US20040013656A1 - Bone matebolism improving agent - Google Patents

Bone matebolism improving agent Download PDF

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Publication number
US20040013656A1
US20040013656A1 US10/398,507 US39850703A US2004013656A1 US 20040013656 A1 US20040013656 A1 US 20040013656A1 US 39850703 A US39850703 A US 39850703A US 2004013656 A1 US2004013656 A1 US 2004013656A1
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Prior art keywords
soy milk
bone metabolism
bone
group
improving agent
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US10/398,507
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English (en)
Inventor
Satoshi Matsubara
Hiroko Hayakawa
Yasuhisa Shimakawa
Mitsuyoshi Kano
Harue Sone
Fumiyasu Ishikawa
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Yakult Honsha Co Ltd
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Yakult Honsha Co Ltd
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Assigned to KABUSHIKI KAISHA YAKULT HONSHA reassignment KABUSHIKI KAISHA YAKULT HONSHA ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HAYAKAWA, HIROKO, ISHIKAWA, FUMIYASU, KANO, MITSUYOSHI, MATSUBARA, SATOSHI, SHIMAKAWA, YASUHISA, SONE, HARUE
Publication of US20040013656A1 publication Critical patent/US20040013656A1/en
Priority to US11/768,524 priority Critical patent/US7754255B2/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C11/00—Milk substitutes, e.g. coffee whitener compositions
    • A23C11/02—Milk substitutes, e.g. coffee whitener compositions containing at least one non-milk component as source of fats or proteins
    • A23C11/10—Milk substitutes, e.g. coffee whitener compositions containing at least one non-milk component as source of fats or proteins containing or not lactose but no other milk components as source of fats, carbohydrates or proteins
    • A23C11/103—Milk substitutes, e.g. coffee whitener compositions containing at least one non-milk component as source of fats or proteins containing or not lactose but no other milk components as source of fats, carbohydrates or proteins containing only proteins from pulses, oilseeds or nuts, e.g. nut milk
    • A23C11/106—Addition of, or treatment with, microorganisms
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K10/00—Animal feeding-stuffs
    • A23K10/10—Animal feeding-stuffs obtained by microbiological or biochemical processes
    • A23K10/12—Animal feeding-stuffs obtained by microbiological or biochemical processes by fermentation of natural products, e.g. of vegetable material, animal waste material or biomass
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K20/00—Accessory food factors for animal feeding-stuffs
    • A23K20/10—Organic substances
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L11/00—Pulses, i.e. fruits of leguminous plants, for production of food; Products from legumes; Preparation or treatment thereof
    • A23L11/50—Fermented pulses or legumes; Fermentation of pulses or legumes based on the addition of microorganisms
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L11/00—Pulses, i.e. fruits of leguminous plants, for production of food; Products from legumes; Preparation or treatment thereof
    • A23L11/60—Drinks from legumes, e.g. lupine drinks
    • A23L11/65—Soy drinks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/745—Bifidobacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis

Definitions

  • the present invention relates to a bone metabolism improving agent, and more particularly to a bone metabolism improving agent comprising fermented soy milk that is efficacious in treating and preventing diseases associated with a decrease in bone metabolism such as osteoporosis.
  • isoflavone and a composition consisting of isoflavone and zinc or a peptide increase bone metabolism (Japanese Patent Application Laid-open Nos. 1998-114653 and 2000-139411).
  • obtaining these components requires a complicated process.
  • the isoflavone or the composition may be used as a medicine, it is difficult to say that the isoflavone or composition is suitable for use in applications to be taken continuously during routine life for improving bone metabolism.
  • An object of the present invention is to provide such a method.
  • the present invention provides a bone metabolism improving agent comprising fermented soy milk as an active ingredient which is obtained by fermenting soy milk with one or more microorganisms selected from the group consisting of lactobacillus casei, lactobacillus mali , and bifidobacterium breve.
