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WO2012138212A1 - Composition alimentaire pour une alimentation par tube intra-opératoire - Google Patents

Composition alimentaire pour une alimentation par tube intra-opératoire Download PDF

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Publication number
WO2012138212A1
WO2012138212A1 PCT/NL2011/050231 NL2011050231W WO2012138212A1 WO 2012138212 A1 WO2012138212 A1 WO 2012138212A1 NL 2011050231 W NL2011050231 W NL 2011050231W WO 2012138212 A1 WO2012138212 A1 WO 2012138212A1
Authority
WO
WIPO (PCT)
Prior art keywords
fat
composition
surgery
proteinaceous matter
use according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/NL2011/050231
Other languages
English (en)
Inventor
Zandrie Hofman
Marianne Klebach
Tim Lubbers
Jacco Juri DE HAAN
Willem Andries Buurman
Johannes Wilhelmus Maria Greve
Adrianus Johannes Maria Vriesema
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nutricia NV
Original Assignee
Nutricia NV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nutricia NV filed Critical Nutricia NV
Priority to PCT/NL2011/050231 priority Critical patent/WO2012138212A1/fr
Priority to PCT/NL2012/050234 priority patent/WO2012138224A1/fr
Priority to CN201280027944.7A priority patent/CN103596455B/zh
Priority to EP12717895.2A priority patent/EP2693898A1/fr
Priority to BR112013025604A priority patent/BR112013025604A2/pt
Publication of WO2012138212A1 publication Critical patent/WO2012138212A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids
    • 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
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/18—Peptides; Protein hydrolysates
    • 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
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/185—Vegetable proteins
    • 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
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/19—Dairy proteins
    • 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
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • 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
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
    • 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 invention pertains to liquid nutritional compositions and to the use thereof for mitigat- ing, attenuating or preventing an acute inflammatory response during or after surgery by intraoperative administration by tube feeding of a lipid-rich and protein-rich liquid nutritional composition.
  • the body of mammals may respond to stressors with an inflammatory reaction.
  • Stressors can be of infectious or non-infectious origin.
  • Examples of stressors are microorganisms (viral, bacterial, fungal, or parasitical) or non-endogenous proteins or peptide-related materials which have invaded a tissue locally, physical traumas including surgery, severe blood loss, extracorporal circulation or extensive soft tissue damage and multiple fractures, ischemia/reperfusion events, or damage to cells or tissue due to burns, chemotherapy, radiation or intoxication.
  • many factors play a role.
  • Inflammatory mediators including acute- phase proteins, interleukins, prostaglandins, cytokines and leukotrienes, contribute to a concerted number of responses within the body in order to obtain an appropriate metabolism and host defence reaction (i.e. blood flow to the affected tissue, repair processes and combat against unde- sired exogenous components and apoptosis of endogenous cells) in order to obtain an appropriate host defence-reaction, in particular to rapidly and effectively neutralise stressors, obtain rapid wound healing, prevent tissue damage as caused by ischemia/- reperfusion processes or chemo- or radiotherapy and achieve a fast repair of tissue function.
  • an appropriate metabolism and host defence reaction i.e. blood flow to the affected tissue, repair processes and combat against unde- sired exogenous components and apoptosis of endogenous cells
  • host defence-reaction in particular to rapidly and effectively neutralise stressors
  • Enteral feeding of patients during surgery is known for patients suffering from severe burn injuries (ref. 48-49).
  • the feeding is not performed to mitigate, attenuate or prevent an acute inflammatory response during or after surgery but to meet their significant nutritional demands, reduce caloric deficit and because such patients cannot be fed otherwise.
  • surgery is limited to skin surgery, i.e. non-invasive surgery.
  • the administration of said enteral nutrition is practical to apply by the use of known enteral feeding devices, in particular tubes, and prevents in particular the development of a (too) strong or dysregulated inflammatory response during and following the presence of the stressor and the subsequent healing process by a rapid mode of action.
  • the inflammatory reaction has already started, it prevents a further increase of the inflammatory reaction, a so-called hyperinflammation. A reduction of the hyperinflammatory response has been associated with an enhanced recovery after surgery.
  • the problem to be solved by the invention is to provide a liquid nutritional com- position capable of rapidly averting short-time inflammatory effects, in particular with a surgical medical intervention, preferably an invasive surgical medical intervention.
  • An invasive surgical medical intervention is one which penetrates or breaks the skin or enters a body cavity. Examples of invasive procedures include those that involve perforation, an incision, a catheterization, or other entry into the body.
