WO2016099495A1 - Method and composition for reducing hyperthyroidism - Google Patents

Method and composition for reducing hyperthyroidism Download PDF

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Publication number
WO2016099495A1
WO2016099495A1 PCT/US2014/070989 US2014070989W WO2016099495A1 WO 2016099495 A1 WO2016099495 A1 WO 2016099495A1 US 2014070989 W US2014070989 W US 2014070989W WO 2016099495 A1 WO2016099495 A1 WO 2016099495A1
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WO
WIPO (PCT)
Prior art keywords
animal
vitamin
diet
circulating levels
amount
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Ceased
Application number
PCT/US2014/070989
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English (en)
French (fr)
Inventor
Dennis Jewell
Xiangming Gao
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Hills Pet Nutrition Inc
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Hills Pet Nutrition Inc
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Publication date
Application filed by Hills Pet Nutrition Inc filed Critical Hills Pet Nutrition Inc
Priority to US15/533,248 priority Critical patent/US20170318837A1/en
Priority to PCT/US2014/070989 priority patent/WO2016099495A1/en
Priority to JP2017532768A priority patent/JP6468617B2/ja
Priority to FR1562551A priority patent/FR3030277A1/fr
Publication of WO2016099495A1 publication Critical patent/WO2016099495A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K50/00Feeding-stuffs specially adapted for particular animals
    • A23K50/40Feeding-stuffs specially adapted for particular animals for carnivorous animals, e.g. cats or dogs
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K20/00Accessory food factors for animal feeding-stuffs
    • A23K20/10Organic substances
    • A23K20/174Vitamins
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K40/00Shaping or working-up of animal feeding-stuffs
    • A23K40/20Shaping or working-up of animal feeding-stuffs by moulding, e.g. making cakes or briquettes
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K40/00Shaping or working-up of animal feeding-stuffs
    • A23K40/25Shaping or working-up of animal feeding-stuffs by extrusion
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15Vitamins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/12Ketones
    • A61K31/122Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A61P5/08Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH for decreasing, blocking or antagonising the activity of the anterior pituitary hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/14Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • A61P5/16Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4 for decreasing, blocking or antagonising the activity of the thyroid hormones

Definitions

  • Hyperthyroidism is a common endocrine disorder in pets, especially older pets, such as cats over 10 years of age. Hyperthyroidism results from an overproduction of thyroid hormones and other factors involved in the expression of thyroid hormone, due to diseases, e.g. tumor, of the thyroid gland.
  • the symptoms of hyperthyroidism are varied but may include increased appetite (but in some cases decreased), weight loss (fat and muscle) in spite of a good appetite, increased activity, increased drinking and urination, vomiting, diarrhea, heart disease (e.g. increased heart rate), increased respiration rate, hair coat/skin/nail abnormalities, nighttime yowling/ restlessness/ confusion behavior, or high blood pressure (hypertension). Hyperthyroidism may have severe short and long term consequences to the pet's health.
  • the current invention relates to a method of reducing hyperthyroidism in an animal in need thereof, comprising feeding the animal a diet comprising vitamin K in an amount effective to reduce circulating levels of one or more factors selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • a diet comprising vitamin K in an amount effective to reduce circulating levels of one or more factors selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • the current invention also relates to a food composition
  • a food composition comprising vitamin K in an amount effective to reduce circulating levels of one or more factors in an animal when the animal consumes the food composition, wherein the one or more factors are selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • the one or more factors are selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • the current invention also relates to a method for making a pet food composition
  • a method for making a pet food composition comprising (a) preconditioning by mixing wet and dry ingredients at elevated temperature to form a kibble dough; (b) extruding the kibble dough at a high temperature and pressure; (c) drying the extruded kibble; and (d) enrobing the dried kibble with topical liquid and/or dry ingredients; wherein vitamin K is applied to the kibble at step (a) and/or (d), in an amount effective to reduce circulating levels of one of more factors in an animal when the animal consumes the food composition, and the one or more factors are selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • T3 triiodothyronine
  • TSH thyroid stimulating hormone
  • animal means any non-human organism belonging to the kingdom Animalia.
  • the term "pet” means a domestic animal including but not limited to domestic dogs, cats, horses, cows, ferrets, rabbits, pigs, rats, mice, gerbils, hamsters, horses, minks, and the like.
  • domestic dogs and cats are particular examples of pets. It will be appreciated by one of skill in the art that some pets have different nutritional needs and some pets have similar nutritional needs.
