WO2014128737A1 - Dietary food for the treatment of inflammatory bowel diseases - Google Patents
Dietary food for the treatment of inflammatory bowel diseases Download PDFInfo
- Publication number
- WO2014128737A1 WO2014128737A1 PCT/IT2013/000057 IT2013000057W WO2014128737A1 WO 2014128737 A1 WO2014128737 A1 WO 2014128737A1 IT 2013000057 W IT2013000057 W IT 2013000057W WO 2014128737 A1 WO2014128737 A1 WO 2014128737A1
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- Prior art keywords
- vitamin
- mixture formulation
- dietary
- formulation according
- dietary mixture
- Prior art date
Links
- 235000005911 diet Nutrition 0.000 title claims abstract description 20
- 230000000378 dietary effect Effects 0.000 title claims abstract description 20
- 208000022559 Inflammatory bowel disease Diseases 0.000 title claims abstract description 5
- 235000013305 food Nutrition 0.000 title description 11
- 239000000203 mixture Substances 0.000 claims abstract description 32
- 238000009472 formulation Methods 0.000 claims abstract description 16
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 claims abstract description 7
- 241000186660 Lactobacillus Species 0.000 claims abstract description 6
- 235000020660 omega-3 fatty acid Nutrition 0.000 claims abstract description 6
- 235000019155 vitamin A Nutrition 0.000 claims abstract description 6
- 239000011719 vitamin A Substances 0.000 claims abstract description 6
- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 claims abstract description 5
- FPIPGXGPPPQFEQ-BOOMUCAASA-N Vitamin A Natural products OC/C=C(/C)\C=C\C=C(\C)/C=C/C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-BOOMUCAASA-N 0.000 claims abstract description 5
- 229940012843 omega-3 fatty acid Drugs 0.000 claims abstract description 5
- 229940045997 vitamin a Drugs 0.000 claims abstract description 5
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 claims abstract description 4
- 239000002775 capsule Substances 0.000 claims abstract description 4
- 239000004615 ingredient Substances 0.000 claims abstract description 4
- 239000006014 omega-3 oil Substances 0.000 claims abstract description 4
- 229940100692 oral suspension Drugs 0.000 claims abstract description 4
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 claims abstract description 3
- 235000005282 vitamin D3 Nutrition 0.000 claims abstract description 3
- 239000011647 vitamin D3 Substances 0.000 claims abstract description 3
- 229940021056 vitamin d3 Drugs 0.000 claims abstract description 3
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 9
- 229940106134 krill oil Drugs 0.000 claims description 6
- 235000019165 vitamin E Nutrition 0.000 claims description 4
- 239000011709 vitamin E Substances 0.000 claims description 4
- 229930003427 Vitamin E Natural products 0.000 claims description 3
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims description 3
- 235000015112 vegetable and seed oil Nutrition 0.000 claims description 3
- 229940046009 vitamin E Drugs 0.000 claims description 3
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims description 3
- 244000020551 Helianthus annuus Species 0.000 claims description 2
- 235000003222 Helianthus annuus Nutrition 0.000 claims description 2
- QAQJMLQRFWZOBN-LAUBAEHRSA-N L-ascorbyl-6-palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](O)[C@H]1OC(=O)C(O)=C1O QAQJMLQRFWZOBN-LAUBAEHRSA-N 0.000 claims description 2
- 239000011786 L-ascorbyl-6-palmitate Substances 0.000 claims description 2
- 239000003963 antioxidant agent Substances 0.000 claims description 2
- 235000006708 antioxidants Nutrition 0.000 claims description 2
- 235000010385 ascorbyl palmitate Nutrition 0.000 claims description 2
- 235000021323 fish oil Nutrition 0.000 claims description 2
- 235000020748 rosemary extract Nutrition 0.000 claims description 2
- 229940092258 rosemary extract Drugs 0.000 claims description 2
- 239000001233 rosmarinus officinalis l. extract Substances 0.000 claims description 2
- 229930003799 tocopherol Natural products 0.000 claims description 2
- 235000010384 tocopherol Nutrition 0.000 claims description 2
- 239000011732 tocopherol Substances 0.000 claims description 2
- 229960001295 tocopherol Drugs 0.000 claims description 2