  • An specific invasive surgical medical intervention is an open surgery cutting skin and tissues so the surgeon has a direct access to the structures or organs involved. The structures and tissues involved can be seen and touched, and they are directly exposed to the air of the operating room.
  • open surgery examples include the removal of organs, such as the gallbladder or kidney, and most types of cardiac surgery and neurosurgery. Open surgery involves large incisions, in which the tissues are exposed to the air.
  • the problem was solved by the provision of a liquid nutritional composition having a high amount of fat and a high amount of protein.
  • the lipid-rich nutrition is beneficial for attenuating or preventing an acute inflammatory response and organ damage via a cholecystokinin (CCK)- mediated vagovagal reflex.
  • CCK cholecystokinin
  • the fat provides a fast and high CCK response whereas the protein delivers a lower but more sustainable CCK release. Surprisingly, both responses together deliver the optimal mediation of the cholecystokinin-mediated vagovagal reflex .
  • the high amount of protein provides the necessary amino acids (in particular glutamine) for the recovery of patients, in particular by (i) minimizing catabolic protein response, (ii) maintaining gut function and gut immunity, and (iii) supporting the acute phase protein synthesis.
  • intra-operative feeding is the main application area of the invention.
  • the wording "peri-operative" and/or "peroperative" feeding is often found to denote a feeding protocol which includes preoperative (i.e.
  • the term "intraoperative feeding” refers to a feeding regime during operation and does not refer to pre- or postoperative feeding.
  • the liquid nutritional composition of the invention can also be suitably used for pre- and post-operative feeding.
  • the enteral feeding can be started before the surgical procedure, i.e. in the pre-operative phase, and can be continued after the surgical pro- cedure, i.e. in the post-operative phase.
  • the invention also relates to the liquid nutritional composition of the invention for peri-operative use.
  • a percentage of the total energy of the composition is abbreviated as En and is used to denote the energetic value of a digestible compound (fat, protein, carbohydrates, fibres) (in particular in a human or other mammal).
  • the en- ergetic value is based on the contribution of proteinaceous matter (including proteins, peptides and amino acids), lipids or fat and digestible carbohydrates, using the following calculation factors (Atwater factors): 4 kcal/g for digestible carbohydrates and proteinaceous matter, 9 kcal/g for lipids and 2 kcal/g for digestible fibres.
  • the beneficial effect of a high fat enteral composition for the treatment and/or prevention of sepsis or for combating inflammatory conditions is known from the prior art.
  • the beneficial effect of a high protein content in combination of a high fat content is not disclosed, nor is such a composition according to the invention.
  • EP 1 411 951 Bl discloses the use of a composition containing a fat fraction comprising phospholipids , triglycerides and cholesterol in a weight ratio of 3-90 : 3-80 : 1, a protein fraction and a digestible carbohydrate fraction for the treatment and/or prevention of sepsis, endo toxemia and/or bacteraemia, which may be associated with major surgery, critical illness, inflammatory bowel disease etc., caused by bacteria.
  • EP 1 589 834 Bl similarly discloses the use of a composition containing a fat fraction comprising phospholipids and triglycerides in a weight ratio of greater than 1, with less than 0.5 weight of cholesterol, a protein fraction and a digestible carbohydrate fraction, for the treatment of sepsis and associated conditions.
  • a composition containing a fat fraction comprising phospholipids and triglycerides in a weight ratio of greater than 1, with less than 0.5 weight of cholesterol, a protein fraction and a digestible carbohydrate fraction for the treatment of sepsis and associated conditions.
  • the beneficial role of a high protein content is not disclosed, nor is a composition according to the invention.
  • US 5,968,896 (Beth Israel Deaconess Medical Center) discloses a solid or semi-solid nutritional supplement for pre-operative feeding comprising 26 - 46 En of fat, 20 - 40 En of proteins and 25 - 45 En of digestible carbohydrates for individuals preparing for an imminent major surgical procedure, preferably a non-baked extruded nutritional bar of approximately 200 kcal (one serving).
  • EP 1 041 896 B l discloses compositions containing a fat blend compris- ing [gamma] -linolenic acid, stearidonic acid and eicosapentaenoic acid (2 : 1 : 2) and phospholipids as an enteral food for the treatment of chronic inflammatory diseases, lipid metabolism disorders and weakened immune functions.
  • EP 1 090 636 discloses a composition for use in the treatment of sepsis or inflammatory shock, which comprises more than 35 En of lipids.
  • the lipid fraction comprises 25- 70 weight MCT oil. Less than 15 weight saturated fatty acids excluding MCT and the n-6/n-3 ratio is about 2-7 : 1.
