Nutrient-supplying composition

Abstract

A nutritional feeding composition is provided for use in treating and / or preventing muscle wasting in critically ill patients, comprising 60% to 90% fat by kCal contribution, 5% to 35% protein by kCal contribution, and up to 10% carbohydrate by kCal contribution. The fat comprises medium-chain triglycerides and long-chain triglycerides. The proportion of fat comprising medium-chain triglycerides is 25% to 90% by kCal contribution. The long-chain triglycerides are derived from vegetable sources. The nutritional feeding composition is suitable for administration via a nasogastric tube.

Description

[Technical Field]

[0001] The present invention relates to a nutrient-supplying composition for use in the treatment and / or prevention of muscle wasting in critically ill patients, as well as to a method for preparing said nutrient-supplying composition. [Background technology]

[0002] In the UK, an estimated 195,000 patients are admitted to intensive care units (ICUs) each year. Common reasons for patients requiring intensive care include serious accidents (e.g., road traffic accidents, severe head injuries, serious falls, or severe burns), serious short-term conditions such as heart attack or stroke, serious infections such as sepsis, or recovery from major surgery. Without treatment or medical intervention, they will not survive these conditions. Over 50% of these patients are at risk of muscle atrophy, a loss of muscle strength due to disruption of metabolic processes, prolonged bed rest, immobilization, and often sedation. Currently, no satisfactory techniques exist for preventing muscle atrophy in critically ill patients.

[0003] Critically ill patients, especially those who are unconscious, are often unable to effectively feed themselves and therefore receive enteral nutrition, or tube feeding. Typically, such feeding is via nasogastric tube feeding, which allows food to be transported directly through the nose to the stomach, but it can also be via a gastrostomy tube. However, even with such feeding, critically ill patients continue to lose muscle mass rapidly. One reason for this may be that such patients are unable to use the protein or calories in their nutrition to maintain muscle mass.

[0004] Food compositions are often provided in healthcare settings to deliver specific profiles of macronutrients, vitamins, and minerals. A known food composition is the ketogenic diet, which has been used in medicine since the 1920s and consists primarily of a high amount of fat, a moderate amount of protein, and very little carbohydrate. It has been used to treat epilepsy, a neurological disorder, particularly in pediatric patients. For example, EP 2813149 discloses a composition containing about 4% to about 12% by weight of protein, less than 5% by weight of carbohydrates, and about 25% to about 38% by weight of fat, for treating intractable epilepsy in children.

[0005] Ketogenic diets have also been used to treat patients with neurological disorders. For example, US5308832 discloses a composition comprising about 70% to about 85% kcal contribution of fat, 15% to 30% kcal contribution of protein, and less than 5% kcal contribution of carbohydrates. In a preferred embodiment, the fat comprises up to about 20% kcal contribution of medium-chain triglycerides.

[0006] WO2015 / 034812 discloses a composition comprising 50% to 80% kcal contribution of fat, 10% to 35% kcal contribution of protein, and 0% to 10% kcal contribution of carbohydrates, wherein the fat comprises medium chain triglycerides and fish oil rich in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), i.e., omega-3 fatty acids.

[0007] The ketogenic diet has also been recommended for the treatment of obesity and diabetes, kidney disease and cancer, although the evidence is very limited.

[0008] During acute illness, the ability to utilize carbohydrates and lipids to generate energy is greatly reduced, resulting in energy loss and a catabolic state. Ketogenesis provides an alternative source of energy in the form of ketone bodies, replacing glucose and lipids as the primary source of energy. Endogenously synthesized ketone bodies can be readily utilized for energy production by the heart, muscle tissue, kidneys, and brain. Critically ill patients also require a source of protein. Summary of the Invention

[0009] According to a first aspect of the present invention there is provided a nutritional composition for use in the treatment and / or prevention of muscle wasting in a critically ill patient, comprising 60% to 90% fat by kCal contribution, 5% to 35% protein by kCal contribution and up to 10% carbohydrates by kCal contribution, the fat comprises medium-chain triglycerides and long-chain triglycerides; The proportion of fat containing medium-chain triglycerides is 25% to 90% in terms of kCal contribution, Nutritional compositions are provided in which the long chain triglycerides are derived from a plant source.

[0010] The term "muscle atrophy," as used herein, describes, but is not limited to, changes in muscle structure and function. Typically, muscle atrophy is characterized by generalized muscle weakness and loss of muscle mass.