- 239000003921 oil Substances 0.000 claims 1
- 235000019198 oils Nutrition 0.000 claims 1
- 229940088594 vitamin Drugs 0.000 abstract description 3
- 229930003231 vitamin Natural products 0.000 abstract description 3
- 235000013343 vitamin Nutrition 0.000 abstract description 3
- 239000011782 vitamin Substances 0.000 abstract description 3
- 150000003722 vitamin derivatives Chemical class 0.000 abstract description 3
- 230000000968 intestinal effect Effects 0.000 description 12
- 239000006041 probiotic Substances 0.000 description 5
- 235000018291 probiotics Nutrition 0.000 description 5
- 235000019166 vitamin D Nutrition 0.000 description 5
- 239000011710 vitamin D Substances 0.000 description 5
- 229930003316 Vitamin D Natural products 0.000 description 4
- 201000010099 disease Diseases 0.000 description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 4
- 244000005700 microbiome Species 0.000 description 4
- 229940046008 vitamin d Drugs 0.000 description 4
- 230000004048 modification Effects 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 108090000623 proteins and genes Proteins 0.000 description 3
- 102000004169 proteins and genes Human genes 0.000 description 3
- 150000003710 vitamin D derivatives Chemical class 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 240000004355 Borago officinalis Species 0.000 description 2
- 235000007689 Borago officinalis Nutrition 0.000 description 2
- 241000239370 Euphausia superba Species 0.000 description 2
- 241000239366 Euphausiacea Species 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 2
- VYGQUTWHTHXGQB-FFHKNEKCSA-N Retinol Palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C VYGQUTWHTHXGQB-FFHKNEKCSA-N 0.000 description 2
- MBMBGCFOFBJSGT-KUBAVDMBSA-N all-cis-docosa-4,7,10,13,16,19-hexaenoic acid Chemical compound CC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CCC(O)=O MBMBGCFOFBJSGT-KUBAVDMBSA-N 0.000 description 2
- DTOSIQBPPRVQHS-PDBXOOCHSA-N alpha-linolenic acid Chemical compound CC\C=C/C\C=C/C\C=C/CCCCCCCC(O)=O DTOSIQBPPRVQHS-PDBXOOCHSA-N 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 150000001720 carbohydrates Chemical class 0.000 description 2
- 230000001684 chronic effect Effects 0.000 description 2
- 235000019197 fats Nutrition 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 235000015097 nutrients Nutrition 0.000 description 2
- 235000016709 nutrition Nutrition 0.000 description 2
- 244000052769 pathogen Species 0.000 description 2
- 239000003531 protein hydrolysate Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- JEBFVOLFMLUKLF-IFPLVEIFSA-N Astaxanthin Natural products CC(=C/C=C/C(=C/C=C/C1=C(C)C(=O)C(O)CC1(C)C)/C)C=CC=C(/C)C=CC=C(/C)C=CC2=C(C)C(=O)C(O)CC2(C)C JEBFVOLFMLUKLF-IFPLVEIFSA-N 0.000 description 1
- 241000606125 Bacteroides Species 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 206010009900 Colitis ulcerative Diseases 0.000 description 1
- 208000014997 Crohn colitis Diseases 0.000 description 1
- 208000011231 Crohn disease Diseases 0.000 description 1
- 235000001815 DL-alpha-tocopherol Nutrition 0.000 description 1
- 239000011627 DL-alpha-tocopherol Substances 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 108010009736 Protein Hydrolysates Proteins 0.000 description 1
- 201000006704 Ulcerative Colitis Diseases 0.000 description 1
- JAZBEHYOTPTENJ-JLNKQSITSA-N all-cis-5,8,11,14,17-icosapentaenoic acid Chemical compound CC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O JAZBEHYOTPTENJ-JLNKQSITSA-N 0.000 description 1
- 235000020661 alpha-linolenic acid Nutrition 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- 239000000427 antigen Substances 0.000 description 1
- 108091007433 antigens Proteins 0.000 description 1
- 102000036639 antigens Human genes 0.000 description 1
- 235000013793 astaxanthin Nutrition 0.000 description 1
- MQZIGYBFDRPAKN-ZWAPEEGVSA-N astaxanthin Chemical compound C([C@H](O)C(=O)C=1C)C(C)(C)C=1/C=C/C(/C)=C/C=C/C(/C)=C/C=C/C=C(C)C=CC=C(C)C=CC1=C(C)C(=O)[C@@H](O)CC1(C)C MQZIGYBFDRPAKN-ZWAPEEGVSA-N 0.000 description 1
- 229940022405 astaxanthin Drugs 0.000 description 1
- 239000001168 astaxanthin Substances 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 235000021466 carotenoid Nutrition 0.000 description 1