  • EP 0 265 772 claims a nutritional formula comprising 45 - 60 En of fat, 20 - 37 En of digestible carbohydrates and 8 - 25 En of proteins for humans suffering from glucose intolerance.
  • the disclosed examples are limited to high fat compositions comprising at most 20 En of proteins.
  • EP 0 691 079 claims a nutritional formula comprising 30 - 45 En of fat, at most 50 En of digestible carbohydrates and 8 - 25 En of proteins for use with diabetic patients.
  • the disclosed example is limited to a composition comprising at 18 En of proteins.
  • EP 0 189 160 claims a high fat, low carbohydrate enteral nutritional composi- tion comprising 45 - 60 En of fat, at most 30 En of digestible carbohydrates and 8 - 25 En of proteins for treating patients with respiratory insufficiency.
  • the example discloses a composition comprising 55 En of fat, 19 En of protein and 26 En of carbohydrates.
  • EP 0 611 568 (Fresenius) claims a nutritional composition for cancer patients suitable to be used as a tube feed, comprising 40 to 65 En of fat, 20 to 45 En of digestible carbohy- drates and 12 to 25 En of proteins. All examples disclose compositions with at most 20 En of proteins.
  • US 7,691,906 (Nestec S.A.) discloses an enteral composition for the treatment or prevention of sepsis or inflammatory shock, optionally administered by tube feeding, comprising at least 35 En of fat which comprises at least 40 to 70 weight of an MCT, 10 to 25 En of proteins and 12 to 55 En of carbohydrates.
  • the invention pertains to liquid nutritional compositions comprising a high amount of fat and a high amount of proteinaceous matter and to the use thereof for mitigating, attenuating or preventing an acute inflammatory response during or after surgery of a patient undergoing said surgery, wherein said composition is to be administered to said patient by intra-operative tube feeding.
  • This setting requires an immediate effect of the feeding, wherein the effect of the feeding consists in attenuation of the inflammatory response.
  • the immediate response means that the attenuation starts within 30 minutes, preferably within 15 minutes, and lasts for several hours, in particular for 1 to 3 hours after the intervention has stopped.
  • the invention relates to a liquid nutritional composition
  • a liquid nutritional composition comprising fat and proteinaceous matter, wherein said fat contributes for at least 41 En and said proteinaceous matter contributes for at least 23 En to the total energy content of said composition or mitigating, attenuating or preventing an acute inflammatory response during or after surgery of a patient undergoing said surgery, wherein said composition is to be administered to said patient by intra-operative tube feeding.
  • the invention relates to a liquid nutritional composition
  • a liquid nutritional composition comprising fat, proteinaceous matter and digestible carbohydrates, wherein said fat contributes for at least 41 En , said proteinaceous matter contributes for at least 23 En , and said digestible carbohydrates contribute for at most 36 En to the total energy content of said composi- tion, optionally further comprising at least 1.5 gram, more preferably, at least 1.7 gram of L- glutamine (bound and/or free) per 100 ml of said composition, as well as to its use as a tube feed, in particular for mitigating, attenuating or preventing an acute inflammatory response during or after surgery of a patient.
  • Proteinaceous matter comprising fat, proteinaceous matter and digestible carbohydrates, wherein said fat contributes for at least 41 En , said proteinaceous matter contributes for at least 23 En , and said digestible carbohydrates contribute for at most 36 En to the total energy content of said composi- tion, optionally further comprising at least 1.5 gram, more preferably, at least 1.7
  • the liquid nutritional composition according to the invention comprises at least a source of proteinaceous matter.
  • the liquid nutritional composition according to the invention comprises at least 23 En% of proteinaceous matter, preferably between 23 En% and 59 En%, more preferable between 23 En% and 45 %, most preferably between 23 En% and 40 En% of proteinaceous matter relative to the total energy content of said composition.
  • proteinaceous matter is defined as protein, peptides and amino acids.
  • proteinaceous matter of the liquid nutritional composition according to the invention is the sum of all proteins, peptides and amino acids, free or in any bound form, present in the liquid nutritional composition according to the invention.
  • the proteinaceous matter comprises a source of vegetable proteinaceous matter and a source of dairy proteinaceous matter.
  • the proteinaceous matter comprises 20 to 80 weight% of vegetal proteinaceous matter and 20 to 80 weight% of dairy proteinaceous matter.
  • the wording "vegetable” relates to proteinaceous matter from plant origin, such as, for instance originating from vegetables such as carrot, pea, chickpea, green pea, kidney bean, lupine, rice, soy, canola, hemp, zein, maize, corn, barley, flax, linseed, and wheat. Equivalent wording may be used, such as “vegetal”, “leguminous” or “plant-derived”.