  • the present invention further provides a method for improving bone metabolism in humans and animals comprising administering an absorbent comprising a bone metabolism improving agent containing fermented soy milk as an active ingredient which is obtained by fermenting soy milk with one or more microorganisms selected from the group consisting of lactobacillus casei, lactobacillus mali , and bifidobacterium breve to humans and animals.
  • an absorbent comprising a bone metabolism improving agent containing fermented soy milk as an active ingredient which is obtained by fermenting soy milk with one or more microorganisms selected from the group consisting of lactobacillus casei, lactobacillus mali , and bifidobacterium breve to humans and animals.
  • FIG. 1 shows the results of measurement of deoxypyridinoline discharged in urine.
  • FIG. 2 shows the results of measuring bone density of the tibia.
  • FIG. 3 shows the results of measuring bone density of the femur.
  • FIG. 4 shows the results of measuring mineral content in the tibia.
  • FIG. 5 shows the results of measuring mineral content in the femur.
  • FIG. 6 shows the results of measuring bone density of the tibia.
  • FIG. 7 shows the results of measurement of calcium content in the femur.
  • the bone metabolism improving agent of the present invention controls bone absorption, and as a result, increases bone density and mineral content in bone.
  • the fermented soy milk used as the active ingredient in the bone metabolism improving agent of the present invention is prepared by inoculating one or more microorganisms selected from the group consisting of lactobacillus casei, lactobacillus mali , and bifidobacterium breve in soy milk and causing the soy milk to ferment.
  • the soy milk used as the raw material for the fermented soy milk can be produced by any method as long as the soybean component is suspended or dissolved in a liquid. As examples, whole soybeans or defatted soybeans soaked in water or hydrated, ground into slurry, and filtered to remove insoluble components, and soybean protein dissolved or suspended in water can be given.
  • Lactobacillus bacteria such as L. acidphilus, L. gasseri, L. mali, L. plantarum, L. pentosus, L. buchneri, L. casei, L. johnsonii, L. gallinarum, L. amylovorus, L. brevis, L. rhamnosus, L. kefir, L. paracasei, L. crispatus, L. bulgaricus, L. fermentum, L. reuteri, L. alimentarius , and L.
  • maltaromicus ; Streptococcus bacteria such as S. thermophilus ; Lactococcus bacteria such as L. lactis and L. cremoris ; Leuconostoc bacteria such as L. cremoris ; Bifidobacterium bacteria such as B. bifidum, B. longum , B.
  • L. casei, L. mali, B. breve, L. plantarum, L. rhamnosus, L. paracasei, L. crispatus, L. lactis, B. adolescentis , and B. pseudocatenulatum are preferable due to the increased bone metabolism improving effect and good taste of the fermented soy milk.
  • L. casei, L. mali , and B. breve are particularly preferable.
  • L. casei YIT9029 strain (FERM BP-1366), YIT0078 strain (ATCC393), and YIT0123 strain (ATCC27216)
  • mali YIT0243 strain ATCC27304
  • microorganisms may be combined with the above lactic acid bacterium and bifidobacterium to produce the fermented soy milk of the present invention, for example, Bacillus bacteria such as B. subtilis , Acetobacter bacteria such as A. aceti and A. xylinum , and yeasts belonging to the Saccharomyces, Torulaspora, and Candida groups such as S. cerevisiae, S. unisporus, K. marxianus, T. delbrueckii , and C. kefyr.
  • Bacillus bacteria such as B. subtilis
  • Acetobacter bacteria such as A. aceti and A. xylinum
  • yeasts belonging to the Saccharomyces Torulaspora
  • Candida groups such as S. cerevisiae, S. unisporus, K. marxianus, T. delbrueckii , and C. kefyr.
  • the fermented soy milk used in the present invention can be produced using conventional methods. For example, after pasteurization, the soy milk is inoculated with the above lactic acid bacterium and bifidobacterium and cultured, then homogenized to produce fermented soy milk.
