ENTERAL OR ORAL NUTRITIONAL COMPOSITION

FIELD OF THE INVENTION

[1] The present invention relates to an enteral or oral nutritional composition. Specifically, the present invention relates to an enteral or oral nutritional composition comprising of whole food components, combination of herbs and spices, a source of carbohydrate, a source of protein, a source of fat, a optionally a source of fiber and micronutrients. The enteral or oral nutritional composition of the present invention provides specific nutritional needs to patients as well as aid in recovery in surgery and various illnesses such as cancer, diabetes, liver disorders and kidney diseases.

BACKGROUND OF THE INVENTION

[2] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[3] Patients suffering from various illnesses have specific nutritional needs. Many a times the regular diet is either incompatible as well as insufficient to meet the nutritional requirements of such patients. The regular diet does not help in recovery from the illness. Patients with severe injury, altered consciousness, underwent surgery, and suffering from serious illness like stroke and heart disease cannot be fed with regular diet. They require easily digestible nutritionally complete enteral or liquid oral nutrition.

[4] Critically ill patients often are not able to consume food orally (due to reduced level of consciousness or dysphagia). Enteral nutrition is provided to such patients. Enteral nutrition support refers to the introduction of a nutritionally complete liquid formula directly into the stomach or small intestine via a narrow, often specifically designed tube. In india majority of patients are provided rice kanji as a standard of care to patients on enteral nutrition. 1 liter of Rice ganji has 179 kilocalories and 3.25 gram protein (at maximum viscosity of rice ganji that can pass through the feeding tubes without tube blockage). An adult patient weighing 50- 60 kg requires around 1050 to 1260 calories per day and 35-42 gram protein per day. Rice ganji is grossly insufficient to meet even l/lOth nutritional needs and hence is similar to starvation. Starvation and malnutrition associated patients have 6 times higher risk of death and complications. In India, mahalkar etal study funded by Indian council of medical research, reported that 94% of patients admitted in hospitals are malnourished.

[5] Gut programming- the digestive system gets programmed to type of diet routinely consumed by the population. The type and amount of digestive enzymes, the absorption and digestive processes and peristalsis are optimized to reflexly digest and absorb the type of diet routinely consumed by that population. Thus the digestibility and tolerability will be excellent with diet consumed routinely due to the phenomenon of Gut programming whereas foodstuffs not routinely consumed will be difficult to digest. The commercially available highly processed and synthetic formulas contain ingredients not routinely consumed. Thus they are not gut friendly and tolerable. The enteral/oral formula uses ingredients that are part of routine diet of people since centuries. It contains Natural whole food components, pulses, cereals, milk, fruits, vegetables, spices and herbs routinely consumed by Indian population. Since it simulates average Indian diet, is easily digestible and gut friendly.

[6] Enteral nutrition support refers to the introduction of a nutritionally complete liquid formula directly into the stomach or small intestine via a narrow, often specifically designed tube. Enteral nutrition should be considered when an individual is not safe for oral intake (for example, in dysphagia or reduced level of consciousness) or when oral intake is not adequate to meet their nutritional requirements (for example, when appetite is poor and needs are increased). Enteral nutrition has been shown to be safe, cost effective, and compatible with the body’s normal processes.

[7] Patients with renal insufficiency have nausea, vomiting, loss of appetite, fatigue and weakness. These gastro intestinal symptoms are due to the accumulation of uremic toxins due to renal insufficiency. Patients with renal insufficiency have to make certain dietary modifications to prevent metabolic complications and worsening of symptoms. Protein intake should be restricted to reduce uremic symptoms as well as prevent an increase in the "workload" of surviving nephrons of diseased kidneys in order to minimize further loss of renal function. More recently experimental studies have suggested that a low protein intake may prevent the natural progression of CKD towards ESKD thus delaying the start of maintenance dialysis treatment (Klahr S. New England Journal of Medicine, 1989, 320(l3):864-6, Fouque D. et. ah, Cochrane Database of Systematic Reviews, 2009, Issue 3. Art. No.: CD001892). Most patients in the early stages of kidney disease also need to limit the amount of sodium and potassium in their diet. Further, researchers have opined that vegetarian diet is beneficial in patients suffering from chronic kidney disease (Sharon M. et. al., CJASN, 2011, 6(2), 257-264). Non-dialyzed patients with advanced CRF (i.e, glomerular filtration rate <25 mL/min) and those undergoing maintenance hemodialysis or chronic peritoneal dialysis should be prescribed a dietary energy intake of 35 kcal/kg/day (<60 years of age) and 30 kcal/kg/day (>60 years of age). Regarding protein requirements, 0.60 g protein/kg/day should be prescribed for non-dialyzed patients with CRF (glomerular filtration rate <25 mL/min). For patients who will not accept such a diet or are unable to maintain an adequate energy intake on that diet, a protein intake of up to 0.75 g protein/kg/day may be prescribed (National Kidney Foundation K/DOQI Clinical Practice Guidelines for Nutrition in Chronic Renal Failure Kopple, Joel D. American Journal of Kidney Diseases, Volume 37, Issue 1, S66 - S70). Thus, these patients require high calorie, low protein, low sodium and low potassium vegan based diet. For patients with advanced kidney disease on maintenance hemodialysis, high protein diet in the range of l.2-l.4g/kg/day is recommended as these patients lose protein during dialysis procedure. Thus, dialysis dependent patients require high calorie, high protein, low sodium and low potassium vegan based diet.

[8] Radiotherapy and/or chemotherapy are often used for the treatment of various forms of cancer. In these treatments, healthy cells are damaged while killing cancer cells. This damage causes side effects in cancer treatment. The normal tissue most often affected is the intestinal mucosa because of its rapidly dividing cells and is very sensitive. Some of the more common side effects of cancer treatment that affect eating are nausea, vomiting, diarrhea, and loss of appetite. Under-nutrition and cachexia occur frequently in cancer patients and are indicators of poor prognosis and, per se, responsible for excess morbidity and mortality. Cancer patients require easily digestible nutrient and energy dense diet to overcome the side effects and maintain adequate nutrition status. Bauer, J.D et al demonstrated that nutrition intervention improved outcomes in patients with pancreatic and non-small cell lung cancer. Change in nutritional status was significantly associated with change in quality of life, change in Karnofsky performance status and change in lean body mass (Bauer, J.D. & Capra, S, Support Care Cancer (2005) 13: 270-74). Also the harmful effects of cancer treatment on healthy cells can be minimized with the use of various medicinal herbs proven to be effective in reducing the adverse effects of such treatment.

[9] Type 2 diabetes represents a syndrome with disordered metabolism of carbohydrate and fat. The most prominent clinical feature is hyperglycemia (fasting plasma glucose level >126 mg/dl, or glycosylated hemoglobin Ale (HbAlc) >6.9%). Hyperglycemia leads to glycation and glycoxidation, leading to production of abnormal glycated compounds which predispose the patients to atherosclerosis and target organ damage. The existing treatment options to control blood sugar in critically ill patients is to administer insulin injections leading to hyperinsulinemia and associated complications like hypertension, dyslipedemia, and cardiovascular disorders. Provision of diet having lower glycemic index will reduce requirement of insulin thus reducing hyperinsulinemia. In addition the use of various medicinal herbs proven to be effective in controlling hyperglycemia will reduce insulin requirement but also overcome the associated complications of diabetes and hyperglycemia.