- 150000001747 carotenoids Chemical class 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- CYQFCXCEBYINGO-IAGOWNOFSA-N delta1-THC Chemical compound C1=C(C)CC[C@H]2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3[C@@H]21 CYQFCXCEBYINGO-IAGOWNOFSA-N 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 235000020669 docosahexaenoic acid Nutrition 0.000 description 1
- 229940090949 docosahexaenoic acid Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 235000020673 eicosapentaenoic acid Nutrition 0.000 description 1
- 229960005135 eicosapentaenoic acid Drugs 0.000 description 1
- JAZBEHYOTPTENJ-UHFFFAOYSA-N eicosapentaenoic acid Natural products CCC=CCC=CCC=CCC=CCC=CCCCC(O)=O JAZBEHYOTPTENJ-UHFFFAOYSA-N 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 150000004665 fatty acids Chemical class 0.000 description 1
- 229930003935 flavonoid Natural products 0.000 description 1
- 150000002215 flavonoids Chemical class 0.000 description 1
- 235000017173 flavonoids Nutrition 0.000 description 1
- 235000014105 formulated food Nutrition 0.000 description 1
- 230000002068 genetic effect Effects 0.000 description 1
- 230000007407 health benefit Effects 0.000 description 1
- 230000002519 immonomodulatory effect Effects 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 210000000987 immune system Anatomy 0.000 description 1
- 208000027866 inflammatory disease Diseases 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 210000004347 intestinal mucosa Anatomy 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 229940039696 lactobacillus Drugs 0.000 description 1
- 230000021633 leukocyte mediated immunity Effects 0.000 description 1
- 229960004488 linolenic acid Drugs 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 229940057917 medium chain triglycerides Drugs 0.000 description 1
- 208000008275 microscopic colitis Diseases 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 230000000877 morphologic effect Effects 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 235000021590 normal diet Nutrition 0.000 description 1
- 235000006180 nutrition needs Nutrition 0.000 description 1
- 230000008506 pathogenesis Effects 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 150000003904 phospholipids Chemical class 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 229940108325 retinyl palmitate Drugs 0.000 description 1
- 235000019172 retinyl palmitate Nutrition 0.000 description 1
- 239000011769 retinyl palmitate Substances 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 229960000984 tocofersolan Drugs 0.000 description 1
- 230000001960 triggered effect Effects 0.000 description 1
Classifications
-
- 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
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/115—Fatty acids or derivatives thereof; Fats or oils
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
- A23L33/155—Vitamins A or D
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Definitions
- the present invention relates to dietary foods for special medical purposes, i.e. those foods that are especially formulated for a dietary treatment of a disease having distinctive nutritional needs, that cannot be met by a normal diet.
- Inflammatory bowel diseases including CROHN'S colitis, ulcerative colitis etc., are intestinal chronic disorders with different morphological, immunological and clinical characteristics. It is widely accepted that chronic intestinal inflammations are triggered by an exaggerated, cell-mediated immune response to antigens by genetically predisposed subjects.
- Object of the present invention is a dietary food suitable to be administered to people affected by chronic intestinal inflammatory disorders.
- the interaction between the immune system and the intestinal microbiome is of great interest.
- Studies on bacterial flora of patients affected by microscopic colitis have highlighted a dramatic reduction of beneficial bacteria, such as Firmicutes and Bacteroides, and an increase of pathogenic ones, such as Proteobacteriae. This indicates that the modification in the intestinal flora equilibrium may enhance inflammation of the bowel mucosa.
