A whole nutrition powder for promoting lymphatic vessel healing and a method of making the same

Abstract

This invention discloses a complete nutritional powder for promoting lymphatic vessel healing and its preparation method. The components of the complete nutritional powder include protein, carbohydrates, MCT, mineral elements, and vitamins, and may also contain other anti-inflammatory and / or cell repair components. The complete nutritional powder of this invention has a significant therapeutic effect on patients with lymphatic vessel injury (chylous leakage / lymphorrhea), a common complication after surgery, especially after lymph node dissection. It has a high success rate in treating lymphatic vessel injury and can shorten postoperative recovery and drainage tube removal time. Simultaneously, it provides significant nutritional supplementation, maintaining good nutritional status in patients. Direct use of this invention's complete nutritional powder for promoting lymphatic vessel healing after surgery can reduce or even prevent chylous leakage. Furthermore, this invention's complete nutritional powder can be used as a single source of nutrition in the short term, completely replacing diet, with a suitable nutritional ratio, achieving adequate energy and protein intake for most adults.

Description

Technical Field

[0001] This invention relates to a nutritional supplement and its preparation method, particularly to a nutritional supplement and its preparation method for chylous leakage caused by surgical procedures, belonging to the field of medical nutritional formula foods. Background Technology

[0002] Chyle leakage is a common complication after various surgical procedures, especially those involving simultaneous lymph node dissection. It can occur after radical esophagectomy, radical lung cancer resection, spinal surgery, radical thyroid cancer resection, radical pelvic tumor resection, and radical renal pelvis cancer resection. The main pathogenesis involves damage to the thoracic duct or lymphatic vessels, or excessive permeability, causing chyle to leak into the pleural and peritoneal cavities. This leads to pleural and peritoneal effusion and significant loss of serum proteins, as well as the loss of immune factors, vitamins, and electrolytes, resulting in a series of nutritional and metabolic problems, which can be life-threatening in severe cases.

[0003] The primary treatment for chylous fistula is nutritional therapy, followed by somatostatin-assisted therapy and surgery. However, in cases of abdominal and pelvic lymphatic vessel damage, surgery is not feasible, and only proper nutritional therapy can help the fistula heal. Standardized nutritional therapy can provide patients with sufficient energy and protein after surgery, promoting wound healing; it can also reduce chyle production, addressing the nutritional loss and pleural and peritoneal effusion issues caused by chylous fistula at their source.

[0004] Nutritional therapy for chylous fistula includes total parenteral nutrition (fasting), low-fat diet, and MCT (medium-chain triglycerides) diet. The MCT diet has gradually gained more attention due to its advantages such as sufficient energy and protein, allowing for normal meals, better maintenance of the patient's nutritional status, and faster postoperative recovery.

[0005] The MCT diet is a dietary approach that optimizes energy metabolism by increasing the intake of medium-chain triglycerides (MCTs), including oral or enteral nutritional supplements containing MCTs. MCTs are a special type of fat, primarily found in natural foods such as coconut oil and palm oil. They are metabolized faster than long-chain triglycerides (LCTs) and are quickly converted into ketone bodies for energy. They are commonly used in ketogenic diets, weight management, or specific medical settings. Dietary fats include LCTs, MCTs, and short-chain triglycerides. LCTs are absorbed in the small intestine and enter the lymphatic circulation, draining into the venous system via the thoracic duct or right lymphatic duct. MCTs, on the other hand, are directly transported by intestinal epithelial cells into the mesenteric veins and return to the portal vein, bypassing the lymphatic circulation. This avoids increased lymphatic pressure and a significant increase in lymphatic flow, thus reducing chyle leakage and promoting the healing of lymphatic vessel damage.