[0011] The term "critically ill," as used herein, refers to, but is not limited to, patients suffering from or at risk of developing life-threatening conditions and patients requiring medical intervention in the form of treatment and monitoring. Typically, critically ill patients stay in specialized wards, such as ICUs (Intensive Care Units, also known as ITUs, short for Intensive Therapy Units). These patients are often unable to move due to their condition and / or the equipment required for treatment, which increases the risk of muscle atrophy. Critically ill patients may also suffer from metabolic process disruptions, which interfere with the normal functioning of metabolic processes. Therefore, critically ill patients include not only patients receiving intensive care, but also patients receiving cardiac critical care, patients in high-dependency units (HDUs), patients in respiratory support units, and critically ill neurological patients receiving neurocritical care. In the present invention, the nutritional supply composition is preferably intended for patients expected to survive these critical conditions. Preferably, the patient receiving the nutritional supply composition is an adult.

[0012] The amount of fat, protein and carbohydrate present in the nutritional composition is determined by the contribution of kilocalories (kCal).Fat, protein and carbohydrate generally belong to the term "macronutrient".The proportion and amount of macronutrients are selected to meet the nutritional needs of each individual patient, preferably maintaining the ketogenic diet so that the patient is in a state of ketosis.Typically, the total calorie intake for critically ill patients is based on the patient's weight and the need to meet the goal of about 25 kCal per kilogram per day.

[0013] In nutrition, energy contribution is typically expressed in kCal. A calorie is a unit of energy equal to 4.184 J. 1 kCal is equal to 4.184 kJ.

[0014] The composition comprises fat. Examples of types of fat that can be used alone or in combination in the composition include saturated fatty acids, monounsaturated fatty acids and polyunsaturated fatty acids. The types of fat are medium-chain triglycerides (MCT) and / or long-chain triglycerides (LCT). The MCT used in the nutritional composition can be derived from animal or plant sources.

[0015] LCTs are triglycerides with aliphatic chains of 16 to 20 carbon atoms. Examples of such aliphatic chains include oleic acid and linoleic acid. Vegetable oils typically contain LCTs with aliphatic chains that include oleic acid and linoleic acid.

[0016] The LCT in the nutritional composition is derived from a vegetable source, such as rapeseed oil. Rapeseed oil typically has an oleic acid content of about 65% and a linoleic acid content of about 20% (as determined by kcal contribution not shown). Other known vegetable oils with similar oleic and linoleic acid contents include avocado oil, olive oil, peanut oil, and sunflower oil.

[0017] LCT is not derived from fish oil. Fish oil is typically rich in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Both EPA and DHA are also known as omega-3 fatty acids. The nutritional composition preferably does not contain fish oil, EPA or DHA.

[0018] The amount of total fat in the nutritional composition is at least about 60% kCal contribution of the nutritional composition, preferably at least about 65% kCal contribution, and most preferably at least about 70% kCal contribution.

[0019] The total amount of fat in the nutritional composition is up to about 90% kCal contribution, however, in some embodiments, the total amount of fat in the nutritional composition is about 85% or less kCal contribution of the nutritional composition, such as about 80% or less kCal contribution.

[0020] The total amount of fat in the nutritional composition ranges from about 60% to about 90% kCal contribution, preferably from about 65% to about 85% kCal contribution, and most preferably from about 70% to about 80% kCal contribution. In one embodiment, the nutritional composition comprises about 75% total fat by kCal contribution. In another embodiment, the nutritional composition comprises about 70% total fat by kCal contribution.

[0021] The amounts of total fat, MCT, protein and carbohydrate in the nutritional composition may alternatively be determined as weight percentages.

[0022] As a weight percentage (proportion of (total) fat, protein, and carbohydrate), the amount of total fat in the nutritional composition is at least about 40% by weight of the nutritional composition, preferably at least about 45% by weight. The total amount of fat in the nutritional composition is up to about 65% by weight. However, in some embodiments, the amount of total fat in the nutritional composition is about 60% by weight or less of the nutritional composition.

[0023] Preferably, the total amount of fat in the nutritional composition (percentage of total fat, protein, and carbohydrate) ranges from about 40% to about 65% by weight, preferably from about 45% to about 60% by weight. In one embodiment, the nutritional composition comprises about 50% by weight total fat. In another embodiment, the nutritional composition comprises about 56% by weight total fat.

[0024] At least one fat present in the nutritional composition is MCT. These are triglycerides with shorter aliphatic chains of 6 to 12 carbon atoms. Examples of such aliphatic chains are caproic acid, caprylic acid, capric acid, and lauric acid. Common sources of MCT include palm kernel oil and coconut oil. Advantageously, when a high percentage of the total fat in the nutritional composition is MCT, ketogenesis can be induced. The amount of MCT in the nutritional composition, i.e., the percentage of the total fat that is MCT, is also determined by its kcal contribution.

[0025] The percentage of total fat in the nutritional composition that is MCT is at least about 25% kCal contribution, preferably at least about 30% kCal contribution, and most preferably at least about 35% kCal contribution.