[10] After surgery as well as critical illness like stroke, heart failure, the body needs extra calories and protein for wound healing and recovery from illness. They are unable to eat a normal diet because of surgery and illness related side effects. The body’s ability to use nutrients may also be changed by surgery and illness that affect any part of the digestive tract (like the mouth, esophagus, stomach, small intestine, pancreas, colon, or rectum). Under-nutrition is common and can delay the recovery from illness and surgery. They require easily digestible, tolerable, nutritionally complete enteral or liquid oral nutrition.

[11] The European patent application, EP2584923A1 discloses tube feed formulations comprising nutritional compositions including whole food components and method of improving the overall health of a patient having an underlying medical condition. The said patent application does not mention the way whole food components are processed, nor the quantities and ratio in which ingredients are used. The patent application also does not specify how the formulation meets the requirements of specific diseases and illness, any specific information for the skilled artisan to reproduce the said invention, any prototype or the specific details to reproduce the prototype of the invention, and the use of specific medicinal plants that are useful in aiding in the recovery of those illnesses.

[12] The US patent, US8067359B2 discloses nutritional formulation comprising: a protein source; a fat source; and a carbohydrate source, wherein the protein source, the fat source, and the carbohydrate source are in a ratio of about 1:1:1, each comprising about one third of the total calories of the composition for diabetes. It doesn’t mention the ingredients that act as source of protein fat or carbohydrates. The patent mentions only the ratios in which these sources are to be used. The said patent doesn’t provide any specific information for the skilled artisan to reproduce the said invention and any prototype or the specific details to reproduce the prototype of the invention.

[13] In India, Home-made kanji, fruit juices etc., are used for tube feeding of patients. They are not recommended and pose a markedly increased risk of bacterial contamination. Also one liter of rice kanji has l79kilo calories and 3.5 gram protein. Whereas an adult patient on tube feed weighing 50 kg requires >1050 kilo calories and 35 gram protein as per ESPEN criteria. Hence rice kanji is grossly insufficient to meet per day nutritional requirements of sick patients and is equivalent to starvation. Indeed starvation and malnutrition causes more than 60% higher death rates, mortality and morbidity in sick patients. Also Most of the enteral nutrition products use heavily processed synthetic ingredients. They are not easily digestible and have poor tolerability. None of the enteral products consist of various herbs and spices routinely used by Indian population that are known to aid in recovery from specific illness and surgery.

[14] There is, therefore, a need to develop an enteral or oral nutritional composition which meets all nutritional needs i.e., nutritionally complete and aids in recovery from illness as well. The present invention provides the nutritional composition specifically made to suit the needs of patients suffering from kidney diseases, cancer, diabetes, liver disorders and illness and surgery. The nutritional composition of the present invention not only meets the specific nutritional needs but notably it is similar to the daily food habits of the people. Thus it is having better safety and tolerability. As the people eating certain type of food for decades, their guts are programmed to easily absorb and digest those type of foods. Any type of food that is new and foreign to the digestive system is also difficult to digest due to the lack of gut programming. It also contains various herbs and spices routinely consumed which aid in recovery from cancer and adverse effects of cancer treatment, kidney diseases, diabetes, liver disorders and illness and surgery.

OBJECTS OF THE INVENTION

[15] An object of the present invention is to provide an enteral or oral nutritional composition.

[16] Another object of the present invention is to provide an enteral or oral nutritional composition, (a) which meets all nutritional needs i.e., nutritionally complete and (b) easily digestible to the patients.

[17] Another object of the present invention is to provide an enteral or oral nutritional composition comprising of medicinal plant products, which aids in recovery from various illness.

[18] Another object of the present invention is to provide an enteral or oral nutritional composition that is more similar to the routine food habits of the people thus has better safety and tolerability. [19] Another object of the present invention is to provide an enteral or oral nutritional composition comprising of medicinal plant product, which is safe, cost effective, and compatible with the body’s normal processes. SUMMARY OF THE INVENTION

[20] The present invention relates to an enteral or oral nutritional composition. Specifically, the present invention relates to an enteral nutritional composition comprising of whole food components, medicinal plant products, a source of vitamins or minerals, a source of fat and optionally a source of fiber.

[21] In one aspect, the present invention relates to an enteral or oral nutritional composition comprising of:

(a) whole food components;

(b) combination of herbs, spices, fruits, vegetables or combination thereof;

(c) a source of vitamins or minerals,

(d) a source of fat;

(e) a source of carbohydrate;

(f) a source of protein; and

(g) optionally a source of fibre.

[22] In another aspect, the present invention relates to an enteral or oral nutritional composition comprising of:

(a) whole food components comprising of a processed grains, a processed vegetable/fruit/herbs/spices or a combination thereof;

(b) combination of herbs, spices, fruits, vegetables or combination thereof;

(c) a source of vitamins or minerals,

(d) a source of fat;

(e) a source of carbohydrate;

(f) a source of protein; and

(e) optionally a source of fibre.

[23] In another aspect, the present invention relates to an enteral or oral nutritional composition comprising of:

(a) whole food components;

(b) combination of herbs, spices, fruits, vegetables or combination thereof;

(c) a source of vitamins or minerals,

(d) a source of fat; (e) a source of carbohydrate; and

(f) a source of protein.

[24] In another aspect, the combination of herbs or spices of the enteral or oral nutritional composition is a combination of two or more herbs or spices selected from the group consisting of Ginseng, Aloe vera, Azadirachta Indica Juss leaves, Trigonella Foenum Graecum L., Rhizome ( Zingiber officinale Rose), Phyllanthus embilica, Terminalia arjuna (Roxb.) Wight & Am, Ocimum sanctum L. and Curcuma longa L..

[25] In another aspect, the combination of herbs or spices of the enteral or oral nutritional composition is a combination of two or more herbs or spices selected from the group consisting of G ymnema Sylvester, Moringa, Trigonella Foenum Graecum, Eugenia jambolana, Tinospora, Pterocarpus marsupium, and Ocimum sanctum.

[26] In another aspect, the combination of herbs or spices of the enteral or oral nutritional composition is a combination of two or more herbs or spices selected from the group consisting of Aerva lanata, Curcuma longa and Zingiber officinale.

[27] In another aspect, the combination of herbs or spices of the enteral or oral nutritional composition is a combination of two or more herbs or spices selected from the group consisting of Azadirachta Indica Juss leaves, Withania somnifera DunaL, Trigonella Foenum Graecum L., Rhizome Zingiber officinale Rose, Terminalia Arjuna (Roxb.), Wight & Am, Ocimum sanctum L, and Curcuma Longa.

