FORMULAZIONE ALIMENTARE CHETOGENICA

Description

International Class: A23L 000 / 0000 Description of the invention entitled: "KETOGENIC FOOD FORMULATION" in the name of DR. SCHÄR SPA of Italian nationality with registered office in 5 Winkelau, 9 – 39014 POSTAL (BZ) dep. the at no. * * * * * SCOPE OF APPLICATION The embodiments described herein refer to formulations and 10 Ketogenic Food Products, Examples but Not Limited to be used with a limited extent by individuals affected by particular conditions physiological and / or pathological conditions, based on which they may be recommended and advantageous particular dietary regimes characterized by a low-carb. In particular, embodiments here 15 described refer to a food formulation and a product food obtainable through said food formulation for use in the ketogenic diet. STATE OF THE ART The ketogenic diet is a nutritional intervention capable of inducing 20 the organism to preferentially activate the metabolism of fats, to from which ketogenic bodies are synthesized, in particular beta hydroxybutyrate (BHB), acetoacetate (AcAc) and acetone, which, in certain conditions, are metabolized by the body as an alternative to glucose and used as the main energy source. In order for them to be 25 products ketogenic bodies in high quantities it is necessary that the intake of carbohydrates, and more specifically sugars, are significantly reduced. This is why the ketogenic diet is characterized by a high fat content, a normal protein intake and a low carbohydrate content, characteristics that are described by the ratio 5 ketogenic, i.e. the weight ratio between grams of fat and the sum of grams of carbohydrates and proteins (Wirrell, 2008). There are known food products that meet the ketogenic ratio and which can be consumed by individuals following the diet ketogenic. A ketogenic diet with a high ketogenic ratio 10 (e.g. 4:1) induces on average a higher production of bodies ketogenic and is associated, for example in the case of epilepsy drug-resistant, with greater antiepileptic efficacy. Conversely, a diet with a high fat content may be unpleasant to eat, therefore a ketogenic diet with a lower ketogenic ratio (e.g. 15 example 1.5-3:1) appears to be better tolerated (Hee Seo et al., 2007) and therefore easier to follow. The level of ketosis generally achieved during the ketogenic diet, called nutritional ketosis, ranges from 0.5 mM at 8 mM blood ketogenic bodies (Saris & Timmers, 2022); the onset and maintenance of nutritional ketosis correlates with 20 the clinical efficacy of the ketogenic diet (Kossoff et al., 2018), which is followed for long periods of time by patients. The ketogenic diet was initially used in the treatment of drug-resistant epilepsy, but over the years it has been studied for the treatment of other diseases such as Alzheimer's, Parkinson's, diabetes 25 type II, some types of cancer, obesity (Dowis & Banga, 2021), multiple sclerosis multiple (Storoni & Plant, 2015), migraine (Caminha et al., 2022), rheumatoid arthritis (Ciaffi et al., 2021). Ketogenic foods, such as those described in the International Application WO 2021 / 111483 A1 in the name of the Applicant, 5 are mainly made up of fats, proteins and fibres, while the carbohydrates, a source of sugars, are significantly reduced (< 8%). These characteristics make these foods suitable to be integrated into of the ketogenic diet plan. In ketogenic foods, the use of non-fatty carbohydrates is preferred. 10 digestible as resistant starches, fibres or cellulosic substances traditional complex carbohydrates or simple sugars. In particular, the fibers do not induce an increase in blood sugar since which are not metabolised by the body, but pass through the tract gastrointestinal and are excreted (non-fermentable fibers) or are 15 used by the intestinal microbiota for the production of fatty acids short chain (fermentable fibers); this means that the fibers present in the ketogenic products do not have an adverse effect on weight gain of ketosis. The technological properties of the fibres influence the characteristics of the 20 foods in which they are used. Among the most notable properties technological impact on products, for example, solubility, viscosity, the ability to form gels, the ability to retain water or oil. The presence of specific fibres can therefore have an influence on the texture of the finished product, can help stabilize a food, can 25 help to suspend solids in an aqueous product or influence the perception of the taste of a food (AL Nelson, High - fiber ingredients, 2001, Eagan press handbook series, chapters 2 and 5). The technological properties of the fibres, combined with the fact that they are not assimilated by the body and do not induce an increase in blood sugar levels, the 5 therefore make them suitable for use in ketogenic formulations. Another ingredient that can be used in formulations ketogenic is erythritol, a polyalcohol with sweetening power which, after having been ingested, it is excreted in the urine without being metabolized and consequently has no impact on ketosis (Hiele et al., 1993) and on 10 blood sugar. MCT fats (Medium Chain Triglycerides), medium chain triglycerides with a number of carbon atoms ranging from 6 to 12, they are particularly suitable for use in ketogenic formulations in how quickly they are able to induce an increase in 15 ketosis. This is related to the fact that MCTs pass directly into the portal vein and reach the liver where, in the absence of glucose and insulin, can be metabolized to ketogenic bodies. MCTs are therefore in able to increase ketosis and reduce the time to reach it compared to to other fats when included in a ketogenic diet regimen (Harvey et 20 al., 2018), but also to induce a state of moderate nutritional ketosis (0.5-1 mmol / L of ketogenic bodies) when used as supplements to the diet (about 10-20 g of MCTs, even in the presence of carbohydrates). in this last case, the duration of MCT-induced ketosis lasts for 4-5 hours (Vandenberghe et al., 2020). MCTs are naturally contained 25 in vegetable fats, such as coconut and palm fat, or they are contained in synthetic fats, definable as pure MCTs, specially developed to provide a high content of only these triglycerides. Both of these sources of MCTs can be contained in ketogenic formulations. 