, and Saccharomyces cerevisiae boulardii. In certain embodiments, the non-spore-forming bacterial or yeast strains comprises a combination of L. plantarum and P. pentosaceus. It should be understood that any suitable non-spore-forming bacterial or yeast strains can be used in the dry powder animal supplement.
[0056] In certain embodiments, the spore-forming bacterial or yeast strains can comprise one or more bacterial strains selected from the group consisting of Bacillus coagulans, Bacillus subtilis, Bacillus amyloliquefaciens, Bacillus velenzensis, Bacillus lichenformis, and Bacillus pumilus. It should be understood that any suitable spore-forming bacterial or yeast strains can be used in the dry powder animal supplement.
[0057] It should be understood that within each strain, there can be sub-strains or subspecies which can be utilized alone or in combination.
[0058] In certain embodiments, where two or more strains of bacteria or yeast in the biotic component can be present, the two or more strains can be in any suitable ratio or amount to provide the desired effect. In certain embodiments, a ratio between any two strainsof bacteria or yeast in the biotic component can be from about 200: 1 to 1 :200. In certain embodiments, the ratio between any two strains of bacteria or yeast in the biotic component can be about 200:1, 180:1, 160:1, 150:1, 140:1, 120:1, 100:1, 80:1, 75:1, 60:1, 50:1, 40:1, 30:1, 20:1, 10:1, 9:1, 8:1, 7:1, 6:1, 5:1, 4:1, 3:1, 2:1, and 1:1. In certain embdoments, where two strains of bacteria or yeast are present in the biotic component, the two strains can be present in ratios of about 200:1, 180:1, 160:1, 150:1, 140:1, 120:1, 100:1,80:1,75:1,60:1, 50:1, 40:1, 30:1, 20:1, 10:1, 9:1, 8:1, 7:1, 6:1, 5:1, 4:1, 3:1, 2:1, and 1:1. In certain embodiments, where three strains of bacteria or yeast are present, the three strains can be present in ratios of about 200:1:1, 1:200:1, 1:1:200, 200:1:200, 1:200:200, 200:200:1, preferably about 100: 1 : 1. It should be understood that the ratio can be on a CFU basis or weight (by milligram) basis.
[0059] In certain embodiments, the biotic component can be present in an amount sufficient for the one or more bacterial or yeast strains to become resident within the oral cavity, improve the immune system, embed within the gums and / or surrounding teeth, to promote a beneficial gingival response, or to prevent intrusion of pathogens, allergens or irritants into the tissues surrounding the teeth and / or ultimately the blood stream. In certain embodiments, the biotic component can be present in an amount sufficient to reduce tartar, improve breath or improve quality of life, such as mood, relationships, habits, sleep and / or pain.
[0060] In certain embodiments, the dry powder animal supplement can comprise from about 5.0 x 107to about 1.0 x 1010colony forming units (CFU) of the biotic component. In certain embodiments, the dry powder animal supplement can comprise from about 2.4 x 108colony forming units (CFU) to about 1.6 x 109CFU of the biotic component. In certain embodiments, the dry powder animal supplement can comprise about 5.0 x 107CFU, 1.1 x 108CFU, 1.5 x 108CFU, 2.25 x 108CFU, 2.4 x 108CFU, 2.6 x 108CFU, 2.8 x 108CFU, 3.0 x 108CFU, 3.2 x 108CFU, 3.4 x 108CFU, 3.5 x 108CFU, 3.6 x 108CFU, 4.2 x 108CFU, 4.5 x 108CFU, 4.55 x 108CFU, 4.9 x 108CFU, 5.5 x 108CFU, 5.6 x 108CFU, 5.95 x 108CFU, 6.0 x 108CFU, 6.25 x 108CFU, 6.3 x 108CFU, 6.5 x 108CFU, 7.0 x 108CFU, 7.5 x 108CFU, 8.0 x 108CFU, 8.125 x 108CFU, 8.5 x 108CFU, 8.75 x 108CFU, 9.0 x 108CFU, 9.5 x 108CFU, 1.0 x 109CFU, 1.05 x 109CFU, 1.0625 x 109CFU, 1.125 x 109CFU, 1.1375 x 109CFU, 1.2 x 109CFU, 1.225 x 109CFU, 1.4 x 109CFU, 1.4875 x 109CFU, 1.575 x 109CFU, 3.0 x 109CFU, 5.0 x 109CFU, 1.0 x 1010CFU, or any range or value therebetween of the biotic component. In certain preferred embodiments, the dry powder animal supplement can comprise from about 5.0 x 107to about 4.5 x 108CFU, more preferably about 1.1 x 108toabout 3.5 x 108CFU, and even more preferably about 1.5 x 108to about 3.0 x 108CFU of the biotic component. In certain preferred embodiments, the dry powder animal supplement can comprise about 2.25 x 108to about 7.5 x 108CFU, more preferably about 3.0 x 108to about 6.0 x 108CFU, and even more preferably about 3.5 x 108to about 5.5 x 108CFU of the biotic component. In certain preferred embodiments, the dry powder animal supplement can comprise about 4.5 x 108to about 1.2 x 109CFU, more preferably about 5.5 x 108to about 9.0 x 108CFU, and even more preferably about 6.25 x 108to about 8.5 x 108CFU of the biotic component. In certain preferred embodiments, the dry powder animal supplement can comprise about 7.5 x 108to about 1.0 x 1010CFU, more preferably about 9.5 x 108to about 5 x 109CFU, and even more preferably about 1.0 x 109to about 3.0 x 109CFU of the biotic component.
[0061] In certain embodiments, the dry powder animal supplement can comprise from about 6.0 x 108CFU to about 9.0 x 108CFU of the biotic component, preferably from about 6.5 x 108CFU to about 8.5 x 108CFU, more preferably from about 7.0 x 108CFU to about 8.0 x 108CFU. In certain embodiments, the dry powder animal supplement can comprise from about 40% to about 70% of the foregoing amounts. In certain embodiments, the dry powder animal supplement can comprise from about 125% to about 175% of the foregoing amounts.
[0062] In certain embodiments, the dry powder animal supplement can comprise from about 4.5 x 108to about 1.2 x 109CFU, more preferably from about 5.5 x 108to about 9.0 x 108CFU, even more preferably from about 6.25 x 108to about 8.5 x 108CFU of the biotic component, where the amounts of the ranges can be adjusted by about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200%. In certain embodiments, the dry powder animal supplement composition can comprise about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement composition can include about 200% of these amounts / ranges.
[0063] In certain embodiments, the dry powder animal supplement can comprise from about 2 mg to about 250 mg of the biotic component. In certain embodiments, the dry powder animal supplement composition can comprise about 2 mg, 3 mg, 5 mg, 7 mg, 8 mg, 10 mg, 11 mg, 14 mg, 15 mg, 17 mg, 20 mg, 23 mg, 25 mg, 30 mg, 35 mg, 50 mg, 58 mg, 65 mg, 82 mg, 88 mg, 98 mg, 150 mg, 200 mg, 250 mg, or any range or value therebetween of the biotic component. In certain preferred embodiments, the dry powder animal composition can comprise from about 2 mg to about 35 mg, more preferably about 5 mg to about 30 mg, even more preferably about 7 mg to about 25 mg of the biotic component. In certainpreferred embodiments, the dry powder animal supplement compositon can comprise from about 8 mg to about 65 mg, more preferably about 11 mg to about 58 mg, even more preferably about 14 mg to about 50 mg of the biotic component. In certain preferred embodiments, the dry powder animal supplement composition can comprise from about 17 mg to about 98 mg, more preferably about 20 mg to about 88 mg, even more preferably about 23 mg to about 82 mg of the biotic component. In certain preferred embodiments, the dry powder animal supplement composition can comprise from about 20 mg to about 250 mg, more preferably about 25 mg to about 200 mg, even more preferably about 30 mg to about 150 mg of the biotic component.
[0064] In certain embodiments, the dry powder animal supplement composition can comprise from about 17 mg to about 98 mg, more preferably about 20 mg to about 88 mg, even more preferably about 23 mg to about 82 mg of the biotic component, where the amounts of the ranges can be adjusted by about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200%. In certain embodiments, the dry powder animal supplement composition can comprise about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement composition can include about 200% of these amounts / ranges.
[0065] It should be understood that the amount of the biotic component can refer to the amount of probiotic, for example, the amount of cells in the dry powder animal supplement. It should be understood that the amount of the biotic component can also refer to the total amount of the biotic component, for example, including live cells, formerly alive cells, products and components thereof, and any prebiotics.Ascophyllum nodosum
[0066] Ascophyllum nodosum has been shown to decrease plaque and tartar formation around the teeth as well as lessen the gingivitis (inflammation of the gingival tissue) surrounding the teeth. The actual mechanism of Ascophyllum is not well understood but may be through a systemic route as well as being locally active.
[0067] In certain embodiments, the Ascophyllum nodosum can be present in the dry powder animal supplement in an amount sufficient to decrease plaque and tartar formation around the teeth and / or to lessen gingivitis surrounding the teeth.
[0068] In certain embodiments, the Asophyllum nodosum can be present in the dry powder animal supplement in an amount from about 75 mg to about 1900 mg. In certain embodiments, the Ascophyllum nodosum can be present in the dry powder animal supplement in an amount from about 280 to about 1750 milligrams (mg).
[0069] In certain embodiments, the dry powder animal supplement can comprise about 75 mg, 100 mg, 150 mg, 165 mg, 180 mg, 225 mg, 250 mg, 280 mg, 300 mg, 310 mg, 320 mg, 330 mg, 350 mg, 360 mg, 380 mg, 400 mg, 490 mg, 525 mg, 560 mg, 600 mg, 630 mg, 650 mg, 665 mg, 700, mg, 750 mg, 800 mg, 810 mg, 850 mg, 875 mg, 890 mg, 900 mg,937.5 mg, 950 mg, 1000 mg, 1100 mg, 1125 mg, 1187.5 mg, 1200 mg, 1225 mg, 1250 mg,1312.5 mg, 1400 mg, 1510 mg, 1575 mg, 1600 mg, 1662.5 mg, 1750 mg, 1900 mg, or any range or value therebetween of the Ascophyllum nodosum. In certain preferred embodiments, the dry powder animal supplement can comprise from about 75 mg to about 330 mg, more preferably about 100 mg to about 250 mg, and even more preferably about 150 mg to about 180 mg of the Ascophyllum nodosum. In certain preferred embodiments, the dry powder animal supplement can comprise about 165 mg to about 850 mg, more preferably about 225 mg to about 650 mg, and even more preferably about 310 mg to about 350 mg of the Ascophyllum nodosum. In certain preferred embodiments, the dry powder animal supplement can comprise about 330 mg to about 1510 mg, more preferably about 600 mg to about 1200 mg, and even more preferably about 810 mg to about 890 mg of the Ascophyllum nodosum. In certain preferred embodiments, the dry powder animal supplement can comprise about 850 mg to about 1900 mg, more preferably about 1100 mg to about 1750 mg, and even more preferably about 1400 mg to about 1600 mg of the Ascophyllum nodosum.
[0070] In certain embodiments, the dry powder animal supplement can comprise from about 330 mg to about 1510 mg, more preferably from about 600 mg to about 1200 mg, even more preferably from about 810 mg to about 890 mg of the Ascophyllum nodosum, where the amounts of the ranges can be adjusted by about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200%.
[0071] In certain embodiments, the dry powder animal supplement can comprise from about 280 mg to about 1750 mg of the Ascophyllum nodosum. In certain embodiments, the dry powder animal supplement can comprise from about 700 mg to about 1000 mg of the Ascophyllum nodosum, preferably from about 750 mg to about 950 mg, more preferably from about 800 mg to about 900 mg. In certain embodiments, the dry powder animal supplement can comprise from about 40% to about 70% of the foregoing amounts. In certain embodiments, the dry powder animal supplement can comprise from about 125% to about 175% of the foregoing amounts.
[0072] It should be understood that the Asocphyllum nodosum can be the seaweed itself or a suitable powder, concentrate or extract thereof. It should be understood that in any embodiments of the present disclosure, the Ascophyllum nodosum can be substituted with anyother suitable seaweed, algae, product, concentrate or extract thereof including, by way of example but not limitation, brown algae. By way of example, but not limitation, such seaweeds or algae can be selected from the group consisting of Undaria pinnatifida, Chondrus crispus. Palmaria palmata, Ulva lacluca. Pyropia spp., Porphyra spp., Saccharina lalissima. Hedophuyllum nigripes, Nereocystis leulkeana. Costaria coslala. Eualaria fislulosa. Palmaria mollis, Gracilaria parvispora, Kappaphycus sp., Ecklonia maxima, Fucus vesiculosus, Laminaria digitata, Sar gassum spp., such as Sar gassum stenophyllum, Turbinarias spp., Macrocystis pyrifera, Chorda fdum, Dictyota menstrualis, Fucus evanescens, Fucus serratus, Ficus distichus, Caulerpa racemosa, Hizikia fusiforme, Padina gymnospora, Kjellmaniella crassifolia, Analipus japonicus, and Laminaria hyperborea. It should be further understood that the amount of the seaweed, algae, product, concentrate or extract thereof can be adjusted by one of skill in the art to achieve the desired effect. It should also be understood that the seaweed, algae, product, concentrate or extract thereof can be dried and / or fermented.Antimicrobial Component / Botanical Components
[0073] In certain embodiments, the dry powder animal supplement can further comprise an antimicrobial component. In certain embodiments, the antimicrobial component can comprise one or more botanical components. In certain embodiments the one or more botanical components can comprise one or more plant extracts.
[0074] In certain embodiments, the one or more plant extracts can be selected from the group consisting of rosemary leaf extract, green tea, perilla seed extract, and combinations thereof. In certain embodiments, the one or more plant extracts can comprise rosemary leaf extract and green tea. In certain embodiments, the green tea is decaffeinated.
[0075] Rosemary leaf extract has been shown to inhibit odor causing bacteria as well as biofilm formation. Evidence also indicates reduced gingivitis in the presence of this herbal extract when combined with others. It is expected, without being bound to theory, that the combination of Ascophyllum nodosum and rosemary leaf extract can have a greater effect on inhibiting biofilm formation.
[0076] In certain embodiments, the rosemary leaf extract can be present in an amount sufficient to inhibit odor causing bacteria and / or biofilm formation.
[0077] In certain embodiments, the rosemary leaf extract can be present in an amount from about 10 mg to about 110 mg. In certain embodiments, the rosemary leaf extract can bepresent in an amount from about 24 mg to about 131.25 mg. In certain embodiments, the rosemary leaf extract can be present in an amount from about 24 mg to about 100 mg.
[0078] In certain embodiments, the dry powder animal supplement can comprise about 10 mg, 14 mg, 18 mg, 20.5 mg, 22 mg, 24 mg, 25.2 mg, 26 mg, 28 mg, 28.8 mg, 29 mg, 30 mg, 32 mg, 36 mg, 40.5 mg, 41 mg, 42 mg, 44.1 mg, 45.5 mg, 46 mg, 49 mg, 50 mg, 50.4 mg, 51 mg, 52.5 mg, 56 mg, 57 mg, 60 mg, 61 mg, 63 mg, 65 mg, 68 mg, 69 mg, 70 mg, 72 mg, 75 mg, 78 mg, 78.75 mg, 79.67 mg, 80 mg, 81.25 mg, 85 mg, 87.5 mg, 90 mg, 93.75 mg, 100 mg, 105 mg, 110 mg, 110.25 mg, 113.75 mg, 122.5 mg, 126 mg, 131.25 mg, or any range or value therebetween of the rosemary leaf extract. In certain preferred embodiments, the dry powder animal supplement can comprise from about 10 mg to about 41 mg, more preferably about 14 mg to about 32 mg, and even more preferably about 18 mg to about 22 mg of the rosemary leaf extract. In certain preferred embodiments, the dry powder animal supplement can comprise about 20.5 mg to about 68 mg, more preferably about 29 mg to about 57 mg, and even more preferably about 36 mg to about 46 mg of the rosemary leaf extract. In certain preferred embodiments, the dry powder animal supplement can comprise about 41 mg to about 80 mg, more preferably about 51 mg to about 78 mg, and even more preferably about 61 mg to about 75 mg of the rosemary leaf extract. In certain preferred embodiments, the dry powder animal supplement can comprise about 68 mg to about 110 mg, more preferably about 69 mg to about 100 mg, and even more preferably about 70 mg to about 90 mg of the rosemary leaf extract.
[0079] In certain embodiments, the dry powder animal supplement can comprise from about 41 mg to about 80 mg, more preferably from about 51 mg to about 78 mg, even more preferably from about 61 mg to about 75 mg of the rosemary leaf extract, where the amounts of the ranges can be adjusted by about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200%. In certain embodiments, the dry powder animal supplement composition can comprise about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement composition can include about 200% of these amounts / ranges.