- Probiotics are live microorganisms that may confer a health benefit to the host. Lactic acid bacteria are the most common types of microbes used as probiotics. Various studies have suggested that probiotics may have an antimicrobial effect due to:
- Vitamin D has a calcium modulating effect and in its active form exhibits an immune-modulating activity.
- Krill oil a lipid extract of Antarctic Krill (Euphausia superba) , contains more than 39% of essential eicosapentaenoic acid, docosahexaenoic acid (omega-3 fatty acids) and astaxanthin (a carotenoid) . Moreover, krill oil contains high or significant amounts of phospholipids, flavonoids, Vitamin A, alpha-linolenic acid (an omega-3 fatty acid) and other nutrients.
- the formulation of dietary foods for special medical purposes shall be based on sound medical and nutritional principles; - their use, in accordance with the manufacturer's instructions, shall be safe and beneficial and effective in meeting the particular nutritional requirements of the persons for whom they are intended, as demonstrated by generally accepted scientific data;
- the labelling must indicate: (a) the content in energy value, proteins, carbohydrate and fat; (b) the average quantity of each mineral substance and each vitamin mentioned in the Annex present in the product; (c) selectively the content of components of protein, carbohydrate and fat or of other nutrients and their components; (d) information on osmolality; (e) information on the origin and the nature of the protein or protein hydrolysates contained in the product.
- the Annex regards the essential composition of foods for special medical purposes and such foods must comply with the criteria of the Annex.
- the subject-matter of the present invention is a dietary mixture formulation for special medical purposes according to appended Claim 1. It includes in combination Lactobacillus species and some or all of the following ingredients: omega-3 fatty acids; Vitamin A; Vitamin D3; Vitamin E in a medium. It fulfills Directive 1999/21/EC concerning dietary foods for special medical purposes. Lactobacillus re-equilibrates altered intestinal bacterial flora. So, the above object of the present invention is thereby reached.
- inventive dietary mixture formulation in a gel capsule is also the subject-matter of the present invention according to appended Claim 6.
- the dietary food of the present invention is manufactured from a complete dietary formulation, comprising some or all of the following ingredients, where Lactobacillus species must be present:
- - krill oil a lipidic extract of Antarctic Krill ⁇ Euphausia superba) ;
- - fish oil an omega-3 enriched mixture of fatty acids
- antioxidants such as tocopherol, ascorbyl palmitate, rosemary extract (against rancidity)
- Vitamin E preferably in the form of dl- alpha-tocopherol
- Vitamin A preferably in the form of retinyl palmitate
- the formulation of the present invention includes a combination of krill oil and Vitamins A, D and E marketed under the name KRILLING-D (TM) .
- the mixture formulation is manufactured in the form of soft gel capsules.
- the mixture formulation is manufactured in the form of an oral suspension in bottles.
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Mycology (AREA)
- Chemical & Material Sciences (AREA)
- Nutrition Science (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Microbiology (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
A dietary mixture formulation for special medical purposes, including in combination Lactobacillus species and some or all of the following ingredients: omega-3 fatty acids, Vitamin A, Vitamin D3, Vitamin in a medium, for the treatment of inflammatory bowel disease. The mixture formulation may be manufactured in the form of soft gel capsules or as an oral suspension.
Description
DIETARY FOOD FOR THE TREATMENT OF INFLAMMATORY BOWEL
DISEASES
The present invention relates to dietary foods for special medical purposes, i.e. those foods that are especially formulated for a dietary treatment of a disease having distinctive nutritional needs, that cannot be met by a normal diet.
Inflammatory bowel diseases, including CROHN'S colitis, ulcerative colitis etc., are intestinal chronic disorders with different morphological, immunological and clinical characteristics. It is widely accepted that chronic intestinal inflammations are triggered by an exaggerated, cell-mediated immune response to antigens by genetically predisposed subjects.
Object of the present invention is a dietary food suitable to be administered to people affected by chronic intestinal inflammatory disorders.
Such an object is reached based on the following scientific background.
Intestinal flora
It is now well understood that the intestinal flora plays an important role in the insurgence of inflammatory bowel diseases, as demonstrated by recent studies centred on analyzing the intestinal microbiome, intending with this
term the totality of microbes, their genetic elements (genomes) and their reactions with the specific environment .