5 Foods, including those defined as ketogenic, have a matrix food can be defined as the set of interactions between the components of the formulation. These interactions occur at different levels and induce the formation of specific macro- and micro-structures within of the food itself. During digestion, the matrix modulates the effects 10 of the different nutrients making them more or less available to the body (Capuano & Janssen, 2021), thus acting on bioaccessibility of nutrients (fraction released during digestion) and bioavailability of the same (fraction actually absorbed and available for the organism) (Aguilera, 2019). At a technological level therefore, the ingredients 15 and the matrix of a certain product can be selected and studied for to optimally and gradually release a nutrient that has as its purpose ultimately a positive impact on the consumer's health. A way to get increased ketosis without having to following the ketogenic diet is represented by the use of bodies 20 exogenous ketogenics, mainly in the form of esters or salts carried in formulations to be taken in a free diet regime (Stubbs et al., 2017). Over the past few decades, several types of ketogenic bodies have been developed exogenous: hydroxybutyrate esters (Clarke et al., 2012), salts hydroxybutyrate (Stefan et al., 2020); butanediol esters (Stubbs et 25 al., 2023), tris-hydroxybutyrate glyceryl ester (International Application No. WO 2021 / 070208 A1 on behalf of the Applicant). Once ingested, the salts exogenous ketogenic bodies directly release BHB in a independent enzyme, while the esters of exogenous ketogenic bodies are hydrolyzed by esterases and carboxylesterases releasing BHB or 5 precursors of BHB (such as butanediol) that are assimilated by the body by increasing ketosis in a dose-dependent manner dependent (Clarke et al., 2012). In particular, ketogenic bodies consisting of a glycerol skeleton to which they are esterified by a three molecules of BHB are processed by endogenous lipases. Most 10 some lipases, also known as carboxylesterases, are able to hydrolyze preferentially or exclusively the groups present in the external positions of a triglyceride, i.e. those linked to the first and third carbon of the glycerol skeleton. Some lipases are able to act on each of the three carbon atoms of glycerol, thus also carrying 15 to the hydrolysis of the group present in the second carbon. Although these lipases lead to a complete hydrolysis of the triglyceride, the kinetics of reaction involving positions 1 and 3 is much faster than the one involving position 2 (Park & ​​Park, 2022). Several experiments have been conducted to measure the kinetics of 20 ketosis induced by different ketogenic bodies at different concentrations, such as reported in Table 1 of Figure 1. In general, the course of ketosis after the ingestion of monoesters of exogenous ketogenic bodies is characterized by an initial peak (within first 15-120 minutes), followed by a progressive reduction of the bodies 25 blood ketogenics. Nutritional ketosis is then maintained at maximum for a few hours (1-6 hours), with a corresponding limited window at ketosis values ​​greater than 2 mM. Salts from exogenous ketogenic bodies reach a lower peak of ketosis than esters and ketosis has a even more limited duration in time (about 2.5 hours). This limits 5 significantly the use of monoesters and salts of ketogenic bodies exogenous in case it is necessary to maintain sustained ketosis and prolonged over time, for example as a replacement for a ketogenic diet, as products containing these molecules, notoriously low palatable and very expensive, they should be taken many times during the 10 day or, in the case of exogenous ketogenic body salts, would lead to an overload of cations such as sodium, potassium and magnesium (Daines, 2021). It should be noted that the experiments cited in Table 1 of Figure 1 analyze the kinetics of ketosis induced by ketogenic bodies ingested at which or at most inserted in very simple formulations. It therefore remains 15 the need to extend the duration of the ketosis, which is linked both to the way in which the various bodies exogenous ketogenics are hydrolyzed and metabolized, both at formulation in which these molecules are incorporated. Currently no formulations have been developed that can guarantee a slow 20 release of ketogenic bodies. A second downside of formulations with ketogenic bodies exogenous, particularly those containing BHB monoesters, It concerns their flavour: in fact, they are characterised by a bitter taste (Bolyard et al., 2023) which can limit its use, especially if you want 25 achieve high doses of ketogenic bodies. In the question International WO 2011 / 101171 A1, to overcome the taste problem bitterness of ketogenic bodies is mentioned the use of substances flavorings, such as licorice, coffee, chocolate, blueberry, from add to the formulation containing exogenous ketogenic bodies for 5 make it organoleptically acceptable. In the same question Internationally, other components are also mentioned which are suitable for improve the sensory perception of the formulation, for example gums, emulsifiers, stabilizers and the like to obtain the texture desired, or an adsorbent material, such as a protein, which is 10 pharmaceutically acceptable and possibly also provides a function nutritional; furthermore the possibility of encapsulating the body is mentioned exogenous ketogenic. In another International application (WO 2020 / 185368 A1), a formulation containing bodies is described exogenous ketogenics made palatable, i.e. organoleptically acceptable, 15 thanks to the use of propylene glycol, ethanol, water, natural flavor or synthetic, a high-potency sweetener and a masking agent bitterness. Despite formulation methods aimed at reducing the perception of bitterness already exposed in the documents mentioned above, is the sensory limit of products containing bodies is still present 20 exogenous ketogenics (Bolyard et al., 2023). The main products containing exogenous ketogenic bodies currently present on the market are composed of a limited number of ingredients: esters or salts of ketogenic bodies, in concentrations of approximately 15-20% of the formulation, natural flavors or extracts with flavoring function, 25 natural or artificial sweeteners, polyols and acidifiers, stabilizers, vitamins. These products, developed as ready-to-drink liquids or as powders to be reconstituted with water, they are used as supplements with the aim of improving athletic performance in sports or to improve attention or some cognitive faculties in 5 general population mediated by the intake of approximately 10-20 g of bodies exogenous ketogenics per day. In analogy with the numerous applications of the ketogenic diet, in the potential use