[28] In another aspect, the combination of herbs or spices of the enteral or oral nutritional composition is a combination of two or more herbs or spices selected from the group consisting of Silybum marianum, Flacourtia indica, Aegle marmelos, Lepidium sativum, curcumin Acacia catechu wild, Emblica officinalis.

[29] In another aspect, the enteral or oral nutritional composition of the present invention further comprises a probiotic selected from the group consisting of probiotics include Aerococcus, Aspergillus, Bacteroides, Bifidobacterium, Candida, Clostridium, Debaromyces, Enter ococcus, Fusobacterium, Lactobacillus, Lactococcus, Leuconostoc, Melissococcus, Micrococcus, or combinations thereof.

[30] In another aspect, the enteral or oral nutritional composition of the present invention further comprises two or more fruits consisting of banana, apple, guava, orange, grapes, mango, pomegranate, chickoo or combination thereof.

[31] In another aspect, the enteral or oral nutritional composition of the present invention further comprises two or more vegetables consisting of beetroot, tomato, carrot, radish, onion, spinach or combination thereof. [32] In another aspect, the enteral or oral nutritional composition of the present invention further comprises cereals and pulses comprising of wheat, rice, soyabean, chickpea, or combination thereof.

[33] In another aspect, the enteral or oral nutritional composition of the present invention further comprises a source of co-3 fatty acids selected from the group consisting of a-linolenic acid, docosahexaenoic acid, eicosapentaenoic acid, flax seed, walnuts, almonds, algae, krill, or combinations thereof.

[34] In another aspect, the present invention relates to a method of preparation of an enteral or oral nutritional composition comprising of:

(a) whole food components;

(b) combination of herbs, spice, fruits, vegetables or combination thereof;

(c) a source of vitamins or minerals,

(d) a source of fat;

(e) a source of carbohydrate;

(f) a source of protein; and

(g) optionally a source of fibre.

[35] In yet another aspect, the method of preparation of the enteral or oral nutritional composition of the present invention comprises the steps:

(a) processing the food grains, legumes and herbs or spices mixture at the temperature in the range of 60 °C to 80 °C for 10 to 30 minutes and blending the processed products to obtain a processed food mixture;

(b) blending and homogenizing the maltodextrin with the processed food mixture obtained in step (a) to obtain a food mixture;

(c) blending and homogenizing the fruit, vegetable, spices powder mixture with the food mixture obtained in step (b) to obtain a homogenized food mixture;

(d) fortifying the homogenized food mixture obtained in step (c) with vitamin and mineral premix to obtain fortified product;

(e) blending and homogenizing the fortified product obtained in step (d) with vegetable oil to obtain enteral or oral nutritional composition.

[36] In another aspect, the enteral or oral composition of the present invention is in the form of a powder suitable for reconstitution.

[37] In another aspect, the enteral or oral composition of the present invention is in the form of a powder, accompanied with instructions to dissolve or reconstitute in an aqueous composition or water. [38] In another aspect, the enteral or oral composition of the present is in a ready to use liquid form.

[39] In another aspect, the enteral or oral composition of the present invention is in liquid form suitable for tube feed or administering orally.

[40] In another aspect, the enteral or oral nutritional composition of the present invention is ideal for sole source of nutrition in critically ill patients on enteral or oral nutrition.

[41] In another aspect, the enteral or oral nutritional composition of the present invention is complete cum balanced enteral nutrition meets the recommended dietary allowance (RDA) requirements of calorie/ protein/ fat / fiber.

[42] In another aspect, the enteral or oral nutritional composition of the present invention contains Natural whole food components, pulses, cereals, milk, fruits, vegetables and herbs routinely consumed by Indian population since centuries. Thus, the enteral or oral nutritional composition of the present invention is easily digestible, gut friendly and simulates average Indian diet.

[43] In another aspect, the present invention relates to an enteral or oral nutritional composition comprising medicinal plant products suitable for patients with illness and/or underwent surgery and aid in recovery from illness and surgery.

[44] In another aspect, the present invention relates to an enteral or oral nutritional composition comprising medicinal plant products having lower glycemic index product with hypoglycaemic properties for preventing and/or treating diabetics, insulin-resistance, obesity, hyperglycemia and hyperinsulinemia.

[45] In another aspect, the present invention relates to an enteral or oral nutritional composition comprising medicinal plant products with renoprotective properties having high caloric density cum low protein product suitable for patients with kidney diseases.

[46] In another aspect, the present invention relates to an enteral or oral nutritional composition comprising medicinal plant products having high caloric density product suitable for cancer patients and aid in recovery of patients suffering from cancer.

[47] In another aspect, the present invention relates to an enteral or oral nutritional composition comprising medicinal plant products with hepatoprotective properties having high caloric density product suitable for patients with liver diseases.

[48] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments. DETAILED DESCRIPTION OF THE INVENTION

[49] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[50] Unless the context requires otherwise, throughout the specification which follow, the word“comprise” and variations thereof, such as,“comprises” and“comprising” are to be construed in an open, inclusive sense that is as“including, but not limited to.”

[51] As used in this specification and the appended claims, the singular forms“a,” “an,” and“the” include plural referents unless the content clearly dictates otherwise. It should also be noted that the term“or” is generally employed in its sense including“and/or” unless the content clearly dictates otherwise.

[52] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term“about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable.

[53] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.

[54] All processes described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[55] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[56] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.

[57] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

[58] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description that follows, and the embodiments described herein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.

[59] It should also be appreciated that the present invention can be implemented in numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention.

[60] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.

[61] In a general embodiment, the present invention relates to an enteral or oral nutritional composition comprising of a herbs or spices along with a whole food component consisting of source of protein and source of carbohydrate, a source of fat, and a source of vitamins and minerals.

[62] In an embodiment, the medicinal plant products in the enteral or oral nutritional composition of the present invention, that aid in recovery from illness and surgery include but not limited to Withania somnifera Dunal (Ashwagandha), Ginseng, Ginkgo biloba, bark of Acacia catechu, root of Aegle marmelos, Leaf juice of Aloe vera, Azadirachta Indica Juss (neem) leaves, latex Calotropi procera (Ait.) R. Br, flowers of Centella asiatica (Brahmi), leaf extract of Colocasia esculenta (L.) Schott, Trigonella Foenum Graecum L. (Methi), Rhizome (Zingiber officinale Rose), Phyllanthus embilica (Amla), Terminalia arjuna (Roxb.) Wight &Arn (Arjun), Ocimum sanctum L. (Tulsi) and Curcuma longa L. (Turmeric).

[63] In another embodiment, the enteral or oral nutritional composition of the present invention is low glycemic index product suitable for patients suffering from diabetes, comprising of medicinal plant product with hypoglycaemic properties. The medicinal plant products with hypoglycemic properties, include but not limited to, G ymnema Sylvester, Moringa, Garcina cambogia, Trigonella Foenum Graecum (fenugreek), Momordica charantia (bitter gourd), Eugenia jambolana, Tinospora (guduchi), Pterocarpus marsupium (Indian kino tree’s), Ocimum sanctum, and Opuntia streptacantha.