[0006] However, the preparation of the MCT diet is complex and requires a high level of nutritional and physiological knowledge from both the chef and the diner, leading to several problems in practical clinical application. On the one hand, to achieve better treatment results, the diet must be extremely limited, allowing only egg whites, rice, vegetables, protein powder, and MCT oil (medium-chain triglycerides) for three meals a day. This often results in decreased appetite, micronutrient deficiencies, and weight loss in patients. On the other hand, to achieve a more adequate intake of energy, protein, and micronutrients, the addition of lean meats, dairy products, and egg custard further increases the requirements for the ingredients. This necessitates meticulous preparation; for example, only beef tenderloin and chicken breast with the tendons and fat removed, and shrimp meat with the shrimp paste and vein removed, must be selected. Furthermore, blanching is required before cooking. Moreover, in actual meat procurement, it has been found that the fat content of beef tenderloin varies significantly depending on the origin and feed used, which can also affect the treatment effect. Therefore, in actual clinical practice, problems often arise such as improper procurement and processing of ingredients affecting treatment efficacy, prolonging hospital stays, and patients being unable to maintain the treatment diet after discharge due to limited nutritional knowledge, occasionally leading to chylous recurrence and readmission.

[0007] Existing nutritional supplements containing MCT are mainly used for patients with weakened digestive function and poor nutrient absorption. The purity of the MCT in their fat component is low, with long-chain fatty acid esters accounting for 49% or more. They cannot be used to treat chylous leakage and may even aggravate it. They are not suitable for patients with postoperative lymphatic vessel damage.

[0008] MCT is not absorbed in its original form, but rather in the form of mixed-chain triglycerides. Ingestion of food or supplements containing LCT (i.e., a small amount of LCT intake) can promote the absorption of MCT by the lymphatic system, thereby increasing the pressure within the lymphatic vessels, which can lead to an expansion of the lymphatic vessel damage and worsen chylous leakage.

[0009] In addition, existing nutritional supplements containing MCT have low protein content and a protein energy ratio of less than 15%, which does not meet the high protein requirements and positive nitrogen balance maintenance needs after surgery. They are not suitable for patients in the postoperative recovery period. Furthermore, they contain LCT, and the proportion of MCT to fat is low. Usually, the LCT content is high (usually around 50%). For the reasons mentioned above, they are only suitable for patients with general indigestion and gastrointestinal dysfunction, and cannot be used to treat this disease. Summary of the Invention

[0010] The purpose of this invention is to address the technical problems inherent in existing treatments for chylous leakage, which rely on a well-balanced MCT diet. These MCT diets are complex to prepare, require high levels of nutritional and physiological knowledge from both the cook and the diner, and can lead to increased pressure in lymphatic vessels, slow or non-healing of lymphatic vessel ruptures, chyle recurrence, and prolonged disease course due to variations in nutrient ratios and components. This invention provides a complete nutritional powder that promotes lymphatic vessel healing and its preparation method. The powder is scientifically formulated with precise component ratios, resulting in significant nutritional supplementation and maintaining good nutritional status in patients. It is highly effective in treating chylous leakage / lymphatic leakage, a common complication after lymph node dissection, with a high success rate in treating lymphatic vessel damage and shortening postoperative recovery and drainage tube removal time, thus reducing or preventing chylous leakage. This MCT nutritional powder can serve as a single source of nutrition in the short term, completely replacing the diet. Its appropriate nutrient ratio allows most adults to achieve adequate energy and protein intake.

[0011] To achieve the objectives of this invention, one aspect of this invention provides a complete nutritional powder that promotes lymphatic vessel healing, comprising the following components: protein, carbohydrates, medium-chain triglycerides (MCT), complex mineral elements, and complex vitamins, wherein the complex mineral elements include at least sodium, iron, calcium, phosphorus, magnesium, potassium, chlorine, iodine, zinc, or selenium; the complex vitamins include fat-soluble vitamins and water-soluble vitamins; and all the fat in the complete nutritional powder is derived from MCT.

[0012] Wherein: the protein component is one or more of whey protein, casein, soy protein or lactalbumin.

[0013] In particular, the protein is a mixed protein containing whey protein, wherein the whey protein content is greater than 80%.

[0014] In particular, the remaining proteins in the whey protein-containing mixed protein are casein and / or soy protein, in addition to whey protein.

[0015] In particular, the energy ratio of protein in the complete nutritional powder is greater than 20%, preferably 20-30%.

[0016] In particular, the whey protein can also be hydrolyzed whey protein, i.e., amino acids and dipeptides or tripeptides.

[0017] In particular, the carbohydrate is one or more of maltodextrin, resistant dextrin, or modified starch.

[0018] In particular, the carbohydrate is a carbohydrate mixture containing maltodextrin, wherein the maltodextrin content is greater than 50%.