  • hypothyroidism refers to a condition in which the thyroid gland produces and secretes excessive amounts thyroid hormones such as but not limited triiodothyronine (T3) and/or thyroxine (T4) in an animal.
  • T3 triiodothyronine
  • T4 thyroxine
  • Hyperthyroidism in animals such as cats can be diagnosed and measured as to severity according methods and disease characteristics known in the art. (See, for example, Peterson et al., in The cat: diseases and clinical management, R. G. Sherding, Ed., New York, Churchill Livingstone, 2nd Edition, pp. 1416- 1452,1994; Gerber et al. Vet Clin North Am Small Anim Pract 24:541-65, 1994).
  • T3 refers to the iodine-containing amino acid 3 ,5 ,3 '-triiodothyronine .
  • free T3 refers to T3 that is not bound to a carrier protein such as thyroid-binding globulin, albumin, prealbumin, and the like.
  • TSH thyroid stimulating hormone
  • thyrotrope cells in the anterior pituitary gland, which regulates the endocrine function of the thyroid gland, which produces T3 and T4 (thyroxin e).
  • creatinine refers to 2-Amino-l -methyl- 1 H-imidazol-4-ol, a breakdown product of creatine phosphate in muscle.
  • circulating refers to the status of certain factors when the factors are moving with the blood and/or other body fluids, such as but not limited to circulating within the lymphatic system, of an animal.
  • vitamin K refers to one or more of a group of structurally similar, fat-soluble vitamins known as the vitamin K family.
  • the vitamin K family includes but is not limited to 2-methyl- 1 ,4-naphthoquinone (3-) derivatives such as but not limited to vitamin Kl and vitamin K2.
  • the term "diet” refers to a regulated selection of food and drink for an animal.
  • a diet may comprise a fixed or varied combination or food and/or drink compositions.
  • the diet of the present invention may comprise the food composition of the present invention.
  • the food composition of the present invention may comprise the ingredients and component of the diet herein disclosed.
  • Food compositions can be provided to an animal, such as but not limited to a pet, in the form of pet food.
  • animal such as but not limited to a pet
  • a variety of commonly known types of pet foods are available to pet owners.
  • the selection of pet food includes but is not limited to wet pet food, semi-moist pet food, dry pet food and pet treats.
  • Wet pet food generally has a moisture content greater than about 65%.
  • Semi-moist pet food typically has a moisture content between about 20% and about 65% and may include humectants, potassium sorbate, and other ingredients to prevent microbial growth (bacteria and mold).
  • Dry pet food such as but not limited to food kibbles generally has a moisture content below about 15%.
  • Pet treats typically may be semi-moist, chewable treats; dry treats in any number of forms; chewable bones or baked, extruded or stamped treats; confection treats; or other kinds of treats as is known to one skilled in the art.
  • a food kibble refers to a particulate pellet like component of animal feeds, such as dog and cat feeds.
  • a food kibble has a moisture, or water, content of less than 15% by weight.
  • Food kibbles may range in texture from hard to soft.
  • Food kibbles may range in internal structure from expanded to dense.
  • Food kibbles may be formed by an extrusion process or a baking process.
  • a food kibble may have a uniform internal structure or a varied internal structure.
  • a food kibble may include a core and a coating to form a coated kibble. It should be understood that when the term "kibble” or "food kibble” is used, it can refer to an uncoated kibble or a coated kibble.
  • extrude refers to the process of sending preconditioned and/or prepared ingredient mixtures through an extruder.
  • food kibbles are formed by an extrusion processes wherein a kibble dough, including a mixture of wet and dry ingredients, can be extruded under heat and pressure to form the food kibble.
  • Any type of extruder can be used, examples of which include but are not limited to single screw extruders and twin-screw extruders.
  • the list of sources, ingredients, and components as described hereinafter are listed such that combinations and mixtures thereof are also contemplated and within the scope herein.
  • the current invention relates to a food composition
  • a food composition comprising vitamin K in an amount effective to reduce circulating levels of one or more factors in an animal when the animal consumes the food composition, wherein the one or more factors are selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • the one or more factors are selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • the current invention also relates to a method of reducing hyperthyroidism in an animal in need thereof, comprising feeding the animal a diet comprising ⁇ dtamin K in an amount effective to reduce circulating levels of one or more factors selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • ⁇ dtamin K in an amount effective to reduce circulating levels of one or more factors selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • the animal is a pet.
  • the animal is a cat, such as but not limited to a domesticated house cat.
