(12) Patent Application Publication (10) Pub. No.: US 2010/0210000 A1 Farmer Et Al
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US 2010O21 0000A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0210000 A1 Farmer et al. (43) Pub. Date: Aug. 19, 2010 (54) PROBIOTIC GRAIN-BASED COMPOSITIONS (21) Appl. No.: 12/580,622 (75) Inventors: Sean Farmer, Miami Beach, FL (22) Filed: Oct. 16, 2009 (US); Andrew R. Lefkowitz, University Heights, OH (US); Related U.S. Application Data Michael Bush, Brecksville, OH (60) Provisional application No. 61/106,116, filed on Oct. (US); David Maske, Chagrin Falls, 16, 2008. OH (US) Publication Classification Correspondence Address: (51) Int. Cl. MINTZ, LEVIN, COHN, FERRIS, GLOVSKY CI2N L/20 (2006.01) AND POPEO, PC ONE FINANCIAL CENTER (52) U.S. Cl. ..................................................... 435/252.5 BOSTON, MA 02111 (US) (57) ABSTRACT (73) Assignee: Ganeden Biotech, Inc., Mayfield The present application relates to probiotic grain-based com Heights, OH (US) positions comprising lactic acid-producing bacteria. 3.1 x 10" cfu/g BC30 survival in potato pasta " 10 cfu/g 100--07 BC30 nothermizcfug 1 OOEC6 E. BC30 (GYE after thermiz) cfuig E-4 Giocchi. BC30 TO Grocchi. BC3OT Grocchi +BC3OT2 Gnocchi +BC3T3 Gnocchi +BC3 T4 (no treat) (preboiling 100°C (pasteurization in (horne Cooking (half shelflife 4°C) 1'30") pack 500g, 95°C 100°C 130" h2O) Preparation steps Patent Application Publication Aug. 19, 2010 US 2010/0210000 A1 Figure 1. 3.1 x 10" cfu/g BC30 survival in potato pasta cfu/g OEO g S 100+06 EBC30 no thermiz cfutg w s iz) Cfug OOE-04 Gnocchi- BC3OO Gnocchi. BC3OT1 Gnocchi +BC3O2 Gnocchi +BC303 Gnocci +BC30 A. (no treat) (preboiling 100°C (pasteurization in (home cooking (half shelflife 4°C) 1'30") pack 500g, 95°C 100°C '30" 1 h2O) Preparation steps Figure 2. BC30 Survival in the fresh egg pasta filling 1.OO+8 1.OOE+7 1.OOE+06 100+5 100E+04 Total bacteria 1.OOE+(3 100+C2 1.OOE-- 100+OO Cheese based Cheese based Cheese based Fitting TO (no treat Filing + BC30 TO (no Filing + BC301 treat) (pasteurization 100°C 5) Preparation steps US 2010/021 0000 A1 Aug. 19, 2010 PROBOTC GRAIN-BASED COMPOSITIONS PTA-6086; and GBI-40, ATCC Designation Number PTA 6087; see U.S. Pat. No. 6,849,256 to Farmer). RELATED APPLICATIONS 0008 Optionally, the isolated Bacillus coagulans is in the 0001. This application claims the benefit of U.S. Ser. No. form of a spore. In one aspect, the Bacillus coagulans spores 61/106,116, filed Oct. 16, 2008, the contents of which are activate upon contacting hot liquid. Preferably, the hot liquid incorporated by reference herein in their entirety. is water or milk. Alternatively, the isolated Bacillus coagul lans is in the form of a vegetative cell. In another aspect, the FIELD OF THE INVENTION isolated Bacillus coagulans is in the form of a mixture of Vegetative cells and spores. Preferably, the Bacillus coagul 0002 The present application relates to probiotic grain lans is predominantly in spore form, e.g., about 75%, about based compositions comprising lactic acid-producing bacte 80%, about 85%, about 90%, about 95%, about 99%, or about ria. 100% spores. 0009. The invention also provides compositions compris BACKGROUND OF THE INVENTION ing a dry mix for grain-based compositions comprising a 0003. The gastrointestinal microflora plays a number of grain and an isolated Bacillus coagulans bacterium. Also Vital roles in maintaining gastrointestinal tract function and provided are compositions comprising a dry mix for soup overall physiological health. The growth and metabolism of comprising a dehydrated matter and an isolated Bacillus the many individual bacterial species inhabiting the gas coagulans bacterium. trointestinal tract depend primarily upon the Substrates avail 0010 Also provided are methods of making a grain-based able to them, most of which are derived from the diet. Since composition comprising providing a grain-containing base probiotics do not generally permanently colonize the host, mix and a liquid portion; mixing the grain-containing base they need to be ingested regularly for any health promoting mix and the liquid portion to form a batter or dough; combin properties to persist. ing an isolated Bacillus coagulans bacterium with the batter or dough; and heat processing the batter or dough to cook the SUMMARY OF THE INVENTION grain-based composition. Suitable liquid portions include 0004. The invention is based on the discovery that lactic water and milk. In one aspect, the isolated Bacillus coagulans acid-producing bacteria, particularly Bacillus species, is in the form of a spore. In another aspect, the isolated remain viable and retain their beneficial probiotic properties Bacillus coagulans is in the form of a vegetative cell. In one in food compositions, such as those prepared at high tempera aspect, the isolated Bacillus coagulans comprise between tures (e.g., 80,90, 100, 120, or 150° C.) in boiling water. The about 0.1% to about 50% by weight of the grain-based com