  • the culturing conditions for fermenting the soy milk may be suitably selected. For example, if the bacteria are anaerobic, oxygen in the culture medium can be substituted with an inert gas such as carbon dioxide gas or nitrogen gas, or oxygen in the culture medium can be removed using an oxygen reaction agent to provide anaerobic conditions before culturing the bacteria. If the bacteria are aerobic, aerobic conditions may be selected for culturing.
  • Various saccharides, nutrients, and components for example, carbohydrates such as glucose, sucrose, fructose-glucose syrup, and glucose-fructose syrup, nutrients such as meat extract, yeast extract, peptide, and minerals, plant components such as grains, grain seed sprouts, vegetables, fruits, nuts, and herbs, animal components, and microorganism incubation components may be added to the soy milk used as a raw material in an amount of 0.01-99 mass %.
  • carbohydrates such as glucose, sucrose, fructose-glucose syrup, and glucose-fructose syrup
  • nutrients such as meat extract, yeast extract, peptide, and minerals
  • plant components such as grains, grain seed sprouts, vegetables, fruits, nuts, and herbs, animal components, and microorganism incubation components
  • the bone metabolism improving agent of the present invention is prepared by providing the fermented soy milk obtained above in a proper form such as a medicine or food and in a proper state such as liquid, paste, or solid.
  • the fermented soy milk can be used as is, concentrated to a certain degree, or freeze-dried to form a solid powder.
  • fermented soy milk having a soybean solid component content of 6% is ingested in an amount of 10-1,000 g a day per person, and preferably 100-300 g a day per person.
  • the bone metabolism improving agent of the present invention When using the bone metabolism improving agent of the present invention in a method for improving the bone metabolism of humans and animals, the above amounts are administered to humans and animals.
  • the bone metabolism improving agent when used in the form of a food, various additives may be added and combined to improve the taste and to provide a desired shape, for example.
  • a flavoring agent may be added.
  • additives to be added to and combined with the bone metabolism improving agent of the present invention various carbohydrates, emulsifying agents, thickeners, sweeteners, sour additives, fruit juices, and the like can be given.
  • saccharides such as glucose, sucrose, fructose, tagatose, trehalose, trehalulose, lactulose, xylooligosaccharide, isomaltoligosaccharide, lactose, galactooligosaccharide, fructooligosaccharide, raffinose, stachyose, glucosamine, inulin, honey, maple syrup, and amazake, sugar alcohols such as sorbitol, xylytol, erythritol, lactitol, and palatinit, high intensity sweeteners such as sucralose and aspartame, natural sweeteners such as liquorice, stevia, and gly
  • minerals such as calcium, magnesium, zinc, iron, and dolomite
  • acids such as citric acid, malic acid, ascorbic acid, lactic acid, acetic acid, and amino acid
  • filling materials such as collagen, chondroitin sulfate, hydroxyproline, flavone, flavonol, isoflavone, anthocyan, catechin, and proanthocyanidin
  • vitamins such as vitamin A, vitamin B group, vitamin C, vitamin E, vitamin D group, vitamin K group, beta carotene, retinoic acid, and folic acid
  • herb extracts such as black cohosh, soybeans, butternut seeds, pomegranate seeds, St.
  • John's wort, passion flower, valerian, pueraria mirifica, rosemary, peppermint, lemon balm, and marigold, grains and grain seed sprouts such as rice, wheat, barley, rye, oat, and corn, vegetables such as potato, sweet potato, purple-fleshed sweet potato, yam, pumpkin, eggplant, tomato, bitter melon, green pepper, sesame seed, cabbage, broccoli, cauliflower, lettuce, red beam, broad bean, soybean, green soybean, green pea, ginger, burdock, celery, Japanese radish, Japanese horseradish, avocado, carrot, spinach, onion, garlic, lily, shallot, beefsteak plant ( Perilla frutescens ), leek, parsnip, bracken, bamboo shoot, shiitake mushroom, and mushroom, fruits such as lemon, apple, grape, strawberry, orange, persimmon, guava, banana, blueberry, pineapple guava, tree tomato, acerola, lime, hirami lemon, melon, peach, mango, y
  • yogurt, berry, orange, Chinese quince, beefsteak plant ( Perilla frutescens ), citrus, apple, mint, grape, pear, custard cream, peach, melon, banana, tropical, herb, tea, coffee, and the like can be given.