[0019] In particular, the carbohydrates containing maltodextrin, in addition to maltodextrin, consist of resistant dextrin and / or modified starch.

[0020] In particular, the energy ratio of carbohydrates in the complete nutritional powder is greater than 45%, preferably 50-55%.

[0021] In particular, the MCT powder is a medium-chain fatty acid triglyceride with a carbon atom length of 6 to 12, preferably a medium-chain fatty acid with a carbon atom length of 6 to 8, and more preferably a medium-chain fatty acid with a carbon atom length of 8.

[0022] For example, 6 carbon atoms make hexanoic acid, 8 carbon atoms make octanoic acid, 10 carbon atoms make decanoic acid, and 12 carbon atoms make lauric acid.

[0023] In particular, the medium-chain triglyceride is trihexanoic acid glyceride, tricaprylic acid glyceride, tridecanoic acid glyceride, or a mixed-chain triglyceride composed of two or three of acetic acid, caprylic acid, and capric acid, with tricaprylic acid glyceride being preferred. Tricaprylic acid glyceride is used to treat lymphatic vessel injury diseases (especially traumatic lymphorrhea / chylous leakage).

[0024] In particular, the medium-chain triglyceride is 100% pure MCT, containing no LCT (long-chain triglycerides), and has an LCT content of 0.

[0025] In particular, the amount of the compound mineral elements used is basically consistent with the Chinese Dietary Reference Intakes (2023), with corresponding adjustments made based on the perioperative situation and the metabolic characteristics of chylous fistula itself.

[0026] In particular, the composite mineral elements also include copper, chromium, fluorine, manganese, or molybdenum.

[0027] In particular, the mineral elements are derived from composite mineral powder and sodium chloride, and the amount of sodium chloride used is (0.5-1.5) g / 100g, preferably 1g / 100g.

[0028] In particular, the composite mineral powder contains excipients but does not contain LCT.

[0029] In particular, the composite mineral powder contains one or more of the following: iron, calcium, phosphorus, magnesium, potassium, iodine, zinc, and selenium.

[0030] Zinc helps with postoperative wound healing; selenium helps with anti-tumor and antioxidant effects, which is beneficial for the target population; chromium works synergistically with niacin to increase insulin sensitivity, which helps control postoperative stress hyperglycemia, thereby improving wound healing.

[0031] Vitamin B1 helps prevent postoperative refeeding syndrome; vitamin B6 can reduce nausea and vomiting caused by postoperative anesthesia pumps.

[0032] The complete nutritional powder of this invention has the synergistic effect of mineral elements and vitamins to improve nutritional status, reduce inflammation, shorten wound healing time, promote lymphatic vessel healing, shorten hospital stay, and reduce medical-related expenses.

[0033] In particular, the fat-soluble vitamins include vitamins A, D, and E; and the water-soluble vitamins include vitamins B1, B2, B6, B12, C, niacin, pantothenic acid, biotin, and folic acid.

[0034] In particular, the multivitamins are derived from commercially available multivitamin powder raw materials, which contain excipients but not LCT.

[0035] In particular, the dosage of the multivitamin is consistent with the Chinese Dietary Reference Intakes (2023).

[0036] In particular, adjustments should be made based on the perioperative situation and the metabolic characteristics of chylous fistula itself.

[0037] It is based on a combination of clinical experience and theoretical changes in human metabolism, but there are no specific standard references or relevant guideline studies.

[0038] In particular, the amounts of the constituent ingredients are as follows, per 100g of complete nutritional powder:

[0039] Protein 15-32g / 100g

[0040] Carbohydrates 46.8-62.4g / 100g

[0041] Medium-chain triglycerides (MCT) 9-20g / 100g

[0042] Complex mineral elements 0.8-3g / 100g

[0043] Multivitamins 7-75mg / 100g.

[0044] In particular, the fat-soluble vitamins include vitamins A, D, and E in the following amounts:

[0045]

[0046] The water-soluble vitamins include vitamins B1, B2, B6, B12, C, niacin, pantothenic acid, biotin, and folic acid in the following amounts:

[0047]

[0048] In particular, the protein energy ratio in the complete nutritional powder is 20-30%, preferably 25.67%; the carbohydrate energy ratio is 45-60%, preferably 50-55%, and more preferably 54.86%.