In particular, the interaction between the immune system and the intestinal microbiome is of great interest. Studies on bacterial flora of patients affected by microscopic colitis have highlighted a dramatic reduction of beneficial bacteria, such as Firmicutes and Bacteroides, and an increase of pathogenic ones, such as Proteobacteriae. This indicates that the modification in the intestinal flora equilibrium may enhance inflammation of the bowel mucosa.
Probiotics
Due to the recognised role that the disequilibrium of the intestinal flora has in the pathogenesis of intestinal bowel diseases, it has been suggested to use probiotics to re-establish the equilibrium.
Probiotics are live microorganisms that may confer a health benefit to the host. Lactic acid bacteria are the most common types of microbes used as probiotics. Various studies have suggested that probiotics may have an antimicrobial effect due to:
modifications of the microbiome;
competing mechanism for the adhesion to the intestinal mucosa with pathogens;
secretion of antibacterial substances;
competition with pathogens for the same nourishing materials .
Vitamin D
A recent observation has demonstrated that the lack of vitamin D would constitute a risk factor for the development of intestinal bowel diseases in some patients. It is widely accepted that Vitamin D has a calcium modulating effect and in its active form exhibits an immune-modulating activity.
Krill oil
Krill oil, a lipid extract of Antarctic Krill (Euphausia superba) , contains more than 39% of essential eicosapentaenoic acid, docosahexaenoic acid (omega-3 fatty acids) and astaxanthin (a carotenoid) . Moreover, krill oil contains high or significant amounts of phospholipids, flavonoids, Vitamin A, alpha-linolenic acid (an omega-3 fatty acid) and other nutrients.
Directive 1999/21/EC states that dietary foods for special medical purposes may be marketed within the European Community only if they comply with the following requirements :
the formulation of dietary foods for special medical purposes shall be based on sound medical and nutritional principles;
- their use, in accordance with the manufacturer's instructions, shall be safe and beneficial and effective in meeting the particular nutritional requirements of the persons for whom they are intended, as demonstrated by generally accepted scientific data;
- their labelling must indicate: (a) the content in energy value, proteins, carbohydrate and fat; (b) the average quantity of each mineral substance and each vitamin mentioned in the Annex present in the product; (c) selectively the content of components of protein, carbohydrate and fat or of other nutrients and their components; (d) information on osmolality; (e) information on the origin and the nature of the protein or protein hydrolysates contained in the product. The Annex regards the essential composition of foods for special medical purposes and such foods must comply with the criteria of the Annex.
Therefore, the subject-matter of the present invention is a dietary mixture formulation for special medical purposes according to appended Claim 1. It includes in combination Lactobacillus species and some or all of the following ingredients: omega-3 fatty acids; Vitamin A; Vitamin D3; Vitamin E in a medium. It fulfills
Directive 1999/21/EC concerning dietary foods for special medical purposes. Lactobacillus re-equilibrates altered intestinal bacterial flora. So, the above object of the present invention is thereby reached.
The inventive dietary mixture formulation in a gel capsule is also the subject-matter of the present invention according to appended Claim 6.
Also subject-matter of present invention according to appended Claim 7 is the inventive dietary mixture formulation in an oral suspension.
The present invention will be clarified by the following examples of manufacturing processes only given as a matter of example, absolutely not of restriction.
The dietary food of the present invention is manufactured from a complete dietary formulation, comprising some or all of the following ingredients, where Lactobacillus species must be present:
- krill oil : a lipidic extract of Antarctic Krill {Euphausia superba) ;
- fish oil : an omega-3 enriched mixture of fatty acids;
- medium-chain triglycerides,
- antioxidants, such as tocopherol, ascorbyl palmitate, rosemary extract (against rancidity)
- starflower {Borago officinalis) seed oil;
- flavouring;
- natural Vitamin E, preferably in the form of dl- alpha-tocopherol;
- Vitamin A, preferably in the form of retinyl palmitate;
- Vitamin D in the form of cholecalcipherol (Vitamin
D3) ;
- Lactobacillus species,
in a medium of sunflower (Helihantus annuus) seed oil.