[0026] In some embodiments, the percentage of total fat that is MCT is up to about 90% kCal contribution, however, in other embodiments, the percentage of total fat in the nutritional composition that is MCT is about 85% kCal contribution or less, such as about 80% kCal contribution or less.

[0027] The percentage of total fat in a nutritional composition that is MCT typically ranges from about 25% to about 90% kCal contribution, preferably from about 30% to about 85% kCal contribution, and most preferably from about 35% to about 80% kCal contribution.

[0028] Fatty sedatives are frequently administered to critically ill patients in the ICU. An example of a fatty sedative used in the ICU is propofol, which is usually formulated as an emulsion containing oil, such as soybean oil, and therefore contributes significantly to the total daily intake of fat received by the patient.

[0029] The fatty sedative is typically administered via peripheral intravenous (IV) therapy. The amount of fatty sedative administered varies between patients and is not simply a function of the patient's weight. Typically, critically ill patients receive an initial dose of fatty sedative, and the dose is then reduced over time. Therefore, the amount of MCT in the nutritional composition can be modified to meet the desired nutritional needs of each individual patient while maintaining a ketogenic diet.

[0030] In these embodiments, the percentage of total fat in the nutritional composition that is an MCT is typically at least about 55% kCal contribution, preferably at least about 60% kCal contribution, and most preferably at least about 65% kCal contribution. In these embodiments, the percentage of total fat in the MCT is up to about 90% kCal contribution. However, in other embodiments, the percentage of total fat in the nutritional composition that is an MCT is about 85% kCal contribution or less, for example, about 80% kCal contribution or less.

[0031] In these embodiments, the percentage of total fat that is MCT ranges from about 55% to about 90% kCal contribution, preferably from about 60% to about 85% kCal contribution, and most preferably from about 65% to about 80% kCal contribution.

[0032] In a particularly preferred embodiment where critically ill patients are receiving high fat sedation, the percentage of total fat in the nutritional composition that is MCT is 70% contributed by kCal.

[0033] In a particularly preferred embodiment in which the critically ill patient is not receiving high fat sedation, the percentage of total fat in the nutritional composition that is MCT is 76% contributed by kCal.

[0034] As a percentage of kCal from total fat, protein, and carbohydrates, the amount of MCTs in the nutritional composition is at least about 40% kCal contribution, preferably at least about 45% kCal contribution, however, in some embodiments, the amount of MCTs as a percentage of kCal from total fat, protein, and carbohydrates is 65% kCal contribution or less, for example, about 60% kCal contribution or less.

[0035] Preferably, in some embodiments, the amount of MCTs as a percentage of kCal from total fat, protein, and carbohydrates ranges from about 40% to about 65% kCal contribution, preferably from about 45% to about 60% kCal contribution.

[0036] In a particularly preferred embodiment where critically ill patients are receiving high fat sedation, the percentage of kCal from total fat, protein and carbohydrate in the nutritional composition that is MCT is 50% kCal contribution.

[0037] In a particularly preferred embodiment where the critically ill patient is not receiving high fat sedatives, the percentage of kCal from total fat, protein and carbohydrates in the nutritional composition that is MCT is 57% kCal contribution.

[0038] As a weight percentage (proportion of (total) fat, protein, and carbohydrate), the amount of MCT in the nutritional composition is at least about 30% by weight of the nutritional composition, preferably at least about 35% by weight. Up to about 55% by weight of the nutritional composition can be MCT. However, in some embodiments, the amount of MCT in the nutritional composition is about 50% by weight or less of the nutritional composition.

[0039] Preferably, the amount of MCTs in the nutritional composition (proportion of (total) fat, protein, and carbohydrates) ranges from about 30% to about 55% by weight, preferably from about 35% to about 50% by weight. In one preferred embodiment, the nutritional composition contains about 38% by weight of MCTs. In another preferred embodiment, the nutritional composition contains about 45% by weight of MCTs.

[0040] Another option for maintaining a ketogenic diet while modifying the amount of MCTs to meet the desired nutritional needs of an individual patient, whether or not receiving high-fat sedation, is to adjust the volume of the nutritional composition administered to the critically ill patient.

[0041] The amount of nutritional composition administered to each critically ill patient is individualized to reflect the patient's clinical condition as well as their body mass index.

[0042] In embodiments in which the critically ill patient is receiving high-fat sedation, the volume of the nutritional composition administered to the critically ill patient is typically at least about 300 mL, preferably at least about 375 mL, and most preferably at least about 450 mL.