of exogenous ketogenic bodies has been studied for years various pathologies, such as neurodegenerative diseases (Mild 10 Cognitive Impairment, Alzheimer's, Parkinson's, Lateral Sclerosis Amyotrophic lateral sclerosis (ALS) (Poff et al., 2021)), cardiovascular diseases (Berg- Hansen et al., 2023), diabetes (Falkenhain et al., 2022). However, the products known to date have the disadvantage of not being formulated to maintain a prolonged ketosis over time as the progression of ketosis is 15 linked exclusively to the hydrolysis and metabolism of monoesters of exogenous ketogenic bodies and the dissociation of ketogenic body salts exogenous and in the formulations there are no ingredients that induce a controlled release of the ketogenic body from the food matrix. In in addition to this, the dosage indication of products containing bodies 20 exogenous ketogenic is one or two servings per day in a diet regime normal, therefore with a very limited dosage and without restriction of carbohydrates and sugars, the main limiting agents of ketosis. This does not allows you to reach sufficient and constant ketosis over time of the entire day necessary for the treatment of many pathologies. 25 administering a greater number of servings per day would be extremely difficult due to the poor palatability of these products and of their high cost. There are currently no products on the market with ketogenic bodies exogenous also containing macronutrients, fibers and possibly others 5 ingredients, such as MCT, which are able to ensure a release gradual over time of exogenous ketogenic bodies and to promote the production endogenous of the same, which can be defined as products ketogenic, which are nutritionally balanced and which have good organoleptic properties. 10 There is therefore a need to refine formulations and products ketogenic foods that can overcome at least one of the drawbacks of the technique. To overcome the drawbacks of the known art and to obtain these and further purposes and advantages, the Applicant has studied, experimented and 15 realized the present invention. EXHIBITION OF THE FINDING The present invention is expressed and characterized in the claims independent. Dependent claims exhibit other characteristics of the present invention or variants of the main solution idea. 20 In accordance with the above purposes, embodiments described herein are refer to ketogenic food formulations and products, that is, suitable for the use in the ketogenic diet, which exceed the limits of the known art and eliminate the defects present in it. In accordance with embodiments, a food formulation 25 ketogenic includes fats and fiber, possibly carbohydrates and proteins, wherein said formulation comprises di- and polyesters of bodies exogenous ketogenics, particularly di- and polyester esters of beta-hydroxybutyrate (BHB), medium-chain triglycerides (MCTs), and fiber. According to embodiments, the formulation features a ratio 5 ketogenic, defined by the weight ratio of grams of fat to the sum of grams of carbohydrates and proteins, which promotes increased ketosis blood. In embodiments, the formulation, or the product food made with it, can have a ketogenic ratio of 10 at least 1:1, meaning that the ketogenic ratio can be 1:1 or greater than 1:1, e.g. 1.5:1, 2:1, 2.5:1 3:1, 3.5:1 4:1, 4.5:1, 5:1 or even more, including further intermediate values ​​between these ratios. In embodiments the above formulation prolongs the time of release of BHB from di- and polyesteresters of beta-hydroxybutyrate (BHB) by 15 of endogenous lipases and production of endogenous ketogenic bodies from MCTs at the gastric and / or intestinal level and consequently increases ketosis blood, in which the release and production of ketogenic bodies are prolonged also from the presence of fibres. According to embodiments, the di- and polyesters of ketogenic bodies 20 exogenous include for example glycerol esters of BHB, mixtures of BHB glycerol esters, BHB esters and fibers, BHB esters and amino acids, BHB and inositol esters, BHB and malic acid esters, BHB and carnitine esters. A possible example is tris-hydroxybutyrate glyceryl ester (T-BiB). 25 According to embodiments, the fibers are soluble fibers, fibers insoluble or their combination. According to embodiments, the fibers comprise bamboo fiber and / or psyllium fiber. According to embodiments, bamboo fiber and psyllium fiber are 5 present in said formulation in a reciprocal weight ratio of 0.5:1 to 10:1, e.g. 3:1, 3.1:1, 3.2:1, 3.3:1; 3.4:1, 3.5:1, 3.6:1, 3.7:1, 3.8:1, 3.9:1, 4:1. According to embodiments, the formulation comprises fats containing MCTs as a source of said MCTs, in particular coconut fat 10 and / or palm fat or pure MCTs. According to embodiments, the formulation comprises pure MCTs or fats containing MCTs from 2% to 35% by weight of the formulation. According to embodiments, the formulation has a weight ratio di- and polyester esters of BHB and MCT from 0.5:1 to 5:1. 15 According to embodiments, the formulation further comprises, one or more of polyols and / or ingredients with sensory action. According to embodiments, the polyols include erythritol. According to embodiments, the formulation described herein may include di- and polyester esters of beta hydroxybutyrate (BHB), e.g. tris- 20-hydroxybutyrate glyceryl ester (T-BiB), medium-chain triglycerides (MCT), bamboo and psyllium fibers and erythritol. According to embodiments, the ingredients with sensory action include one or more of sweeteners, flavorings, minerals and elements in traces, bitter masking agents. 25 According to embodiments, the formulation comprises di- and poly- beta-hydroxybutyrate (BHB) esters up to 35% by weight of the formulation. For example, di- and polyester esters of beta hydroxybutyrate can be envisaged. (BHB) from 5% to 25% by weight of the formulation in case the formulation 5 either in gel or cream form. In another example, it may be provided for- and beta-hydroxybutyrate (BHB) polyester esters up to 35% by weight of the formulation in case the formulation is in the form of a powder reconstitute with water. According to embodiments, the formulation described herein is for 10 use in the treatment of one or more epilepsies, including epilepsy drug-resistant, metabolic diseases (e.g. GLUT 1), disease fatty acid oxidation load (e.g. VL-FAOD), mild cognitive impairment (MCI), Alzheimer's disease, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, migraine, type II diabetes, 15 cancer, obesity, rheumatic diseases such as rheumatoid arthritis, head trauma, refeeding syndrome, autism, syndrome metabolic, chronic obstructive pulmonary disease (COPD), diseases chronic inflammatory bowel diseases (e.g. Crohn's disease and colitis ulcerative), age-related macular degeneration (AMD). 