[64] In another embodiment, the enteral or oral nutritional composition of the present invention is high caloric density cum low protein product suitable for patients with kidney diseases, comprising of medicinal plant product with renoprotective properties. The medicinal plant product with renoprotective properties, include but not limited to, Boerhaavia diffusa L, Crataeva nurvala (Buch Ham), Indigofera barberi, Pimpinella tirupatiensis , Aerva lanata, Curcuma longa L. (Turmeric), Zingiber officinale, and Butea monosperma.

[65] In another embodiment, the enteral or oral nutritional composition of the present invention is high caloric density product suitable for patients suffering from cancer, comprising of medicinal plant with anticarcinogenic and antioxidant properties. The medicinal plant product with anticarcinogenic and antioxidant properties, include but not limited to Azadirachta Indica Juss (Neem) leaves, Latex Calotropi Sprocera (Ait.) R. Br, Withania somnifera Dunal. (Ashwagandha), Trigonella Foenum Graecum L. (Methi), Rhizome Zingiber officinale Rose, Phyllanthus Embilica (Amla), Terminalia Arjuna (Roxb.) Wight & Arn (Arjun), Ocimum sanctum L (Tulsi), and Curcuma Longa L (Turmeric).

[66] In another embodiment, the present disclosure also provides formulation of high caloric density product suitable for patients suffering from liver disorders, containing proven medicinal plant products with hepatoprotective and antioxidant properties. The proven medicinal plant products with hepatoprotective and antioxidant properties include and not limited to milk thistle, Silybum marianum, Flacourtia indica, Chamomile capitula, Annona squamosa, Coccinia grandis, Wedelia calendulacea, Aegle marmelos, Lepidium sativum, cur cumin Acacia catechu wild, Emblica officinalis.

[67] In an embodiment, the enteral or oral nutritional composition of the present invention incorporates medicinal plant products with health promoting properties that aid in recovery from illness and surgery. These plant products that aid in recovery from illness and surgery and their beneficial properties are described in the subsequent paragraphs.

[68] WITHANIA SOMNIFERA DUNAL (ASHWAGANDHA, WS)

[69] Withania somnifera, commonly known as Ashwagandha (winter cherry), is an important medicinal plant that has been used in Ayurvedic and indigenous medicine for more than 3,000 years. Ashwagandha contains various alkaloids, steroidal lactones and saponins. Ashwagandha has been used for its purported antistress/adaptogenic, antitumor, tonic, anxiolytic, anti-inflammatory and antiarthritic properties.

[70] TRIGONELLA FOENUM GRAECUM (FENUGREEK)

[71] Trigonella foenum graecum L. (Fenugreek) is an annual leguminous herb that belongs to the family, Fabaceae. The common names of the plant are methi, Greek hayseed, and bird’s foot. Fenugreek seed contains pyridine type alkaloids, such as trigonelline (0.2- 0.36%), choline (0.5%), gentianine and carpaine; flavonoids, such as apigenin, luteolin, orientin, quercetin, vitexin and isovitexin; and free amino acids, such as 4- hydroxyisoleucine (0.09%); arginine, histidine and lysine. Fenugreek possesses anticancer, antioxidant, anti inflammatory, and glycemic control properties.

[72] ZINGIBER OFFICINALE ROSCOE, ZINGIBERACAE (GINGER)

[73] Ginger has been consumed worldwide as a spice and flavoring agent from the ancient time. The main chemical constituents in ginger include maldehyde, gingerol, shogaol, and paradol. Ginger has antioxidant, nephroprotective and antineoplastic properties.

[74] ACACIA CATECHU (Mimosa catechu)

[75] Acacia catechu , commonly known as Mimosa catechu, is a deciduous, thorny tree. It is found in Asia, China, India and the Indian Ocean area. The heart wood and bark of the tree are used in traditional medicine. It is known to possess anti-microbial, hepatoprotective, antipyretic, anti-inflammatory and potent wound healing properties.

[76] AZADIRACHTA INDICA (NEEM) LEAF

[77] Azadirachta indica (A. indica ), commonly known as Neem is reported to possess anti-inflammatory, hypoglycemic, hypolipidaemic and immune-stimulant properties.

[78] CALOTROPIS PROCERA

[79] Calotropis procera, commonly known as apple of sodom is a species of flowering plant in the family, Apocynaceae. This plant is native to North Africa, Western Asia, South Asia, and Indochina. It is known to have antimicrobial, anticancer and cytotoxic properties.

[80] CENTELLA ASIATICA

[81] Centella asiatica (CA), commonly known as centella, Brahmi, Asiatic pennywort or Gotu kola, is an herbaceous, frost-tender perennial plant in the flowering plant family Apiaceae. It is native to wetlands in Asia. It is used as a culinary vegetable and as a medicinal herb.

[82] OCIMUM SANCTUM E.

[83] Ocimum sanctum L. commonly known as holy basil, Tulasi is an aromatic perennial plant in the family Lamiaceae. It is native to the Indian subcontinent and widespread as a cultivated plant throughout the Southeast Asian tropics. It has wound healing, anti-diabetic, analgesic, radiation protection, antineoplastic, neuroprotective and antimicrobial properties.

[84] EMBLICA OFFICINALIS (AMLA, PHYLLANTHUS EMBLICA OR

INDIAN GOOSEBERRY)

[85] Emblica Officinalis is a deciduous tree of the family Phyllanthaceae. Amla fruit is used as medicinal herb and for culinary use. Many studies have shown that amla possesses adaptogenic, cardioprotective, wound healing, antiathero sclerotic, hepatoprotective, nephroprotective, neuroprotective and antineoplastic properties. Amla, primarily contains tannins, alkaloids, phenolic compounds, amino acids and carbohydrates. Fruit juice of amla contains vitamin C.

[86] TERMINAEIA ARJUNA (ROXB .) WIGHT & ARN

[87] Terminalia arjuna is a tree of the genus Terminalia. It is commonly known as arjuna or arjun tree in English. The arjuna is usually found growing on river banks or near dry river beds in Bangladesh, Uttar Pradesh, Madhya Pradesh, West Bengal and south and central India. Various medicinal properties of T. arjuna such as antioxidant, cardioprotective, anti inflammatory, anti-carcinogenic and antimicrobial properties are reported.

[88] CURCUMA LONGA (TURMERIC)

[89] Turmeric is a rhizomatous herbaceous perennial plant of the ginger family, Zingiberaceae. It is native to the Indian subcontinent and southeast Asia. Phytochemical components of turmeric include diarylheptanoids, a class including numerous curcuminoids, such as curcumin, demethoxycurcumin, and bisdemethoxycurcumin. It is mainly used as a spice for culinary use and as a medicinal herb. It is known to possess anti-inflammatory, antioxidant, anti-carcinogenic and antimicrobial properties

[90] In another embodiment, the enteral or oral nutritional composition of the present invention incorporates medicinal plant products with renoprotective properties. The plant products and their beneficial properties are described in the subsequent paragraphs.