[0043] In embodiments in which the critically ill patient is receiving high-fat sedation, the volume of the nutritional composition administered to the critically ill patient may be up to about 800 mL, however, in other embodiments, the volume of the nutritional composition administered to the critically ill patient is about 725 mL or less, e.g., about 650 mL or less.

[0044] In embodiments in which the critically ill patient is receiving a high-fat sedative, the volume of the nutritional composition administered to the critically ill patient typically ranges from about 300 mL to about 800 mL, preferably from about 375 mL to about 725 mL, and most preferably from about 450 mL to about 650 mL. In these embodiments, the nutritional composition supplements the macronutrients the critically ill patient receives from the high-fat sedative.

[0045] In embodiments in which the critically ill patient is not receiving high-fat sedation, the volume of the nutritional composition administered to the critically ill patient is typically at least about 600 mL, preferably at least about 675 mL, and most preferably at least about 750 mL.

[0046] In embodiments in which the critically ill patient is not receiving high-fat sedation, the volume of the nutritional composition administered to the critically ill patient can be up to about 1400 mL, however, in other embodiments, the volume of the nutritional composition administered to the critically ill patient is about 1325 mL or less, e.g., about 1250 mL or less.

[0047] In embodiments in which the critically ill patient is not receiving high-fat sedation, the volume of the nutritional supply composition administered to the critically ill patient typically ranges from about 600 mL to about 1400 mL, preferably from about 675 mL to about 1325 mL, and most preferably from about 750 mL to about 1250 mL. In these embodiments, the nutritional supply composition provides at least a majority, e.g., all, of the macronutrients provided to the critically ill patient. Thus, the amount of nutritional supply composition administered to a critically ill patient not receiving high-fat sedation is typically greater than the amount administered to a critically ill patient receiving high-fat sedation.

[0048] In an alternative embodiment in which a critically ill patient is receiving a high-fat sedative, the percentage of total fat in the nutritional feeding composition that is MCT ranges from about 40% to about 50% kCal contribution. In a particular alternative embodiment in which a critically ill patient is receiving a high-fat sedative, the percentage of total fat in the nutritional feeding composition that is MCT is 47% kCal contribution.

[0049] In other alternative embodiments, the percentage of total fat that is MCTs ranges from about 60% to about 90% by kCal contribution, for example, from about 65% to about 85% by kCal contribution. These embodiments are alternative embodiments for patients not receiving high-fat sedatives. In an alternative embodiment in which the critically ill patient is not receiving high-fat sedatives, the percentage of total fat in the nutritional feeding composition that is MCTs ranges from about 70% to about 80% by kCal contribution. In a particular alternative embodiment in which the critically ill patient is not receiving high-fat sedatives, the percentage of total fat in the nutritional feeding composition that is MCTs is 75% by kCal contribution.

[0050] In a preferred embodiment, the fat and MCT sources used in the nutritional composition include K.Quik™ (formerly BETAQUIK™) and / or FRESUBIN™ 5 kcal Shot. The amounts of energy and macronutrients present in K.Quik™ and FRESUBIN™ are provided in Table 1.

[0051] [Table 1]

[0052] The MCTs in K.Quik™ are derived from coconut oil and palm kernel oil.

[0053] The LCT in FRESUBIN™ 5 kcal Shot is derived from rapeseed oil.

[0054] The composition also contains protein. Protein is a macronutrient composed of amino acids and is derived from both animal and plant sources. The amount of protein required by critically ill patients fed nasogastrically is based on the individual patient's weight and is typically 0.88 to 1.25 grams per kilogram per day. The amount of protein required in a nutritional feeding composition is also determined by its kcal contribution.

[0055] The amount of protein in the nutritional composition is at least about 5% by kCal contribution of the nutritional composition, preferably at least about 10% by kCal contribution.

[0056] Up to about 35% of the kCal contribution of the nutritional composition is protein. However, in some embodiments, the amount of protein in the nutritional composition is about 30% or less of the kCal contribution of the nutritional composition.

[0057] The amount of protein in the nutritional composition ranges from about 5% to about 35% by kCal contribution, preferably from about 10% to about 30% by kCal contribution. In one embodiment, the nutritional composition comprises about 20% protein by kCal contribution. In another embodiment, the nutritional composition comprises about 26% protein by kCal contribution.

[0058] As a weight percentage (proportion of (total) fat, protein, and carbohydrate), the amount of protein in the nutritional composition is typically at least about 25% by weight of the nutritional composition, preferably at least about 30% by weight. Up to about 50% by weight of the nutritional composition can be protein. However, in some embodiments, the amount of protein in the nutritional composition is about 45% by weight or less of the nutritional composition.