  • dairy proteinaceous matter relates to milk- derived proteinaceous matter, i.e. to proteinaceous matter from animal milk, such as derived from species such as camel, cow, goat, horse, human, reindeer, sheep, water buffalo and yak.
  • the proteinaceous matter comprises a hydrolysed protein, for example an hydrolysate of soy, casein, whey or wheat proteins.
  • the proteinaceous matter substantially consists of hydrolysed protein, preferably at least 90 weight%, more preferably at least 95 weight%.
  • the hydrolysed proteins are obtained by the enzymatic hydrolysis of proteins, for example whey proteins.
  • suitable proteins can be found in Peptamen® (Nestle), a 100% whey peptide based enteral tube nutrition, ensuring optimal absorption and better protein utilization.
  • the proteinaceous matter comprises any one or more of casein, whey, soy, pea and wheat protein.
  • the liquid nutritional composition according to the invention preferably comprises one or more of said casein, whey, soy and wheat protein each individually in an amount between 0.1 and 10 gram of proteins per 100 ml of said liquid nutri- tional composition, more preferably between 1 and 10 gram per 100 ml of said liquid nutritional composition, more preferably 2, 3, 4, 5, 6, 7, 8 or 9 gram of proteinaceous matter per 100 ml of said liquid nutritional composition, or any integer and non-integer fraction in between.
  • the liquid nutritional composition according to the invention comprises casein and wheat protein, each individually in an amount between 0.1 and 10 gram of proteins per 100 ml of said liquid nutritional composition, more preferably between 1 and 10 gram per 100 ml of said liquid nutritional composition, more preferably 2, 3, 4, 5, 6, 7, 8 or 9 gram of proteinaceous matter per 100 ml of said liquid nutritional composition, or any integer and non-integer fraction in between.
  • the liquid nutritional composition according to the invention comprises 30 to 50 weight of casein and 30 to 50 weight of wheat protein relative to the total weight of the proteinaceous matter. More preferably, the casein:wheat protein weight ratio is about 1.
  • the liquid nutritional composition according to the invention comprises 2 to 4 gram of casein and 2 to 4 gram of wheat protein per 100 ml of said liquid nutritional composition.
  • the proteinaceous matter comprises an amount of L- glutamine (bound and/or free) which exceeds the amount naturally present in intact vegetal or dairy proteins.
  • such amount of L-glutamine is at least 20 gram, more preferably at least 25 gram per 100 gram of total proteinaceous matter.
  • L-Glutamine (abbreviated as Gin or Q) is one of the 20 amino acids encoded by the standard genetic code. It is not recognized as an essential amino acid but may become conditionally essential in certain situations, including intensive athletic training or certain gastrointestinal disorders. Its side-chain is an amide formed by replacing the side-chain hydroxyl of L-glutamic acid with an amine functional group. Therefore, it can be considered the amide of L-glutamic acid.
  • glutamine'Or “L-glutamine” also comprises a glutamine equivalent, which is a compound that can be converted to L-glutamine in the body, such as an L-glutamine dipeptide or a 2-acylaminoglutaric acid monoamide. It is specifically stated here that (L-) glutamic acid is excluded from the definition of glutamine.
  • the liquid nutritional composition according tot the invention comprises at least 1.5 gram, more preferably, at least 1.7 gram of L-glutamine (bound and/or free) per 100 ml of total liquid nutritional composition.
  • the liquid nutritional composition according to the invention comprises between 1.5 gram and 5 gram, more preferably between 1.7 gram and 4 gram, most preferably between 1.9 and 3 gram of L-glutamine (bound and/or free) per 100 ml of total liquid nutritional composition.
  • the amount of L-glutamine required according to the invention cannot be provided by intact vegetal or dairy proteins alone and an L-glutamine-enriched source should be present.
  • the source of L-glutamine is selected from the group of wheat protein, which is rich in L- glutamine, the free amino acid L-glutamine, and an L-glutamine-containing dipeptide, such as L- alanyl-L-glutamine.
  • said L-alanyl-L-glutamine dipeptide is synthetically produced.
  • the dipeptide is used, since the free amino acid is not stable during sterilization. Fat
  • the liquid nutritional composition according to the invention comprises at least a source of fat.
  • the total amount of energy supplied by the fat should be at least about 41 En , at least about 42 En , at least about 43 En or at least about 44 En per 100 ml of said liquid nutritional composition.
  • the total amount of energy supplied by the fat should be preferably between 41 En and 77 En , more preferably between 41 En and 70 En , most preferably between 41 En and 65 En , relative to the total energy content of said composition.
  • the fat may be an animal fat or a vegetable fat or both.