[91] BOERHAVIA DIFFUSA L.

[92] Boerhavia diffusa is a species of flowering plant commonly known as punamava. It is used as a medicinal plant and as a vegetable for culinary use. It is known to possess renoprotective and antihyperglycaemic properties.

[93] CRATAEVA NURVAFA BUCH HAM

[94] Crataeva Nurvala Buch Ham is a small wild or cultivated tree widespread from India to Southeast Asia, south of China. It grows in lowlands to an altitude of 1000 m above sea level. The dried bark is used as medicine in traditional systems of medicine in India.

[95] INDIGOFERA BARBERI

[96] It is a species of flowering plant in the legume family Fabaceae. It is native to the northwestern Himalayas of Tibet, in Asia. It is known to possess nephroprotective property.

[97] PIMPINEFFA TIRUPATIENSIS

[98] Pimpinella tirupatiensis is an erect, herbaceous perennial plant growing 30 - lOOcm tall from a tuberous rootstock. The plant is commonly harvested for medicinal use and sold in local markets. This species has a very narrow range, covering just 200 square kilometres in the Tirupati hills of Andhra Pradesh, India. The whole plant is dried and used as antimicrobial, purgative, hypoglycaemic, abortificient, analgesic, antiseptic, antipyretic and antiinflammatory .

[99] A FRY A FANATA [100] Aerva lanata is an erect or prostrate undershrub with a long tap-root and many woolly-tomentose branches. This is found in the wild throughout India. Aerva lanata has significant pharmacological activities like diuretic, anti-inflammatory and lithotriptic action. The antioxidant, cytotoxic and hepatoprotective activity of Aerva lanata has also been demonstrated by scientific studies. The plant contains flavanoids such as Kaempferol 3- rhamnoside and Kaempferol 3-galactoside, which are well known potent antioxidant and free radical scavengers.

[101] BUTE A MONOSPERMA

[102] Butea monosperma is a species of Butea, native to tropical and sub-tropical parts of the Indian Subcontinent and Southeast Asia. It is a medium-sized dry season- deciduous tree. It is known to possess nephroprotective property.

[103] In another embodiment, the enteral or oral nutritional composition of the present invention incorporates proven medicinal plant products with hypoglycaemic properties. The plant products and their hypolycemic properties are described in the subsequent paragraphs.

[104] GYMNEMA SYLVESTER

[105] Gymnema Sylvester is an herb, native to the tropical forests of southern and central India and Sri lanka. The active principle include a glycoside mixture, the gymnemic acid and a peptide gurmarin, both inhibit the sweet taste response in mammals.

[106] MORINGA OEEIFERA

[107] M. oleifera is a fast-growing, deciduous tree. The leaves of Moringa oleifera have been reported to have antidiabetic, antitumor, hypotensive, antiinflammatory, antibiotic and diuretic properties.

[108] GARCINA CAMBOGIA

[109] Garcinia is a plant that bears small fruits and has traditionally been used as a food additive to both enhance the flavor of food products and to enhance satiety following consumption. The extract and rind of G. cambogia is a curry condiment in India. Fruits of Garcinia Cambogia contain hydroxycitric acid, benzophenones, garcinol and isogarcinol.

[110] MOMORDICA CHARANTIA (BITTER GOURD)

[111] Bitter gourd ( Momordica charantia L.) is a climbing perennial, tendril-bearing vine that belongs to family, cucurbitaceae. Owing to the presence of insulin like molecules, bitter gourd has the potential to become a component of the diet or a dietary supplement for diabetic and pre-diabetic patients.

[112] EUGENIA JAMBOEANA [113] Eugenia Jambolana is an evergreen tropical tree in the flowering plant family, Myrtaceae. The fruits are also known as Jambul or Indian Blackberry having sweet and sour taste. The dried seed powder is known to control Type 2 diabaetes.

[114] TINOSPORA CORDIFOLIA (GUDUCHI)

[115] T. cordifolia (Guduchi) is a large, glabrous, perennial, deciduous, climbing shrub of weak and fleshy stem found throughout India. It is reported to contain an a- glucosidase inhibitor, characterized as saponarin. T. cordifolia has antidiabetic property.

[116] PTEROCAIPUS MARSUPIUM

[117] Pterocarpus marsupium, also known as Indian kino tree or vijayasar, is a medium to large, deciduous tree. It is reported that this plant possess anti diabetic property.

[118] MANGIFERA INDICA (Mango)

[119] Mango peel is rich in polyphenols, carotenoids and dietary fibre. Recent reports indicated that the whole peel powder ameliorates diabetes. Researchers have reported that the mango peel extract inhibits a-amylase and a-glucosidase activities and produces hypoglycaemic effect. These beneficial effects were indeed comparable to metformin.

[120] In still another embodiment, the whole food component of the composition of the present invention is non-toxic and nutritious.

[121] In an embodiment, the carbohydrate source can be selected from the group consisting of sources of complex carbohydrates or whole grains such as, for example, barley, beans, rice, and peas. Any suitable carbohydrate may be used in the present nutritional compositions including, but not limited to, sucrose, lactose, glucose, fructose, corn syrup solids, maltodextrin, modified starch, amylose starch, tapioca starch, corn starch or combinations thereof.

[122] In an embodiment, the protein source can be selected from the group consisting of dairy based proteins, plant based proteins, and animal based proteins or combinations thereof. The plant based protein sources are selected from the group consisting of soy protein, pea protein, canola protein, wheat and fractionated wheat proteins, com proteins, rice proteins, oat proteins, potato proteins, peanut proteins, chick pea protein, proteins derived from beans, lentils, buckwheat, pulses, or combinations thereof.

[123] In an embodiment, the fat source can be selected from the group consisting of vegetable fat (such as olive oil, corn oil, sunflower oil, rapeseed oil, hazelnut oil, soy oil, palm oil, coconut oil, canola oil, lecithins, and the like), animal fats (such as milk fat, fish oil, etc.), or combinations thereof. [124] In an embodiment, the fiber source can be soluble and insoluble fibers. Soluble fibers may include, for example, isabgol husk fructooligosaccharides, acacia gum, inulin, etc. Insoluble fibers may include, for example, stabilised rice bran/fiber, wheat bran/fiber, oat bran/fiber, com bran/fiber, soy bran/fiber, pea bran / fiber or combinations thereof.

[125] In an embodiment, the nutritional composition further includes a source of co-3 fatty acids selected from the group consisting of a-linolenic acid, docosahexaenoic acid, eicosapentaenoic acid, or combinations thereof. The source of co-3 fatty acids may be selected from the group consisting of fish oil, flax seed, walnuts, almonds, algae, krill, modified plants, or combinations thereof.