It is particularly envisaged that the formulation of the present invention includes a combination of krill oil and Vitamins A, D and E marketed under the name KRILLING-D (TM) .
According to a way of carrying out the invention, the mixture formulation is manufactured in the form of soft gel capsules.
According to another way of carrying out the invention, the mixture formulation is manufactured in the form of an oral suspension in bottles.
A way of carrying out the invention has been disclosed, but modifications may be made without departing from the scope of the invention, as defined by the appended claims.
Claims
1. A dietary mixture formulation for special medical purposes, including in combination Lactobacillus species and some or all of the following ingredients: omega-3 fatty acids; Vitamin A; Vitamin D3; Vitamin E in a medium, for the treatment of inflammatory bowel diseases.
2. A dietary mixture formulation according to Claim 1, wherein said medium is sunflower (Helihantus annuus) seed oil.
3. A dietary mixture formulation according to Claim 1, including krill oil and fish oil.
4. A dietary mixture formulation according to Claim 1, including KRILLING-D (TM) oil.
5. A dietary mixture formulation according to Claim 1, further including antioxidants, tocopherol, ascorbyl palmitate, Rosemary extract.
6. Gel capsules of the dietary mixture formulation according to any one Claims 1 to 5.
7. Oral suspension of the dietary mixture formulation according to any one Claims 1 to 5.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IT2013/000057 WO2014128737A1 (en) | 2013-02-25 | 2013-02-25 | Dietary food for the treatment of inflammatory bowel diseases |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IT2013/000057 WO2014128737A1 (en) | 2013-02-25 | 2013-02-25 | Dietary food for the treatment of inflammatory bowel diseases |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2014128737A1 true WO2014128737A1 (en) | 2014-08-28 |
Family
ID=48087658
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IT2013/000057 WO2014128737A1 (en) | 2013-02-25 | 2013-02-25 | Dietary food for the treatment of inflammatory bowel diseases |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2014128737A1 (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2300807A (en) * | 1995-05-15 | 1996-11-20 | Tillotts Pharma Ag | Oral dosage forms of omega-3 polyunsaturated acids for the treatment of inflammatory bowel disease |
| US20030113306A1 (en) * | 2001-07-26 | 2003-06-19 | Collins John Kevin | Probiotic lactobacillus casei strains |
| WO2007001185A1 (en) * | 2005-06-27 | 2007-01-04 | Pharmalogica As | Drink comprising a combination of fish oil and probiotics |
| EP2250912A1 (en) * | 2009-05-06 | 2010-11-17 | Oriola, OY | A health-enhancing preparation administrable in the form of drops, and a method for preparing the same |
-
2013
- 2013-02-25 WO PCT/IT2013/000057 patent/WO2014128737A1/en active Application Filing
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2300807A (en) * | 1995-05-15 | 1996-11-20 | Tillotts Pharma Ag | Oral dosage forms of omega-3 polyunsaturated acids for the treatment of inflammatory bowel disease |
| US20030113306A1 (en) * | 2001-07-26 | 2003-06-19 | Collins John Kevin | Probiotic lactobacillus casei strains |
| WO2007001185A1 (en) * | 2005-06-27 | 2007-01-04 | Pharmalogica As | Drink comprising a combination of fish oil and probiotics |
| EP2250912A1 (en) * | 2009-05-06 | 2010-11-17 | Oriola, OY | A health-enhancing preparation administrable in the form of drops, and a method for preparing the same |
Non-Patent Citations (2)
| Title |
|---|
| HUR SUN JIN ET AL: "Review of natural products actions on cytokines in inflammatory bowel disease", November 2012, NUTRITION RESEARCH, VOL. 32, NR. 11, PAGE(S) 801-816, ISSN: 0271-5317, XP002697231 * |
| SUNG MI-KYUNG ET AL: "Nutritional modulators of ulcerative colitis: clinical efficacies and mechanistic view.", 21 February 2013, WORLD JOURNAL OF GASTROENTEROLOGY : WJG 21 FEB 2013, VOL. 19, NR. 7, PAGE(S) 994 - 1004, ISSN: 1007-9327, XP002697230 * |
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