  • animal fats such as lard or butter have essentially equal caloric and nutritional values and can be used interchangeably, vegetable oils are highly preferred in the practice of the present invention due to their readily availability, ease of formulation, absence of cholesterol and lower concentration of saturated fatty acids.
  • the present composition comprises rapeseed oil, corn oil and/or sun- flower oil.
  • the fat may include a source of medium chain fatty acids, such as medium chain triglycerides (MCT, defined as 8 to 10 carbon atoms long), a source of long chain fatty acids, such as long chain triglycerides (LCT) and phospholipid-bound fatty acids such as phospholipid-bound EPA or DHA, or any combination of the two types of sources.
  • MCT medium chain triglycerides
  • LCT long chain triglycerides
  • phospholipid-bound fatty acids such as phospholipid-bound EPA or DHA
  • the liquid nutritional composition according to the invention comprises medium-chain fatty acids (MCTs), having a chain length of 8, 10 or 12 carbon atoms, preferably in an amount of 0 to 25 weight , more preferably 0 to 20 weight , and especially less than 3 weight , and myristic acid (C 14:0).
  • MCTs are beneficial because they are easily absorbed and metabolized in a metabolically- stressed patient. Moreover, the use of MCTs will reduce the risk of nutrient malabsorption.
  • LCT sources such as canola oil, rapeseed oil, sunflower oil, soybean oil, olive oil, coconut oil, palm oil, linseed oil, marine oil or corn oil are beneficial because it is known that LCTs may modulate the immune response in the human body.
  • the fat in the liquid nutritional composition according to the invention comprises at most 25 weight of medium chain triglycerides (MCTs), relative to the total weight of said fat.
  • MCTs medium chain triglycerides
  • the fat comprises a glyceride fraction.
  • This may contain mono-, di- and tri-glycerides.
  • part of the glyceride fraction consists of mono and/or diglycerides of fatty acids.
  • the mono- and diglycerides were also found to assist in administering relatively large amounts of lipids, without excessively raising the caloric content of the composition.
  • the lipid comprises at least 5 weight , at least 6 weight , or at least 7 weight of polyunsaturated fatty acids (PUFA's), calculated relative to the total amount of fatty acids, preferably eicosapentaenoic acid (EPA) and docosapentaenoic acid (DHA).
  • PUFA's polyunsaturated fatty acids
  • EPA eicosapentaenoic acid
  • DHA docosapentaenoic acid
  • the lipid comprises at least 400 mg of PUFA's, preferably eicosapentaenoic acid (EPA) and docosapentaenoic acid (DHA) per 100 ml of liquid nutritional composition according to the invention, more preferably between 400 and 1000 mg, more preferably between 450 to 750 mg per 100 ml of said liquid nutritional composition.
  • the fat in the liquid nutritional composition according to the invention may contain phospholipids or cholesterol.
  • the fat in the liquid nutritional composition according to the invention comprises less than 10 weight of phospholipids, relative to the total weight of said fat, or the fat comprises less than 0.5 weight of cholesterol, relative to the total weight of said fat.
  • the liquid nutritional composition according to the invention comprises a digestible carbohydrate.
  • the digestible carbohydrates positively influence the energy level of a subject, and add to the advantageous effect of the nutritional composition according to the invention.
  • the digestible carbohydrate may comprise simple and/or complex digestible carbohydrates, or any mixture thereof. Suitable for use in the present invention are glu- cose, fructose, sucrose, lactose, trehalose, palatinose, corn syrup, malt, maltose, isomaltose, partially hydrolysed corn starch, maltodextrins, glucose oligo- and polysaccharides.
  • the digestible carbohydrate contributes for at most 36 En to the total energy content of the liquid nutritional composition.
  • the digestible carbohydrate contributes for at most 35 , 34 % , 33 En , 32 En , 31 En or 30 En to the total energy content of the liquid nutritional composition.
  • a low digestible carbohydrate amount lowers the stress-induces hyperglycaemia, insulin resistance, and therefore the infection rate.
  • composition of the invention may further contain other nutritional components, such as trace elements, vitamins, minerals, dietary fibres, e.a. in an amount which is adapted to suit the needs of the patient.
  • nutritional components such as trace elements, vitamins, minerals, dietary fibres, e.a. in an amount which is adapted to suit the needs of the patient.
  • the liquid composition according to the invention comprises fat, proteinaceous matter and digestible carbohydrates, wherein said fat contributes for at least 41
  • said proteinaceous matter contributes for at least 23 En
  • said digestible carbohydrates contribute for at most 36 En to the total energy content of said composition, further comprising at least 1.5 gram, more preferably, at least 1.7 gram of L-glutamine (bound and/or free) per 100 ml of said composition.