20 In accordance with embodiments, a food product comprises, or is obtained from, a formulation according to this description. According to embodiments, the food product may be in gel, cream or powder form to be reconstituted with water, in particular 25 powder containing di- and polyesters of the exogenous ketogenic bodies above described, in particular for example tris-hydroxybutyrate glyceryl ester (T- BiB), encapsulated to be reconstituted with water. According to embodiments, the food product may be in liquid product form, capsules, soft capsules, bars, products from 5 oven, ready meals. Another aspect described here is a method for the production of ketogenic formulations which involve mixing fats, carbohydrates and possibly proteins and include in said formulation di- and polyesters of exogenous ketogenic bodies as described here, e.g. tris- 10-hydroxybutyrate glyceryl ester (T-BiB), medium-chain triglycerides (MCT) and fibers. DESCRIPTION OF EMBODIMENTS We will now refer in detail to the various embodiments of the found. Each example is provided for illustration of the finding and 15 is not intended as a limitation of the same. For example, the features illustrated or described as being part of a form of implementation may be adopted on, or in association with, other embodiments to produce a further embodiment. It is understood that this invention will include such modifications and 20 variants. Before describing the embodiments, it is clarified that the present description may be expected to be realized or put into practice in other various ways. It is also clarified that the phraseology and terminology here used is for descriptive purposes and should not be considered limiting. 25 Unless otherwise defined, all technical and scientific terms used here and below have the same commonly understood meaning by a person of ordinary experience in the field of the technique to which the present finding belongs to. Although methods and materials similar or equivalent to those described herein 5 can be used in practice or in tests to verify the This disclosure, the following are described, by way of example, the methods and materials. In case of conflict, this question, including the definitions, shall prevail. The materials, methods and examples are purely illustrative and 10 should not be construed as limiting. Furthermore, all percentages, fractions and ratios between the different components are to be understood as fractions by weight (w / w) with respect to the weight total of the formulation, composition or product, even if not explicitly indicated, unless otherwise indicated. 15 All ranges reported here are inclusive of the extremes, including those that report a range “between” two values, unless otherwise stated indication. Also included in this description are the intervals that arise from the overlapping or union of two or more intervals described, except 20 different indication. Also included in this description are the intervals that can derive from the combination of two or more specific values ​​described, unless otherwise indicated. All percentage ranges given here are given with the 25 forecast that the sum in relation to the overall composition is 100%, unless otherwise stated. Here and in the following of this description, with the expression food formulation can be understood as a recipe, for example, together, mixture, composition or similar of food ingredients which can be 5 ready for consumption or can be used for the production of a food product, such as gel, cream or powder, possibly to be reconstituted with water. Embodiments described herein refer to formulations ketogenic foods, that is, food formulations with a ratio 10 ketogenic promoting ketosis, and therefore for use in the diet ketogenic, including: - exogenous ketogenic bodies that include, or consist of, di- and polyesters of beta hydroxybutyrate (BHB). The possibility of their combination. A possible example is T-BiB: glyceryl tris-hydroxybutyrate 15 ester, or tris-betahydroxybutyrate (T-BiB) which is a ketogenic body exogenous consisting of a glycerol molecule to which three are linked beta-hydroxybutyrate molecules. The molecule contains exclusively R- hydroxybutyrate which, once released from the glycerol molecule by of the endogenous lipases present in the digestive tract, enters the circulation 20 blood and induces an increase in ketosis; - MCT: medium chain triglycerides naturally present in fats vegetable fats (e.g. coconut fat or palm fat) or contained in fats enriched in this lipid fraction. MCTs are absorbed at intestinal level, through the portal vein they enter directly into the liver 25 and can be transformed into ketogenic bodies, thus contributing to the Blood ketosis. Temporarily, BHB is released from the body's hydrolysis. exogenous ketogenic induces an initial increase in ketosis while the bodies ketogenic produced endogenously by the metabolism of MCTs induce a second increase in ketosis; 5 - Fibers: the fibers present in the formulation can be soluble (for example example psyllium fiber) or insoluble (e.g. bamboo fiber) or their combinations and, thanks to their ability to adsorb liquid ingredients and / or oily, have the purpose of slowing down the release of ketogenic bodies exogenous described above and MCT from the formulation, thus prolonging the 10 ketosis. In addition, the fibers included in the formulation have the ability to influence the texture and sensory characteristics of the formulations. The formulations described here are characterized by a ratio ketogenic, defined by the weight ratio of grams of fat to the sum of grams of carbohydrates and proteins. In particular, food formulations 15 described here contain a high amount of fat, a very high amount low in carbohydrates, especially simple sugars, and possibly proteins in order to recreate a ketogenic ratio that favors the increase in blood ketosis. In embodiments, the formulation, or the product 20 food made with it, can have a ketogenic ratio of at least 1:1. In addition to these macronutrients, in the formulations described here one or more ingredients having various functions may be present and which do not inhibit ketosis, such as, in addition to the fibers already mentioned, 25 polyols and ingredients with sensory action. The ingredients with sensory action present in the formulations