[0080] In certain embodiments, the dry powder animal supplement can comprise from about 60 mg to about 75 mg of the rosemary leaf extract, preferably from about 63 mg to about 72 mg, more preferably from about 65 mg to about 70 mg. In certain embodiments, the dry powder animal supplement can comprise from about 40% to about 70% of the foregoing amounts. In certain embodiments, the dry powder animal supplement can comprise from about 125% to about 175% of the foregoing amounts.
[0081] Green tea can increase the activity of oral peroxidases which can create antimicrobial agents and inactivate carcinogenic and genotoxic substance which can result in improved oral microbiota due to oral peroxidase activity.
[0082] In certain embodiments, the green tea can be present in an amount sufficient to increase the activity of oral peroxidases.
[0083] In certain embodiments, the green tea can be present in an amount from about 1.6 mg to about 21 mg.
[0084] In certain embodiments, the dry powder animal supplement can comprise from about 1 to about 20 mg of the green tea. In certain embodiments, the dry powder animal supplement can comprise about 1 mg, 1.25 mg, 1.6 mg, 1.75 mg, 2 mg, 2.4 mg, 2.5 mg, 2.8 mg, 3 mg, 3.5 mg, 4 mg, 4.2 mg, 4.4 mg, 4.6 mg, 4.8 mg, 5 mg, 5.5 mg, 6 mg, 6.25 mg, 7 mg,7.5 mg, 7.7 mg, 8 mg, 8.2 mg, 8.4 mg, 8.75 mg, 9 mg, 9.3 mg, 9.5 mg, 10 mg, 10.5 mg, 12 mg, 12.5 mg, 13.75 mg, 15 mg, 17.5 mg, 19.25 mg, 20 mg, 21 mg, or any range or value therebetween of the green tea. In certain preferred embodiments, the dry powder animal supplement can comprise from about 1 mg to about 5 mg, more preferably about 1.25 mg to about 4 mg, and even more preferably about 1.75 mg to about 3 mg of the green tea. In certain preferred embodiments, the dry powder animal supplement can comprise about 2.5 mg to about 8 mg, more preferably about 3 mg to about 7.5 mg, and even more preferably about 3.5 mg to about 7 mg of the green tea. In certain preferred embodiments, the dry powder animal supplement can comprise about 5 mg to about 9 mg, more preferably about5.5 mg to about 9.5 mg, and even more preferably about 6 mg to about 10 mg of the green tea. In certain preferred embodiments, the dry powder animal supplement can comprise about 8 mg to about 20 mg, more preferably about 7.5 mg to about 15 mg, and even more preferably about 7 mg to about 12 mg of the green tea.
[0085] In certain embodiments, the dry powder animal supplement can comprise from about 5 mg to about 9 mg, more preferably from about 5.5 mg to about 9.5 mg, even more preferably from about 6 mg to about 10 mg of the green tea, where the amounts of the ranges can be adjusted by about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200%. In certain embodiments, the dry powder animal supplement composition can comprise about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement composition can include about 200% of these amounts / ranges.
[0086] In certain embodiments, the dry powder animal supplement can comprise from about 4 mg to about 12 mg of the green tea, preferably from about 5 mg to about 11 mg, more preferably from about 4 mg to about 10 mg. In certain embodiments, the dry powder animalsupplement can comprise from about 40% to about 70% of the foregoing amounts. In certain embodiments, the dry powder animal supplement can comprise from about 125% to about 175% of the foregoing amounts.
[0087] In certain embodiments, the perilla seed extract can be present in an amount from about 10 mg to about 80 mg. In certain embodiments, the perilla seed extract can be present in an amount from about 10 mg to about 30 mg, about 20 mg to about 60 mg, or about 40 to about 80 mg, about 10 mg, about 20 mg, about 30 mg, about 40 mg, about 60 mg, about 80 mg, or any range or value therebetween.
[0088] In certain embodiments, the perilla seed extract can be present in an amount from about 2 mg to about 110 mg. In certain embodiments, the dry powder animal supplement can comprise about 2 mg, 5 mg, 7 mg, 8 mg, 10 mg, 15 mg, 17 mg, 18 mg, 20 mg, 30 mg, 33 mg, 35 mg, 36 mg, 40 mg, 60 mg, 68 mg, 75 mg, 80 mg, 95 mg, 110 mg, or any range or value therebetween of the perilla seed extract. In certain preferred embodiments, the dry powder animal supplement can comprise from about 2 mg to about 35 mg, more preferably about 3 mg to about 17 mg, and even more preferably about 5 mg to about 15 mg of the perilla seed extract. In certain preferred embodiments, the dry powder animal supplement can comprise from about 7 mg to 36 mg, more preferably about 8 mg to about 33 mg, and even more preferably about 10 mg to about 30 mg of the perilla seed extract. In certain preferred embodiments, the dry powder animal supplement can comprise from about 15 mg to 75 mg, more preferably about 17 mg to about 68 mg, and even more preferably about 20 mg to about 60 mg of the perilla seed extract. In certain preferred embodiments, the dry powder animal supplement can comprise from about 30 mg to 110 mg, more preferably about 35 mg to about 95 mg, and even more preferably about 40 mg to about 80 mg of the perilla seed extract.
[0089] In certain embodiments, the dry powder animal supplement can comprise from about 15 mg to 75 mg, more preferably about 17 mg to about 68 mg, and even more preferably about 20 mg to about 60 mg of the perilla seed extract, where the amounts of the ranges can be adjusted by about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200%. In certain embodiments, the dry powder animal supplement composition can comprise about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement composition can include about 200% of these amounts / ranges.Sodium Hexametaphosphate
[0090] Sodium hexametaphosphate helps remove calcium ions which make up the tartar formed due to excessive biofilm (plaque) formation. The removal of calcium from the tartar helps weaken the tartar so it is more easily removed from the surface of the teeth.
[0091] In certain embodiments, the dry powder animal supplement further comprises sodium hexametaphosphate.
[0092] In certain embodiments, the sodium hexametaphosphate can be present in an amount sufficient to remove at least a portion of calcium ions which make up tartar formed due to excessive biofilm (plaque) formation and / or to weaken tartar.
[0093] In certain embodiments, the sodium hexametaphosphate can be present in an amount from about 10 mg to about 250 mg. In certain embodiments, the sodium hexametaphosphate can be present in an amount from about 34 mg to about 201.25 mg.
[0094] In certain embodiments, the dry powder animal supplement can comprise about 10 mg, 18 mg, 26 mg, 29 mg, 32 mg, 34 mg, 36 mg, 38 mg, 42 mg, 44 mg, 45 mg, 46 mg, 52 mg, 58 mg, 58.3 mg, 59.5 mg, 63 mg, 64 mg, 66.5 mg, 73.5 mg, 74 mg, 77 mg, 80.5 mg, 82 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 106.25 mg, 110 mg, 112.5 mg, 115 mg, 118 mg, 118.75 mg, 125 mg, 131.25 mg, 137.5 mg, 140 mg, 143.75 mg, 148.75 mg, 157.5 mg, 166.25 mg, 183.75 mg, 192.5 mg, 201.25 mg, 205 mg, 250 mg, or any range or value therebetween of the sodium hexametaphosphate. In certain preferred embodiments, the dry powder animal supplement can comprise from about 10 mg to about 58 mg, more preferably about 18 mg to about 45 mg, and even more preferably about 26 mg to about 32 mg of the sodium hexametaphosphate. In certain preferred embodiments, the dry powder animal supplement can comprise about 29 mg to about 100 mg, more preferably about 64 mg to about 82 mg, and even more preferably about 52 mg to about 63 mg of the sodium hexametaphosphate. In certain preferred embodiments, the dry powder animal supplement can comprise about 58 mg to about 125 mg, more preferably about 74 mg to about 118 mg, and even more preferably about 90 mg to about 110 mg of the sodium hexametaphosphate. In certain preferred embodiments, the dry powder animal supplement can comprise about 100 mg to about 250 mg, more preferably about 105 mg to about 205 mg, and even more preferably about 110 mg to about 140 mg of the sodium hexametaphosphate.
[0095] In certain embodiments, the dry powder animal supplement can comprise from about 34 mg to about 201.25 mg of the sodium hexametaphosphate. In certain embodiments, the dry powder animal supplement can comprise from about 85 mg to about 115 mg of the sodium hexametaphosphate, preferably from about 90 mg to about 110 mg, more preferablyfrom about 95 mg to about 105 mg. In certain embodiments, the dry powder animal supplement can comprise from about 40% to about 70% of the foregoing amounts. In certain embodiments, the dry powder animal supplement can comprise from about 125% to about 175% of the foregoing amounts. In certain embodiments the dry powder animal supplement can comprise about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200% of the foregoing amounts / ranges. In certain embodiments the dry powder animal supplement can comprise about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement can comprise about 200% of the foregoing amounts / ranges.
[0096] In certain embodiments, the dry powder animal supplement can comprise from about 58 mg to about 125 mg, more preferably from about 74 mg to about 118 mg, even more preferably from about 90 mg to about 110 mg of the sodium hexametaphosphate, where the amounts of the ranges can be adjusted by about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200%. In certain embodiments, the dry powder animal supplement composition can comprise about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement composition can include about 200% of these amounts / ranges.Carriers
[0097] In certain embodiments, the dry powder animal supplement can further comprise a carrier. In certain embodiments, the carrier can comprise brewers yeast. In certain embodiments, the carrier is selected from the group consisting of cellulose, pea fiber, dried yeast. In certain embodiments, the dry powder animal supplement composition can comprise an amount of carrier that is sufficient for the dry powder animal supplement to comprise about 0.25 g, 0.5 g, 0.75 g, 1 g, 1.5 g, 2 g, 2.5 g, 3 g, 3.5 g, 4 g, or more. In certain embodiments, the dry powder animal supplement can comprise an amount of the carrier sufficient to that the dry powder animal supplement comprises from about 0.25 g to about 4 g total weight. In certain embodiments, the dry powder animal supplement can comprise an amount sufficient to make about 1 g, more preferably to make about 0.75 g, even more preferably to make about 0.25 g total weight of the dry powder animal supplement. In certain embodiments, the dry powder animal supplement can comprise an amount sufficient to make about 2 g, more preferably to make about 1.5 g, even more preferably to make about 0.75 g total weight of the dry powder animal supplement. In certain embodiments, the dry powder animal supplement can comprise an amount sufficient to make about 2.5 g, more preferably to make about 2 g, even more preferably to make about 1.5 g total weight of the dry powder animal supplement. In certain embodiments, the dry powder animal supplement cancomprise an amount sufficient to make about 3 g, more preferably to make about 2.5 g, even more preferably to make about 2 g total weight of the dry powder animal supplement. In certain embodiments, the dry powder animal supplement can comprise an amount sufficient to make about 4 g, more preferably to make about 3 g, even more preferably to make about 2.5 g total weight of the dry powder animal supplement.Colorants
[0098] In certain embodiments, the dry powder animal supplement can further comprise a colorant. In certain embodiments, the colorant comprises dried spinach. In certain embodiments, the colorant is selected from the group consisting of spinach, spirulina, chlorella, parsley, wheatgrass, kale, and alfalfa nutrient concentrate. In certain embodiments, the colorant is provided in an amount sufficient to provide a desired color to the dry powder animal supplement. In some embodiments, the dry powder animal supplement comprises from about 5% to about 30% (w / w) of the colorant. In certain embodiments, the dry powder animal supplement comprises from about 10% to about 30%, more preferably from about 15% to about 25%, even more preferably from about 18% to about 22% (w / w) of the colorant. In certain embodiments, the dry powder animal supplement comprises from about 5% to about 25%, more preferably from about 10% to about 20%, even more preferably from about 13% to about 17% (w / w) of the colorant.Anti-Caking Agents
[0099] In certain embodiments, the dry powder animal supplement can further comprise an anti-caking agent. In certain embodiments, the anti-caking agent comprises Novasil (montmorillonite clay). In certain embodiments, the anti-caking agent can comprise bentonite, such as calcium bentonite. In certain embodiments, the anti-caking agent can comprise bentonite, silicon dioxide, calcium silicate, sodium aluminosilicate, calcium carbonate, magnesium carbonate, or a combination thereof. In certain embdoiments, the anticaking agent is provided in an amount sufficient to prevent caking of the dry powder animal supplement. In certain embodiments, the dry powder animal supplement comprises from about 0.1% to about 2.5% (w / w) of the anti-caking agent. In certain embodiments, the dry powder animal supplement comprises from about 0.1% to about 2.5%, more preferably about 0.4% to about 1.6%, even more preferably about 0.75% to about 1.25% (w / w) of the anticaking agent.Flavoring Agents
[0100] In certain embodiments, the dry powder animal supplement can further comprise a flavoring agent. In certain embodiments, the flavoring agent can comprise hydrolyzed chicken, beef, lamb, salmon, or a combination thereof. In certain embodiments, the flavoring agent can comprise a chicken liver palatant. In certain embodiments, the flavoring agent is provided in an amount sufficient to provide a palatable flavor to the dry powder animal supplement. In certain embodiments, the dry powder animal supplement comprises from about 1% to about 10% (w / w) of the flavoring agent. In certain embodiments, the dry powder animal supplement comprises from about 1% to about 10%, more preferably about 2% to about 5%, even more preferably about 2.5% to about 3% (w / w) of the flavoring agent.Oral Residence Time Enhancer
[0101] To increase the efficacy of a dry powder animal supplement, its oral residence time can be lengthened to allow the active ingredients in the dry powder animal supplement more time to act.
[0102] In certain embodiments, the dry powder animal supplement can further comprise an oral residence time enhancer. In certain embodiments, the oral residence time enhancer can comprise a soluble gum fiber. In certain embodiments, the soluble gum fiber can comprise one or more soluble gum fibers selected from the group consisting of xanthan gum, guar gum, gum Arabic, gellan gum, carboxymethylcellulose, hydroxyethylcellulose, and hydroxypropyl methylcellulose. In certain embodiments, the active components, e.g. biotic component, Ascophyllum nodosum, antimicrobial component, and / or SHMP, can be encapsulated into the soluble gum fiber.
[0103] In certain embodiments, a dry powder animal supplement, including those not specifically disclosed herein, can further comprise and / or be combined with an oral residence time enhancer as described herein.
[0104] In certain embodiments, the oral residence time enhancer can be present in an amount sufficient to increase the oral residence time of the dry powder animal supplement. In certain embodiments, the oral residence time enhancer can be present in an amount from about 0.1% to about 5% (w / w) of the dry powder animal supplement. In certain embodiments, the oral residence time enhancer can be present in an amount from about 0.1% to about about 5% (w / w), about 0.1% to about 4.5% (w / w), about 0.1% to about 4% (w / w), about 0.1% to about 3.5% (w / w), about 0.1% to about 3% (w / w), about 0.1% to about 2.5%(w / w), about 0.1% to about 2% (w / w), about 0.1% to about 1.5% (w / w), about 0.1% to about 1% (w / w), about 0.1% to about 0.5% (w / w), 0.5% to about about 5% (w / w), about 0.5% to about 4.5% (w / w), about 0.5% to about 4% (w / w), about 0.5% to about 3.5% (w / w), about 0.5% to about 3% (w / w), about 0.5% to about 2.5% (w / w), about 0.5% to about 2% (w / w), about 0.5% to about 1.5% (w / w), about 0.5% to about 1% (w / w), 1% to about about 5% (w / w), about 1% to about 4.5% (w / w), about 1% to about 4% (w / w), about 1% to about 3.5% (w / w), about 1% to about 3% (w / w), about 1% to about 2.5% (w / w), about 1% to about 2% (w / w), about 1% to about 1.5% (w / w), about 1.5% to about 5% (w / w), about 1.5% to about 4.5% (w / w), about 1.5% to about 4% (w / w), about 1.5% to about 3.5% (w / w), about 1.5% to about 3% (w / w), about 1.5% to about 2.5% (w / w), about 1.5% to about 2% (w / w), about 2% to about 5% (w / w), about 2% to about 4.5% (w / w), about 2% to about 4% (w / w), about 2% to about 3.5% (w / w), about 2% to about 3% (w / w), about 2% to about 2.5% (w / w), about 2.5% to about 5% (w / w), about 2.5% to about 4.5% (w / w), about 2.5% to about 4% (w / w), about 2.5% to about 3.5% (w / w), about 2.5% to about 3% (w / w), about 3% to about 5% (w / w), about 3% to about 4.5% (w / w), about 3% to about 4% (w / w), about 3% to about 3.5% (w / w), about 3.5% to about 5% (w / w), about 3.5% to about 4.5% (w / w), about 3.5% to about 4% (w / w), about 4% to about 5% (w / w), about 4% to about 4.5% (w / w), about 4.5% to about 5% (w / w), about 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5% (w / w) or any range or value therebetween.Dry Food Affinity Enhancer
[0105] Consumption of a dry powder animal supplement and its active ingredients relies on an animal subject being able to completely consume all or a substantial portion of the dry powder animal supplement. Because the mass and volume of the powder can be relatively low, an improvement in its efficacy can occur if it adheres better to dry food. Wet foods provide considerable moisture to affix the powder and assure its complete consumption. Dry foods, on the other hand, lack such a “glue” or sticky aspect by which the powder will stick to the kibble.