[0049] In particular, the mass of the components of the complete nutritional powder is as follows (per 100g of complete nutritional powder):

[0050] Protein 15-32 g

[0051] Carbohydrates 46.8-62.4 g

[0052] Medium-chain triglycerides (MCT) 9-20 g

[0053] In particular, the mass of the components of the complete nutritional powder is as follows (per 100g of complete nutritional powder):

[0054] Protein 15-32 g

[0055] Carbohydrates 46.8-62.4 g

[0056] Medium-chain triglycerides (MCT) 9-20 g

[0057] Complex mineral elements 0.8-3g

[0058] Multivitamin 7-75 mg

[0059] In particular, the mass of the components of the complete nutritional powder is as follows (per 100g of complete nutritional powder):

[0060] Protein 26.7 g

[0061] Carbohydrates 57.05 g

[0062] Medium-chain triglycerides (MCT) 9 g

[0063] Complex mineral elements 1776.045 mg

[0064] Multivitamin 25.2155 mg

[0065] In particular, the multivitamins are derived from commercially available multivitamin powder, which is a fat-soluble or water-soluble vitamin powder.

[0066] In particular, the vitamin powder contains excipients but does not contain LCT.

[0067] In particular, the dosage of the multivitamin is as follows (based on 100g of complete nutritional powder):

[0068]

[0069] In particular, the amount of the complex mineral elements is as follows (based on 100g of complete nutritional powder):

[0070]

[0071] In particular, the amounts of the compound mineral elements copper and chromium are as follows (based on 100g of complete nutritional powder):

[0072]

[0073] In particular, it also includes other auxiliary components, which are one or more of choline, coenzyme Q10, or proanthocyanidins. These other auxiliary components are used for anti-inflammatory and cell repair purposes.

[0074] In particular, the amounts of choline, coenzyme Q10, and proanthocyanidins among the other auxiliary ingredients are as follows (based on 100g of complete nutritional powder):

[0075]

[0076] In particular, it also includes dietary fiber, which includes soluble dietary fiber and / or insoluble dietary fiber.

[0077] In particular, the amount of dietary fiber used is consistent with the "Chinese Dietary Reference Intakes (2023)".

[0078] In particular, the water-soluble dietary fiber includes one or more of xylooligosaccharides, fructooligosaccharides, inulin, galactooligosaccharides, beta-glucan, polydextrose, or pectin.

[0079] In particular, the insoluble dietary fiber includes cellulose and / or hemicellulose, etc.

[0080] Soluble dietary fiber can help patients recover their gastrointestinal function as soon as possible after surgery, improve the activity of intestinal flora, and promote rapid intestinal recovery, which is especially important for patients undergoing abdominal and pelvic surgery.

[0081] Insoluble dietary fiber may be more irritating to the gastrointestinal tract and is not easily digested. Therefore, it is packaged separately and is mainly used for patients who have been post-operatively for a longer period of time (such as 2 to 4 weeks or more, depending on the surgical site) but are still concerned that the chylous leakage has not completely healed. It is used to increase satiety and promote normal bowel movements.

[0082] In particular, the amount of dietary fiber is 2-17.1 g / 100g, preferably 2-6 g / 100g.

[0083] In particular, the amounts of water-soluble and insoluble dietary fiber in the dietary fiber component are as follows (based on 100g of complete nutritional powder):

[0084]

[0085] In particular, it also includes dietary nutrients, including taurine and / or carnitine.

[0086] Taurine is a sulfur-containing amino acid that can be extracted from cysteine ​​metabolism. It is particularly abundant in skeletal muscle. A rich dietary source of taurine is animal protein. Taurine possesses antioxidant, anti-inflammatory, metabolic-improving, and tissue-repair-promoting properties, and as an immune nutrient, it plays a certain auxiliary role in the recovery of postoperative patients. Taurine also has some effect on maintaining intestinal flora and reducing ectopic flora. L-carnitine has potential anti-tumor effects.

[0087] In particular, the dietary nutrients also include inositol and / or hexaphosphate.