invention describes probiotic grain-based compositions. Spe position. Preferably, the isolated Bacillus coagulans com cifically, the invention provides an isolated Bacillus coagul prise between about 1% and about 10% by weight of the lans bacterium in a grain-based composition. grain-based composition. Most preferably, the amount of 0005. The invention provides compositions comprising a Bacillus coagulans bacteria is about 5x10" colony forming cooked or uncooked composition of a grain and an isolated units (CFU) of bacteria per gram of food matrix. Bacillus coagulans bacterium or spore. The grain is pro 0011 Bacillus coagulans bacteria are included in the cessed, e.g., altered from its naturally-occurring state. For grain-based or Soup compositions of this invention. Bacterial example, the grain is husked, crushed, cracked, or ground. species include Bacillus coagulans, e.g., Bacillus coagulans The grain is in the form of flour or a composition made from hammer, preferably Bacillus coagulans hammer Strain further manipulation of a grain-based flour. Exemplary grains Accession No. ATCC 31284, or one or more strains derived include wheat, rice, buckwheat, barley, Kamut, corn and oats. from Bacillus coagulans hammer strainAccession No. ATCC Exemplary cooked compositions include pasta, oatmeal, and 31284 (e.g., ATCC Numbers: GBI-20, ATCC Designation grits. Suitable pastas include egg pasta, spaghetti (solid, thin Number PTA-6085; GBI-30 or BC, ATCC Designation cylinders), macaroni (tubes or hollow cylinders), fusilli (spi Number PTA-6086; and GBI-40, ATCC Designation Number ral-shaped), lasagna (sheets), tagliatelle (flat ribbons), Vermi PTA-6087; see U.S. Pat. No. 6,849.256 to Farmer). celli (thin spaghetti), ravioli (filled pasta), spätzle and gnoc 0012. In one aspect, the isolated Bacillus coagulans is in chi. Other suitable pastas include penne rigate (furrowed the form of a spore. The invention provides for the activation cylinder-shaped pasta), penne lisce (Smooth cylinder-shaped of Bacillus coagulans spores upon heating. Optionally, the pasta), rotini (corkscrew-shaped pasta), and rigatoni (tube isolated Bacillus coagulans is in the form of a vegetative cell. shaped pasta). In another aspect, the isolated Bacillus coagulans is in the 0006. In one aspect, the isolated Bacillus coagulans com form of a mixture of vegetative cells and spores. prise between about 0.01% to about 50% by weight of the 0013 The Bacillus coagulans Hammer strains of the grain-based composition. Optionally, the isolated Bacillus invention are non-pathogenic and generally regarded as safe coagulans comprise between about 0.01% and about 10% by for use in human nutrition (i.e., GRAS classification) by the weight of the grain-based composition. Preferably, the iso U.S. Federal Drug Administration (FDA) and the U.S. lated Bacillus coagulans comprise between about 0.01% and Department of Agriculture (USDA), and by those skilled in about 0.1% by weight of the grain-based composition. the art. Furthermore, the Bacillus coagulans Hammer strains 0007. The invention also provides bacterial species of the invention germinate at or below human body tempera including Bacillus coagulans, e.g., Bacillus coagulans ham ture, rendering them useful as probiotics. Many Bacillus mer, preferably Bacillus coagulans hammer Strain Accession coagulans Strains outside the Hammer group have mostly No. ATCC 31284, or one or more strains derived from Bacil industrial applications, little or no nutritional benefit, and lus coagulans hammer strain Accession No. ATCC 31284 environmental contaminants that have not been evaluated for (e.g., ATCC Numbers: GBI-20, ATCC Designation Number safety. Moreover, many other non-Hammer strains of Bacil PTA-6085; GBI-30 or BC, ATCC Designation Number lus coagulans grow optimally at temperatures that exceed US 2010/021 0000 A1 Aug. 19, 2010 human body temperature and, thus, do not germinate effi endonucleases (e.g., U.S. Pat. No. 5,200,336); amylase (U.S. ciently in the human body. Such strains are less or not suitable Pat. No. 4,980,180); lactase (U.S. Pat. No. 4.323,651); and as probiotics for human consumption. cyclo-malto-dextrin glucano-transferase (U.S. Pat. No. 0014 Cited publications are incorporated herein by refer 5,102,800). B. coagulans has been used to produce lactic acid ence. Both the foregoing general description and the follow (U.S. Pat. No. 5,079,164). A strain of B. coagulans (referred ing detailed description and examples are exemplary and to as L. Sporogenes; Sakaguti & Nakayama (ATCC 31284)) explanatory only and are not restrictive of the invention as has been combined with other lactic acid producing bacteria claimed. and B. natto to produce a fermented food product from BRIEF DESCRIPTION OF THE DRAWINGS steamed soybeans (U.S. Pat. No. 4,110.477). 0022. Bacterial species include Bacillus coagulans, e.g., 0015 FIG. 1 is a bar graph demonstrating the survival of Bacillus coagulans hammer, preferably Bacillus coagulans BC" in gnocchi (potato pasta).