[0106] In certain embodiments, a dry powder animal supplement can comprise or further comprise a dry food affinity enhancer. In certain embodiments, the dry food affinity enhancer comprises a companion oil. A companion oil can be applied to kibble before the powder is added to promote adhesion of the powder to the kibble. In certain embodiments, the companion oil comprises an essential oil. In certain embodiments, the essential oilcomprises oregano oil, cinnamon oil, clove oil, rosemary oil, orange oil, tea tree oil, spearmint oil, peppermint oil, neem oil, or a combination thereof.
[0107] In certain embodiments, a kit is provided that comprises a dry powder animal supplement and the dry food affinity enhancer.
[0108] In certain embodiments, a composition is provided comprising a dry animal feed, a dry powder animal supplement and the dry food affinity enhancer. In certain embodiments, the dry animal feed is dog kibble.
[0109] In certain embodiments, the dry powder animal supplement is a dry powder animal supplement of the present disclosure.Grind Size
[0110] Another mechanism by which improved adherence of a dry powder animal supplement to dry food can be achieved is by reducing the grind size of the dry powder animal supplement. By further milling the powder, individual particle size can decrease which can improve the ability of van der Waals forces to improve the attraction of the particles of the powder onto the dry food pieces.
[0111] In certain embodiments, a dry powder animal supplement comprises an average particle size sufficient to promote adherence of the dry powder animal supplement to a dry animal feed. In certain embodiments, the dry powder animal supplement can pass through a 30 mesh screen. In certain embodiments, the dry animal feed is dog kibble.Saliva-inducing Component
[0112] Adding a saliva-inducing substance to a dry powder animal supplement can induce saliva secretion. Increased saliva secretion can help to wet the mouth and aid the efficacy of the active ingredients to promote oral health. As more saliva is created, the activity of the active ingredients can increase due to improved dispersion in the mouth.
[0113] In certain embodiments, a dry powder animal supplement can comprise or further comprise a saliva-inducing component.
[0114] In certain embodiments, the saliva-inducing component comprises powdered vinegar, glycerin, carboxymethylcellulose, hydroxyethylcellulose, dried celery, dried cucumbers, dried apples, dried broccoli, dried cauliflower, dried pears, dried tomatoes, dried cheese, or a combination thereof.
[0115] In certain embodiments, the dry powder animal supplement is a dry powder animal supplement of the present disclosure.Water Activity
[0116] The moisture content of a dry powder animal supplement of the present disclosure relies on balancing the activity of the various ingredients. By way of example, but not limitation, too high of a water activity will make SHMP more active which can negatively impact the probiotic component. Similarly, too high of a water activity can allow the antimicrobial component to negatively impact the probiotic component.
[0117] In certain embodiments, a dry powder animal supplement of the present disclosure can have a water activity (aw) of less than about 0.25. In certain embodiments, the dry powder animal supplement of the present disclosure can have a water activity (aw) of at least 0.10. In certain embodiments, the dry powder animal supplement of the present disclosure can have a water activity (aw) of about 0.10 to about 0.25, about 0.10 to about 0.20, about 0.10 to about 0.15, about 0.15 to about 0.25, about 0.15 to about 0.20, about 0.20 to about 0.25, about 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.20, 0.21, 0.22, 0.23, 0.24, or 0.25 or any range or value therebetween.Stability
[0118] In certain embodiments, the dry powder animal supplement is stable after storage at room temperature for a period of 12 months as measured by 25% or greater recovery of the probiotic component.
[0119] To measure probiotic recovery, one quantifies the probiotics (cfu / g) residing in the dry powder animal supplement after 12 months from the date of manufacture. The percent recovery is then calculated by the following equation:
[0120] If the percent recovery exceeds 25%, then the probiotics are deemed stable in the dry powder animal supplement. In certain embodiments, the precent recovery is at least 25%, 30%, 35%, 40%, 50%, 60%, 70%, 80%, 90% or more.Delivery Device
[0121] Another approach to prolong exposure of a dry powder animal supplement to the oral cavity can be by use of a delivery device from which the animal has to lick the drypowder animal supplement out. This extra action can slow consumption of the powder to increase exposure in the oral cavity.
[0122] In certain embodiments, the delivery device can be a tube. In certain embodiments, the tube can be of variable diameter in order to adjust the diameter depending on the size of the animal. In certain embodiments, the tube can be of variable length in order to adjust the length depending on the size of the animal. The diameter and / or length can be varied to also vary the consumption time.Dose
[0123] In certain embodiments, the dry powder animal supplement can comprise about 0.25 gram (g) of powder, 0.75 g of powder, 1 g of powder, 1.5 g of powder, 2 g of powder, 2.5 g of powder, 3 g of powder, 4 g of powder or more.
[0124] It should be understood that the concentration of components in the dry powder animal supplement can be modified depending on the size of the dose and / or frequency of dosing of the dry powder animal supplement.
[0125] The table below provides preferred, more preferred, and even more preferred ranges for components of an exemplary formulation:**Very Small: < 12#, Small: 12 to 25#, Medium: 25 to 75#, Large: > 75# ***m = million****b = billion
[0126] The table below provides preferred, more preferred, and even more preferred ranges for the biotic component.**Very Small: < 12#, Small: 12 to 25#, Medium: 25 to 75#, Large: > 75#Compositions
[0127] In certain embodiments, a composition is provided comprising a dry powder animal supplement of the present disclosure and an animal feed. In certain embodiments, the animal feed is wet animal feed. In certain embodiments, the animal feed is dry animal feed. In certain embodiments, the animal feed is dog kibble.Methods of Use
[0128] In certain embodiments, a method comprises the step of providing a dry powder animal supplement of the present disclosure for consumption by an animal subject; and allowing the animal subject to consume to dry powder animal supplement. In certain embodiments, the dry powder animal supplement is combined with a wet or dry animal feed prior to providing the dry powder animal supplement for consumption. In certain embodiments, the method is a method for reducing bacterial plaque and / or dental calculus, improving gum health, reducing inflammation, treating halitosis, improving the oral microbiome or whitening teeth in the animal subject.
[0129] In certain embodiments, a method for increasing the oral residence time of a dry powder animal supplement is provided comprising the step of combining the dry powder animal supplement with an oral residence time enhancer as described herein. In certain embodiments, the method further comprises providing the combined dry powder animal supplement and oral residence time enhancer to the animal subject for consumption and allowing the animal subject to consume the combined dry powder animal supplement and oral residence time enhancer.
[0130] In certain embodiments, a method for increasing the affinity of a dry powder animal supplement for dry food comprises the step of combining the dry powder animal supplement, a dry food affinity enhancer and dry food. In certain embodiments, the dry foodcan be dog kibble. In certain embodiments, the method further comprises providing the combined dry powder animal supplement, dry food affinity enhancer and dry food to the animal subject for consumption and allowing the animal subject to consume the combined dry powder animal supplement, dry food affinity enhancer and dry food.
[0131] In certain embodiments, a method for inducing saliva production in an animal subject comprises the step of combining a dry powder animal supplement with a salivainducing component. In certain embodiments, the method further comprises providing the dry powder animal supplement and saliva-inducing component to the animal subject for consumption and allowing the animal subject to consume the combined dry powder animal supplement and saliva-inducing component.
[0132] In certain embodiments, the dry powder animal supplement of any of the methods herein can be a dry powder animal supplement of the present disclosure.
[0133] In certain embodiments, the animal subject of any of the methods herein can be a canine. In certain embodiments, the animal subject of any of the methods herein can be very small (weight of less than about 12 pounds), small (weight of about 12 pounds to about 25 pounds), medium (weight of about 25 pounds to about 75 pounds), and large (weight of greater than 75 pounds). In certain embodiments, the animal subject of the methods herein can have a weight of less than 25 pounds, from about 25 pounds to about 75 pounds, or greater than 75 pounds.
[0134] In certain embodiments, a method for slowing consumption of a dry powder animal supplement comprises the step of providing the dry powder animal supplement in a container configured to slow consumption of the dry powder animal supplement. In certain embodiments, the container is a delivery device of the present disclosure.
[0135] In certain embodiments, a method is provided for improving breath odor in an animal subject comprising providing the dry powder animal supplement to the animal subject for consumption and allowing the animal subject to consume the combined dry powder animal supplement. In certain embodiments, the method results in a reduction in odors. In certain embodiments, the improvement in breath odor and / or reduction in odors is measured by a halimeter. A halimeter measures total volatile sulfur compounds which are the sum of hydrogen sulfide, methylmercaptan, and dimethyl sulfide. In certain embodiments, an owner answers a questionnaire to describe the type of odors. In certain embodiments, descriptions of odors by the pet’s owner can be selected from barnyard, cabbage, decay / rot, fish, musty, rotten eggs, salty, other odors, no odor, and combinations thereof.
[0136] In certain embodiments, the method results in the elimination of breath odor.
[0137] In certain embodiments, a method is provided for improving quality of life of an animal subject comprising providing the dry powder animal supplement to the animal subject for consumption and allowing the animal subject to consume the dry powder animal supplement. In certain embodiments, an improvement in quality of life can include an improvement in a characteristic selected from the group consisting of mood, sleep, relationships, habits, pain, and combinations thereof. In certain embodiments, quality of life comprises mood, sleep, and pain. In certain embodiments, quality of life comprises mood and sleep. In certain embodiments, quality of life comprises mood and pain. In certain embodiments, quality of life comprises sleep and relationships. In certain embodiments, quality of life comprises sleep and habits. In certain embodiments, quality of life comprises sleep, habits, and relationships. In certain embodiments, quality of life comprises mood and habits. In certain embodiments, quality of life comprises mood and relationships. In some embodiments, quality of life comprises mood, sleep, habits, and relationships. In certain embodiments, these characteristics can be measured by using a monitoring device, such as a Fitbark®.
[0138] In certain preferred embdoiments, the improvement in sleep as a percentage increase in sleep can be at least about 4%, more preferably at least about 8%, most preferably at least about 12%.
[0139] In certain embodiments, a method is provided for improving mood, sleep, relationships, and / or or habits of an animal subject comprising providing the dry powder animal supplement to the animal subject for consumption and allowing the animal subject to consume the dry powder animal supplement.
[0140] In certain embodiments, a method is provided for treating a dental condition in an animal subject in need thereof comprising providing the dry powder animal supplement to the animal subject for consumption and allowing the animal subject to consume the dry powder animal supplement. In certain embodiments, the dental condition can be plaque, tartar, halitosis, or gingivitis. In certain embodiments, the dental condition can be plaque, tartar, or gingivitis. In certain embodiments, the dry powder animal supplement can prevent the dental condition.
[0141] In certain embodiments, the animal subject is suffering from a dental condition. In certain embodiments, the dental condition can be plaque, tartar, halitosis, or gingivitis. In certain embodiments, the dental condition can be plaque, tartar, or gingivitis. In certain embodiments, the dry powder animal supplement can prevent the dental condition.
[0142] In certain embodiments, the dry powder animal supplement is provided to the animal subject for consumption for at least 30 days or more. In some embodiments, the dry powder animal supplement is provided to the animal subject for consumption for at least 10 days, 20 days, 30 days, 40 days, 50 days, 60 days, 90 days, 120 days, 180 days, 1 year or more.
[0143] It should be understood that the dry powder animal supplements of the present disclosure can be provided as compositions for use in any of the methods herein.
[0144] It should be understood that the methods disclosed herein can be combined in any suitable manner. For example, in a method for treating halitosis, the dry powder animal supplement can be combined with an oral residence time enhancer (e.g. if it does not already contain an oral residence time enhancer) or can be adhered to dry food by combining the dry powder animal supplement, a dry food affinity enhancer and dry food.Dosing
[0145] In certain embodiments, the dry powder animal supplement can be delivered to the animal subject once per day. In certain embodiments, the dry powder animal supplement can be delivered to the animal subject more than once per day, by way of example but not limitation, twice per day, three times per day, four times per day or more. In certain embodiments, the dry powder animal supplement can be delivered to the animal subject in an amount sufficient to deliver the desired dose of the components of the dry powder animal supplement.Biotic Component Dose
[0146] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 5.0 x 107to about 1.0 x 1010colony forming units (CFU) of the biotic component per day to the animal subject. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 2.4 x 108colony forming units (CFU) to about 1.6 x 109CFU of the biotic component per day to the animal subject. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 5.0 x 107CFU, 1.1 x 108CFU, 1.5 x 108CFU, 2.25 x 108CFU, 2.4 x 108CFU, 2.6 x 108CFU, 2.8 x 108CFU, 3.0 x 108CFU, 3.2 x 108CFU, 3.4 x 108CFU, 3.5 x 108CFU, 3.6 x 108CFU, 4.2 x 108CFU, 4.5 x 108CFU, 4.55 x 108CFU, 4.9 x 108CFU, 5.5 x 108CFU, 5.6 x 108CFU, 5.95 x 108CFU, 6.0 x 108CFU, 6.25 x 108CFU, 6.3 x 108CFU, 6.5 x 108CFU, 7.0 x 108CFU, 7.5 x 108CFU, 8.0 x 108CFU, 8.125 x 108CFU, 8.5 x 108CFU, 8.75 x 108CFU, 9.0 x 108CFU, 9.5 x 108CFU, 1.0 x 109CFU, 1.05 x 109CFU, 1.0625 x 109CFU, 1.125 x 109CFU, 1.1375 x 109CFU, 1.2 x 109CFU, 1.225 x 109CFU, 1.4 x 109CFU, 1.4875 x 109CFU, 1.575 x 109CFU, 3.0 x 109CFU, 5.0 x 109CFU, 1.0 x IO10CFU, or any range or value therebetween of the biotic component per day to the animal subject. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 5.0 x 107to about4.5 x 108CFU, more preferably about 1.1 x 108to about 3.5 x 108CFU, and even more preferably about 1.5 x 108to about 3.0 x 108CFU of the biotic component per day to the animal subject, such as where the animal subject weighs less than about 12 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 2.25 x 108to about 7.5 x 108CFU, more preferably about 3.0 x 108to about 6.0 x 108CFU, and even more preferably about 3.5 x 108to about 5.5 x 108CFU of the biotic component per day to the animal subject, such as where the animal subject weighs from about 12 to about 25 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 4.5 x 108to about 1.2 x 109CFU, more preferably about 5.5 x 108to about 9.0 x 108CFU, and even more preferably about 6.25 x 108to about 8.5 x 108CFU of the biotic component per day to the animal subject, such as where the animal subject weighs from about 25 to about 75 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 7.5 x 108to about 1.0 x 1010CFU, more preferably about9.5 x 108to about 5 x 109CFU, and even more preferably about 1.0 x 109to about 3.0 x 109CFU of the biotic component per day to the animal subject, such as where the animal subject weighs greater than 75 pounds.
[0147] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 6.0 x 108CFU to about 9.0 x 108CFU of the biotic component, preferably from about 6.5 x 108CFU to about 8.5 x 108CFU, more preferably from about 7.0 x 108CFU to about 8.0 x 108CFU per day to the animal subject. In certain embodiments, the animal subject has a weight between about 25 pounds and about 75 pounds. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 40% to about 70% of the foregoing amounts. In certain embodiments, the animal subject has a weight of less than about 25 pounds, and the dry powder animal supplement can be provided in an amount sufficient to deliver from about 40% to about 70% of the foregoing amounts. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 125% to about175% of the foregoing amounts. In certain embodiments, the animal subject has a weight of greater than 75 pounds, and the dry powder animal supplement can be provided in an amount sufficient to deliver from about 125% to about 175% of the foregoing amounts.
[0148] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 2 mg to about 250 mg of the biotic component per day to the animal subject. In certain embodiments, the dry powder animal supplement composition can be provided in an amount sufficient to deliver about 2 mg, 3 mg, 5 mg, 7 mg, 8 mg, 10 mg, 11 mg, 14 mg, 15 mg, 17 mg, 20 mg, 23 mg, 25 mg, 30 mg, 35 mg, 50 mg, 58 mg, 65 mg, 82 mg, 88 mg, 98 mg, 150 mg, 200 mg, 250 mg, or any range or value therebetween of the biotic component per day to the animal subject. In certain embodiments, the dry powder animal composition can be provided in an amount sufficient to deliver from about 2 mg to about 35 mg, more preferably about 5 mg to about 30 mg, even more preferably about 7 mg to about 25 mg of the biotic component per day to the animal subject, such as where the animal subject weighs less than about 12 pounds. In certain embodiments, the dry powder animal compositon can be provided in an amount sufficient to deliver from about 8 mg to about 65 mg, more preferably about 11 mg to about 58 mg, even more preferably about 14 mg to about 50 mg of the biotic component per day to the animal subject, such as where the animal subject weighs from about 12 pounds to about 25 pounds. In certain embodiments, the dry powder animal composition can be provided in an amount sufficient to deliver from about 17 mg to about 98 mg, more preferably about 20 mg to about 88 mg, even more preferably about 23 mg to about 82 mg of the biotic component per day to the animal subject, such as where the animal subject weighs from about 25 pounds to about 75 pounds . In certain embodiments, the dry powder animal composition can be provided in an amount sufficient to deliver from about 20 mg to about 250 mg, more preferably about 25 mg to about 200 mg, even more preferably about 30 mg to about 150 mg of the biotic component per day to the animal subject, such as where the animal subject weighs greater than about 75 pounds. In certain embodiments, the dry powder animal supplement can comprise about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement can comprise about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement can include about 200% of these amounts / ranges.