  • the animal is a cat older than 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, or 15 years.
  • the term "reduction” or “reduce” in the context of hyperthyroidism is used to refer, for example, to a decrease of circulating levels of one or more factors in an animal over time during which the animal consumes the food composition containing effective amount of vitamin K of the present invention compared to the circulating levels of the one or more factors in the same animal before the consumption of the food composition containing the effective amount of vitamin K.
  • the method may further comprise measuring the levels of the one or more factors in the animal prior to feeding the animal the diet comprising vitamin K.
  • baseline levels of the one or more factors in the animal are established.
  • the baseline levels are measurements of the circulating levels of the one or more factors.
  • the baseline levels are averages of a number of measurements for the circulating levels of each of the one or more factors.
  • the method may further comprise measuring the circulating levels of the one or more factors in the same animal after the animal consumes the diet comprising vitamin K at different time points. Moreover, the method may further comprise comparing the baseline circulating levels of the one or more factors in the animal prior to feeding the animal the diet comprising effective amount of ⁇ dtamin K to the circulating levels of the one or more factors in the same animal after the animal consumes the diet comprising effecti ve amount of vitamin K for a period of time.
  • the vitamin K in the diet is effective to reduce the circulating levels of the one or more factors, such as but not limited to creatinine, T3 and TSH.
  • the amount of the vitamin K in the diet is effective to reduce circulating levels of creatinine, but not free T3 or TSH. In some embodiments, the amount of the vitamin K in the diet is effective to reduce circulating levels of creatinine and free T3, but not TSH. In some embodiments, the amount of the vitamin K in the diet is effective to reduce circulating levels of creatinine and TSH, but not free T3. In some embodiments, the amount of the vitamin K in the diet is effective to reduce circulating levels of creatinine, free T3 and TSH. In some embodiments, the amount of the vitamin K in the diet is effective to reduce circulating levels of free T3, but not creatinine or TSH.
  • the amount of the vitamin K in the diet is effective to reduce circulating levels of free T3 and TSH, but not creatinine. In some embodiments, the amount of the ⁇ itamin K in the diet is effective to reduce circulating levels of TSH, but not creatinine or free T3.
  • the circulating levels of creatinine may be measured with methods known in the art, such as but not limited to an enzymatic colorimetric method, e.g. a method using the Roche Diagnostic's Cobas 6000 Analyzer Series.
  • the circulating levels of free T3 may be measured with radioimmunoassay (RIA), such as but not limited to the method disclosed by Werner S. et al. J. Clin. Endocrinol. Metab. 38 (3): 493-5 (1974), which is incorporated herein by reference.
  • the circulating levels of TSH may be measured with radioimmunoassay (RIA), such as but not limited to the method disclosed by Spencer C. et al. Clin Chim Acta. 108 (3): 415-24 (1980), which is incorporated herein by reference.
  • the methods of the present invention may comprise treating hyperthyroidism in an animal in need thereof, comprising feeding the animal a diet comprising vitamin K in an amount effective to reduce circulating levels of one or more factors selected from the group consisting of creatinine, triiodothyronine (T3 ), and thyroid stimulating hormone (TSH).
  • the method may further comprise identifying animals with hyperthyroidism prior to feeding the animals with the diet comprising vitamin K.
  • the animals with hyperthyroidism are identified by the baseline levels of factors such as but not limited to creatinine, free T3 and TSH.
  • the methods of the present invention may comprise reducing the likelihood of developing hyperthyroidism in an animal, comprising feeding the animal a diet comprising vitamin K in an amount effective to reduce circulating levels of one or more factors selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • a diet comprising vitamin K in an amount effective to reduce circulating levels of one or more factors selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • the vitamin K in the diet may be in an amount effective to reduce the circulating levels of creatinine, free T3 or TSH in an animal after the animal consumes the diet for a period of time.
  • the amount of vitamin K in the diet may be effective to reduce the circulating levels of creatinine, free T3 or TSH in an animal after the animal consumes the diet comprising effective amount of vitamin K for at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 1 1, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 101, 105, 1 10, 113, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195 or 200 days.
  • the amount of vitamin K in the diet may be effective to reduce the circulating levels of creatinine, free T3 or TSH in an animal after the animal consumes the diet comprising effective amount of vitamin K for within about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 101, 105, 1 10, 113, 1 15, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195 or 200 days.