  • These flavoring agents may be used singularly or in a combination of two or more.
  • hermetic containers having low or high oxygen permeability can be given. Furthermore, the inside of these hermetic containers may be substituted with an inert gas.
  • control group the ovariectomized-control feed group
  • ovariectomized-soy milk group the ovariectomized-soy milk feed group
  • transfermented soy milk group the ovariectomized-fermented soy milk group
  • the placebo surgery and control feed groups were given control feed, the soy milk group was given soy milk feed, and the fermented soy milk group was given fermented soy milk feed.
  • Animals were fed by pair feeding so that the feed intake of each group was almost equal and allowed to freely take ion-exchanged water.
  • urine was collected for 24 hours using a metabolic cage. After measuring the volume, the urine was stored at ⁇ 20° C. until analysis. Vaginal mucous membrane epithelial cells were extracted for six days starting one week before dissection to observe the existence of keratosis cells, whereby it was confirmed that the placebo surgery group was sexually excited and the other groups were not sexually excited.
  • the rats were slaughtered by draining the blood from the abdominal aorta, dissected, and the womb, femur, and tibia were removed.
  • the bone density of the tibia and femur was determined by measuring the mass and volume after drying at 100° C. for 24 hours. Then, the tibia and femur were burnt to ash at 550° C. for 24 hours and the mass was measured. The mass per volume is indicated as the mineral content in the bone.
  • Tukey's method was conducted after variance analysis (As shown in the drawing, there is a significant difference among the groups that do not possess the same letter (P ⁇ 0.05)).
  • FIG. 1 The results of measuring deoxypyridinoline discharged in urine, which indicates the degree of bone resorption, are shown in FIG. 1.
  • the results of measuring bone density of the tibia and femur are shown in FIGS. 2 and 3, respectively, and the results of measuring the mineral content in the bone are shown in FIGS. 4 and 5, respectively.
  • the amount of deoxypyridinoline was measured using a clinical examination kit (Pyrilinks-D, manufactured by Mettler-Toledo International, Inc.) and the concentration per unit amount of creatinine measured beforehand using a Creatinine B tester (manufactured by Wako Pure Chemical Industries, Ltd.) is indicated.
  • Deoxypyridinoline is the substance for crosslinking collagen and mainly exists in the bone.
  • This substance is known as an excellent bone resorption indicator because the substance is released in response to bone resorption, discharged in urine without being metabolized, not absorbed by the alimentary canal, and not influenced by diet. It has been reported that deoxypyridinoline has a significant negative correlation with bone reduction rate (Fledelius C. et al., Calcif. Tissue Int. 54, 381-384, 1994).
  • the fermented soy milk group has a significantly low concentration of the bone metabolism indicator deoxypyridinoline in urine as compared with the control group and soy milk group, and this concentration is close to that of the placebo surgery group. Also, reduction in bone density and bone mineral content of the fermented soy milk group is less than that of the control group and soy milk group, and tibia bone density and femur mineral content is significantly higher than that of the control group. On the other hand, although the womb mass decreased to 11% due to ovariectomy, there was no significant difference on the womb mass among the control group, soy milk group, and fermented soy milk group.
  • An AIN-76 composition partly changed to be a preparation feed with a protein content of 25% and a fat content of 17%, was used as a control feed.
  • Soy milk and fermented soy milk feeds respectively containing 30% of soy milk powder and 30% fermented soy milk powder, (both powders containing 48% of crude protein and 24.3% of crude fat), were prepared by adding casein, corn oil, CaCO 3 , KH 2 PO 4 , MgO, and sucrose to make the content of crude protein, crude fat, calcium, phosphorus, and magnesium equal to that of the control feed.