[0149] It should be understand that the amount of the biotic component can refer to the amount of probiotic, for example, the amount of cells in the dry powder animal supplement. It should be understood that the amount of the biotic component can also referto the total amount of the biotic component, for example, including live cells, formerly alive cells, products and components thereof, and any prebiotics.Ascophyllum nodosum Dose
[0150] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 75 mg, 100 mg, 150 mg, 165 mg, 180 mg, 225 mg, 250 mg, 280 mg, 300 mg, 310 mg, 320 mg, 330 mg, 350 mg, 360 mg, 380 mg, 400 mg, 490 mg, 525 mg, 560 mg, 600 mg, 630 mg, 650 mg, 665 mg, 700, mg, 750 mg, 800 mg, 810 mg, 850 mg, 875 mg, 890 mg, 900 mg, 937.5 mg, 950 mg, 1000 mg, 1100 mg, 1125 mg, 1187.5 mg, 1200 mg, 1225 mg, 1250 mg, 1312.5 mg, 1400 mg, 1510 mg, 1575 mg, 1600 mg, 1662.5 mg, 1750 mg, 1900 mg, or any range or value therebetween of the Ascophyllum nodosum to the animal subject per day. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 75 mg to about 330 mg, more preferably about 100 mg to about 250 mg, and even more preferably about 150 mg to about 180 mg of the Asophyllum nodosum to the animal subject per day, such as where the animal subject weighs less than 12 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 165 mg to about 850 mg, more preferably about 225 mg to about 650 mg, and even more preferably about 310 mg to about 350 mg of the Asophyllum nodosum to the animal subject per day, such as where the animal subjects weights from about 12 pounds to about 25 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 330 mg to about 1510 mg, more preferably about 600 mg to about 1200 mg, and even more preferably about 810 mg to about 890 mg of the Ascophyllum nodosum to the animal subject per day, such as where the animal subject weighs from about 25 pounds to about 75 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 850 mg to about 1900 mg, more preferably about 1100 mg to about 1750 mg, and even more preferably about 1400 mg to about 1600 mg of the Ascophyllum nodosum to the animal subject per day, such as where the animal subject weighs greater than 75 pounds.
[0151] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 280 mg to about 1750 mg of the Ascophyllum nodosum per day to the animal subject. In certain embodiments, the dry powder animalsupplement can be provided in an amount sufficient to deliver from about 700 mg to about 1000 mg of the Ascophyllum nodosum, preferably from about 750 mg to about 950 mg, more preferably from about 800 mg to about 900 mg per day to the animal subject. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 40% to about 70% of the foregoing amounts. In certain embodiments, the animal subject has a weight of less than about 25 pounds, and the dry powder animal supplement can be provided in an amount sufficient to deliver from about 40% to about 70% of the foregoing amounts. In certain embodiments, the animal subject has a weight between about 25 pounds and about 75 pounds. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 125% to about 175% of the foregoing amounts. In certain embodiments, the animal subject has a weight of greater than 75 pounds, and the dry powder animal supplement can be provided in an amount sufficient to deliver from about 125% to about 175% of the foregoing amounts. In certain embodiments the dry powder animal supplement can be provided in an amount sufficient to deliver about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200% of the foregoing amounts / ranges. In certain embodiments the dry powder animal supplement can be provided in an amount sufficient to deliver about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 200% of the foregoing amounts / ranges. For example, the dose range can be for a canine weighing between 25 and 75 pounds, the 25% amount can be for a canine weighing less than 25 pounds and the 200% amount can be for a canine weighing greater than 75 pounds.Rosemary Leaf Extract Dose
[0152] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 10 mg, 14 mg, 18 mg, 20.5 mg, 22 mg, 24 mg, 25.2 mg, 26 mg, 28 mg, 28.8 mg, 29 mg, 30 mg, 32 mg, 36 mg, 40.5 mg, 41 mg, 42 mg, 44.1 mg, 45.5 mg, 46 mg, 49 mg, 50 mg, 50.4 mg, 51 mg, 52.5 mg, 56 mg, 57 mg, 60 mg, 61 mg, 63 mg, 65 mg, 68 mg, 69 mg, 70 mg, 72 mg, 75 mg, 78 mg, 78.75 mg, 79.67 mg, 80 mg, 81.25 mg, 85 mg, 87.5 mg, 90 mg, 93.75 mg, 100 mg, 105 mg, 110 mg, 110.25 mg, 113.75 mg, 122.5 mg, 126 mg, 131.25 mg, or any range or value therebetween of the rosemary leaf extract to the animal subject per day. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 10 mg to about 41 mg, more preferably about 14 mg to about 32 mg, and even more preferably about 18 mg to about 22mg of the rosemary leaf extract to the animal subject per day, such as where the animal subject weighs less than 12 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 20.5 mg to about 68 mg, more preferably about 29 mg to about 57 mg, and even more preferably about 36 mg to about 46 mg of the rosemary leaf extract to the animal subject per day, such as where the animal subject weighs from about 12 pounds to about 25 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 41 mg to about 80 mg, more preferably about 51 mg to about 78 mg, and even more preferably about 61 mg to about 75 mg of the rosemary leaf extract to the animal subject per day, such as where the animal subject weighs from about 25 pounds to about 75 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 68 mg to about 110 mg, more preferably about 69 mg to about 100 mg, and even more preferably about 70 mg to about 90 mg of the rosemary leaf extract to the animal subject per day, such as where the animal subject weighs greater than 75 pounds.
[0153] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 60 mg to about 75 mg of the rosemary leaf extract, preferably from about 63 mg to about 72 mg, more preferably from about 65 mg to about 70 mg per day to the animal subject per day. In certain embodiments, the animal subject has a weight between about 25 pounds and about 75 pounds. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 40% to about 70% of the foregoing amounts. In certain embodiments, the animal subject has a weight of less than about 25 pounds, and the dry powder animal supplement can be provided in an amount sufficient to deliver from about 40% to about 70% of the foregoing amounts. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 125% to about 175% of the foregoing amounts. In certain embodiments, the animal subject has a weight of greater than 75 pounds, and the dry powder animal supplement can be provided in an amount sufficient to deliver from about 125% to about 175% of the foregoing amounts. In certain embodiments the dry powder animal supplement can be provided in an amount sufficient to deliver about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 200% of the foregoing amounts / ranges. In certain embodiments the dry powder animal supplement can be provided in an amount sufficient to deliver about 25% of theforegoing amounts / ranges. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 200% of the foregoing amounts / ranges. For example, the dose range can be for a canine weighing between 25 and 75 pounds, the 25% amount can be for a canine weighing less than 25 pounds and the 200% amount can be for a canine weighing greater than 75 pounds.
[0154] In certain embodiments, the animal subject has a weight of less than about 25 pounds, and the rosemary leaf extract is provided in an amount sufficient to deliver from about 24 mg to about 56 mg per day to the animal subject. In certain embodiments, the animal subject has a weight between about 25 pounds and about 75 pounds, and the rosemary leaf extract is provided in an amount sufficient to deliver from about 50 mg to abot 85 mg per day to the animal subject. In certain embodiments, the animal subject has a weight of greater than 75 pounds, and the rosemary leaf extract is provided in an amount sufficient to deliver from about 70 mg to about 100 mg per day to the animal subject.Green Tea Dose
[0155] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 1 to about 20 mg of the green tea per day to the animal subject. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 1 mg, 1.25 mg, 1.6 mg, 1.75 mg, 2 mg, 2.4 mg, 2.5 mg, 2.8 mg, 3 mg, 3.5 mg, 4 mg, 4.2 mg, 4.4 mg, 4.6 mg, 4.8 mg, 5 mg, 5.5 mg, 6 mg, 6.25 mg, 7 mg, 7.5 mg, 7.7 mg, 8 mg, 8.2 mg, 8.4 mg, 8.75 mg, 9 mg, 9.3 mg, 9.5 mg, 10 mg, 10.5 mg, 12 mg, 12.5 mg, 13.75 mg, 15 mg, 17.5 mg, 19.25 mg, 20 mg, 21 mg, or any range or value therebetween of the green tea per day to the animal subject. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 1 mg to 5 mg, more preferably about 1.25 mg to about 4 mg, and even more preferably about 1.75 mg to about 3 mg of the green tea per day to the animal subject, such as where the animal subject weighs less than 12 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 2.5 mg to about 8 mg, more preferably about 3 mg to about 7.5 mg, and even more preferably about 3.5 mg to about 7 mg of the green tea per day to the animal subject, such as where the animal subject weighs between about 12 pounds and about 25 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 5 mg to about 9 mg, more preferably about 5.5 mg to about 9.5 mg, and even more preferably about 6 mg to about 10 mg of the green tea per day to theanimal subject, such as where the animal subject weighs from about 25 pounds to about 75 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 8 mg to about 20 mg, more preferably about 7.5 mg to about 15 mg, and even more preferably about 7 mg to about 12 mg of the green tea per day to the animal subject, such as where the animal subject weighs greater than 75 pounds.
[0156] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 4 mg to about 12 mg of the green tea, preferably from about 5 mg to about 11 mg, more preferably from about 4 mg to about 10 mg per day to the animal subject. In certain embodiments, the animal subject has a weight between about 25 pounds and about 75 pounds. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 40% to about 70% of the foregoing amounts. In certain embodiments, the animal subject has a weight of less than about 25 pounds, and the dry powder animal supplement can be provided in an amount sufficient to deliver from about 40% to about 70% of the foregoing amounts. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 125% to about 175% of the foregoing amounts. In certain embodiments, the animal subject has a weight of greater than 75 pounds, and the dry powder animal supplement can be provided in an amount sufficient to deliver from about 125% to about 175% of the foregoing amounts. In certain embodiments the dry powder animal supplement can be provided in an amount sufficient to deliver about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200% of the foregoing amounts / ranges. In certain embodiments the dry powder animal supplement can be provided in an amount sufficient to deliver about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 200% of the foregoing amounts / ranges. For example, the dose range can be for a canine weighing between 25 and 75 pounds, the 25% amount can be for a canine weighing less than 25 pounds and the 200% amount can be for a canine weighing greater than 75 pounds.Perilla Seed Extract Dose
[0157] In certain embodiments, dry powder animal supplement can be provided in an amount sufficient to deliver about 10, about 20 mg, about 30 mg, about 40 mg, about 60 mg, about 80 mg, or any range or value therebetween per day to the animal subject.
[0158] In certain embodiments, the perilla seed extract can be provided in an amount sufficient to deliver from about 2 mg to about 110 mg per day to the animal subject. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 2 mg, 5 mg, 7 mg, 8 mg, 10 mg, 15 mg, 17 mg, 18 mg, 20 mg, 30 mg, 33 mg, 35 mg, 36 mg, 40 mg, 60 mg, 68 mg, 75 mg, 80 mg, 95 mg, 110 mg, or any range or value therebetween of the perilla seed extract per day to the animal subject. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 2 mg to about 35 mg, more preferably about 3 mg to about 17 mg, and even more preferably about 5 mg to about 15 mg of the perilla seed extract per day to the animal subject, such as where the animal subject weighs less than 12 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 7 mg to 36 mg, more preferably about 8 mg to about 33 mg, and even more preferably about 10 mg to about 30 mg of the perilla seed extract per day to the animal subject, such as where the animal subjects weighs from about 12 pounds to about 25 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 15 mg to 75 mg, more preferably about 17 mg to about 68 mg, and even more preferably about 20 mg to about 60 mg of the perilla seed extract per day to the animal subject, such as where the animal subject weighs from about 25 pounds to about 75 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 30 mg to 110 mg, more preferably about 35 mg to about 95 mg, and even more preferably about 40 mg to about 80 mg of the perilla seed extract per day to the animal subject, such as where the animal subject weighs greater than 75 pounds. In certain embodiments the dry powder animal supplement can be provided in an amount sufficient to deliver about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200% of the foregoing amounts / ranges. In certain embodiments the dry powder animal supplement can be provided in an amount sufficient to deliver about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 200% of the foregoing amounts / ranges. For example, the dose range can be for a canine weighing between 25 and 75 pounds, the 25% amount can be for a canine weighing less than 25 pounds and the 200% amount can be for a canine weighing greater than 75 pounds.Sodium Hexametaphosphate Dose31
[0159] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 10 mg, 18 mg, 26 mg, 29 mg, 32 mg, 34 mg, 36 mg, 38 mg, 42 mg, 44 mg, 45 mg, 46 mg, 52 mg, 58 mg, 58.3 mg, 59.5 mg, 63 mg, 64 mg, 66.5 mg, 73.5 mg, 74 mg, 77 mg, 80.5 mg, 82 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 106.25 mg, 110 mg, 112.5 mg, 115 mg, 118 mg, 118.75 mg, 125 mg, 131.25 mg, 137.5 mg, 140 mg, 143.75 mg, 148.75 mg, 157.5 mg, 166.25 mg, 183.75 mg, 192.5 mg, 201.25 mg, 205 mg, 250 mg, or any range or value therebetween of the sodium hexametaphosphate per day to the animal subject. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 10 mg to about 58 mg, more preferably about 18 mg to about 45 mg, and even more preferably about 26 mg to about 32 mg of the sodium hexametaphosphate per day to the animal subject, such as where the animal subject weighs less than 12 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 29 mg to about 100 mg, more preferably about 64 mg to about 82 mg, and even more preferably about 52 mg to about 63 mg of the sodium hexametaphosphate per day to the animal subject, such as where the animal subject weighs from about 12 pounds to about 25 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 58 mg to about 125 mg, more preferably about 74 mg to about 118 mg, and even more preferably about 90 mg to about 110 mg of the sodium hexametaphosphate per day to the animal subject, such as where the animal subject weighs from about 25 pounds to about 75 pounds. In certain preferred embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 100 mg to about 250 mg, more preferably about 105 mg to about 205 mg, and even more preferably about 110 mg to about 140 mg of the sodium hexametaphosphate per day to the animal subject, such as where the animal subject weighs greater than about 75 pounds.
[0160] In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 34 mg to about 201.25 mg of the sodium hexametaphosphate per day to the animal subject. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 85 mg to about 115 mg of the sodium hexametaphosphate, preferably from about 90 mg to about 110 mg, more preferably from about 95 mg to about 105 mg per day to the animal subject. In certain embodiments, the animal subject has a weight between about 25 pounds and about 75 pounds. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 40% to about 70% of the foregoing amounts. Incertain embodiments, the animal subject has a weight of less than about 25 pounds, and the dry powder animal supplement can be provided in an amount sufficient to deliver from about 40% to about 70% of the foregoing amounts. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver from about 125% to about 175% of the foregoing amounts. In certain embodiments, the animal subject has a weight of greater than 75 pounds, and the dry powder animal supplement can be provided in an amount sufficient to deliver from about 125% to about 175% of the foregoing amounts. In certain embodiments the dry powder animal supplement can be provided in an amount sufficient to deliver about 25%, 50%, 75%, 100%, 125%, 150%, 175%, or 200% of the foregoing amounts / ranges. In certain embodiments the dry powder animal supplement can be provided in an amount sufficient to deliver about 25% of the foregoing amounts / ranges. In certain embodiments, the dry powder animal supplement can be provided in an amount sufficient to deliver about 200% of the foregoing amounts / ranges. For example, the dose range can be for a canine weighing between 25 and 75 pounds, the 25% amount can be for a canine weighing less than 25 pounds and the 200% amount can be for a canine weighing greater than 75 pounds.Total Dose
[0161] In certain embodiments, the total dose of the dry powder animal supplement composition administered to the animal subject can be about 0.25 g, 0.5 g, 0.75 g, 1 g, 1.5 g, 2 g, 2.5 g, 3 g, 3.5 g, 4 g or more. In certain embodiments, the total dose can be about 1.5 g where the animal subject weighs less than about 25 pounds. In certain embodiments, the total dose can be about 1.5 g where the animal subject weighs less than 25 pounds. In certain embodiments, the total dose can be about 2 g where the animal subject weighs from about 25 pounds to about 75 pounds. In certain embodiments, the total dose can be about 3 g where the animal subject weighs greater than 75 pounds.EXAMPLESExample 1. Dental Powder for Dogs
[0162] An exemplary dry powder animal supplement of the present disclosure was prepared and contained the following ingredients:*2 gram dose for medium sized dogExample 2. Evaluation of Exemplary FormulationBackground
[0163] Dental health is a very important part of canine overall health. Dental problems can cause, or be caused by, other health problems. Periodontal disease in dogs is a common condition seen by veterinarians and it is estimated that by the age of three years many dogs will have early evidence of periodontal disease, which will worsen as the dog ages if preventive measures are not taken.