  • the vitamin K in the diet may be about or more than about 0.01 mg/kg, 0.05 mg/kg, 0.1 mg/kg, 0.15 mg/kg, 0.2 mg/kg, 0.25 mg/kg, 0.3 mg/kg, 0.35 mg/kg, 0.4 mg/kg, 0.45 mg/kg, 0.5 mg/kg, 0.55 mg/kg, 0.6 mg/kg, 0.65 mg/kg, 0.7 mg/kg, 0.75 mg/kg, 0.8 mg/kg, 0.85 mg/kg, 0.9 mg/kg, 0.95 mg/kg, 1 mg/kg, 1.5 mg/kg, 2 mg/kg, 2.5 mg/kg or 3 mg/kg of total food by weight.
  • the animal may have a daily intake of vitamin K that effectively reduces circulating levels of creatinine, free T3 or TSH, and the daily intake of vitamin K may be in an amount of about or more than about 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 1 1, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 microgram per day.
  • the animal may have a daily intake of vitamin K that effectively reduces circulating levels of creatinine, free T3 or TSH, and the daily intake of vitamin K may be in an amount of about 1- 100, 1-90, 1-80, 1-70, 1-60, 1-50, 1-40, 1-30, 1-25, 1-20, 1-15, 1-10, 1-5, 5-100, 5-90, 5-80, 5- 70, 5-60, 5-50, 5-40, 5-30, 5-25, 5-20 5-15, 5-10, 10-100, 10-90, 10-80, 10-70, 10-60, 10-50, 10- 40, 10-30, 10-25, 10-20, or 10-15 microgram per day.
  • the vitamin K in the diet is in an amount effective to reduce the circulating levels of creatinine in the animal.
  • the circulating levels of creatinine in the animal may be reduced by at least about 5%, 6%, 7%, 8%, 9%, 10%, 1 1 %, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31 %, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95% compared to circulating levels of creatinine prior to consumption of the diet comprising effective amount of vitamin K
  • the amount of vitamin K in the diet is effective to reduce the circulating levels of creatinine by at least about 30%. In one specific embodiment, the amount of vitamin K in the diet is effective to reduce the circulating levels of creatinine by at least about 30% after the animal consumes the diet comprising the effective amount of vi tamin K for at least a period of time selected from the group consisting of 25, 50, 75, 100 and 125 days. In a more specific embodiment, the amount of vitamin K in the diet is effective to reduce the circulating levels of creatinine by at least about 30% after the animal consumes the diet comprising the effective amount of vitamin K for at least about 100 days.
  • the vitamin K in the diet is in an amount effective to reduce the circulating levels of free T3 in the animal.
  • the circulating levels of T3 in the animal may be reduced by at least about 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95% compared to circulating levels of free T3 prior to consumption of the diet comprising effective amount of vitamin K.
  • the amount of vitamin K in the diet is effective to reduce the circulating levels of free T3 by at least about 30%. In one specific embodiment, the amount of vitamin K in the diet is effective to reduce the circulating levels of free T3 by at least about 30% after the animal consumes the diet comprising the effective amount of vitamin K for at least a period of time selected from the group consisting of 25, 50, 75, 100 and 125 days. In a more specific embodiment, the amount of vitamin K in the diet is effective to reduce the circulating levels of free T3 by at least about 30%> after the animal consumes the diet comprising the effective amount of vitamin K. for at least about 100 days.
  • the vitamin K in the diet is in an amount effective to reduce the circulating levels of TSH in the animal.
  • the circulating levels of TSH in the animal may be reduced by at least about 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 55%, 60%», 65%, 70%, 75%, 80%, 85%, 90%, or 95% compared to circulating levels of TSH prior to consumption of the diet comprising effective amount of vitamin K.
  • the amount of vitamin K in the diet is effective to reduce the circulating levels of TSH by at least about 80%. In one specific embodiment, the amount of vitamin K in the diet is effective to reduce the circulating levels of TSH by at least about 80% after the animal consumes the diet comprising the effective amount of vitamin K for at least a period of time selected from the group consisting of 25, 50, 75, 100 and 125 days. In a more specific embodiment, the amount of vitamin K in the diet is effective to reduce the circulating levels of TSH by at least about 80% after the animal consumes the diet comprising the effective amount of vitamin K for at least about 100 days.
  • the amount of vitamin K in the diet is effective to reduce the circulating levels of creatinine by at least about 30%, the circulating levels of T3 by at least about 30%, and the circulating levels of TSH by at least about 80%.