  • the liquid composition according to the invention comprises about 45 En of fat, about 23 En of proteinaceous matter , about 29 En of digestible carbo- hydrates, and about 2 gram of L-glutamine per 100 ml of said composition.
  • the composition is a liquid composition, wherein liquid is defined as a substance being suitable for enteral administration by tube at room temperature, using for example a feeding pump, gravity, syringe administration and the like.
  • Said composition has a certain viscosity, which is adapted to said enteral administration.
  • the viscosity of the liquid enteral nutritional composition is lower than 500 mPa.s, measured at 20 °C (i.e. room temperature) at a shear rate of 100 s "1 , preferably between 10 and 200 mPa.s, more preferably between 10 and 100 mPa.s, most preferably below 50 mPa.s.
  • the viscosity may suitably be determined using a rotational viscosity meter using a cone/plate geometry.
  • This viscosity is ideal for orally administering the liquid en- teral nutritional composition according to the invention because a person may easily consume a serving having a low viscosity such as that displayed by the present invention. This viscosity is also ideal for unit dosages that are tube fed.
  • the density of the composition ranges between 1.00 g/ml and 1.20 g/ml, especially between 1.05 g/ml and 1.15 g/ml.
  • the liquid enteral nutritional composition according to the invention may have the form of a complete food, i.e. it can meet all nutritional needs of the user.
  • the liquid enteral nutri- tional composition according to the invention preferably contains 1000 to 2500 kcal per daily dosage. Depending on the condition of the patient, a daily dose is about 25 to 35 kcal/kg body- weight/day. Therefore, a typical daily dose for a 70 kg person contains about 2000 kcal.
  • the complete food can be in the form of multiple dosage units, e.g. from 8 (250 ml/unit) to 2 units (1 1/unit) per day for an energy supply of 2000 kcal/day using a liquid enteral nutritional composi- tion according to the invention of 1.0 kcal/ml.
  • the nutritional composition is adapted for tube feeding, i.e. in the form of a tube feed.
  • the liquid enteral nutritional composition can also be a food supplement, especially for use as a tube feed to be administered to a patient undergoing surgery by intra- operative tube feeding.
  • the liquid enteral nutritional composition contains per daily dosage less than 1500 kcal, in particular as a supplement, the liquid enteral nutritional composition contains 500 to 1000 kcal per daily dose.
  • the food supplement can be in the form of multiple dosage units, e.g. from 2 (250 ml/unit) to 10 units (50 ml/unit) per day for an energy supply of 500 kcal/day using the liquid enteral nutritional composition according to the invention.
  • the dosage unit may be adapted in size and composition.
  • the nutritional composition is packaged, stored and provided in a container such as plastic bag or a pouch or the like.
  • a container such as plastic bag or a pouch or the like.
  • a variety of such containers is known, for example 500 ml, 1000 ml, and 1500 ml containers are known in the art. It should be noted that any suitable container can be used to package, store and provide the nutritional composition according to the invention.
  • the liquid enteral nutritional composition is provided in a ready to use liquid form and does not require reconstitution or mixing prior to use.
  • the liquid enteral nutritional composition according to the invention can be tube fed or administered orally.
  • the composition according to the invention can be provided in a can, on spike, and hang bag.
  • a composition may be provided to a person in need thereof, in powder form, suitable for reconstitution using an aqueous solution or water such that the enteral nutritional composition according to the invention is produced.
  • the present composition is in the form of a powder, accompanied with instructions to dissolve or reconstitute in an aqueous composition or water to arrive at the liquid nutritional enteral composition according to the present invention.
  • the present liquid nutritional enteral composition may thus be obtained by dissolving or reconstituting a powder, preferably in an aqueous composition, in particular water.
  • a suitable packaging mode is a powder in a container, e.g. a sachet, preferably with instructions to dissolve or reconstitute in an aqueous composition or water.
  • liquid nutritional composition according to the invention may be prepared using standard preparation methods known to the skilled person and they will not be further described.
  • the liquid nutritional composition according to the invention need to undergo some sort of sterilization treatment in order to reduce the number of or remove possible pathogens, for in- stance spores, bacteria and other microorganisms, which cause spoilage of the protein composition, preferably by using heat (sterilization, pasteurization), radiation (UV-treatment), or filtration methods (ultrafiltration, diafiltration, nanofiltration).
  • sterilization treatments include heat treatments at high temperatures for a short period, such as using a UHT (Ultra High Temperature) treatment.
  • the liquid nutritional composition according to the invention is in a sterilized or pasteurized form.