[0164] Periodontal disease starts with plaque that hardens into tartar (a.k.a. calculus). Plaque and tartar below the gumline are damaging and set the stage for infection and damage to the bone and tissues that connect teeth to bone. In most dogs, periodontal disease is preventable.
[0165] Current recommendations for the prevention of periodontal conditions include (1) mechanical or abrasion, such as toothbrush or chew, (2) nonmechanical or chemical, such as powder to be added to food, (3) a combination of mechanical and chemical modes of action, and (4) anesthetized cleaning and polishing by a veterinarian.
[0166] This study evaluated the effects of once-daily dental powder (Test) compared to a Placebo (Control) on oral health outcomes including halitosis (bad breath), tartar, and whiteness in adult dogs.
[0167] This was a prospective, randomized, double-blinded study of the effect of test supplement with control supplement on oral health outcomes of halitosis, tartar, and whiteness in adult dogs, as assessed by owners. The treatment differences between groups were statistically evaluated.
[0168] A single study protocol was followed for all owners and dogs. Client-owned dogs were enrolled directly by the client. Clients answered questions related to inclusion / exclusion criteria, to ensure they qualified for the study. Additionally, owners were asked to complete questions to assess the overall well-being of their dog and further assess the response to treatment. The study enrolled about 112 evaluable dogs, 57 receiving test and 55 receiving control once each day with food for 90 days. 51 dogs in the test group and 53 dogs in the control group completed the study. Clients were masked to treatment. Day 0 was the first day of dosing. Study product was sent to the owner’s home and administered each day by the owner. Owners assessed their dogs once each week throughout the study.Questions about overall well-being and response to treatment were completed by the owner (Table 1).Table 1. Questionnaire.
[0169] Client-owned dogs with mild dental conditions such as halitosis (bad breath) and tartar were recruited for the study. Dogs were recruited to be at least three years of age with the average age of the dog being eight years old. Over twenty breeds were represented ranging in size from Chihuahas to Great Pyrenees. 46 dogs were reported as less than 25pounds, 56 dogs were reported as being between 25 and 75 pounds, and 18 dogs were reported as greater than 75 pounds in body weight. Eight intact males, four intact females, 52 neutered males, and 56 spayed females participated in the study. Recruited dogs were in good health, had visible tartar on their teeth, and owners refrained from using home dental care products on their dog’s teeth. Pregnant or lactating bitches were excluded as well as those dogs with a history of cancer, uncontrollable metabolic disease, autoimmune, or immunosuppressive disease, those with advanced periodontal disease, or those who recently had received antibiotics, corticosteroids, or a dental prophylaxis within the past year.
[0170] Dogs were given food and water and housed in their home environments as normal.
[0171] The Test powder was a proprietary blend of probiotics, plant materials and extracts, and sodium hexametaphosphate. The probiotics in the Test powder were beneficial bacteria (e.g., Pediococcus pentosaceus, Lactiplantibacillus plantarum, and L. plantarum) that inhibit high-risk periodontal pathogens, thereby preventing periodontal disease.
[0172] The composition of the test product was as follows:*Inactive: Calcium bentonite (1% for all dogs), dried brewer’s yeast (the remaining % (w / w) of the dry powder animal supplement), spinach powder (20% (w / w) for extra small and small dogs; 15% (w / w) for medium and large dogs), and chicken liver palatant (3% (w / w) for all dogs).
[0173] For the probiotic blend used, the blend comprised >98% P. pentosaceus, >1% of the first L. plantarum, and >1% CFU of the second L. plantarum).
[0174] Extra small and small dogs were considered between about 4 pounds to about 12 pounds and about 12.1 pounds to about 25 pounds, respectively. Medium dogs were considered between about 25.1 pounds to about 75 pounds. Large dogs were considered greater than about 75 pounds.
[0175] The control product contained only the inactive ingredients.
[0176] The test and control products were administered by adding the dry powder animal supplement on top of the dog’s food.
[0177] A questionnaire was developed for the study which assessed several variables. The questionnaire was filled out online by dog owners.
[0178] Breath: Owners assessed their dog’s breath on a scale of 0 to 10 on Days 0, 7, 14, 28, 35, 42, 49, 56, 63, 70, 77, 84, and 91. Zero (0) being non-existent odor and ten (10) being putrid and foul. Scores of 5 or above were further evaluated with the type of smell (barnyard, cabbage, decay / rot, fish, musty, rotten eggs, salty, or other) ranked by odor of most to least present. One or all could be ranked.
[0179] Tartar: Owners evaluated the amount of tartar on their dog’s right upper fourth premolar tooth on a scale of 0 to 3 on Days 0, 7, 14, 28, 35, 42, 49, 56, 63, 70, 77, 84, and 91. Zero (0) being no signs of tartar, one (1) being <25% coverage, two (2) being 25 - 50% coverage, three (3) being 51 - 75% coverage and four (4) being > 75% coverage.
[0180] Quality of Life. On Days 0, 7, 14, 28, 35, 42, 49, 56, 63, 70, 77, 84, and 91 owners answered questions related to the Quality of Life (QoL) of their pet (Table 1). The rating scale for QoL characteristics was: (0) not at all; (1) a little; (2) quite a bit; and (3) very much.
[0181] Global Assessment of Treatment Efficacy. On Days 0, 7, 14, 28, 35, 42, 49, 56, 63, 70, 77, 84, and 91, owners assessed treatment efficacy.
[0182] For statistical analysis, each dog served as the experimental unit. All data tabulations, listings, and figures was generated using SAS® for JMP V17.0.0 (Cary, NC). The following were excluded from the effectiveness analysis: Dogs withdrawn early from the study due to situations unrelated to the treatment, such as owner’s decision to withdraw the dog from the study or owner non-compliance; Dogs that were withdrawn early due to uncooperativeness (e.g., will not eat the dental powder), serious injury, or serious illness; and Dogs that never completed any treatment time periods (z.e., d 7 or later).
[0183] For eight dogs during the experiment, there were only certain attributes that were available to be included in the analysis.
[0184] The regression-based approach for comparing Placebo (Control) vs PLC- 001 (Test) for various quantitative attributes from the Dental Questionnaire study that change with time (analogous to stability data) is based on The International Council for Harmonization (ICH) Tripartite Guidelines, Q1E and Q1A(R2), both recognized by US FDA (ICH Q1E, 2025; ICH Q1A, 2025). The approach is as follows:) Analysis of covariance (ANCOVA) is used to test the statistical difference between the slopes and intercepts of best fit regression lines (or curves) generated for Placebo and Test tratments, using time as a covariate ) The nature of the relationship between the mean value of the attribute (e.g. Breath) and time (i.e., day) determines whether the data should be transformed (e.g. log scale) for linear regression analysis. Usually, the relationship between the attribute mean value and time can be represented by a linear, quadratic, or cubic function on an arithmetic or logarithmic scale. ) Next, it is statistically-determined if the data from Placebo and Test can be pooled (i.e. combined and treated as one). According to the ICH guidelines, ANCOVA is used to test statistical difference between both slopes and intercepts of the regression fits generated for Placebo vs Test, using time as a covariate. The full statistical model includes the intercept and slope terms of all main effects (e.g. treatment, day [and dayA2, if applicable]) and interaction effects (between Day and Treatment), and a term reflecting the random error of measurement. ) A significance level of 0.25 is used as the criterion to separately determine poolability of slopes and intercepts. This significance level is chosen to compensate for the expected low power of the study design due to the relatively limited sample size at each timepoint in a typical formal study where the attribute changes over time. ) If the statistical test rejects the hypothesis of equality of intercepts (i.e., p-value for the intercept term is < 0.25), then there is a significant difference in intercepts, and it is concluded that the Placebo and Test regression models have different Day 0 values (i.e. intercepts) ) Similarly, if the test rejects the hypothesis of equality of slopes (i.e., p-value for the interaction term is < 0.25), then there is a significant difference in regression model slopes and it is concluded that the Placebo and PLC-001 slopes cannot be combined and represent different time profiles ) Results from the ANCOVA are usually categorized as follows when drawing conclusions:Common intercept common slope (CICS)Common intercept separate slope (CISS)Separate intercept separate slope (SISS)Separate intercept common slope (SICS)
[0185] All dogs that received at least seven consecutive days of test or control were included in the safety evaluation.
[0186] The study data was log transformed to improve the model fit with the actual data for the following attributes: mood, pain, mood+sleep+pain, mood+sleep, mood+pain, mood+habits, mood+relationships, and mood+sleep+habits+relationships.
[0187] For those combined quality of life assessments (e.g., mood+sleep+pain, mood+sleep, mood+pain, sleep+relationships, sleep+habits, sleep+habits+relationships, mood+habits, mood+relationships, mood+sleep+pain+relationships), the sum of the individual parameters were assessed.
[0188] Where appropriate (mood, mood+sleep+pain, mood+sleep, mood+pain, mood+habits, mood+relationships, mood+sleep+pain+relationships), the results related to the outcome (Y axis) and time (X axis) were transformed as follows. The Y axis values were log-transformed (Log 10 scale) to stabilize the variance in Mood values across timepoints, since variance of the dependent variable should remain relatively constant across different values of the independent variable. This is a pre-requisite for regression analysis. After the Y-axis values were log-transformed, it was noticed that simultaneously log-transforming the X-axis values makes it easier to clearly discern a visual trend between the dependent and independent variables, which in turn makes the relationship between the Y and the X axis variables easier to model using regression methods. Additionally, since a value of zero (i.e. Day = 0) cannot be log-transformed a conventionally accepted constant value of 1 was added to each “Day” observation prior to log-transforming. This is why the x-axis reads Logl0(Day +1). Nevertheless, the X-axis reflects results starting on Day 0 through the end of the study, day 90.
[0189] For determining effectiveness outcomes, the dental powder rating questions of the Owner’s assessment were summarized with descriptive statistics for each day collected by group. The number and percentage of “Yes”, “No” responses were tabulated by day and group for “Difficulty giving the dental powder”.
[0190] Each of the questions of the QOL questionnaire were scored as 0=”Not at all”, 1=”A little”, 2=”Quite a bit” and 3=”Very much” and a total score was calculated. Descriptive statistics (number of dogs, mean, standard deviation, minimum, median, maximum values) were presented for each day collected by group.
[0191] Descriptive statistics were presented for dog’s breath (halitosis), tartar coverage and dental whiteness for each day collected by group. Within group and between group differences were assessed as described for the QOL scores.
[0192] For the overall response, breath response and appearance of the mouth, the number and percentage of dogs per category were presented for each day collected by group.Results
[0193] Breath Character'. Line fit analysis indicated no difference (P>0.25) between intercepts but slope of the lines differed (P<0.25) for the “other smell” (Figure 2) and “no smell” (Figure 3) breath attributes (CISS). The interpretation of these regressed slope difference is that consumers less often reported “other smell” and more often reported “no smell” for breath when supplemented with the test compared to the control.
[0194] Tartar'. For tartar scores, there was a significant effect (P<0.25) on both intercept and slope of the lines (SISS; Figure 4). This indicates that both the treatment means were different at time 0 (change in intercept) and there was a difference between the control and test (difference in line slopes). Although the two treatments at baseline differed (significant intercept), the treatments during the study (significant difference in slopes of the lines) appeared to differ as well. While the change in line slopes between control and test for tartar was significant, magnitude of the change appears small based on the graph. Further, when the data were log transformed, the significant difference in line slopes disappeared. These data indicate consumers reported faster improvement in tartar as the study progressed when supplemented with the test.
[0195] Mood. Regarding consumers’ observations about mood, line fit analysis indicated no effect (P>0.25) on the intercept but the slopes of the lines differed (P<0.25; CISS; Figure 5). The interpretation of these differences in regressed line slopes is that consumers saw improved mood in their pets when supplemented with the test compared to the control.
[0196] Sleep'. Regarding consumers’ observations about sleep, line fit analysis indicated no effect (P>0.25) on the intercept but the slopes of the lines differed (P<0.25; CISS; Figure 6). The interpretation of these differences in regressed line slopes is that consumers saw improved sleep in their pets when supplemented with the test compared to the control.
[0197] Relationships'. For relationships, there was a significant effect (P<0.25) on both intercept and slope of the lines (SISS; Figure 7). This indicates that the treatment means were different at time 0 (change in intercept) and there was also a difference between the control and test (differences in slopes of the lines). Inspection of the graph (Figure 9) indicates that the test is decreasing more rapidly than the control indicating a benefit of the test product on relationships. This indicates consumers reported a faster improvement inrelationships as the study progressed when supplemented with the test compared to the control.
[0198] Habits'. Regarding consumers’ observations about habits, line fit analysis indicated no effect (P>0.25) on the intercept but the slope of the lines differed (P<0.25; CISS; Figure 8). The interpretation of these regressed lines’ differences in slopes is that consumers saw improved habits, including a return to normal, in their pets when supplemented with the test compared to the control.
[0199] Pain'. There was no effect (P>0.25) on intercept or slope of the lines (CICS) for the line fit analysis of pain. This indicates that neither were the treatment means different at time 0 (no change in intercept) nor did the control and test differ (no change in the slopes of the lines).
[0200] Total Score : Total Score is the sum of the impact of the dental condition on condition severity, mood, sleep, meals, relationships, habits, and pain.
[0201] For total score, there was a significant effect (P<0.25) on the intercept but not (P>0.25) on the slope of the lines (SICS). This indicates that the treatment means were different at time 0 (change in intercept) but there was not a difference between the control and test (no difference in slopes of the lines).
[0202] Additional Indices: Given the finding that the impact of the dental condition to various individual responses such as sleep, relationships and habits improved with test compared to control supplementation, some additional indices were created based on various combinations of individual assessments.
[0203] The following additional indices were created to assess the impact of dental condition on their impact on conditions afflicting animal well-being: Mood+Sleep+Pain (Figure 9), Mood+Sleep (Figure 10), Sleep+Habits (Figure 13), Mood+Habits (Figure 15), Mood+Relationships (Figure 16). Line fit analysis indicated no effect (P>0.25) on the intercept but the slopes of the lines differed (P<0.25; CISS). The interpretation of these regressed slope changes is that for these combined indices, consumers saw improvements in their pets when supplemented with the test compared to the control.
[0204] The following various indices were created to assess the impact of dental condition on their impact on conditions afflicting animal well-being: Mood+Pain (Figure 11), Sleep+Relationships (Figure 12), Sleep+Habits+Relationships (Figure 14), and Mood+Sleep+Habits+Relationships (Figure 17). Line fit analysis indicated a difference (P<0.25) in the intercepts and the slopes of the lines differed (P<0.25; SISS). Theinterpretation of these regressed slope changes is that consumers saw improvements in their pets when supplemented with test compared to control even after the baseline time period.Discussion
[0205] The use of the line fit technique was made possible due to the large number of repeated observations that were made (weekly instead of the original planned monthly observations). The line fit technique is an accepted technique for analysis by USDA and FDA for stability sample analyses which also gather similar amounts of extensive, repeated observations over time data. And the use of the line fit technique results in powerful conclusions being able to be made. For example, mood changed with test compared to control without being constrained to a certain timeframe.
[0206] This type of study gives insight into how consumers are perceiving treatment impact which may or may not be similar to how the product impacts breath or tooth parameters (e.g., calculus, gingivitis, plaque) as assessed in other study designs.Summary
[0207] An experiment was conducted to evaluate a test product containing dental actives compared to control. This was a double blind, placebo-controlled study which was conducted online with owners filling out questionnaires. About 50 dogs in each group completed the 90 day study with weekly observations made throughout the 90 day study length. Several quality of life (QOL) questions (condition severity, mood, sleep, meals, relationships, habits, pain) were posed to owners related to how they perceived their dog responding to treatment. Results indicated significant improvement by the test product in the following QOL assessments: mood, sleep, habits, relationships and several indices based on combinations of these QOL responses. Finally, consumers observed the “barnyard” smell of breath decreased in control supplemented dogs whereas consumers observed “other smells” to be decreased more in test than control supplemented dogs. Over the course of the study, consumers observed increased numbers of dogs’ breath with “no smell” with test rising more rapidly than control. Study results indicate that a dental active supplement can improve owners’ perceptions of QOL attributes, especially those related to dog’s mood, sleep, habits, and relationships and improved certain aspects of breath heretofore not known about said test product.Example 3. Assessment of Oral HealthSummary
[0208] A double blind, placebo-controlled study using 58 client-owned dogs was designed to evaluate the impact of the ProBright Advanced product on oral health over athree month period. Results indicate improvements in gingivitis, plaque, and calculus during the study. Specifically, plaque absolute change and percent change after three months of feeding were significantly (P < 0.05) improved in dogs fed the ProBright Advanced product.Methods
[0209] A single-center, prospective, randomized, double-blinded study of the effect of an exemplary composition of the present disclosure on oral health outcomes of gingivitis, plaque, calculus, and halitosis was conducted in adult, client-owned dogs.