here described can be for example sweeteners (artificial sweeteners such as sucralose and advantame, polyols such as erythritol), flavours (natural, artificial, extracted), minerals and trace elements, masking agents 5 bitter, also called bitter masking agents or bitter masking agents. The Applicant has developed different types of food formulations in accordance with this description: gel, cream, powder containing the bodies exogenous ketogenics described above encapsulated to be reconstituted with water. Other embodiments of the formulation may be a 10 liquid product, capsules, softgels, bars, baked goods (including for example biscuits, bread, crackers, breadsticks, etc.), ready meals, or formulation for parenteral nutrition. A possible embodiment of the formulation is that of a powdered product containing the exogenous ketogenic bodies described above 15 inserted inside a cap specially designed to be crushed and release the powder into a liquid contained in a bottle or bottle under the cap itself to obtain a liquid ready to use consumption. The products developed can be foods, food for consumption purposes specialty medications, supplements, or nutraceutical products. 20 In embodiments of the formulations described herein, they may contain the exogenous ketogenic bodies described above from 5% to 25% by weight of the formulation. The percentage of exogenous ketogenic bodies above described contained in powder formulations to be reconstituted with water can reach 35% instead. 25 The formulations described here may contain pure MCTs or fats containing MCTs, such as coconut fat, palm fat, palm heart fat, from 2% to 35% by weight of the formulation. The formulations described here may have a weight ratio between the exogenous ketogenic bodies described above and MCTs ranging from 0.5:1 to 5:1. 5 The combined use of exogenous ketogenic bodies described above and MCTs or fats containing MCTs allow you to have a double source of bodies ketogenic: the first mediated by the metabolism of the ketogenic body exogenous, the second mediated by fat metabolism, and in particular of MCTs, which are also transformed into ketogenic bodies. 10 The formulations described here have been developed in order to prolong the release time of BHB from the ketogenic bodies described above and production of endogenous ketogenic bodies from MCTs at gastric level and / or intestinal, and consequently the increase of blood ketosis, thanks to the synergistic action of four elements: 15 - the kinetics of BHB release from the ketogenic body molecule exogenous by endogenous lipases; - the combination of two sources of ketogenic bodies, namely the body exogenous ketogenic described above and MCT fats; - the slow release of ketosis-promoting ingredients by the 20 fibers; - the ketogenic ratio, that is, the ratio favoring ketogenesis, of the formulation. The release of BHB from the ketogenic body described above by the Endogenous lipases involve two steps: initially the 25 ester bonds at position 1 and 3 of glycerol and subsequently is hydrolyzed the ester bond at position 2. This leads to a prolongation of BHB release from the body's glycerol skeleton exogenous ketogenic. Alongside this release of BHB, the production of bodies occurs 5 endogenous ketogenic induced by metabolism at the liver level of MCTs present in the formulation. These two phases of release and production of ketogenic bodies are also prolonged by the presence of fibres in the formulations: thanks to their power to adsorb exogenous ketogenic body and MCT, fibers induce a 10 slow release of these ingredients from the formulation at the tract level gastrointestinal. This implies that the ketogenic body quota exogenous present in the formulation is gradually made available to the endogenous lipases and that the absorption and metabolism of MCTs is prolonged over time. 15 Finally, the fact that the formulations described here are based on the concept of ketogenic ratio creates the ideal conditions to promote induction of ketosis. In fact, the formulations described here can be defined ketogenic products as they contain ingredients that promote ketosis (exogenous ketogenic body, MCT or MCT-containing fats) and 20 ingredients that prevent the rise in blood sugar and insulin (fiber, possibly polyols, and possibly proteins). These formulations can therefore be integrated into a ketogenic diet or diet regime frees promoting the consumer's state of ketosis. Depending on whether these foods are used in a diet regime 25 normal or on a ketogenic diet and depending on the portions and the quantities administered depending on the pathology, the formulations and the products described here allow you to reach a moderate level of ketosis (about 0.5-1 mM) at a high, constant level throughout the day and with controlled oscillations. 5 The formulations described here contain not only ketogenic bodies exogenous but also macronutrients that give the product a contribution non-secondary caloric intake. The products described here therefore become foods nutritionally balanced, covering part of the daily caloric requirement, induce the consumer to reduce 10 the caloric intake from generic foods, which could moderate ketosis. A further new nutritional aspect of the formulations described here concerns the use of macronutrients such as MCTs and fibers that could have additional positive functions beyond direct or indirect elevation 15 of ketosis, such as the reduction of inflammatory conditions or the interaction with the microbiome. In the formulations described here, moreover, it can be favourably reduced perception of the bitter taste of the exogenous ketogenic body thanks to the use of a core of ingredients, in particular including 20 fibres, for example psyllium and bamboo, possibly combined with ingredients with sensory action, e.g. erythritol, sweeteners, flavorings, bitter-masking agents. In addition to a sensorial role, the aforementioned core of ingredients also has a technological effect. It has in fact been studied so that, used in 25 different quantity in the developed products, allows to obtain textures and different product forms. The change in texture of the product allows to further mask the body's perception of the bitter taste exogenous ketogenic in different products. The core ingredients may for example include bamboo fiber and fiber 5 of psyllium, for example in a weight ratio of 0.5:1 to 10:1, to example in particular 3:1. The percentage of total fiber, e.g. bamboo fiber and fiber of psyllium, on the formulation can be from 0.3% to 20% of