  • the liquid nutritional composition of the invention may be used as a tube feed, i.e. for tube feeding a patient. Said tube feeding may be provided continuously, or intermittently. According to another embodiment, the liquid nutritional composition of the invention may be used for tube feeding of a patient undergoing surgery, in particular non-invasive surgery such as skin-surgery, invasive surgery such as organ surgery, cardiac surgery and neurosurgery, by intra-operative tube feeding.
  • non-invasive surgery such as skin-surgery
  • invasive surgery such as organ surgery, cardiac surgery and neurosurgery
  • the liquid nutritional composition of the invention is also advantageously used for mitigating, attenuating or preventing an acute inflammatory response during or after surgery of a patient.
  • the patient is a patient that is undergoing surgery, that has undergone surgery or that is a critically-ill patient.
  • FIG. 1 Experimental design. Subjects are admitted to the intensive care unit (ICU) after an overnight fast. One hour prior to LPS administration, subjects are prehydrated and the continuous administration of enteral nutrition started in the nutritional intervention groups, lasting until six hours after LPS administration. Blood is withdrawn at indicated time points during the experiment. Subjects leave the hospital 12 hours after intravenous administration of LPS and return the day after for final blood sampling.
  • ICU intensive care unit
  • Enriched nutrition modulates the inflammatory response during endotoxemia.
  • Enriched nutrition attenuates TNF-* , IL-6 and IL-1RA levels compared with control nutrition (p ⁇ .05) and fasting (p ⁇ .0001).
  • FIG. 3 Administration of LPS results in sub-clinical intestinal damage. Intravenous administration of LPS results in a gradual increase of plasma i-FABP levels in all groups (A). Subjects fed enriched nutrition display a smaller increase in circulating i-FABP levels (A-B), although this does not reach statistical significance.
  • Example 1 Tube-feed according to the invention (all values per 100 ml of total liquid composition)
  • the nutritional intervention groups received continuous postpyloric infusion of a liquid, enriched or an isocaloric control enteral nutrition for 7 hours via a self-advancing nasal-jejunal feeding tube (Tiger 2, Cook Medical, Bloomington, IN, Figure 1), which was placed on the evening before the experiment.
  • the rate of feeding for each subject was based on their individual total energy requirement (TER).
  • the TER was calculated by multiplying the basal metabolic rate of each subject with their activity level (1.55 times for all subjects) using the Harris-Benedict equation (Table 1).
  • the enriched nutrition contained 44 En% fat, 25 En% protein and 31 En% carbohydrates.
  • the protein consisted of intact casein, whey protein and soy protein hydrolysate.
  • the control nutrition contained 20 En% fat, 16 En% protein and 64 En% carbohydrates. Both the enriched and control nutrition provided 1 kcal/ml.
  • Systemic CCK levels were determined in plasma using a CCK- radioimmunoassay (Eurodiagnostica, Malmo, Sweden).
  • TNF-* , IL-6, IL-10, and IL-1 receptor antagonists were measured batchwise using a multiplex Luminex Assay according to the manufacturer's instructions (Millipore, Billerica, MA). Intestinal-fatty acid binding protein (i-FABP) was determined in plasma using an in-house developed ELISA.
  • i-FABP Intestinal-fatty acid binding protein
  • T time expressed in hours after lipopolysaccharide administration
  • MAP mean arterial pressure
  • HR heart rate
  • ND not determined.
  • Intravenous administration of LPS resulted in a marked pro-inflammatory response.
  • the TNF-* values of one subject in the enriched nutrition group were removed from the analysis after being identified as significant outlier.
  • Treatment with enriched nutrition significantly attenuated TNF-* levels compared with fasted (p ⁇ 0.0001) and control nutrition (p ⁇ 0.05; Figure 2A).
  • Enriched nutrition lowered peak TNF-* levels with 40 + 8% compared with fasted subjects and 29 + 10% compared to control nutrition.
  • Enriched nutrition significantly reduced IL-6 plasma concentrations during the endotoxemia protocol compared with control nutrition (p ⁇ 0.001) and fasting (p ⁇ 0.05. Figure 2B), while the control nutrition did not affect IL-6 compared with fasted subjects (p 0.63).
  • Intravenous injection of LPS is known to trigger a complex compensatory anti-inflammatory response.
  • the specific IL-1 receptor antagonist, IL-1RA is released during inflammation and is thought to control the immune-modulatory effects of IL- 1.
  • Enriched nutrition decreased circulating IL-IRA during the experiment compared with control nutrition (p ⁇ 0.0001) and fasted (p ⁇ 0.0001; Figure 2C). Peak levels of IL-IRA were 37 + 8% lower in the enriched nutrition group compared with fasted subjects and 25 + 6% compared with control nutrition. The control nutrition did not affect IL-1 RA levels compared with fasted.