  • the amount of vitamin K in the diet is effective to reduce the circulating levels of creatinine by at least about 30%>, the circulating levels of T3 by at least about 30%, and the circulating levels of TSH by at least about 80% after the animal consumes the diet comprising the effective amount of vitamin K for at least about 100 days.
  • the food composition of the present invention may comprise vitamin K.
  • the vitamin K may be about or less than about 0.0001%, 0.001 %, 0.01 %, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 1 1%, 12%, 13%, 14%, 15%, 20%, or 25% of the total food composition by weight.
  • the ⁇ dtamin K may be more than about 0.0001%, 0.001 %, 0.01 %, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1 %, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 20%, or 25% of the total food composition by weight.
  • the food composition containing effective amount of vitamin K may be combined or mixed with food composition that does not contain vitamin K.
  • the food composition containing effective amount of vitamin K may be more than about 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 99% of the total food composition by weight.
  • the food composition containing effective amount of vitamin K may be less than about 1 %>, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99% or 100% of the total food composition by weight.
  • the diet of the present invention may comprise the food composition comprising effective amount of vitamin K and other food compositions that do not comprise vitamin K.
  • the food composition containing effective amount of vitamin K may comprise different kinds of food products.
  • the food composition containing effective amount of vitamin K may comprise one or more types of dry food (e.g. kibbles), semi-moist food or wet food.
  • the different kinds of food products may comprise different amount of vitamin K and some of the food products may not comprise vitamin K.
  • a food composition may comprise dry food comprising vitamin K and semi-moist food that does not comprise vitamin K and/or we food that does not comprise vitamin K.
  • the dry food containing vitamin K may be more than about 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 99% of the total food composition by weight. In another embodiment, the dry food containing vitamin K may be less than about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99% or 100% of the total food composition by weight.
  • the dry food containing vitamin K may be combined or mixed with semi-moist food or wet food that also contain vitamin K, in the same or a different amount.
  • the dry food containing vitamin K may be more than about 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 99% of the total food composition by weight.
  • the dry food containing vitamin K may be less than about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99% or 100% of the total food composition by weight.
  • the current invention also relates to methods of making a pet food composition, wherein the food composition comprises vitamin K in an amount effective to reduce circulating levels of one or more factors in an animal after the animal consumes the food composition, wherein the one or more factors are selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • the food composition may comprise one or more of dry food, semi-moist food and wet food.
  • current invention also relates to methods of making a dry food composition, comprising (a) preconditioning by mixing wet and dry ingredients at elevated temperature to form a kibble dough; (b) extruding the kibble dough at a high temperature and pressure; (c) drying the extruded kibble; and (d) enrobing the dried kibble with topical liquid and/or dry ingredients; wherein vitamin K.
  • the kibble is applied to the kibble at step (a) and/or (d), in an amount effective to reduce circul ating levels of one of more factors i n an an imal when the an imal consumes the food composition, and the one or more factors are selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • the one or more factors are selected from the group consisting of creatinine, triiodothyronine (T3), and thyroid stimulating hormone (TSH).
  • the vitamin K is applied to the kibble dough in step (a) by mixing with other ingredient to form the kibble dough.
  • the vitamin K is applied to the food composition at step (d) by adding the vitamin K to the topical liquid and/or dry ingredients.
  • the kibble dough can be prepared in any suitable means from any suitable ingredients, such as, for example, a protein source, a carbohydrate source, a fat source, and any other ingredients suitable for animal or pet nutrition.
  • suitable ingredients such as, for example, a protein source, a carbohydrate source, a fat source, and any other ingredients suitable for animal or pet nutrition.
  • topical liquid and/or dry ingredients that are used to enrobing the food composition can be prepared in any suitable means from any suitable ingredients, such as, for example, a protein source, a carbohydrate source, a fat source, and any other ingredients suitable for animal or pet nutrition.
  • the food composition of the present invention comprise one or more ingredients such as but not limited to flax, com, rim brewers, pea, chicken, soybean, tomato, cellulose, wheat, beet, lysine, potassium chloride, methionine, sodium chloride, carrot, dicalcium phosphate, vitamin premix, carnitine,, lipoic acid alpha, mineral premix, calcium carbonate, taurine, glucosamine hydrochloride, chondroitin sulfate, grain blend, lactic acid, choline chloride, grain blend, palatant, fish oil, coconut oil, vitamin E oil, starch, poultry, fish, dairy, pork, beef, lamb, venison, and rabbit.