the formulation to obtain a product of different consistency: semi-liquid 10 gel type a soft cream like yogurt, a thick cream like pudding and other. Using a core amount of ingredients as described above more than 20% of the formulation, possibly added with erythritol, you can get a granulated powder containing ketogenic body 15 exogenous adsorbed to the dry ingredient mixture, which can be coated to give an encapsulated powder to be reconstituted with water or used in baked goods or similar. The use of the formulations thus created allows obtaining dosages of exogenous ketogenic body corresponding to the use of the product as 20 supplement (5-15 g of exogenous ketogenic bodies) and higher dosages, corresponding to a range of 0.5 to 3 g of ketogenic body per kg of body weight per day, for use in foods such as foods for special medical purposes. Another aspect is given by the fact that the fibres, for example bamboo 25 and psyllium, can be used as structuring agents of various formulations described here, for example maintaining the same ratio between the two fibers and only varying their total percentage in the formulation. In addition to this, fibres, such as bamboo and psyllium, can be used within ketogenic formulations without inhibiting 5 the increase of ketosis (they are not metabolized and do not induce a increase in glucose or insulin). The presence of fibers in the different formulations allow to obtain the reduction of taste perception bitterness of the exogenous ketogenic body, as demonstrated by analysis with electronic language and with a panel of trained tasters as described 10 in detail below. As described above, within the formulations there may be also contains ingredients used to improve the sensory profile of formulations with exogenous ketogenic bodies, such as sweeteners low or high intensity, one or more types of flavourings, flavouring agents 15 Bitter masking, minerals and trace elements and similar ingredients. The formulations described here can be used by consumers of different age groups, as well as consumers with different needs. products can in fact target the general population or 20 patients suffering from various pathologies, such as epilepsy, among others including drug-resistant epilepsy, metabolic diseases such as GLUT 1, a disease affecting the oxidation of fatty acids, for example VL-FAOD, mild cognitive impairment (MCI), Alzheimer's disease, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, 25 migraine, type II diabetes, cancer, obesity, rheumatic diseases, ad example rheumatoid arthritis, head trauma, refeeding syndrome, autism, metabolic syndrome, chronic obstructive pulmonary disease (COPD), chronic inflammatory bowel diseases (e.g. Chron and ulcerative colitis), age-related macular degeneration (AMD). 5 EXPERIMENTAL TESTS Characterization of the core ingredients made of bamboo fiber and psyllium The specific surface area of ​​powders is a very important property. important in the formulation of a product as it has different 10 technological implications (for example regarding movement of powders (Bui et al., 2022)) and formulations (for example as regards concerns the dissolution and release of an active ingredient (Bui et al., 2022)) or the ability of a material to hydrate (Włodarczyk-Stasiak & Jamroz, 2009)). In particular, the value of specific surface area can 15 be used to explain the propensity of a material to adsorb a component, such as an active ingredient or a liquid ingredient, and to give a granulate (Sujka & Wiącek, 2024). The analysis of the area specific surface of a material can be done through the technique Brunauer, Emmett and Teller (BET), in which nitrogen is used as 20 test molecule and is put in contact with the solid to be investigated in precise conditions. Through specific equations, it correlates gas adsorption with the presence and size of pores on the surface of the material itself, which determines its surface area specific surface area (Zielinski, 2013). The specific surface area was analyzed 25 of bamboo fiber, psyllium fiber, erythritol and blend of ingredients which includes bamboo fiber and psyllium in a ratio of 3.9:1 and erythritol, defined in this description as the core ingredient. The ingredients were degassed at 50°C under vacuum during the night, using nitrogen or krypton as the adsorbed gas. 5 Specific surface area results expressed in m / g are reported in the table 2 below. Table 2 Surface area Coefficient of Sample 2 2 specific (m / g) correlation R 1. Bamboo fiber 1.32 0.9991428 2. Psyllium fiber 0.34 0.9994084 3. Erythritol 0.01 0.9996005 4. Bamboo fiber mix, psyllium fiber, 0.91 0.9989385 erythritol The specific surface area of ​​the core mixture of ingredients bamboo and psyllium and erythritol were found to be in line with the area values specific surface of excipients known to be used in the field 10 food or pharmaceutical as porous materials to adsorb ingredients 2 2 liquids, such as starches (native 0.56 m / g; modified 1.66 m / g (Sujka & Wiącek, 2024)) or microcrystalline cellulose (0.78 m / g (Hamad et al., 2015)). The viscosity of the core ingredient mixture was analyzed with the Brookfield viscometer. The fiber mix with bamboo ratio psyllium 3.9:1 was tested at a concentration in water of 2% 5 following a defined internal procedure for the analysis of viscosity at cold thickeners generally used in food formulations, such as carob seed flour or guar gum. sample was prepared by dissolving the mix of fibres in water (10 minutes at 1000 rpm with RW 20 IKA stirrer). 10 sample viscosity analyzed at Brookfield viscometer at 20 rpm with impeller RV3 at 30 seconds was found to be 860 cP, a very close value to that generally obtained during the analysis of guar gum, which is equal to 1000 cP. The characterization analyses of the core ingredient mixture are 15 it emerges that bamboo and psyllium, two fibres famously used in the food sector, when combined in a ratio of 3.9:1 they assume typical characteristics of food and / or pharmaceutical additives typically used to obtain a certain consistency or shape of the products depending on the quantity of the fiber mix present in the formulation. 