[0059] The amount of protein in the nutritional feeding composition (proportion of (total) fat, protein, and carbohydrate) typically ranges from about 25% to about 50% by weight, preferably from about 30% to about 45% by weight. In one preferred embodiment, the nutritional feeding composition contains about 33% by weight of protein. In another preferred embodiment, the nutritional feeding composition contains about 41% by weight of protein.

[0060] In a preferred embodiment, the source of protein used in the nutritional composition is RENAPRO™ Shot, which contains bovine collagen peptides. The amounts of energy and macronutrients present in RENAPRO™ are provided in Table 2.

[0061] [Table 2]

[0062] The nutritional composition also includes carbohydrates. Preferably, the nutritional composition includes carbohydrates in a relatively small amount compared to fat and protein in order to provide a ketogenic diet, i.e., the amount of carbohydrates is preferably less than the amount of fat and protein in the nutritional composition.

[0063] Preferably, carbohydrate sources that can be used alone or in combination in the composition include polysaccharides, oligosaccharides, disaccharides, and monosaccharides. Particularly preferred types of carbohydrates are monosaccharides, such as glucose. In one embodiment, the carbohydrate source in the nutritional composition includes Super Soluble Maxijul™, which contains dried glucose syrup.

[0064] The amounts of energy and macronutrients present in Super Soluble Maxijul™ are provided in Table 3.

[0065] [Table 3]

[0066] Carbohydrates are present in an amount of up to about 10% kCal contribution of the nutritional feeding composition, more preferably up to about 8% kCal contribution of the nutritional feeding composition, and most preferably up to about 6% kCal contribution of the nutritional feeding composition. In one preferred embodiment, the nutritional feeding composition comprises about 5% kCal contribution of carbohydrates. In another preferred embodiment, the nutritional feeding composition comprises about 3% kCal contribution of carbohydrates.

[0067] As a weight percentage (proportion of (total) fat, protein, and carbohydrate), carbohydrates are preferably present in an amount of up to about 15% by weight of the nutritional feeding composition, more preferably up to about 13% by weight of the nutritional feeding composition. In one preferred embodiment, the nutritional feeding composition comprises about 9% by weight carbohydrates. In another preferred embodiment, the nutritional feeding composition comprises about 11% by weight carbohydrates.

[0068] In one particularly preferred embodiment according to the first aspect, the nutritional composition comprises about 70% to about 75% fat by kCal contribution (of which about 70% to about 76% kCal contribution is MCT), about 20% to about 26% protein by kCal contribution, and about 3% to about 5% carbohydrate by kCal contribution.

[0069] As weight percentages (proportion of (total) fat, protein, and carbohydrate), the nutritional composition comprises about 50% to about 56% by weight fat, about 38% to about 45% by weight MCTs, about 33% to about 41% by weight protein, and about 9% to about 11% by weight carbohydrates.

[0070] The composition may further comprise micronutrients, including vitamins, minerals and / or trace elements. Minerals and trace elements may include, but are not limited to, sodium, potassium, chloride, calcium, phosphorus, iron, magnesium and zinc. Vitamins may include, but are not limited to, vitamin A, vitamin B (including B1 (thiamine), B2 (riboflavin), B3 (niacin), B5 (pantothenic acid), B6 ​​(pyridoxine), B7 (biotin), B9 (folic acid) and B12 (cobalamin)), vitamin C, vitamin D, vitamin E and vitamin K.

[0071] Preferably, the nutritional composition is provided to the patient by enteral feeding, meaning that the nutritional composition is fed directly to the gastrointestinal tract. Examples of enteral feeding include providing the nutritional composition via a nasogastric tube (using a thin, flexible tube that passes through the nose, down the back of the throat, and through the esophagus to the stomach) or a gastrostomy tube (a feeding tube that is inserted endoscopically or surgically through the abdominal wall directly into the stomach). The device used for enteral feeding is known as a giving set, which typically includes a feeding tube with an appropriate attachment for connection to a feeding bag. Enteral feeding is advantageous for critically ill patients, as they are usually unable to feed orally due to their condition or equipment such as a ventilator. Most preferably, the nutritional composition is provided via a nasogastric tube.

[0072] Alternatively, the nutritional composition can be provided to the patient via oral administration, for example, as a drink. Embodiments in which the nutritional composition is provided via oral administration are particularly advantageous for patients who are not sedated and have sufficient ability to swallow the nutritional composition. Providing the nutritional composition in this form allows for the nutritional composition to be provided in a less invasive manner, where appropriate.

[0073] Preferably, the nutritional composition is in a flowable liquid state. By providing the nutritional composition in a flowable liquid state, the nutritional composition is suitable for passing through a feeding tube of an administration set, such as a nasogastric tube or a gastrostomy tube. A flowable liquid state also allows the nutritional composition to be administered as a drink. Water may be present in the nutritional composition to form a flowable liquid nutritional composition.