[0088] Inositol and hexaphosphate (IP6), as polyphosphate compounds naturally found in cereals, have anti-inflammatory and anti-tumor activities. They have an indirect anti-inflammatory effect on postoperative recovery, especially in patients with chylous fistula who have often undergone systematic lymph node dissection (lymph node dissection is often performed in patients with malignant tumors).

[0089] In particular, the amounts of taurine, phospholipids, or carnitine in the dietary nutrients are as follows (per 100g of complete nutritional powder):

[0090] Taurine 10-100mg / 100g

[0091] Carnitine 2-40mg / 100g.

[0092] The energy produced by all energy-producing nutrients (carbohydrates, MCT powder, and protein) in the complete nutritional powder of the present invention is 300-600 kcal, preferably 416 kcal; wherein:

[0093] The energy calculation formula for complete nutritional powder is as follows: 4 × total mass of protein (g) + 4 × total mass of carbohydrates (g) + 9 × mass of MCT (g).

[0094] This invention uses a mixture of raw materials such as MCT, whey protein, maltodextrin, various vitamins, minerals, and dietary fiber in a certain proportion (including but not limited to all kinds of nutrients). Referring to the "Chinese Dietary Reference Intakes (2023)," it meets the daily energy supply ratio of the three macronutrients for normal adults. In addition, it appropriately increases the protein energy supply ratio based on the protein catabolism characteristics of perioperative or cancer patients. At the same time, when using this nutritional powder as a complete meal replacement, it can ensure that the daily intake of all micronutrients for general adults is appropriate (close to the recommended intake (RNI) of each nutrient in the "Chinese Dietary Reference Intakes (2023)," with an appropriate increase in anti-inflammatory and anabolic nutrient intakes, but not exceeding the tolerable upper intake level (UL), which meets the nutritional needs of Chinese people.

[0095] Meanwhile, this product contains a small amount of dietary fiber, which can maintain the patient's gastrointestinal function to a certain extent and play an auxiliary role in the recovery of postoperative intestinal function and the stability of intestinal flora.

[0096] 100% pure MCT, free of other fats, but other edible ash impurities are permitted.

[0097] Vitamins, minerals, dietary fiber, and other dietary components are matched with the Chinese Dietary Reference Intakes (2023).

[0098] Another aspect of the present invention provides a method for preparing a complete nutritional powder for promoting lymphatic vessel healing, comprising the following steps in sequence:

[0099] 1) Prepare the ingredients according to the following dosage, where the dosage is calculated per 100g of complete nutritional powder:

[0100] Protein 15-32 g

[0101] Carbohydrates 46.8-62.4 g

[0102] Medium-chain triglycerides (MCT) 9-20 g

[0103] 2) Mix the raw materials containing the ingredients described in step 1) evenly to obtain the final product.

[0104] In another aspect, the present invention provides a method for preparing a complete nutritional powder for promoting lymphatic vessel healing, comprising the following steps in sequence:

[0105] 1) Prepare the ingredients according to the following composition: protein; carbohydrates; medium-chain triglycerides (MCT); complex minerals; complex vitamins;

[0106] 2) Mix the protein, carbohydrates, medium-chain triglycerides (MCT), complex mineral elements, and complex vitamins as described in step 1) until homogeneous to obtain the final product;

[0107] Specifically, per 100g of complete nutritional powder: protein 15-32g; carbohydrates 46.8-62.4g; medium-chain triglycerides (MCT) 9-20g.

[0108] Wherein, the protein component mentioned in step 1) is one or more of whey protein, casein, soy protein or lactalbumin; the carbohydrate is one or more of maltodextrin, resistant dextrin or modified starch;

[0109] In particular, in step 1), the raw materials for the protein component are whey protein powder, casein powder, soy protein powder, or lactalbumin powder; the raw materials for the carbohydrate component are one or more of maltodextrin powder, resistant dextrin powder, or modified starch powder; the raw material for the medium-chain triglyceride (MCT) component is MCT powder; the raw materials for the complex mineral element component are complex mineral powder and sodium chloride; and the raw materials for the complex vitamin component are complex fat-soluble vitamin powder and complex water-soluble vitamin powder.

[0110] In particular, the raw materials protein powder, carbohydrate powder, MCT powder, compound mineral powder, sodium chloride, and compound vitamin powder contain ash and do not contain LCT.