20 The use of fibres is preferable to the use of additives, such as example modified starches, cellulose, guar gum, as they are not regulatory-limited and can act as both regulatory and regulatory agents. structuring and nourishing. Organoleptic characterization of formulations 25 The electronic tongue analysis was conducted with the Taste- system Sensing System SA 402B (Intelligent Sensor Technology Co., Japan). The instrument consists of artificial taste sensors capable of giving impulses electrical currents of different intensity in response to contact with a certain chemical compound (Kobayashi et al., 2010). In the study conducted for 5 To analyze the different formulations developed, the sensor was used for the BT0 bitter. Initially, a calibration line was created using increasing concentrations from 0:10 to 2:10 of T-BiB (used as an example of an exogenous ketogenic body according to this description) dissolved in water. As the concentration of T- increases 10 BiB has increased the response of the BT0 sensor, highlighting a clear dependence between increase in concentration of the ingredient and response of the bitterness sensor. Table 3 below shows the formulations. containing T-BiB and the core ingredients as described here analyzed with electronic language. Formulations similar to those described in the table 15 but without the T-BiB were used to clean up the sensor signal from interference from ingredients other than the body exogenous ketogenic. All formulations were diluted in water for report the T-BiB concentration in the tested range by means of a straight line calibration and were analyzed together with the known standard (T-BiB 20 dissolved in water at a concentration of 0.7:10) and water (control negative). Table 3 % T-BiB in % Dilution Core Concentration Sample formulation bamboo and the real ne of the psyllium in T-BiB sample after formulation for dilution analysis (g:10 ml) (g:10 ml) 1. Gel containing T-BiB, core of 20.50% 1% 0.7:10 0.14 bamboo and psyllium and others ingredients 2. Cream containing T-BiB, core of 17.70% 2% 0.6:10 0.114 bamboo and psyllium and others ingredients 3. Dust encapsulated 32% 20% 1.4:10 0.45 containing T-BiB, the core of bamboo and psyllium and others ingredients The signal from the BT0 bitterness sensor of each formulation was subtracted the background signal of the corresponding formulations without T- BiB, and the value thus obtained was used to calculate the equivalent in terms of perceived T-BiB concentration using the equation 5 of the calibration line, as reported in table 4. Table 4 Equivalent Answer in Concentration of the Deviation terms of T-BiB Royal Standard concentration sensor sample after dilution BT0 (mV) of the ingredient (g:10 ml) (mV) and (g:10 ml) 1. Gel containing T-BiB, 5.91 0.47 0.12 0.14 core of bamboo and psyllium and others ingredients 2. Cream containing T-BiB, core of 1.77 0.10 0 0.114 bamboo and psyllium and others ingredients 3. Dust encapsulated containing T-BiB, the core of 5.09 0.20 0.09 0.45 bamboo and psyllium and others ingredients Reference (T-BiB 0.7 26.495 1.63 0.75 0.7 g:10 ml) For each formulation it was possible to compare the actual concentration of T-BiB with the resulting equivalent concentration from the response of the bitter sensor and thus calculate the reduction percentage of response to bitterness. As shown in the graph in Figure 2, the equivalent concentration of T-BiB of the formulations containing the The core of ingredients is reduced by 14% for the gel formulation, by 100% 5 for the cream formulation and 84% for the encapsulated formulation compared to the actual concentration of T-BiB. The sensory analysis of the formulations was conducted according to the DIN EN ISO 13299 (quantitative sensory analysis). A panel of 8 properly trained tasters evaluated the bitter taste of the 10 formulations reported in table 5, comparing it to a known standard consisting of T-BiB dissolved in water, corresponding to a bitterness value of 9 on a scale from 1 (parameter absent, not perceptible) to 9 (extremely perceptible parameter). Table 5 % T-BiB in Sample formulation Reference 1 – 20% T-BiB solution in water 760 – gel containing T-BiB, bamboo core and 20.50% psyllium and other ingredients 465 – cream containing T-BiB, bamboo core 22.4% and psyllium and other ingredients Reference 2 - 10% T-BiB solution in water 191 – encapsulated powder containing T-BiB, 10.1%* bamboo core and psyllium and other ingredients Table 5 reports the formulations tested by the sensory panel of trained tasters. *T-BiB concentration after reconstitution of the powder with water. In table 6 below are reported the average values ​​of the given bitterness values 5 from the tasters to the formulations, which turned out to be 6.9 for the gel formulation, 7.5 for the cream formulation and 7.1 for the powder encapsulated. Applying the ANOVA statistical analysis it emerged that there is a statistical difference between reference solutions and formulations studied. Table 6 191 Dust 760 Gel 465 Cream encapsulated Dev Dev Ref Dev Parameter Ref 1 Average Average Average std std 2 std Taste abbab 9 6.9 1.1 7.5 0.5 9 7.1 1.6 bitter 10 The analyses carried out confirm that, in the formulations containing T- BiB and the core blend of ingredients that includes bamboo and psyllium, the bitterness parameter was statistically lower compared to the reference (pure T-BiB dissolved in water), whether it is analyzed by electronic tongue analysis or by sensory analysis with panel of trained tasters. 5 EXAMPLES Example 1: product in gel form Portion % (g) T-BiB 18 10 Promoting ingredients ketosis MCT 15 8.3 Bamboo fiber 0.75 0.4 Ingredients with action multiple Psyllium fiber 0.25 0.1 Sweeteners 0.3 0.2 Aroma 1.5 0.8 Ingredients with action Bitter masking 3 1.7 sensory Additives (e.g. 5 2.8 emulsifiers) water 56 31 Portion 55 Example 2: product in cream form Portion % (g) T-BiB 22 10 Promoting ingredients ketosis Coconut fat 32 14 Bamboo fiber 1.4 0.6 Ingredients with action multiple Psyllium fiber 0.50 0.2 Sweeteners 0.6 0.3 Aroma 2 0.9 Ingredients with action Bitter masking 3 1.4 sensory Additives (e.g. 5.5 2.5 emulsifiers) water 33 14.9 Portion 45 Example 3: powdered product to be reconstituted with water % (product Portion % reconstituted with (g) waterfall) Ingredients T-BiB 28 5 10 promoting the MCT 11 2 4 ketosis Bamboo fiber 14 2.7 5.3 Ingredients with multiple action Psyllium fiber 5 1.0 1.9 Erythritol 12 2.3 4.56 Ingredients with Sweeteners 0.3 0.06 0.1 action Aroma 3 0.6 1.1 sensory Bitter masking 0.1 0.02 0.04 Additives (ad example 25 4.8 9.5 emulsifiers) water - 80 160 Portion 100 200 It is clear that the ketogenic food formulations and products up to now changes and / or additions of components may be made to the described items, without thereby departing from the scope of this invention as defined from the claims. 5 BIBLIOGRAPHY Aguilera, J. 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Claims