[0074] The amount of water can be up to about 85% by volume of the nutrient feeding composition, more preferably up to about 80% by volume of the nutrient feeding composition, and most preferably up to about 75% by volume of the nutrient feeding composition.

[0075] The nutritional composition is preferably continuously delivered. The rate of continuous delivery is determined by the individual patient's weight, with a target delivery rate of 25 kcal per kilogram per day. Typically, the delivery rate of the nutritional composition is a maximum of about 70 mL per hour to about 80 mL per hour. When critically ill patients in the ICU are transferred for a period of time for medical scans, procedures, and / or surgery, it is often not possible to provide the patient with the nutritional composition. In such situations, patients can receive the maximum amount of the nutritional composition upon their return to the ICU, which is achieved by administering the nutritional composition at an increased rate to reach the patient's daily target kcal.

[0076] Alternatively, the nutritional composition is delivered intermittently as boluses. When the boluses are delivered orally, the boluses are preferably delivered in the form of a drink.

[0077] In embodiments in which the nutritional feeding composition is provided as a bolus or as a drink, the nutritional feeding composition is preferably provided to the patient three to six times daily. In these embodiments, the amount of nutritional feeding composition provided is also determined by the individual patient's weight, with a target nutritional feeding rate of 25 kCal per kilogram per day.

[0078] Examples of less preferred nutrient feed compositions are provided in Tables 4 and 5.

[0079] [Table 4]

[0080] [Table 5]

[0081] According to a second aspect of the present invention, there is provided a method for preparing a nutrient-supplying composition, comprising the steps of: mixing a nutritional composition according to the first aspect of the present invention in a container; and as needed decanting the mixture into a feeding bag wherein the nutritional supply bag is optionally provided with the administration set.

[0082] The nutritional composition may be used immediately after preparation or may be stored at a temperature between 0°C and 5°C until needed for nutritional provision.

[0083] A method for preparing a nutritional feeding composition according to the second aspect is provided, comprising mixing 40% to 65% by weight of fat, 25% to 50% by weight of protein, and up to 15% by weight of carbohydrates in a container, and optionally decanting the mixture into a nutritional feeding bag, which optionally accompanies an administration set. The nutritional feeding composition may be used immediately after preparation or may be stored at a temperature of 0°C to 5°C until needed for nutritional feeding.

[0084] Without wishing to be bound by any theory, the inventors believe that the ketones induced by MCTs in the ketone nutritional composition provide cells with an alternative substrate for energy production instead of protein. Carbohydrate metabolism switches to anaerobic mode during severe illness via the Pasteur effect, which produces less adenosine triphosphate (ATP). Fatty acid beta-oxidation, the process by which fatty acids are broken down to produce energy, is disrupted.

[0085] Features described in connection with one aspect of the invention may be used in combination with any aspect of the invention. DETAILED DESCRIPTION OF THE INVENTION

[0086] The invention will now be illustrated by the following non-limiting examples.

[0087] Example 1 – Patient receiving propofol The percentages of kCal contribution and weight percentages of total fat, MCT, protein, and carbohydrate in exemplary nutritional feeding compositions according to the present invention for patients receiving propofol are provided in Tables 6 and 7.

[0088] [Table 6]

[0089] In Table 6, the % kCal contribution of the combined (total) fat, protein, and carbohydrate is equal to 100% kCal contribution. The % kCal contribution of MCT as a percentage of total fat is 70%, i.e., 70% of the fat kCal contribution comes from MCT. The % kCal contribution of MCT as a percentage of total kCal from (total) fat, protein, and carbohydrate is 49.5%, i.e., 49.5% of the total kCal of the nutritional supply comes from MCT. If a patient receives an average daily volume of 367 mL of propofol, 46% of the fat kCal contribution comes from MCT, i.e., the amount of MCT the patient receives together from the nutritional supply composition and propofol has a kCal contribution of 46%.

[0090] [Table 7]

[0091] In Table 7, the combined weight percent of (total) fat, protein, and carbohydrates equals 100% by weight. Thus, the combined weight percent of (total) fat, protein, and carbohydrates excludes other components in the nutritional composition, such as water. The weight percent of MCT is not a percentage of the weight percent of total fat, but instead is a percentage of the weight percent of the combined weight percent of (total) fat, protein, and carbohydrates. The water content is approximately 70% by volume.

[0092] The ingredients used to obtain the nutritional feeding compositions in Tables 6 and 7 are provided in Table 8. In the ICU food pantry, the ingredients were measured into measuring cups and mixed together in the cups using sterile spoons. The resulting compositions were then transferred into nutritional feeding bags provided with the administration sets and stored in the refrigerator until needed.