  • the present study is the first to investigate the immediate immunomodulatory effect of continuous enteral administration of nutrition enriched with lipids and protein in human.
  • Our data reveal that enriched nutrition modulates the innate immune response during human endotoxemia, resulting in attenuated plasma levels of TNF-* , IL-6, IL-1RA and elevated circulating IL-10, indicating a reduced pro-inflammatory response and an augmented anti-inflammatory response.
  • circulating levels of TNF-* and IL-6 are correlated with the severity of sepsis in patients [31] .
  • the current study demonstrates that enriched nutrition limits inflammation during human experimental endotoxemia by attenuating circulating levels of TNF-* and IL-6.
  • the intervention with enriched nutrition resulted in decreased IL- 1RA plasma levels.
  • IL-10 has been shown to reduce endotoxin-induced lethality in mice [36] .
  • the beneficial effect of enriched nutrition on the immune response during human endotoxemia is in line with previous studies using well-known pharmacological agents, including epinephrine and glucocorticoids which inhibit plasma levels of pro-inflammatory cytokines and augment circulating IL- 10 [34, 37] .
  • these data indicate that enriched enteral nutrition is a promising and physiological intervention to control acute inflammation.
  • intravenous administration of LPS resulted in increased i-FABP levels.
  • CCK-mediated activation of vagal afferents plays a dominant role in nutrient-induced digestive, metabolic and immunologic feedback [19, 42, 43] .
  • Intestinal release of CCK is predominantly triggered by the luminal presence of lipid and protein [20, 44] , while termination of nutrient exposure results in a rapid drop of CCK levels [44] .
  • Our nutritional intervention resulted in detectable circulating CCK levels during the entire endotoxin-induced inflammatory response.
  • GLP-1 glucagon-like peptide 1
  • Nicotinic acetylcholine receptor alpha7 subunit is an essential regulator of in- flammation. Nature 2003, 421(6921):384-388.
  • Lowry SF Human endotoxemia: a model for mechanistic insight and therapeutic targeting.
  • Calder PC n-3 polyunsaturated fatty acids, inflammation, and inflammatory diseases. Am J Clin Nutr 2006, 83(6 Suppl): 1505S- 1519S.
  • Vermeulen MA van de Poll MC, Ligthart-Melis GC, Dejong CH, van den Tol MP, Bo- elens PG, van Leeuwen PA: Specific amino acids in the critically ill patient— exogenous glutamine/arginine: a common denominator? Crit Care Med 2007, 35(9 Suppl):S568-576.
  • Interleukin 1 receptor antagonist (IL- IRa) is an acute-phase protein. / Clin Invest 1997, 99(12):2930-2940.

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Abstract

La présente invention concerne une composition nutritionnelle liquide comprenant des graisses et une matière protéinée, lesdites graisses représentant au moins 41 % en En et ladite matière protéinée représentant au moins 23 % en En par rapport à la teneur totale en énergie de ladite composition, pour diminuer, atténuer ou prévenir une réponse inflammatoire aiguë pendant ou après une chirurgie d'un patient subissant ladite chirurgie, ladite composition devant être administrée audit patient par alimentation par tube intra-opératoire. L'invention concerne également des compositions nutritionnelles liquides spécifiques, appropriées pour être utilisées comme alimentation par tube, et notamment pour diminuer, atténuer ou prévenir une réponse inflammatoire aiguë pendant ou après une chirurgie d'un patient.
PCT/NL2011/050231 2011-04-06 2011-04-06 Composition alimentaire pour une alimentation par tube intra-opératoire Ceased WO2012138212A1 (fr)

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CN201280027944.7A CN103596455B (zh) 2011-04-06 2012-04-06 用于术中管饲的食物组合物
EP12717895.2A EP2693898A1 (fr) 2011-04-06 2012-04-06 Composition nutritionnelle pour alimentation peropératoire par sonde
BR112013025604A BR112013025604A2 (pt) 2011-04-06 2012-04-06 uso de uma preparação na fabricação de uma composição nutricional líquida, composição nutricional líquida e uso da composição nutricional líquida

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CN110302214A (zh) * 2019-08-21 2019-10-08 中国人民解放军总医院 一种乳酸菌联合中链甘油三酯在修复肠道炎症中的应用

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CN110302214A (zh) * 2019-08-21 2019-10-08 中国人民解放军总医院 一种乳酸菌联合中链甘油三酯在修复肠道炎症中的应用

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