1. Ketogenic food formulation comprising fats and fibres, possibly carbohydrates and proteins, wherein said formulation comprises di- and polyesteresters of beta hydroxybutyrate (BHB) and medium-chain triglycerides (MCT).

2. Formulation as in claim 1, wherein said formulation has a ketogenic ratio, defined by the weight ratio between grams of fat and the sum of grams of carbohydrates and proteins, which promotes an increase in blood ketosis.

3. Ketogenic food formulation as in claim 1 or 2, wherein said formulation prolongs the release time of BHB from di- and polyester-esters of beta-hydroxybutyrate (BHB) by endogenous lipases and the production of endogenous ketogenic bodies from MCTs at gastric and / or intestinal level and consequently increases blood ketosis, wherein the release and production of ketogenic bodies are also prolonged by the presence of fibres.

4. Formulation as in claim 1, 2 or 3, wherein the fibres are soluble fibres, insoluble fibres or a combination thereof.

5. Formulation as in any of claims 1 to 4, wherein the fibers comprise bamboo fiber and / or psyllium fiber.

6. Formulation as in claim 5, wherein bamboo fiber and psyllium fiber are present in said formulation in a mutual weight ratio of 0.5:1 to 10:

1.

7. Formulation as in any of the preceding claims, comprising MCT-containing fats as a source of said MCTs, in particular coconut fat and / or palm fat and / or pure MCTs.

8. Formulation as in claim 7, wherein said formulation comprises MCT or MCT-containing fats from 2% to 35% by weight of the formulation.

9. Formulation as in any preceding claim, wherein said formulation has a weight ratio of di- and polyester esters of beta hydroxybutyrate (BHB) to MCT of 0.5:1 to 5:

1.

10. Formulation as in any preceding claim, wherein said formulation further comprises one or more polyols and / or ingredients with sensorial action.

11. Formulation as in claim 10, wherein the polyols include erythritol.

12. Formulation as in claim 10 or 11 when dependent on claim 5 or 6, wherein the formulation comprises di- and polyesters of beta hydroxybutyrate (BHB), medium chain triglycerides (MCT), bamboo and psyllium fibers and erythritol.

13. Formulation as in claim 10, 11 or 12, wherein the sensorial ingredients comprise one or more of sweeteners, flavourings, minerals and trace elements, bitter masking agents.

14. Formulation as in any of the preceding claims, wherein said formulation comprises di- and polyester-esters of beta hydroxybutyrate (BHB) up to 35% by weight of the formulation.

15. Formulation as in any preceding claim for use in the treatment of one or more of epilepsies, including drug-resistant epilepsy, metabolic diseases, e.g., GLUT 1, fatty acid oxidation disease, e.g., VL-FAOD, mild cognitive impairment (MCI), Alzheimer's disease, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, migraine, type II diabetes, cancer, obesity, rheumatic diseases, e.g., rheumatoid arthritis, 5 head trauma, refeeding syndrome, autism, metabolic syndrome, chronic obstructive pulmonary disease (COPD), chronic inflammatory bowel diseases (e.g., Crohn's disease and ulcerative colitis), age-related macular degeneration (AMD).

16. Food product comprising, or obtained from, a 10 formulation as in any of the preceding claims.

17. Food product as claimed in claim 16, in the form of a gel, cream or powder to be reconstituted with water, in particular powder containing said encapsulated di- and polyester-esters of beta hydroxybutyrate (BHB) to be reconstituted with water, or in the form of a liquid product, capsules, softgels, bars, baked goods, ready meals, or formulation for parenteral nutrition.