[0093] [Table 8]

[0094] The total volume of the nutritional composition is 561 mL.

[0095] Example 2 - Patient not receiving propofol The percentages of kCal and weight percentage contributions of total fat, MCT, protein, and carbohydrates in exemplary nutritional feeding compositions according to the present invention for patients not receiving propofol are provided in Tables 9 and 10.

[0096] [Table 9]

[0097] In Table 9, the combined % kCal contribution of (total) fat, protein, and carbohydrate is equal to 100% kCal contribution. The % kCal contribution of MCTs as a percentage of total fat is 75.5%, i.e., 75.5% of the fat kCal contribution comes from MCTs. The % kCal contribution of MCTs as a percentage of total kCal from (total) fat, protein, and carbohydrates is 57.1%, i.e., 57.1% of the total kCal of the nutrient supply comes from MCTs.

[0098] [Table 10]

[0099] In Table 10, the combined weight percent of (total) fat, protein, and carbohydrates equals 100% by weight. Thus, the combined weight percent of (total) fat, protein, and carbohydrates excludes other components in the nutritional composition, such as water. The weight percent of MCT is not a percentage of the weight percent of total fat, but instead is a percentage of the weight percent of the combined weight percent of (total) fat, protein, and carbohydrates. The water content is approximately 70% by volume.

[0100] The ingredients used to obtain the nutrient-feeding compositions in Tables 9 and 10 are provided in Table 11. The compositions were prepared as in Example 1.

[0101] [Table 11]

[0102] The total volume of the nutrient feeding composition is 1003 mL.

[0103] The nutritional feeding compositions of Examples 1 and 2 were provided to a group of 29 ICU patients to meet an individualized target nutritional feeding rate of 25 kcal per kilogram per day. Patients receiving propofol were provided with the composition of Example 1, while patients not receiving propofol were provided with the composition of Example 2. Any changes to the patient's daily routine, such as medical scans, treatments, or surgeries, were recorded, and the nutritional feeding rate was subsequently increased as a "maximum" to achieve the target daily calorie intake. The amount of nutritional feeding composition administered to each patient per day was monitored and averaged to provide nutritional feeding compositions for future use. The nutritional feeding compositions were found to place the patients in a state of ketosis.

[0104] Table 12 shows the mean (from upper and lower levels) % kCal contribution of MCT administered to patients over a 10-day period. Patients received the nutritional feeding composition while also receiving propofol. The dose of propofol was reduced over a 10-day period. The mean (from upper and lower levels) % kCal contribution of MCT value is the amount of MCT as a % of the fat kCal contribution that the patient received from the nutritional feeding composition and propofol together. The % kCal contribution of MCT was increased from a mean kCal contribution of 44.41% to a mean kCal contribution of 73.96%, while monitoring the patients to ensure that the % kCal contribution of MCT was safe, well-tolerated, and feasible for administration to a critically ill population. After monitoring the patients, the % kCal contribution of MCT administered to the patient group was determined to be safe.

[0105] [Table 12]

[0106] Aspects of the present invention include the following.

[0107] #1. A nutritional composition comprising 60%-90% fat by kcal contribution, 5%-35% protein by kcal contribution, and up to 10% carbohydrate by kcal contribution for use in the treatment and / or prevention of muscle wasting in critically ill patients.

[0108] #2. A nutritional composition according to #1, wherein the composition is suitable for oral administration and / or enteral nutritional feeding, for example via gastrostomy or nasogastric administration.

[0109] #3. A nutritional composition according to either #1 or #2, wherein the patient is an adult.

[0110] #4. The nutritional composition of any preceding embodiment, comprising 75% fat by kCal contribution.

[0111] #5. The nutritional composition of any of the preceding aspects, wherein the fat comprises medium chain triglycerides.

[0112] #6. A nutritional composition as described in #5, wherein the percentage of fat containing medium chain triglycerides is preferably 25% to 90% kcal contribution, more preferably 35% to 60% kcal contribution, and most preferably 40% to 55% kcal contribution.

[0113] #7. The nutritional composition of #5, wherein the proportion of fat containing medium chain triglycerides is 60% to 90% in terms of kcal contribution, preferably 65% ​​to 85% in terms of kcal contribution.

[0114] #8. The nutritional composition of #5, wherein the percentage of fat containing medium chain triglycerides is 47% in terms of kcal contribution.

[0115] #9. The nutritional composition of #5, wherein the proportion of fat containing medium chain triglycerides is 75% in terms of kcal contribution.

[0116] #10. The nutritional composition of any preceding embodiment, comprising 20% ​​protein by kCal contribution.

[0117] #11. The nutritional composition of any preceding embodiment, comprising 5% carbohydrates by kCal contribution.