[126] In an embodiment, the vitamins are selected from the group consisting of vitamin A, vitamin B l (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin or niacinamide), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine, pyridoxal, or pyridoxamine, or pyridoxine hydrochloride), vitamin B7 (biotin), vitamin B9 (folic acid), vitamin B 12 (various cobalamins; commonly cyanocobalamin in vitamin supplements), vitamin C, vitamin D, vitamin E, vitamin K, folic acid, biotin, choline, or combinations thereof.

[127] In an embodiment, the minerals are selected from the group consisting of boron, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorus, potassium, selenium, silicon, tin, vanadium, zinc, or combinations thereof.

[128] In an embodiment, the nutritional composition further includes a probiotic selected from the group consisting of probiotics include Aerococcus, Aspergillus, Bacteroides, Bifidobacterium, Candida, Clostridium, Debaromyces, Enter ococcus, Fusobacterium, Lactobacillus, Lactococcus, Leuconostoc, Melissococcus, Micrococcus, Mucor, Oenococcus, Pediococcus, Penicillium, Peptostrepococcus, Pichia, Propionibacterium, Pseudocatenulatum, Rhizopus, Saccharomyces, Staphylococcus, Streptococcus, Torulopsis, Weissella, or combinations thereof.

[129] In an embodiment, the nutritional composition may contain source of phytonutrients in the form of fruits and vegetables. Fruits included in the present nutritional compositions may include any known fruit such as, but not limited to, apples, bananas, coconut, pear, apricot grapes, watermelon, pomegranate, lemon, lime, mandarin, orange, tangerine, guava, mango, pineapple, etc. Similarly, vegetables may include any known vegetable such as, but not limited to, amaranth, cabbage, spinach, pumpkin, mushrooms, peas, beans, beetroot, carrots, potatoes, radish, turnips, etc.

[130] In an embodiment, the medicinal plant can be used in their crude form or in the form of extracts.

[131] In an embodiment, the nutritional composition may contain food components specific to cultures / regions of the world.

[132] In an embodiment, the enteral or oral nutritional composition of the present invention is ideal for sole source of nutrition in critically ill patients on enteral or oral nutrition.

[133] In an embodiment, the enteral or oral nutritional composition of the present invention is complete cum balanced enteral nutrition meets the recommended dietary allowance (RDA) requirements of calorie/ protein/ fat / fiber.

[134] In an embodiment, the enteral or oral nutritional composition of the present invention contains Natural whole food components, pulses, cereals, milk, fruits, vegetables and herbs routinely consumed by Indian population since centuries. Thus, the enteral or oral nutritional composition of the present invention is easily digestible, gut friendly and simulates average Indian diet.

[135] In yet another aspect, the present invention relates to a method of preparation of the enteral or oral nutritional composition, wherein the method comprises the steps:

(a) blending the processed food grains, legumes and medicinal plant product mixture at the temperature in the range of 60 °C to 80 °C for 10 to 30 minutes to obtain homogenized food mixture;

(b) blending and homogenizing maltodextrin with the food mixture obtained in step (a) to obtain homogenized food mixture;

(c) blending and homogenizing the fruit, vegetable, spices powder mixture with the food mixture obtained in step (b) to obtain homogenized food mixture;

(d) fortifying the homogenized food mixture obtained in step (c) with vitamin and mineral premix to obtain fortified product;

(e) blending and homogenizing the fortified product obtained in step (d) with vegetable oil to obtain final product.

[136] In an embodiment, the method of preparation of an enteral or oral nutritional composition comprises the steps:

(a) decorticating, toasting and pulverizing food grains and legumes at the temperature in the range of 60 °C to 80 °C for 10 to 30 minutes to obtain processed food grains; (b) blending the processed food grains to obtain homogenized food grains;

(c) toasting and pulverizing medicinal plant product mixture and optionally soy bran at the temperature in the range of 60 °C to 80 °C for 10 -30 minutes;

(d) blending the pulverised medicinal plant and the homogenized food grains optionally with pulverised soy fiber to obtain food mixture;

(e) blending and homogenizing the maltodextrin with the food mixture obtained in step (d) to obtain homogenized food mixture;

(f) blending and homogenizing the fruit, vegetable, spices powder mixture with the food mixture obtained in step (e) to obtain homogenized food mixture;

(g) fortifying the homogenized food mixture obtained in step (f) with vitamin and mineral premix to obtain fortified product; and

(h) blending and homogenizing the fortified product obtained in step (g) with vegetable oil to obtain final product.

[137] In yet another aspect of the present invention, the enteral or oral nutritional composition of the present invention is in the form of powder, suitable for reconstitution using an aqueous solution, preferably water.

[138] In another embodiment, the composition of the present invention is in the form of a powder, accompanied with instructions to dissolve or reconstitute in an aqueous composition, preferable water to arrive at the liquid nutritional enteral composition.

[139] In another embodiment, the composition of the present invention is in a ready to use liquid form and does not require reconstitution or mixing prior to use.

[140] In yet another embodiment, the composition of the present invention can be tube fed or administered orally. The ready to use liquid formulation is homogenised, pasteurised and filled in suitable packaging material and sterilized.

[141] A skilled artisan will appreciate that the quantity and type of each ingredient including the medicinal plant can be used in different combinations or singly. All such variations and combinations would be falling within the scope of present disclosure

[142] While the foregoing describes various embodiments of the disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art. EXAMPLES

[143] The present invention is further explained in the form of following examples.

However, it is to be understood that the following examples are merely illustrative and are not to be taken as limitations upon the scope of the invention.

[144] Example 1:

This example describes the preparation of composition suitable for patients with illness and/or underwent surgery, containing proven medicinal plant products that aid in recovery from illness and surgery suitable for enteral and/or liquid oral nutrition.

Composition:

[145] Step 1:

Wheat (17.5 kg) and rice (27.5 kg) were decorticated, toasted and pulverized at 60 °C to 80 °C for 10 to 30 minutes to obtain golden brown colour. The pulverized rice and wheat were blended with 55 kg of defatted toasted soya flour to obtain homogenized product.

[146] Step 2:

Soy bran (625 g) and the medicinal plant product mixture, ashwagandha (625 g), ginseng (625 g), turmeric (625 g), fenugreek (625 g), Azadirachta Indica Juss (neem) Leaves (625 g), Flowers of Centella asiatica (Brahmi) (625 g), Rhizome Zingiber officinale Rose (625 g), Phyllanthus embilica (Amla) (625 g), Terminalia arjuna (Roxb.) (625 g), Wight & Am (Arjun) (625 g), and Ocimum sanctum L (tulsi) (625 g) were toasted and pulverized at 60 °C to 80 °C for 10 to 30 minutes and the pulverized Soy bran and pulverized medicinal plant were blended.

[147] Step 3:

The blended product obtained in step 2 was blended with the homogenised product obtained in step 1. To the mixture, maltodextrin (87.5 kg) and powdered table sugar (25 kg) were added and homogenized. The homogenized mixture obtained was mixed with a combination of toasted and pulverized vegetable/fruit powder (tomato powder (625 g), beet root powder (625 g), cabbage powder (625 g), spinach (625 g), carrot (625 g), Guava (625 g), banana (625 g)).