[0210] All owners were informed and agreed to an informed consent agreement. All animals were brought to a clinic and evaluated by veterinarians for general physical health and blood samples at days 0, 60 and 90 after study initiation. Since animals’ teeth were not cleaned prior to study, this study is sometimes referred to as a “dirty mouth” study.
[0211] The Test article was daily given to 38 dogs while a placebo supplement (Control) was daily given to 20 dogs. Dogs weighing less than 25 pounds were administered 1.5 grams of powder daily. Dogs weighing 25 to 75 pounds were given 2 grams of powder daily. Dogs weighing more than 75 pounds were given 3 grams of powder daily. All dogs consumed the diet they were on at the beginning of the study, throughout the study. On Day 0, Day 60 (±3) and Day 90 (±3) the client and dog returned to the clinic for dental scoring and halitosis measurement.
[0212] The Test and Control articles were the same as in Example 2.
[0213] Plaque was evaluated using a modification of the Quigley and Hein (1962) plaque index (Turesky 1970). Extent of plaque and plaque thickness was determined by placing a disclosing agent on the teeth and rinsing the excess off with water. The whole tooth was scored for the percentage of coronal surface covered with plaque and thickness of the plaque (according to the table below). The score for each tooth was calculated by multiplying the coverage and thickness scores. Scores were divided by the number of teeth examined (18) to obtain a whole mouth mean plaque score for each dog.
[0214] Each dog served as the experimental unit. All data tabulations, listings, and figures were generated using SAS® for Windows version 9.4 or higher (Cary, NC). Statistical significance was evaluated at an alpha level=0.05, 2-sided. There was no adjustment for multiple comparisons.
[0215] The following were excluded from the effectiveness analysis: 1) Dogs withdrawn early from the study due to situations unrelated to the treatment, such as owner’s decision to withdraw the dog from the study or owner non-compliance; and 2) Dogs that were withdrawn early due to uncooperativeness (e.g., will not eat the dental powder), serious injury, or serious illness.
[0216] For whole whole mouth plaque score, the changes from Day 0 to Day 60 and to Day 90 were calculated. The paired t-test or Wilcoxon signed rank test, depending on the distribution of the data, were applied to the changes from Day 0.
[0217] An analysis of the changes from Day 0 to Day 60 and Day 90 was performed for the test group. Differences between groups for the changes from Day 0 were assessed by repeated measures analysis of covariance (ANCOVA) modeling. The model contained Day 0 value as a covariate with group, day and group-by-day interaction as fixed effects. Further, a within time assessment at days 0, 60 and 90 was done comparing the test and control groups.Results
[0218] Results for plaque index are displayed in the tables below which display the absolute change at days 60 and 90 from time 0, and the percent change at days 60 and 90 from time 0, respectively. The absolute change in plaque index and percent change in plaque index are provided in Figs. 18 and 19, respectively (a,b reflect significant differences (p < 0.05).
[0219] For both plaque coverage and thickness, a growing divergence in mean scores occurred during the experiment with test being lower after 90 d in spite of higher values at time 0 (Table 5). Plaque index is a means of combining the two assessments of coverage and thickness. The divergence between test and control products is statistically evident when viewing the absolute change and percent change for plaque index in Tables 6 and 7. The absolute change in plaque index after 90 d was 76% less (P < 0.05) in the test than the control (1.03 vs. 0.24, respectively; Fig. 18), indicating a reduction in plaque accumulation when the dogs consumed the test product. Further, the percent change in plaque index after 90 d was 25% less (P < 0.05) in the test than the control (33% vs. 8%, respectively; Fig. 19).Conclusions
[0220] Results from this experiment supported the role of the test product in improving oral health as assessed by plaque changes over 90 d of feeding when compared to a control product. For the assessments taken, statistical significance between the control and test products was evident for plaque. This makes sense as plaque accumulation is what occurs prior to calculus formation and gingivitis (ie., gum irritation). Without being bound to theory, a longer time course would likely lead to greater treatment differences, including in gingivitis and calculus. Results are most remarkable given that this was a double blind (both owner and assessor), placebo (ie., test product without the active ingredients) controlled study.
Claims
What is claimed is:
1. A dry powder animal supplement composition comprising a biotic component and Ascophyllum nodosum.
2. The dry powder animal supplement composition of claim 1, further comprising rosemary leaf extract, decaffeinated green tea, and sodium hexametaphosphate (SHMP).
3. The dry powder animal supplement composition of claim 1, wherein: a) the biotic component is present in an amount from about 5.0 x 107CFU to about 1.0 x IO10CFU; and b) the Ascophyllum nodosum is present in an amount from about 75 milligrams (mg) to about 1900 mg.
4. The dry powder animal supplement composition of claim 2, wherein: a) the biotic component is present in an amount from about 5.0 x 107CFU to about 1.0 x 1010CFU; b) the Ascophyllum nodosum is present in an amount from about 75 milligrams (mg) to about 1900 mg; c) the rosemary leaf extract is present in an amount from about 10 mg to about 110 mg; d) the decaffeinated green tea is present in an amount from about 1 mg to about 20 mg; and e) the SHMP is present in an amount from about 10 mg to about 250 mg.
5. The dry powder animal supplement composition of claim 4, further comprising a carrier, a colorant, a flavoring agent, and an anti-caking agent.
6. The dry powder animal supplement composition of claim 5, wherein: a) the carrier is present in an amount sufficient for the dry powder animal supplement composition to comprise 0.25 grams (g), 0.75 g, 1 g, 1.5 g, 2 g, 2.5 g, 3 g, or 4 g, optionally wherein the carrier comprises brewer’s yeast; b) the colorant is present in an amount from about 5% to about 30% (w / w) of the dry powder animal supplement composition, optionally wherein the colorant comprises spinach; c) the flavoring agent is present in an amount from about 1% to about 10% (w / w) of the dry powder animal supplement composition, optionally wherein the flavoring agent comprises a chicken liver palatant; andd) the anti-caking agent is present in an amount from about 0.1% to about 2.5% (w / w) of the dry powder animal supplement composition, optionally wherein the anti-caking agent comprises calcium bentonite.
7. The dry powder animal supplement composition of claim 2, wherein: a) the biotic component is present in an amount from about 4.5 x 108CFU to about 1.2 x 109CFU, more preferably from about 5.5 x 108CFU to about 9.0 x 108CFU, even more preferably from about 6.25 x 108CFU to about 8.5 x 108CFU; b) the Ascophyllum nodosum is present in an amount from about 330 mg to about 1510 mg, more preferably from about 600 mg to about 1200 mg, even more preferably from about 810 mg to about 890 mg; c) the rosemary leaf extract is present in an amount from about 41 mg to about 80 mg, more preferably from about 51 mg to about 78 mg, even more preferably from about 61 mg to about 75 mg; d) the decaffeinated green tea is present in an amount from about 5 mg to about 9 mg, more preferably from about 5.5 mg to about 9.5 mg, even more preferably from about 6 mg to about 10 mg; and e) the SHMP is present in an amount from about 58 mg to about 125 mg, more preferably from about 74 mg to about 118 mg, even more preferably from aout 90 mg to about 110 mg.
8. The dry powder animal supplement composition of claim 3, wherein the biotic component comprises a combination of Pediococcus pentosaceus and Lactiplantibacillus plantarum.
9. The dry powder animal supplement composition of any one of claims 7-8, further comprising a carrier, a colorant, a flavoring agent, and an anti-caking agent, optionally wherein the carrier is brewer’s yeast, the colorant is spinach, the flavoring agent is a chicken liver palatant, and the anti-caking agent is calcium bentonite.
10. The dry powder animal supplement composition of claim 9, wherein the brewer’s yeast is present in an amount sufficient for the dry powder animal supplement composition to comprise 2 g, the spinach is present at about 15% (w / w), the chicken liver palatant is present at about 3% (w / w), and the calcium bentonite is present at about 1% (w / w) of the dry powder animal supplement composition.
11. The dry powder animal supplement composition of claim 2, wherein:a) the biotic component is present in an amount from about 5.0 x 107CFU to about4.5 x 108CFU, more preferably from about 1.1 x 108CFU to about 3.5 x 108CFU, even more preferably from about 1.5 x 108CFU to about 3.0 x 108CFU; b) the Ascophyllum nodosum is present in an amount from about 75 mg to about 330 mg, more preferably from about 100 mg to about 250 mg, even more preferably from about 150 mg to about 180 mg; c) the rosemary leaf extract is present in an amount from about 10 mg to about 41 mg, more preferably from about 14 mg to about 32 mg, even more preferably from about 18 mg to about 22 mg; d) the decaffeinated green tea is present in an amount from about 1 mg to about 5 mg, more preferably from about 1.25 mg to about 4 mg, even more preferably from about 1.75 mg to about 3 mg; and e) the SHMP is present in an amount from about 10 mg to about 58 mg, more preferably from about 18 mg to about 45 mg, even more preferably from aout 26 mg to about 32 mg.
12. The dry powder animal supplement composition of claim 11, wherein the biotic component comprises a combination of Pediococcus pentosaceus and Lactiplantibacillus plantarum.
13. The dry powder animal supplement composition of any one of claims 11-12, further comprising a carrier, a colorant, a flavoring agent, and an anti-caking agent, optionally wherein the carrier is brewer’s yeast, the colorant is spinach, the flavoring agent is a chicken liver palatant, and the anti-caking agent is calcium bentonite.
14. The dry powder animal supplement composition of claim 13, wherein the brewer’s yeast is present in an amount sufficient for the dry powder animal supplement composition to comprise 1.5 g, the spinach is present at about 20% (w / w), the chicken liver palatant is present at about 3% (w / w), and the calcium bentonite is present at about 1% (w / w) of the dry powder animal supplement composition.
15. The dry powder animal supplement composition of claim 2, wherein: a) the biotic component is present in an amount from about 2.25 x 108CFU to about7.5 x 108CFU, more preferably from about 3.0 x 108CFU to about 6.0 x 108CFU, even more preferably from about 3.5 x 108CFU to about 5.5 x 108CFU; b) the Ascophyllum nodosum is present in an amount from about 165 mg to about 850 mg, more preferably from about 225 mg to about 650 mg, even more preferably from about 310 mg to about 350 mg;c) the rosemary leaf extract is present in an amount from about 20.5 mg to about 68 mg, more preferably from about 29 mg to about 57 mg, even more preferably from about 36 mg to about 46 mg; d) the decaffeinated green tea is present in an amount from about 2.5 mg to about 8 mg, more preferably from about 3 mg to about 7.5 mg, even more preferably from about 3.5 mg to about 7 mg; and e) the SHMP is present in an amount from about 29 mg to about 100 mg, more preferably from about 64 mg to about 82 mg, even more preferably from aout 52 mg to about 63 mg.
16. The dry powder animal supplement composition of claim 15, wherein the biotic component comprises a combination of Pediococcus pentosaceus and Lactiplantibacillus plantarum.
17. The dry powder animal supplement composition of any one of claims 15-16, further comprising a carrier, a colorant, a flavoring agent, and an anti-caking agent, optionally wherein the carrier is brewer’s yeast, the colorant is spinach, the flavoring agent is a chicken liver palatant, and the anti-caking agent is calcium bentonite.
18. The dry powder animal supplement composition of claim 17, wherein the brewer’s yeast is present in an amount sufficient for the dry powder animal supplement composition to comprise 1.5 g, the spinach is present at about 20% (w / w), the chicken liver palatant is present at about 3% (w / w), and the calcium bentonite is present at about 1% (w / w) of the dry powder animal supplement composition.
19. The dry powder animal supplement composition of claim 2, wherein: a) the biotic component is present in an amount from about 7.5 x 108CFU to about 1.0 x 1010CFU, more preferably from about 9.5 x 108CFU to about 5.0 x 109CFU, even more preferably from about 1 x 109CFU to about 3.0 x 109CFU; b) the Ascophyllum nodosum is present in an amount from about 850 mg to about 1900 mg, more preferably from about 1100 mg to about 1750 mg, even more preferably from about 1400 mg to about 1600 mg; c) the rosemary leaf extract is present in an amount from about 68 mg to about 110 mg, more preferably from about 69 mg to about 100 mg, even more preferably from about 70 mg to about 90 mg; d) the decaffeinated green tea is present in an amount from about 8 mg to about 20 mg, more preferably from about 7.5 mg to about 15 mg, even more preferably from about 7 mg to about 12 mg; ande) the SHMP is present in an amount from about 100 mg to about 250 mg, more preferably from about 105 mg to about 205 mg, even more preferably from aout 110 mg to about 140 mg.
20. The dry powder animal supplement composition of claim 19, wherein the biotic component comprises a combination of Pediococcus pentosaceus and Lactiplantibacillus plantarum.
21. The dry powder animal supplement composition of any one of claims 19-20, further comprising a carrier, a colorant, a flavoring agent, and an anti-caking agent, optionally wherein the carrier is brewer’s yeast, the colorant is spinach, the flavoring agent is a chicken liver palatant, and the anti-caking agent is calcium bentonite.
22. The dry powder animal supplement composition of claim 21, wherein the brewer’s yeast is present in an amount sufficient for the dry powder animal supplement composition to comprise 3 g, the spinach is present at about 15% (w / w), the chicken liver palatant is present at about 3% (w / w), and the calcium bentonite is present at about 1% (w / w) of the dry powder animal supplement composition.
23. The dry powder animal supplement composition of claim 1, wherein the biotic component comprises one or more bacterial or yeast strains.
24. The dry powder animal supplement composition of claim 23, wherein the biotic component is or comprises a probiotic.
25. The dry powder animal supplement composition of claim 23, wherein the biotic component is or comprises a synbiotic.
26. The dry powder animal supplement composition of claim 24, further comprising a prebiotic.
27. The dry powder animal supplement composition of claim 23, wherein the biotic component comprises a probiotic and a prebiotic.
28. The dry powder animal supplement composition of claim 23, wherein the one or more bacterial or yeast strains comprise non-spore-forming bacterial or yeast strains, sporeforming bacterial or yeast strains, or a combination thereof.
29. The dry powder animal supplement composition of claim 28, wherein the non-sporeforming bacterial or yeast strains comprise one or more strains selected from the group consisting of Bifidobacterium animalis. Bifidobacterium longum, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus rhamnosus, Lactiplantibacillus plantarum, Pediococcus pentosaceus, Enterococcus faecium, Saccharomyces cerevisiae, and Saccharomyces cerevisiae boulardii.
30. The dry powder animal supplement composition of claim 28, wherein the non-sporeforming bacterial or yeast strains comprise a combination of L. plantarum and P. pentosaceus.
31. The dry powder animal supplement composition of claim 28, wherein the sporeforming bacterial or yeast strains comprise one or more bacterial strains selected from the group consisting of Bacillus coagulans, Bacillus sublilis. Bacillus amyloliquefaciens. Bacillus velenzensis. Bacillus lichenformis. and Bacillus pumilus.
32. The dry powder animal supplement composition of any one of the preceding claims, wherein the biotic component comprises from about 2 mg to about 250 mg, optionally wherein: a) the biotic component comprises from about 2 mg to about 35 mg, more preferably about 5 mg to about 30 mg, even more preferably about 7 mg to about 25 mg; b) the biotic component comprises from about 8 mg to about 65 mg, more preferably about 11 mg to about 58 mg, even more preferably about 14 mg to about 50 mg; c) the biotic component comprises from about 17 mg to about 98 mg, more preferably about 20 mg to about 88 mg, even more preferably about 23 mg to about 82 mg; or d) the biotic component comprises from about 20 mg to about 250 mg, more preferably about 25 mg to about 200 mg, even more preferably about 30 mg to about 150 mg.
33. The dry powder animal supplement composition of any one of the preceding claims, wherein the biotic component comprises from about 2.4 x 108to about 1.6 x 109colony forming units (CFU) of the biotic component.
34. The dry powder animal supplement composition of any one of claims 1-32, wherein the dry powder animal supplement composition comprises from about 1.5 x 108CFU to about 1.0 x 1010CFU of the biotic component.
35. The dry powder animal supplement composition of claim 34, wherein the dry powder animal supplement composition comprises from about 4.5 x 108CFU to about 1.2 x 109CFU, more preferably from about 5.5 x 108CFU to about 9.0 x 108CFU, even more preferably from about 6.25 x 108CFU to about 8.5 x 108CFU of the biotic component.