[0118] #12. The nutritional composition of any of the preceding aspects, further comprising a micronutrient selected from vitamins, minerals, and trace elements.

[0119] #13. A nutritional composition containing 75% fat by kCal contribution, 20% protein by kCal contribution, and 5% carbohydrate by kCal contribution.

[0120] #14. The nutritional composition of #13, wherein the fat comprises a medium-chain triglyceride.

[0121] #15. A nutritional composition as described in #14, wherein the proportion of fat containing medium chain triglycerides is 47% in terms of kCal contribution.

[0122] #16. A nutritional composition as described in #14, wherein the proportion of fat containing medium chain triglycerides is 75% in terms of kCal contribution.

[0123] #17. Mixing in a container 60% to 90% fat by kCal contribution, 5% to 35% protein by kCal contribution, and up to 10% carbohydrate by kCal contribution, and optionally decanting the mixture into a feeding bag wherein the feeding bag is optionally provided in an administration set.

[0124] #18. The method according to #17, further comprising storing the mixture at a temperature between 0°C and 5°C.

[0125] #19. A nutritional composition comprising 9% to 21% by weight of fat, 6% to 17% by weight of protein and up to 5% by weight of carbohydrates for use in the treatment and / or prevention of muscle wasting in critically ill patients.

[0126] #20. A nutritional composition according to #19, containing 15% or 17% fat by weight.

[0127] #21. A nutritional composition described in any one of #19 to #20, wherein the fat comprises a medium-chain triglyceride.

[0128] #22. A nutritional composition according to #21, comprising 8% to 18% by weight of medium-chain triglycerides.

[0129] #23. A nutritional composition according to either #21 or #22, comprising 12% or 14% by weight of medium-chain triglycerides.

[0130] #24. A nutritional composition described in any one of #19 to #23, containing 10% or 13% protein by weight.

[0131] #25. A nutritional composition described in any one of #19 to #24, containing 3% by weight of carbohydrates.

Claims

1. 1. A nutritional composition for use in the treatment and / or prevention of muscle wasting in critically ill patients, comprising 60% to 90% fat by kCal contribution, 5% to 35% protein by kCal contribution and up to 10% carbohydrate by kCal contribution, the fat comprises medium-chain triglycerides and long-chain triglycerides; the proportion of fat containing medium chain triglycerides is between 25% and 90% by kCal contribution; A nutritional composition wherein the long chain triglycerides are derived from a plant source.

2. 2. The nutrient supply composition of claim 1, wherein the plant source is rapeseed oil.

3. 3. A nutritional composition according to claim 1 or 2, wherein the fat has a kCal contribution of between 65% and 85%, preferably between 70% and 80% kCal contribution.

4. 4. A nutritional composition according to any one of claims 1 to 3, wherein the proportion of fat comprising medium chain triglycerides is between 55% and 90% kCal contribution, preferably between 60% and 85% kCal contribution.

5. 5. The nutritional composition of any one of claims 1 to 4, wherein the protein has a kCal contribution of 10% to 30%.

6. A nutritional composition according to any one of claims 1 to 5, wherein the carbohydrates have a maximum kCal contribution of 8%, preferably a maximum kCal contribution of 6%.

7. 7. The nutritional composition according to any one of claims 1 to 6, further comprising a micronutrient selected from vitamins, minerals and trace elements.

8. A nutritional composition according to any one of claims 1 to 7, wherein the composition is suitable for oral administration and / or enteral nutritional feeding, for example via gastrostomy or nasogastric administration.

9. The nutritional composition according to any one of claims 1 to 8, wherein the patient is an adult.

10. The nutritional composition of any one of claims 1 to 9, wherein the patient is receiving high-fat sedatives.

11. The nutritional composition of any one of claims 1 to 9, wherein the patient is not receiving high-fat sedatives.

12. Contains 70% kCal contribution from fat, 26% kCal contribution from protein, and 3% kCal contribution from carbohydrates, 12. A nutritional composition according to any one of claims 1 to 11, wherein the proportion of fat comprising medium chain triglycerides is 70% by kCal contribution.

13. Contains 75% fat by kCal contribution, 20% protein by kCal contribution, and 5% carbohydrate by kCal contribution; 13. A nutritional composition according to any one of claims 1 to 12, wherein the proportion of fat comprising medium chain triglycerides is 76% by kCal contribution.

14. Mixing the nutritional composition according to any one of claims 1 to 13 in a container; and as needed A method of preparing a feeding composition comprising the step of decanting the mixture into a feeding bag, said feeding bag optionally being included in an administration set.

15. 15. The method of claim 14, further comprising storing the mixture at a temperature between 0°C and 5°C.

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