[148] Step 4:

The homogenized blended product obtained in step 3 was fortified with vitamin and mineral premix to obtain fortified product. The fortified mixture was blended with 25 kg of vegetable oil (sunflower oil (12.5 kg) + soya oil (12.5 kg)) and homogenizing the mixture to obtain final product.

[149] The final product of example 1 (250 g) reconstituted in one litre of water yields 1020 kilo calories, 32 g of protein, 25 g of fat, 167 g of carbohydrates, and recommended daily intake (RDI) of vitamin and minerals; caloric concentration of 1 kilo calorie per ml and viscosity is below 550 milli Pascal-second, which is suitable for tube feeding.

[150] Example 2:

This example describes the preparation of composition with high caloric density cum low protein product suitable for patients with kidney diseases, containing proven medicinal plant with renoprotective properties suitable for enteral and/or liquid oral nutrition.

Composition:

[151] The final product was obtained by following the similar procedure as described in example 1 by using the ingredients given in the table above.

[152] The final product of example 2 (375 g) reconstituted in one litre of water yields 1542 kilo calories, 18 g of protein, 40 g of fat, 280 g of carbohydrates, and recommended daily intake (RDI) of vitamin and minerals; caloric concentration of 1.5 kilo calorie per ml and viscosity is below 550 milli Pascal-second, which is suitable for tube feeding.

[153] Example 3

This example describes the preparation of composition of lower glycemic index product suitable for enteral or oral nutrition, containing proven medicinal plant with hypoglycaemic properties for preventing and/or treating diabetics, insulin-resistance, obesity, postprandial glucose response, metabolic syndrome, syndrome X, hyperglycemia, hypertriglyceridemia, hyperinsulinemia and dyslipidemia.

Composition:

[154] The final product was obtained by following the same procedure as described in example 1 by using the ingredients given in the table above.

[155] The final product of example 3 (250 g) reconstituted in one litre of water yields 1000 kilo calories, 32 g of protein, 26 g of fat, 155 g of carbohydrates, and RDI requirements of vitamin and minerals; caloric concentration of 1 kilo calorie per ml and viscosity is below 550 milli Pascal- second, which is suitable for tube feeding.

[156] Example 4

This example describes the preparation of composition with high caloric density product suitable for cancer patients, containing proven medicinal plant that aid in recovery from cancer, suitable for enteral and/or liquid oral nutrition.

Composition:

[157] The final product was obtained by following the similar procedure as described in example 1 by using the ingredients given in the table above.

[158] The final product of example 4 (310 g) reconstituted in one litre of water yields 1270 kilo calories, 33 g of protein, 31 g of fat, 213 g of carbohydrates, and RDI requirements of vitamin and minerals; caloric concentration of 1.2 kilo calorie per ml and viscosity is below 550 milli Pascal- second, which is suitable for tube feeding.

[159] Example 5

This example illustrates clinical evaluation of Glycemic index of diabetic nutritional formula in ten normal healthy volunteers in the age group of 20-25 years. The study was conducted after due approval and clearance from institutional ethics committee, Karnataka institute of medical sciences, Hubli, Karnataka. The written informed consent was obtained from the volunteers after fully explaining the study procedure to their satisfaction. Volunteers satisfying the inclusion and exclusion criteria were recruited for the study.

Inclusion criteria

Age: >18 years old.

Subjects give verbal informed consent to participate in the study.

Exclusion criteria:

Subjects with diabetes mellitus

Those who refused to participate in the data collection.

The glycemic index evaluation was carried out as per the internationally accepted guidelines (Wolever, t. M. S., jenkins, d. J. A., the use of the glycemic index in predicting the blood glucose response to mixed meals, American journal of clinical nutrition, vol. 43, 1674172, 1986). D-dextrose from a reputed manufacturing company (Ambuja, Gujarat, India) served as control. The subjects were to follow 12 hr overnight fasting and were instructed not to indulge in physical exercise or exhaustion on the day of the study. On day 1, test subjects were given 50 gram dextrose dissolved in 200ml water. The subjects were asked to drink the reconstituted dextrose solution within 10 mins. The fasting blood sugar and the changes in blood glucose at 15, 30, 45, 60, 90, 120 and 150 min, were recorded by finger prick method using gluco-one bg-03 glucometer (Dr, Morepen, India). On day 5, 80 gram of diabetic formula (Example 3, equivalent to 50 gram of glucose) dissolved in 200 ml of water was administered. The subjects were asked to drink the reconstituted formula within 10 mins, the glycemic index (GI) was calculated as follows,

Incremental area under the glucose curve for the test food

GI = - x 100

Incremental area under the glucose curve for standard glucose

[160] Results:

The GI value so determined was 54 for the diabetic formula.

[161] Example 6

This example illustrates clinical evaluation of safety and tolerability of novel enteral formula specific for general illness, surgery, cancer, diabetic and renal failure patients. The enteral nutritional composition was tested for safety and tolerability in 120 patients admitted in Karnataka institute of medical sciences, Hubli, Karnataka. Based upon inclusion and exclusion criteria, the patients were divided into four subgroups i.e. group A (general illness/surgery), group B (diabetes), group C (onco), group D (renal). Each subgroup consisted of 30 patients.

The outcomes of the study were safety and tolerability. Safety was measured by the number of adverse events and serious adverse events, coded using the Common Terminology Criteria for Adverse Events, version 3.0. Participants were defined as tolerant of the diet if they began the study diet and were compliant with more than 90% of the prescribed diet during the intervention. The study was conducted after due approval and clearance from institutional ethics committee, Karnataka institute of medical sciences, Hubli, Karnataka. The written informed consent was obtained from the patient after fully explaining the study procedure to their satisfaction. The clinical history of the disease was documented. Patients satisfying the inclusion and exclusion criteria were allocated the scheduled enteral composition. They were educated about the probable effects of feed intolerance and personally interviewed to detect the development of any such events during the course of enteral feed. All the adverse events that have occurred were recorded in the pre-prepared proforma sheet.

Inclusion criteria general illness, surgery (group A): All patients of age group 18-60 years, on enteral nutrition, admitted in KIMS hospital, Hubli.

Patients willing to give consent for the study.

Exclusion criteria general illness, surgery (group A):

Those who are not willing to participate in the study

Patients of liver cirrhosis or portal hypertension

Patients with diabetes mellitus, renal dysfunction, cancer

Patients with pancreatic dysfunction

Decompensated CHF

Malabsorption syndromes like crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease

Pregnancy

Patients having food allergy to any of the ingredients used in the enteral formula

Inclusion criteria for diabetes subgroup (group B):

All patients of age group 18-60 years, on enteral nutrition with type 2 diabetes mellitus, admitted in KIMS hospital, hubballi.

Patients willing to give consent for the study

Those with adequate hepatic and pancreatic function

Exclusion criteria for diabetes subgroup (group B):

Those who are not willing to participate in the study.

Patients of liver cirrhosis or portal hypertension

Patients with pancreatic dysfunction.

Patients with renal dysfunction.