36. The dry powder animal supplement composition of claim 34, wherein the dry powder animal supplement composition comprises from about 5.0 x 107CFU to about 4.5 x 108CFU, more preferably from about 1.1 x 108CFU to about 3.5 x 108CFU, evenmore preferably from about 1.5 x 108CFU to about 3.0 x 108CFU of the biotic component.
37. The dry powder animal supplement composition of claim 34, wherein the dry powder animal supplement composition comprises from about 2.25 x 108CFU to about 7.5 x 108CFU, more preferably from about 3.0 x 108CFU to about 6.0 x 108CFU, even more preferably from about 3.5 x 108CFU to about 5.5 x 108CFU of the biotic component.
38. The dry powder animal supplement composition of claim 34, wherein the dry powder animal supplement composition comprises from about 7.5 x 108CFU to about 1.0 x IO10CFU, more preferably 9.5 x 108CFU to about 5.0 x 109CFU, even more preferably from about 1.0 x 109CFU to about 3.0 x 109CFU of the biotic component.
39. The dry powder animal supplement composition of any one of the preceding claims, wherein the biotic component comprises a probiotic and one or more components or products thereof and / or substrate upon which live microorganism(s) of the probiotic were grown.
40. The dry powder animal supplement composition of any one of the preceding claims, wherein the biotic component comprises a probiotic that comprises formely alive microorganisms.
41. The dry powder animal supplement composition of any one of the preceding claims, wherein the Ascophyllum nodosum is present in an amount from about 280 to about 1750 milligrams.
42. The dry powder animal supplement composition of any one of claims 1-40, wherein the Ascophyllum nodosum is present in an amount from about 75 milligrams (mg) to about 1900 mg.
43. The dry powder animal supplement composition of claim 42, wherein the Ascophyllum nodosum is present in an amount from about 330 mg to 1510 mg, more preferably from about 600 mg to about 1200 mg, even more preferably from about 810 mg to about 890 mg.
44. The dry powder animal supplement composition of claim 42 wherein the Ascophyllum nodosum is present in an amount from about 75 mg to about 330 mg, more preferably from about 100 mg to about 250 mg, even more preferably from about 150 mg to about 180 mg.
45. The dry powder animal supplement composition of claim 42, wherein the Ascophyllum nodosum is present in an amount from about 165 mg to about 850 mg,more preferably from about 225 mg to about 650 mg, even more preferably from about 310 mg to about 350 mg.
46. The dry powder animal supplement composition of claim 42, wherein the Ascophyllum nodosum is present in an amount from about 850 mg to about 1900 mg, more preferably from about 1100 mg to about 1750 mg, even more preferably from about 1400 mg to about 1600 mg.
47. The dry powder animal supplement composition of any one of the preceding claims, further comprising an antimicrobial component.
48. The dry powder animal supplement composition of claim 47, wherein the antimicrobial component comprises one or more botanical components.
49. The dry powder animal supplement composition of claim 48, wherein the one or more botanical components comprise one or more plant extracts.
50. The dry powder animal supplement composition of claim 49, wherein the one or more plant extracts are selected from the group consisting of rosemary leaf extract, green tea, and perilla seed extract.
51. The dry powder animal supplement composition of claim 50, wherein the rosemary leaf extract is present in an amount from about 24 to about 131.25 milligrams.
52. The dry powder animal supplement composition of claim 50, wherein the rosemary leaf extract is present in an amount from about 10 mg to about 110 mg.
53. The dry powder animal supplement composition of claim 52, wherein the rosemary leaf extract is present in an amount from about 41 mg to about 80 mg, more preferably from about 51 mg to about 78 mg, even more preferably from about 61 mg to about 75 mg.
54. The dry powder animal supplement composition of claim 52, wherein the rosemary leaf extract is present in an amount from about 10 mg to about 41 mg, more preferably from about 14 mg to about 32 mg, even more preferably from about 18 mg to about 22 mg.
55. The dry powder animal supplement composition of claim 52, wherein the rosemary leaf extract is present in an amount from about 20.5 mg to about 68 mg, more preferably from about 29 mg to about 57 mg, even more preferably from about 36 mg to about 46 mg.
56. The dry powder animal supplement composition of claim 52, wherein the rosemary leaf extract is present in an amount from about 68 mg to about 110 mg, morepreferably from about 69 mg to about 100 mg, even more preferably from about 70 mg to about 90 mg.
57. The dry powder animal supplement composition of any one of claims 50-56, wherein the green tea is present in an amount from about 1.6 to about 21 milligrams.
58. The dry powder animal supplement composition of any one of claims 50-56, wherein the green tea is present in an amount from about 1 mg to about 20 mg.
59. The dry powder animal supplement composition of claim 58, wherein the green tea is present in an amount from about 5 mg to about 9 mg, more preferably from about 5.5 mg to about 9.5 mg, even more preferably from about 6 mg to about 10 mg.
60. The dry powder animal supplement composition of claim 58, wherein the green tea is present in an amount from about 1 mg to about 5 mg, more preferably from about 1.25 mg to about 4 mg, even more preferably from about 1.75 mg to about 3 mg.
61. The dry powder animal supplement composition of claim 58, wherein the green tea is present in an amount from about 2.5 mg to about 8 mg, more preferably from about 3 mg to about 7.5 mg, even more preferably from about 3.5 mg to about 7 mg.
62. The dry powder animal supplement composition of claim 58, wherein the green tea is present in an amount from about 8 mg to about 20 mg, more preferably from about 7.5 mg to about 15 mg, even more preferably from about 7 mg to about 12 mg.
63. The dry powder animal supplement composition of any one of claims 57-62, wherein the green tea is decaffeinated.
64. The dry powder animal supplement composition of any one of the preceding claims, further comprising sodium hexametaphosphate (SHMP).
65. The dry powder animal supplement composition of claim 64, wherein the SHMP is present in an amount from about 34 to 201.25 milligrams.
66. The dry powder animal supplement composition of claim 64, wherein the SHMP is present in an amount from about 10 mg to about 250 mg.
67. The dry powder animal supplement composition of claim 66, wherein the SHMP is present in an amount from about 58 mg to about 125 mg, more preferably from about 74 mg to about 118 mg, even more preferably from about 90 mg to about 110 mg.
68. The dry powder animal supplement composition of claim 66, wherein the SHMP is present in an amount from about 10 mg to about 58 mg, more preferably from about 18 mg to about 45 mg, even more preferably from about 26 mg to about 32 mg.
69. The dry powder animal supplement composition of claim 66, wherein the SHMP is present in an amount from about 29 mg to about 100 mg, more preferably from about 64 mg to about 82 mg, even more preferably from about 52 mg to about 63 mg.
70. The dry powder animal supplement composition of claim 66, wherein the SHMP is present in an amount from about 100 mg to about 250 mg, more preferably from about 105 mg to about 205 mg, even more preferably from about 110 mg to about 140 mg.
71. The dry powder animal supplement composition of any one of the preceding claims, further comprising an oral residence time enhancer.
72. The dry powder animal supplement composition of claim 71, wherein the oral residence time enhancer comprises a soluble gum fiber.
73. The dry powder animal supplement composition of claim 72, wherein the oral residence time enhancer comprises one or more soluble gum fibers selected from the group consisting of xanthan gum, guar gum, gum Arabic, gellan gum, carboxymethylcellulose, hydroxyethylcellulose, and hydroxypropyl methylcellulose.
74. The dry powder animal supplement composition of any one of the preceding claims, further comprising a carrier.
75. The dry powder animal supplement composition of claim 74, wherein the carrier comprises brewers yeast.
76. The dry powder animal supplement composition of any one of claims 74-75, wherein the carrier is present in an amount sufficient to produce a dry powder animal supplement composition in an amount of about 0.25 g, 0.75 g, 1 g, 1.5 g, 2 g, 2.5 g, 3 g, or 4 g.
77. The dry powder animal supplement composition of any one of the preceding claims, further comprising a flavoring agent.
78. The dry powder animal supplement composition of claim 77, wherein the flavoring agent comprises hydrolyzed chicken, beef, lamb, salmon, or a combination thereof.
79. The dry powder animal supplement composition of claim 78, wherein the flavoring agent comprises a chicken liver palatant.
80. The dry powder animal supplement composition of any one of claims 77-79, wherein the flavoring agent is present in an amount from about 5% to about 30% (w / w) of the dry powder animal supplement composition.
81. The dry powder animal supplement composition of claim 80, wherein the flavoring agent is present in an amount from about 5% to about 25% (w / w), more preferablyabout 10% to about 20% (w / w), even more preferably from about 13% to about 17% (w / w) of the dry powder animal supplement composition.
82. The dry powder animal supplement composition of claim 80, wherein the flavoring agent is present in an amount from about 10% to about 30% (w / w), more preferably about 15% to about 25% (w / w), even more preferably from about 18% to about 22% (w / w) of the dry powder animal supplement composition.
83. The dry powder animal supplement composition of any one of the preceding claims, further comprising a saliva-inducing component.
84. The dry powder animal supplement composition of claim 83, wherein the salivainducing component is selected from the group consisting of powdered vinegar, glycerin, carboxymethylcellulose, hydroxyethylcellulose, dried celery, dried cucumbers, dried apples, dried broccoli, dried cauliflower, dried pears, dried tomatoes, dried cheese, and combinations thereof.
85. The dry powder animal supplement composition of any one of the preceding claims having an average particle size of less than 30 mesh.
86. The dry powder animal supplement composition of any one of the preceding claims having a water activity of less than about 0.25.
87. The dry powder animal supplement composition of any one of the preceding claims, further comprising a dry food affinity enhancer.
88. The dry powder animal supplement composition of claim 87, wherein the dry food affinity enhancer comprises a companion oil.
89. The dry powder animal supplement composition of claim 88, wherein the companion oil comprises an essential oil selected from the group consisting of oregano oil, cinnamon oil, clove oil, rosemary oil, orange oil, tea tree oil, spearmint oil, peppermint oil, neem oil, and combinations thereof.
90. The dry powder animal supplement composition of any of one of the preceding claims, further comprising an anti-caking agent.
91. The dry powder animal supplement composition of claim 90, wherein the anti-caking agent is selected from the group consisting of bentonite, silicon dioxide, calcium silicate, sodium aluminosilicate, calcium carbonate, magnesium carbonate, or a combination thereof.
92. The dry powder animal supplement composition of claim 91, wherein the anti-caking agent comprises calcium bentonite.
93. The dry powder animal supplement composition of claim any one of claims 90-92, wherein the anti-caking agent is present in an amount from about 0.1% to about 2.5% (w / w) of the dry powder animal supplement composition.
94. The dry powder animal supplement composition of claim 93, wherein the anti-caking agent is present in an amount from about 0.1% to about 2.5% (w / w), more preferably from about 0.4% to about 1.6% (w / w), even more preferably from about 0.75% to about 1.25% (w / w) of the dry powder animal supplement composition.
95. The dry powder animal supplement composition of any one of claims 1-94, wherein the composition comprises 0.25 g, 0.5 g, 0.75 g, 1 g, 1.5 g, 2 g, 2.5 g, 3 g, 3.5 g, 4 g or more.
96. A dry powder animal supplement composition, comprising: a) a biotic component comprising a combination of Pediococcus pentosaceus and Lactiplantibacillus plantarum in an amount of about 7.5 x 108CFU; b) Ascophyllum nodosum in an amount of about 850 mg; c) rosemary leaf extract in an amount of about 68 mg; d) decaffeinated green tea in an amount of about 8 mg; and e) sodium hexametaphosphate in an amount of about 100 mg, wherein the dry powder animal supplement composition comprises 2 g.
97. The dry powder animal supplement composition of claim 96, further comprising: a) spinach in an amount of about 15% (w / w) of the dry powder animal supplement composition; b) a chicken liver palatant in an amount of about 3% (w / w) of the dry powder animal supplement composition; c) calcium bentonite in an amount of about 1% (w / w) of the dry powder animal supplement composition; and d) brewer’ s yeast.
98. A dry powder animal supplement composition, comprising: a) a biotic component comprising a combination of Pediococcus pentosaceus and Lactiplantibacillus plantarum in an amount of about 2.25 x 108CFU; b) Ascophyllum nodosum in an amount of about 165 mg; c) rosemary leaf extract in an amount of about 20.5 mg; d) decaffeinated green tea in an amount of about 2.5 mg; and e) sodium hexametaphosphate in an amount of about 29 mg, wherein the dry powder animal supplement composition comprises 1.5 g.
99. The dry powder animal supplement composition of claim 98, further comprising: a) spinach in an amount of about 20% (w / w) of the dry powder animal supplement composition; b) a chicken liver palatant in an amount of about 3% (w / w) of the dry powder animal supplement composition; c) calcium bentonite in an amount of about 1% (w / w) of the dry powder animal supplement composition; and d) brewer’ s yeast.
100. A dry powder animal supplement composition, comprising: a) a biotic component comprising a combination of Pediococcus pentosaceus and Lactiplantibacillus plantarum in an amount of about 4.5 x 108CFU; b) Ascophyllum nodosum in an amount of about 330 mg; c) rosemary leaf extract in an amount of about 41 mg; d) decaffeinated green tea in an amount of about 5 mg; and e) sodium hexametaphosphate in an amount of about 58 mg, wherein the dry powder animal supplement composition comprises 1.5 g.
101. The dry powder animal supplement composition of claim 100, further comprising: a) spinach in an amount of about 20% (w / w) of the dry powder animal supplement composition; b) a chicken liver palatant in an amount of about 3% (w / w) of the dry powder animal supplement composition; c) calcium bentonite in an amount of about 1% (w / w) of the dry powder animal supplement composition; and d) brewer’ s yeast.
102. A dry powder animal supplement composition, comprising: a) a biotic component comprising a combination of Pediococcus pentosaceus and Lactiplantibacillus plantarum in an amount of about 1.2 x 109CFU; b) Ascophyllum nodosum in an amount of about 1510 mg; c) rosemary leaf extract in an amount of about 80 mg; d) decaffeinated green tea in an amount of about 9 mg; and e) sodium hexametaphosphate in an amount of about 125 mg, wherein the dry powder animal supplement composition comprises 3 g.
103. The dry powder animal supplement composition of claim 102, further comprising: a) spinach in an amount of about 15% (w / w) of the dry powder animal supplement composition; b) a chicken liver palatant in an amount of about 3% (w / w) of the dry powder animal supplement composition; c) calcium bentonite in an amount of about 1% (w / w) of the dry powder animal supplement composition; and d) brewer’ s yeast.
104. A kit comprising a dry powder animal supplement and a dry food affinity enhancer.
105. The kit of claim 104, wherein the dry food affinity enhancer comprises a companion oil.
106. The kit of claim 105, wherein the companion oil comprises an essential oil selected from the group consisting of oregano oil, cinnamon oil, clove oil, rosemary oil, orange oil, tea tree oil, spearmint oil, peppermint oil, neem oil, and combinations thereof.
107. The kit of any one of claims 104-106, wherein the dry powder animal supplement is the dry powder animal supplement of any one of claims 1-103.
108. A composition comprising a dry animal feed, a dry powder animal supplement, and a dry food affinity enhancer.
109. The composition of claim 108, wherein the dry animal feed is dog kibble.
110. The composition of any one of claims 108-109, wherein the dry powder animal supplement is the dry powder animal supplement of any one of claims 1-103.
111. The composition of any one of claims 108-110, wherein the dry food affinity enhancer comprises a companion oil.
112. The composition of claim 111, wherein the companion oil comprises an essential oil selected from the group consisting of oregano oil, cinnamon oil, clove oil, rosemary oil, orange oil, tea tree oil, spearmint oil, peppermint oil, neem oil, and combinations thereof.
113. A delivery device comprising a dry powder animal supplement, wherein the delivery device comprises a tube, wherein the tube is configured to contain the dry powder animal supplement.
114. The delivery device of claim 113, wherein the delivery device has a variable diameter, a variable length, or both.
115. The delivery device of any one of claims 113-114, wherein the dry powder animal supplement is the dry powder animal supplement of any one of claims 1-103.
116. A method comprising: providing a dry powder animal supplement of any one of claims 1-103 for consumption by an animal subject; and allowing the animal subject to consume the dry powder animal supplement.
117. The method of claim 116, wherein the dry powder animal supplement is combined with a wet or dry animal feed prior to providing the dry powder animal supplement for consumption.
118. The method of any one of claims 116-117, wherein the method is a method for reducing bacterial plaque and / or dental calculus, improving gum health, reducing inflammation, treating halitosis, improving the oral microbiome, improving breath odor, improving quality of life, or whitening teeth in the animal subject.