[0111] Protein, carbohydrates, and MCT contained in each ingredient are all included in the total nutritional powder content to ensure that the total nutritional powder content meets the above-mentioned proportion requirements.

[0112] In particular, the amounts of the composite mineral elements are as follows:

[0113]

[0114] In particular, the amount of the multivitamin is as follows:

[0115]

[0116] In particular, in step 2), the raw materials containing the above-mentioned components are mixed evenly by manual or automatic enteral nutrition preparation machine in a laminar flow table or a 300,000-level cleanroom to obtain the complete nutritional powder of the present invention.

[0117] Through repeated experiments, the inventors discovered that long-chain triglycerides (LCTs) ingested orally, such as egg yolks, oils, and common oral nutritional supplements or preparations, are absorbed into the bloodstream via the lymphatic vessels of the small intestine. This process increases the volume of lymph fluid, and simultaneously increases the composition of the lymph fluid, including proteins, fats, and tissue fluid. This leads to increased pressure within the lymphatic vessels and the loss of nutrients through leaks, potentially causing further tearing and expansion of any ruptured lymphatic vessels. In contrast, medium-chain triglycerides (MCTs) do not circulate through the lymphatic system and hardly increase pressure within the lymphatic vessels (even drinking water has a slight impact on lymphatic flow).

[0118] The complete nutritional powder of this invention has a high protein content, making it suitable for cancer patients and postoperative recovery patients. It helps maintain and increase skeletal muscle mass and has a good effect on improving the overall nutritional status and hypoproteinemia of patients.

[0119] The complete nutritional powder of this invention contains prebiotics such as water-soluble dietary fiber, which promotes the recovery of intestinal function after surgery.

[0120] In this formula, all the fat comes from MCT. The purity of MCT in this invention is 100%, and it does not contain LCT (long-chain fatty acid fat). This avoids increasing the pressure in the lymphatic vessels and ensures that the ingested nutritional powder does not increase the production of fluid in the lymphatic vessels, thereby reducing the pressure in the lymphatic vessels, promoting wound healing, and achieving a definite healing effect.

[0121] However, because the formula does not contain long-chain fatty acids and lacks essential fatty acids (essential fatty acids are all long-chain fatty acids, such as linoleic acid and alpha-linolenic acid; essential fatty acids are fatty acids that the human body cannot synthesize and must obtain from external diets), this formula is not suitable as a single source of nutrition for a long period of time. Generally, the duration of continuous use at a single time should not exceed 2-4 weeks. If long-term use is required, it is necessary to intermittently or continuously supplement with essential fatty acids, such as supplements containing DHA, if the condition permits, or to regularly visit the hospital for intravenous supplementation with fat emulsions containing essential fatty acids.

[0122] Compared with the prior art, the present invention has the following advantages and benefits:

[0123] The complete nutritional powder formula of this invention has high stability and is not affected by the selection and processing of ingredients. It is suitable for the diet of patients with chylous fistula and effectively promotes lymphatic vessel healing.

[0124] The complete nutritional powder of this invention has higher MCT purity, does not contain long-chain fatty acids, and has a good therapeutic effect on traumatic chylous leakage (including tumors, trauma, surgery, etc.), and is not limited to patients with poor digestive function or long-chain fatty acid metabolism disorders.

[0125] Existing MCT nutritional supplements contain long-chain fatty acids, which can lead to the absorption of LCT into the bloodstream via the small intestinal lymphatic vessels. This increases lymphatic fluid volume, raises intra-lymphatic pressure, and causes nutrients to leak out through the opening. Furthermore, the ruptured lymphatic vessel wound may further tear and enlarge, hindering postoperative recovery. The MCT nutritional powder of this invention does not contain long-chain fatty acids.

[0126] The formula of the complete nutritional powder of this invention is suitable for the metabolic characteristics and needs of the Chinese population, meets the Chinese Dietary Reference Intakes, and contains a small amount of dietary fiber, which is beneficial for the recovery of gastrointestinal function after surgery.

[0127] The complete nutritional powder of this invention has a high protein content and a high protein energy ratio, reaching 25.67%, which meets the protein requirements of a perioperative high-protein diet (20%~30%).