  • ingredients such as but not limited to flax, com, rim brewers, pea, chicken, soybean, tomato, cellulose, wheat, beet, lysine, potassium chloride, methionine, sodium chloride, carrot, dicalcium phosphate, vitamin premix, carnitine,, lip
  • the food composition of the present invention comprise one or more amino acid such as but not limited to arginine, histidine, isoleucine, leucine, lysine, methionine, phenylala nine, threonine, tryptophan, valine, taurine, carnitine, alanine, aspartate, cystine, glutamate, glutamine, glycine, proline, serine, tyrosine, and hydroxyproline.
  • amino acid such as but not limited to arginine, histidine, isoleucine, leucine, lysine, methionine, phenylala nine, threonine, tryptophan, valine, taurine, carnitine, alanine, aspartate, cystine, glutamate, glutamine, glycine, proline, serine, tyrosine, and hydroxyproline.
  • the food composition of the present invention comprise one or more fatty acids such as but not limited to lauric acid, myristic acid, palmitic acid, palmitoleic acid, margaric acid, margaroleic acid, stearic acid, oleic acid, linoleic acid, g-linolenic acid, a- linolenic acid, stearidonic acid, arachidic acid, gadoleic acid, DHGLA, arachidonic acid, eicossatetra acid, EPA, behenic acid, erucic acid, docosatetra acid, and DP A.
  • fatty acids such as but not limited to lauric acid, myristic acid, palmitic acid, palmitoleic acid, margaric acid, margaroleic acid, stearic acid, oleic acid, linoleic acid, g-linolenic acid, a- linolenic acid, stearidonic acid, arachi
  • the food composition of the present invention comprise one or more macro nutrients such as but not limited to moisture, protein, fat, crude fiber, ash, dietary fiber, soluble fiber, insoluble fiber, raffinose, and stachyose.
  • macro nutrients such as but not limited to moisture, protein, fat, crude fiber, ash, dietary fiber, soluble fiber, insoluble fiber, raffinose, and stachyose.
  • the food composition of the present invention comprise one or more micro nutrients such as but not limited to beta-carotene, alpha-lipoic acid, glucosamine, chondroitin sulfate, lycopene, lutein, and quercetin.
  • micro nutrients such as but not limited to beta-carotene, alpha-lipoic acid, glucosamine, chondroitin sulfate, lycopene, lutein, and quercetin.
  • the food composition of the present invention comprise one or more minerals such as but not limited to calcium, phosphorus, potassium, sodium, chloride, iron, copper, copper, manganese, zinc, iodine, selenium, selenium, cobalt, sulfur, fluorine, chromium, boron, and oxalate.
  • minerals such as but not limited to calcium, phosphorus, potassium, sodium, chloride, iron, copper, copper, manganese, zinc, iodine, selenium, selenium, cobalt, sulfur, fluorine, chromium, boron, and oxalate.
  • the food composition of the present invention comprise one or more vitamins such as but not limited to vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, thiamine, riboflavin, niacin, pyridoxine, pantothenic acid, folic acid, vitamin B12, biotin, and choline
  • vitamins such as but not limited to vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, thiamine, riboflavin, niacin, pyridoxine, pantothenic acid, folic acid, vitamin B12, biotin, and choline
  • Control refers to cats that were fed with control food - food that does not contain vitamin K
  • Test refers to cats that were fed with food comprising vitamin K.
  • DF degree of freedom
  • DLSM differences of least squares means
  • Pr probability. Circulating creatinine was measured by an enzymatic calorimetric method (Roche Diagnostics, Cobas® 6000 Analyzer Series c501 Module).
  • Control refers to cats that were fed with control food - food that does not contain vitamin K
  • Test refers to cats that were fed with food comprising vitamin K.
  • DF degree of freedom
  • DLSM differences of least squares means
  • Pr probability. Circulating free T3 was measured with radioimmunoassay (RIA) at Michigan State University.
  • Control refers to cats that were fed with control food -- food that does not contain vitamin K
  • Test refers to cats that were fed with food comprising vitamin K.
  • DF degree of freedom
  • DLSM differences of least squares means
  • Pr probability. Circulating TSH was measured with radioimmunoassay (RIA) at Michigan State University.
  • Test group showed a more significant reduction of circulating TSH compared to the Control group.

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JP2017532768A JP6468617B2 (ja) 2014-12-17 2014-12-17 甲状腺機能亢進症を減少させるための方法および組成物
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JP7026429B2 (ja) 2017-04-04 2022-02-28 明治飼糧株式会社 反芻家畜の免疫賦活化用飼料組成物

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