  • the placebo surgery and control feed groups were given control feed, the soy milk group was given soy milk feed, and the fermented soy milk group was given fermented soy milk feed for 12 weeks.
  • the rats were allowed to freely drink ion-exchanged water.
  • the rats were not given food for four hours, anesthetized with Nembutal, slaughtered by draining the blood from the abdominal aorta, and dissected.
  • the womb, femur, and tibia were removed.
  • the bone density of the tibia was measured in the same manner as Example 2.
  • To measure the calcium content of the femur the femur was freeze-dried and burnt to ash at 550° C. for five hours. Wet ash obtained by adding nitric acid and perchloric acid to the ash was analyzed using a Sequential Plasma Spectrometer ICP-S2000 (manufactured by Shimadzu Corporation).
  • the results of measuring the bone density of the tibia are shown in FIG. 6, and the results of measuring the calcium content of the femur are shown in FIG. 7.
  • the calcium content per dry mass and calcium content per volume of the femur for the fermented soy milk group were significantly higher than those of the control group.
  • the calcium content for the soy milk group was the same as the control group.
  • the bone density and calcium content per volume of the tibia for the fermented soy milk group were significantly higher than those of the control group.
  • the soy milk group displayed the same values as the control group. Furthermore, there was no difference in womb mass among the three ovariectomized groups, and there was no significant difference in initial weight, final weight, and feed intake.
  • fermented soy milk is effective in preventing a decrease in the bone density resulting from an ovariectomy surgery.
  • fermented soy milk prepared from bifidobacterium breve YIT4065 is effective in improving bone metabolism.
  • fermented soy milk used as a bone metabolism improving agent is useful for women after menopause when the ability to synthesize and secrete female hormones is decreased.
  • the fermented soy milk is also useful as a food for preventing harm to bone metabolism due to female hormone disorders that happen before menopause.
  • the fermented soy milk has a superior effect on bone metabolism as compared with soy milk.
  • the bone metabolism improving agent of the present invention is very effective in treating and preventing diseases that accompany a decline in bone metabolism such as osteoporosis.

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WO2006058033A2 (en) 2004-11-22 2006-06-01 T.F.H. Publications, Inc. Animal chew containing fermented soyfood
US20080199568A1 (en) * 2004-11-22 2008-08-21 T.F.H. Publications, Inc. Fish Food containing Fermented Soyfood
US20090004334A1 (en) * 2007-06-29 2009-01-01 Vijaya Nair Dietary nutritional supplements for heal thcare
US20110104237A1 (en) * 2008-05-02 2011-05-05 Ishikawa Co., Ltd. Bone strengthening food supplement
US9468659B2 (en) * 2014-11-06 2016-10-18 NWO Stem Cure, LLC Nutraceutical supplement with Lactobacillus rhamnosus
US9980993B2 (en) 2014-11-06 2018-05-29 NWO Stem Cure, LLC Nutraceutical supplement with Lactobacillus rhamnosus
US11457641B2 (en) * 2015-02-17 2022-10-04 Kabushiki Kaisha Yakult Honsha Method for producing fermented milk food

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DE60123986D1 (de) 2006-11-30
EP1325749B1 (de) 2006-10-18
EP1325749A4 (de) 2005-09-07
JP4880861B2 (ja) 2012-02-22
ATE342725T1 (de) 2006-11-15
CN1469750A (zh) 2004-01-21
PT1325749E (pt) 2007-01-31
EP1325749A1 (de) 2003-07-09
DK1325749T3 (da) 2007-02-12
US20070298146A1 (en) 2007-12-27
DE60123986T2 (de) 2007-02-15
KR20030048427A (ko) 2003-06-19
ES2273888T3 (es) 2007-05-16
CN100548320C (zh) 2009-10-14

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