Decompensated CHF

Malabsorption syndromes like crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease

Pregnancy.

Patients having food allergy to any of the ingredients used in the enteral formula

Inclusion criteria for onco subgroup (group C):

All histologically proven cancer patients of age group 18-60 years, on enteral nutrition admitted in KIMS hospital, Hubli.

Patients willing to give consent for the study. Those with adequate hepatic and pancreatic function.

Exclusion criteria onco subgroup (group C):

Those who are not willing to participate in the study.

Patients of liver cirrhosis or portal hypertension

Patients with pancreatic dysfunction.

Patients with renal dysfunction.

Decompensated CHF

Malabsorption syndromes like crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease

Pregnancy.

Patients having food allergy to any of the ingredients used in the enteral formula

Inclusion criteria for renal subgroup (group D):

All renal failure patients of age group 18-60 years, on enteral nutrition admitted in KIMS hospital, Hubli.

Patients with serum creatinine level>4 mg/dl, or urine output <0.3/kg/hr in 24 hrs ( as per RIFLE classification (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease ) )

Patients willing to give consent for the study.

Those with adequate hepatic and pancreatic function.

Exclusion criteria renal subgroup (group D):

Those who are not willing to participate in the study.

Patients of liver cirrhosis or portal hypertension

Patients with pancreatic dysfunction.

Decompensated CHF

Malabsorption syndromes like crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease

Pregnancy

Patients having food allergy to any of the ingredients used in the enteral formula.

Enteral feeding protocol

Patients satisfying the criteria were recruited for the study. The head end of the bed was elevated to 30° to 45° for all patients before enteral feeding was commenced to prevent aspiration. The enteral formula was administered for 3 consecutive days in the patients recruited for the study.

a. For Group A, Group B, and Group C

The enteral feedings was administered as 200ml bolus gastric feedings using 50 ml syringe over a period of 15-20 mins, every 2 hours. The tube was flushed with 20 ml water before and after administration of bolus feed to prevent blockage of the tube. The first bolus feeding was administered at 9 am in the morning, and subsequent feeds were given every 2hourly till 9pm. Thus a total of 7 bolus feeds and a volume of l400ml of enteral formula were administered in the l2hr period extending from morning 9am to 9pm.

b. For Group D

The enteral feedings was administered as lOOml bolus gastric feedings using 50 ml syringe over a period of 15-20 mins, every 2 hours. The tube was flushed with 20 ml water before and after administration of bolus feed to prevent blockage of the tube. The first bolus feeding was administered at 9 am in the morning, and subsequent feeds were given every 2 hourly till 9pm. Thus a total of 7 bolus feeds and a volume of 700ml of enteral formula were administered in the l2hr period extending from morning 9am to 9pm.

Any adverse event indicating feed intolerance during the study period was recorded in the pre-prepared proforma sheet. Feed intolerance indicators include daily abdominal girth measurements (using a measuring tape at umbilicus) to monitor abdominal distension, bowel charts to record stool amount, consistency, and frequency (Bristol stool chart for objective classification of stool) and abdominal discomfort. Safety was measured by the number of adverse events and serious adverse events, coded using the Common Terminology Criteria for Adverse Events, version 3.0. Participants were regarded as tolerant if they were compliant the study diet during the 5 day period of study intervention.

Statistical analysis

The target sample size was calculated as 120 patients (30 in each group) to provide 90% power to detect adverse events expected to occur in at least 10% of patients in each group. The data collected was analysed with the help of excel 2007 and SPSS 16 statistical software. The adverse events were entered in the excel 2007 worksheet for each variable.

[162] RESULTS

The study was performed in a total of 120 patients with 30 subjects in each group specific to general illness, surgery, cancer, diabetes and renal failure. The study was conducted for a period 11 months. 28 patients (93%) in general illness/surgery group, all 30 in diabetes group (100%), 27 in renal failure (90%), and 28 patients (93%) in cancer group tolerated the formula during the study period. Thus the enteral composition of the present invention was well tolerated in majority of the patient subgroups. 2 patients in surgery group developed mild abdominal distension (grade 1) due to delayed gastric emptying. Administering lower volume feeds resolved the abdominal distension in these patients. 3 patients in renal failure group, 2 patients in general illness and cancer group developed mild nausea (gradel). No patient during the study period developed vomiting or diarrhea. No patient developed grade 2 or 3 or 4 adverse effects. The calorie intake was increased from an average mean of 120 calories to 1200 calories on shifting the patients to study enteral feeds from rice Ganji feeding.

[163] Based on above results, it is very clear that the enteral or oral nutritional composition of the present invention is complete cum balanced enteral nutrition meets the recommended dietary allowance (RDA) requirements of calorie/ protein/ fat / fiber. Further, the enteral or oral nutritional composition of the present invention is easily digestible, gut friendly, simulates average Indian diet and ideal for sole source of nutrition in critically ill patients on enteral or oral nutrition.

[164] Thus the novel composition of the present is very well tolerated, and safe even in critically ill patients. The excellent tolerability in critical ill patients of novel composition is due to the fact that it simulates average Indian diet, is easily digestible and gut friendly. The digestive system gets programmed to type of diet routinely consumed by the population. The type and amount of digestive enzymes, the absorption and digestion processes, and peristalsis are optimized to reflexly digest and absorb the type of diet routinely consumed by that population. Thus the digestibility and tolerability is excellent due to the phenomenon of Gut programming. The commercially available highly processed and synthetic formulas contain ingredients not routinely consumed. Thus they are not gut friendly and tolerable. The composition of the present invention unexpectedly possess excellent digestibility and tolerability thereby solves the problem of commercially available composition.

[165] A skilled artisan will appreciate that the quantity and type of each ingredient including the medicinal plant can be used in different combinations or singly. All such variations and combinations would be falling within the scope of present disclosure

[166] The foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.

ADVANTAGES OF THE PRESENT INVENTION

[167] The present invention provides an enteral or oral nutritional composition which meets all nutritional needs i.e., nutritionally complete and easily digestible to the patients. Ideal for sole source of nutrition in critically ill patients on enteral or oral nutrition.

[168] The present invention provides an enteral or oral nutritional composition comprising of herbs or spices, which aids in recovery from illness as well as surgery.

[169] The present invention provides an enteral or oral nutritional composition comprising of medicinal plant, which is safe, cost effective, and compatible with the body’s normal processes even in critically ill patients. Aids in preventing malnutrition and starvation deaths.

[170] The enteral/ oral nutritional composition of the present invention meets the specific nutritional needs of patients with various illnesses such as cancer, diabetes, kidney and liver diseases as well as patients who have underwent surgery.

[171] The enteral/oral nutritional composition of the present invention is complete cum balanced enteral nutrition meets the RDA requirements of calorie/ protein/ fat / fiber. It contains natural whole food components, pulses, cereals, milk, fruits, vegetables and herbs routinely consumed by Indian population since centuries. Thus simulates average Indian diet, is easily digestible and gut friendly.