119. The method of claim 118, wherein the method is a method for treating halitosis.
120. The method of any one of claims 116-119, wherein the animal subject is a canine.
121. A method for increasing the oral residence time of a dry powder animal supplement, comprising: combining the dry powder animal supplement with an oral residence time enhancer.
122. The method of claim 121, wherein the oral residence time enhancer comprises a soluble gum fiber.
123. The method of claim 121, wherein the oral residence time enhancer comprises one or more soluble gum fibers selected from the group consisting of xanthan gum, guar gum, gum Arabic, gellan gum, carboxymethylcellulose, hydroxyethylcellulose, and hydroxypropyl methylcellulose.
124. The method of any one of claims 121-123, further comprising: providing the combined dry powder animal supplement and oral residence time enhancer to the animal subject for consumption; and allowing the animal subject to consume the combined dry powder animal supplement and oral residence time enhancer.
125. The method of claim 124, wherein the animal subject is a canine.
126. The method of any one of claims 121-125, wherein the dry powder animal supplement is the dry powder animal supplement of any one of claims 1-103.
127. A method for increasing the affinity of a dry powder animal supplement for dry food, comprising: combining the dry powder animal supplement, a dry food affinity enhancer and dry food.
128. The method of claim 127, wherein the dry food affinity enhancer comprises a companion oil.
129. The method of claim 128, wherein the companion oil comprises an essential oil.
130. The method of claim 129, wherein the essential oil comprises oregano oil, cinnamon oil, clove oil, rosemary oil, orange oil, tea tree oil, spearmint oil, peppermint oil, neem oil, or a combination thereof.
131. The method of any one of claims 127-130, wherein the dry food is dog kibble.
132. The method of any one of claims 127-131, further comprising providing the combined dry powder animal supplement, dry food affinity enhancer and dry food to an animal subject for consumption; and allowing the animal subject to consumer the combined dry powder animal supplement, dry food affinity enhancer and dry food.
133. The method of claim 132, wherein the animal subject is a canine.
134. The method of any one of claims 127-133, wherein the dry powder animal supplement is the dry powder animal supplement of any one of claims 1-103.
135. A method for inducing saliva production in an animal subject, comprising: combining a dry powder animal supplement with a saliva-inducing component.
136. The method of claim 135, wherein saliva-inducing component comprises powdered vinegar, glycerin, carboxymethylcellulose, hydroxyethylcellulose, dried celery, dried cucumbers, dried apples, dried broccoli, dried cauliflower, dried pears, dried tomatoes, dried cheese, or a combination thereof.
137. The method of any one of claims 135-136, further comprising: providing the dry powder animal supplement and saliva-inducing component to the animal subject for consumption; and allowing the animal subject to consume the combined dry powder animal supplement and saliva-inducing component.
138. The method of any one of claims 135-137, wherein the animal subject is a canine.
139. A method for improving quality of life of an animal subject comprising providing the dry powder animal supplement of any one of claims 1-103 to the animal subject for consumption and allowing the animal subject to consume the dry powder animal supplement.
140. The method of claim 139, wherein the improvement in quality of life is an improvement in a characteristic selected from the group consisting of mood, sleep, relationships, habits, pain, and combinations thereof.
141. The method of claim 139, wherein the improvement in quality of life is an improvement in mood.
142. The method of claim 139, wherein the improvement in quality of life is an improvement in sleep.
143. The method of claim 139, wherein the improvement in quality of life is an improvement in relationships.
144. The method of claim 139, wherein the improvement in quality of life is an improvement in habits.
145. The method of claim 139, wherein the improvement in quality of life is an improvement in mood, sleep, and pain.
146. The method of claim 139, wherein the improvement in quality of life is an improvement in mood and sleep.
147. The method of claim 139, wherein the improvement in quality of life is an improvement in mood and pain.
148. The method of claim 139, wherein the improvement in quality of life is an improvement in sleep and relationships.
149. The method of claim 139, wherein the improvement in quality of life is an improvement in sleep and habits.
150. The method of claim 139, wherein the improvement in quality of life is an improvement in sleep, habits, and relationships.
151. The method of claim 139, wherein the improvement in quality of life is an improvement in mood and habits.
152. The method of claim 139, wherein the improvement in quality of life is an improvement in mood and relationships.
153. The method of claim 139, wherein the improvement in quality of life is an improvement in mood, sleep, habits, and relationships.
154. The method of any one of claims 139-153, wherein the animal subject is a canine.
155. A method for treating a dental condition in an animal subject in need thereof comprising providing the dry powder animal supplement to the animal subject for consumption and allowing the animal subject to consume the dry powder animal supplement.
156. The method of claim 155, wherein the dental condition is selected from the group consisting of plaque, tartar, halitosis, and gingivitis.
157. The method of claim 155, wherein the dental condition is selected from the group consisting of plaque, tartar, and gingivitis.
158. The method of claim 155, wherein the dental condition is tartar.
159. The method of any one of claims 155-158, wherein the animal subject is a canine.
160. The method of any one of claims 116-159, wherein the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 2.4 x 107to about 1.6 x 109CFU per day of the biotic component to the animal subj ect.
161. The method of any one of claims 116-159, wherein the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 5.0 x 107CFU to about 1.0 x IO10CFU per day of the biotic component to the animal subject.
162. The method of claim 160, wherein when the animal subject has a body weight below about 25 pounds, the dry powder animal supplement is provided to the subject in an amount sufficient to deliver from about 2.4 x 108CFU to about 6.3 x 108CFU per day of the biotic component to the animal subject.
163. The method of claim 160, wherein when the animal subject has a body weight from about 25 pounds to about 75 pounds, the dry powder animal supplement is provided to the subject in an amount sufficient to deliver from about 6.0 x 108CFU to about 9.0 x 108CFU per day, preferably from about 6.5 x 108CFU to about 8.5 x 108CFU per day, more preferably from about 7.0 x 108CFU to about 8.0 x 108CFU per day of the biotic component to the animal subject.
164. The method of claim 160, wherein when the animal subject has a body weight above about 75 pounds, the dry powder animal supplement is provided to the subject in an amount sufficient to deliver from about 7.5 x 108CFU to about 1.6 x 109CFU per day of the biotic component to the animal subject.
165. The method of claim 161, wherein the animal subject has a body weight of less than 12 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 5.0 x 107CFU to about 4.5 x 108CFU, more preferably about 1.1 x 108CFU to about 3.5 x 108CFU, even more preferably about 1.5 x 108to about 3.0 x 108CFU per day of the biotic component to the animal subj ect.
166. The method of claim 161, wherein the animal subject has a body weight of about 12 pounds to about 25 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 2.25 x 108CFU to about 7.5 x 108CFU, more preferably about 3.0 x 108CFU to about 6.0 x 108CFU, even more preferably about 3.5 x 108to about 5.5 x 108CFU per day of the biotic component to the animal subject.
167. The method of claim 161, wherein the animal subject has a body weight of about 25 pounds to about 75 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 4.5 x 108CFU to about 1.2 x 109CFU, more preferably about 5.5 x 108CFU to about 9.0 x 108CFU, even more preferably about 6.2 x 108to about 8.5 x 108CFU per day of the biotic component to the animal subject.
168. The method of claim 161, wherein the animal subject has a body weight of greater than about 75 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 7.5 x 108CFU to about 1.0 x 1010CFU, more preferably about 9.5 x 108CFU to about 5.0 x 109CFU, even more preferably about 1.0 x 109to about 3.0 x 109CFU per day of the biotic component to the animal subject.
169. The method of any one of clams 116-159, wherein the animal subject has a body weight of less than about 12 pounds and the dry powder supplement is provided to the subject in an amount sufficient to deliver about 2 mg to about 35 mg, more preferably about 5 mg to about 30 mg, even more preferably about 7 mg to about 25 mg per day of the biotic component to the animal subject.
170. The method of any one of clams 116-159, wherein the animal subject has a body weight of about 12 pounds to about 25 pounds and the dry powder supplement is provided to the subject in an amount sufficient to deliver about 8 mg to about 65 mg, more preferably about 11 mg to about 58 mg, even more preferably about 14 mg to about 50 mg per day of the biotic component to the animal subject.
171. The method of any one of clams 116-159, wherein the animal subject has a body weight of about 25 pounds to about 75 pounds and the dry powder supplement is provided to the subject in an amount sufficient to deliver about 17 mg to about 98 mg, more preferably about 20 mg to about 88 mg, even more preferably about 23 mg to about 82 mg per day of the biotic component to the animal subject.
172. The method of any one of clams 116-159, wherein the animal subject has a body weight of greater than about 75 pounds and the dry powder supplement is provided to the subject in an amount sufficient to deliver about 20 mg to about 250 mg, more preferably about 25 mg to about 200 mg, even more preferably about 30 mg to about 150 mg per day of the biotic component to the animal subject.
173. The method of any one of claims 116-172, wherein the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 280 mg to about 1750 mg per day of the Ascophyllum nodosum per day to the animal subject.
174. The method of any one of claims 116-172, wherein the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 75 mg to about 1900 mg.
175. The method of claim 174, wherein the animal subject has a body weight of less than 12 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 75 mg to about 330 mg, more preferably about 100 mg to about 250 mg, even more preferably about 150 mg to about 180 mg per day of the Ascophyllum nodosum to the animal subject.
176. The method of claim 174, wherein the animal subject has a body weight of about 12 pounds to about 25 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 165 mg to about 850 mg, more preferably about 225 mg to about 650 mg, even more preferably about 310 mg to about 350 mg per day of the Ascophyllum nodosum to the animal subject.
177. The method of claim 174, wherein the animal subject has a body weight of about 25 pounds to about 75 pounds and the dry powder animal supplement isprovided to the subject in an amount sufficient to deliver about 330 mg to about 1510 mg, more preferably about 600 mg to about 1200 mg, even more preferably about 810 mg to about 890 mg per day of the Ascophyllum nodosum to the animal subject.
178. The method of claim 174, wherein the animal subject has a body weight of greater than about 75 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 850 mg to about 1900 mg, more preferably about 1100 mg to about 1750 mg, even more preferably about 1400 mg to about 1600 mg per day of the Ascophyllum nodosum to the animal subject.
179. The method of claim 174, wherein when the animal subject has a body weight below about 25 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 280 mg to about 700 mg per day of the Ascophyllum nodosum per day to the animal subject.
180. The method of claim 174, wherein when the animal subject has a body weight between about 25 pounds to about 75 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 700 mg to about 1000 mg, preferably 750 mg to about 950 mg, more preferably from about 800 mg to about 900 mg per day of the Ascophyllum nodosum per day to the animal subj ect.
181. The method of claim 174, wherein when the animal subject has a body weight above about 75 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 875 mg to about 1750 mg per day of the Ascophyllum nodosum per day to the animal subject.
182. The method of any one of claims 116-181, wherein the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 24 mg to about 131.25 mg of the rosemary leaf extract per day to the animal subj ect.
183. The method of any one of claims 116-181, wherein the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 75 mg to about 1900 mg per day of the rosemary leaf extract to the animal subj ect.
184. The method of claim 183, wherein the animal subject has a body weight of less than 12 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 10 mg to about 41 mg, more preferably about14 mg to about 32 mg, even more preferably about 18 mg to about 22 mg per day of the rosemary leaf extract to the animal subject.
185. The method of claim 183, wherein the animal subject has a body weight of about 12 pounds to about 25 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 20.5 mg to about 68 mg, more preferably about 29 mg to about 57 mg, even more preferably about 36 mg to about 46 mg per day of the rosemary leaf extract to the animal subject.
186. The method of claim 183, wherein the animal subject has a body weight of about 25 pounds to about 75 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 41 mg to about 80 mg, more preferably about 51 mg to about 78 mg, even more preferably about 61 mg to about 75 mg per day of the rosemary leaf extract to the animal subject.
187. The method of claim 183, wherein the animal subject has a body weight of greater than about 75 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 68 mg to about 110 mg, more preferably about 69 mg to about 100 mg, even more preferably about 70 mg to about 90 mg per day of the rosemary leaf extract to the animal subject.
188. The method of claim 183, wherein when the animal subject has a body weight below about 25 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 24 mg to about 52.5 mg per day of the rosemary leaf extract per day to the animal subject.
189. The method of claim 183, wherein when the animal subject has a body weight between about 25 pounds to about 75 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 60 mg to about 75 mg, preferably 63 mg to about 72 mg, more preferably from about 65 mg to about 70 mg per day of the rosemary leaf extract per day to the animal subject.
190. The method of claim 183, wherein when the animal subject has a body weight above about 75 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 75 mg to about 131.25 mg per day of the rosemary leaf extract per day to the animal subject.
191. The method of any one of claims 116-190, wherein the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 1.6 mg to about 21 mg of the green tea per day to the animal subject.
192. The method of any one of claims 116-190, wherein the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 1 mg to about 20 mg of the green tea per day to the animal subject.
193. The method of claim 192, wherein the animal subject has a body weight of less than 12 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 1 mg to about 5 mg, more preferably about1.25 mg to about 4 mg, even more preferably about 1.75 mg to about 3 mg per day of the green tea to the animal subject.
194. The method of claim 192, wherein the animal subject has a body weight of about 12 pounds to about 25 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 2.5 mg to about 8 mg, more preferably about 3 mg to about 7.5 mg, even more preferably about 3.5 mg to about 7 mg per day of the green tea to the animal subject.
195. The method of claim 192, wherein the animal subject has a body weight of about 25 pounds to about 75 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 5 mg to about 9 mg, more preferably about 5.5 mg to about 9.5 mg, even more preferably about 6 mg to about 10 mg per day of the green tea to the animal subject.
196. The method of claim 192, wherein the animal subject has a body weight of greater than about 75 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 8 mg to about 20 mg, more preferably about 7.5 mg to about 15 mg, even more preferably about 7 mg to about 12 mg per day of the green tea to the animal subject.
197. The method of claim 192, wherein when the animal subject has a body weight below about 25 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 1.6 mg to about 8.4 mg per day of the green tea per day to the animal subject.
198. The method of claim 192, wherein when the animal subject has a body weight between about 25 pounds to about 75 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 4 mg to about 12 mg, preferably 5 mg to about 11 mg, more preferably from about 6 mg to about 10 mg per day of the green tea per day to the animal subject.
199. The method of claim 192, wherein when the animal subject has a body weight above about 75 pounds, the dry powder animal supplement is provided to the animalsubject in an amount sufficient to deliver from about 5 mg to about 21 mg per day of the green tea per day to the animal subject.
200. The method of any one of claims 116-199, wherein the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 34 mg to about 201.25 mg of the sodium hexametaphosphate per day to the animal subject.
201. The method of any one of claims 116-199, wherein the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 10 mg to about 250 mg of the sodium hexametaphosphate per day to the animal subj ect.
202. The method of claim 201, wherein the animal subject has a body weight of less than 12 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 10 mg to about 58 mg, more preferably about 18 mg to about 45 mg, even more preferably about 26 mg to about 32 mg per day of the sodium hexametaphosphate to the animal subject.
203. The method of claim 201, wherein the animal subject has a body weight of about 12 pounds to about 25 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 29 mg to about 100 mg, more preferably about 64 mg to about 82 mg, even more preferably about 52 mg to about 63 mg per day of the sodium hexametaphosphate to the animal subject.
204. The method of claim 201, wherein the animal subject has a body weight of about 25 pounds to about 75 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 58 mg to about 125 mg, more preferably about 74 mg to about 118 mg, even more preferably about 90 mg to about 110 mg per day of the sodium hexametaphosphate to the animal subject.
205. The method of claim 201, wherein the animal subject has a body weight of greater than about 75 pounds and the dry powder animal supplement is provided to the subject in an amount sufficient to deliver about 100 mg to about 250 mg, more preferably about 105 mg to about 205 mg, even more preferably about 110 mg to about 140 mg per day of the sodium hexametaphosphate to the animal subject.
206. The method of claim 201, wherein when the animal subject has a body weight below about 25 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 34 mg to about 80.5 mg per day of the sodium hexametaphosphate per day to the animal subject.
207. The method of claim 201, wherein when the animal subject has a body weight between about 25 pounds to about 75 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 85 mg to about 115 mg, preferably 90 mg to about 110 mg, more preferably from about 95 mg to about 105 mg per day of the sodium hexametaphosphate per day to the animal subj ect.
208. The method of claim 201, wherein when the animal subject has a body weight above about 75 pounds, the dry powder animal supplement is provided to the animal subject in an amount sufficient to deliver from about 106.25 mg to about 201.25 mg per day of the sodium hexametaphosphate per day to the animal subject.
209. The method of any one of claims 116-208, wherein the dry powder animal supplement is provided for consumption by the animal subject for at least 30 days.
210. A method for slowing consumption of a dry powder animal supplement, comprising: providing a dry powder animal supplement in a container configured to slow consumption of the dry powder animal supplement.
211. The method of claim 210, wherein the container comprises a tube.
212. The method of claim 211, wherein the tube has a variable diameter, variable length, or both.
Citation Information
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