[0128] The protein in the complete nutritional powder of this invention is mainly derived from whey protein, which is a high-quality protein rich in leucine. It has the best skeletal muscle specificity for people with sarcopenia, tumors, perioperative period and other high catabolic populations, and has high absorption efficiency.

[0129] The complete nutritional powder of this invention also contains hydrolyzed protein, which helps reduce the burden on the gastrointestinal tract and significantly reduces adverse reactions; the casein and soy protein it contains help slow down carbohydrate absorption and regulate lipid metabolism.

[0130] The complete nutritional powder of the present invention may also contain resistant dextrin or modified starch to reduce postoperative stress-induced hyperglycemia and aid in postoperative recovery.

[0131] The formula contains a variety of vitamins and minerals that meet the metabolic needs of the Chinese population. It is further fortified with vitamin C and B vitamins for patients in the perioperative period or those under stress from tumors, to enhance cell repair and antioxidant effects, while preventing metabolic stagnation due to micronutrient deficiencies. The addition of a small amount of soluble dietary fiber promotes the normal function and activity of beneficial gut bacteria, aids in the repair of neglected intestinal epithelial function during the perioperative period, promotes normal intestinal motility, and accelerates postoperative recovery.

[0132] The fat in the complete nutritional powder of this invention is 100% pure MCT. Due to safety issues such as MCT intolerance, the total daily MCT content of the complete nutritional powder of this invention is controlled to not exceed 45g. The complete nutritional powder is high in protein and has a high protein energy ratio. It can be used as a single source of nutrition to completely replace the diet. For most people, it can achieve the dual goals of energy and protein.

[0133] Excessive consumption of MCT can lead to intolerance problems such as ketosis, nausea, vomiting, and indigestion, and also increases the risk of hypertriglyceridemia. Using the MCT complete nutritional powder of this invention, with a daily intake of 400-500g of powder (meeting the energy needs of typical adult men and women after surgery), the MCT intake is 36-45g, far below the safe limit (the safe limit for daily MCT should be 60g or less), greatly improving safety and tolerability. The protein content is 15-32g / 100g, which is high.

[0134] Existing formulas, such as Meiji's MCT Complete Nutrition Powder, contain 24.4g of MCT per 100g, and 97.6g of MCT per 400g, far exceeding the safety limit. However, it contains only 12.9g of protein per 100g, an extremely low amount, making it unsuitable for adult patients, especially those in the perioperative period. This could lead to protein malnutrition, hypoproteinemia, and prolonged wound healing.

[0135] The MCT nutritional powder of this invention has the advantages of being easy to carry, having a stable formula, being able to be prepared and used at home, and not relying on professional nutritional knowledge. When produced and used as a fixed formula, it can reduce the risk of relapse and re-hospitalization due to improper diet.

[0136] The formula of the complete nutritional powder of this invention is scientific. The various nutrients work synergistically to improve nutritional status, reduce inflammation, promote wound healing, promote anabolism, combat muscle weakness, and promote lymphatic vessel healing. Detailed Implementation

[0137] The beneficial effects of the drug described in this invention are further described below through specific embodiments, including pharmacodynamic tests of the MCT nutritional powder of this invention (Example 1). These embodiments are merely exemplary and do not constitute any limitation on the scope of this invention. Those skilled in the art should understand that modifications or substitutions can be made to the details and form of the technical solution of this invention without departing from the formulation concept and scope of application of this invention, but such modifications and substitutions all fall within the protection scope of this invention.

[0138] Example 1

[0139] 1. Prepare the ingredients according to the following dosage (per 100g of complete nutritional powder):

[0140] Protein 26.7

[0141] Carbohydrates 57.05

[0142] MCT 9

[0143] 0.5g of fat-soluble vitamins

[0144] 0.5g of water-soluble vitamins

[0145] Complex mineral elements 1.5

[0146] The protein used is whey protein. In addition to whey protein, it can also be hydrolyzed whey protein, casein, or soy protein; it can also be a mixed protein containing whey protein, wherein the whey protein content is greater than 80%, and the remaining protein is casein and / or soy protein.

[0147] The protein in the complete nutritional powder of this invention is a high-protein formula. In this embodiment, whey protein is used as an example, and the energy ratio of protein is 25.67% (usually 20-30%).

[0148] The carbohydrate is selected from maltodextrin. In addition to maltodextrin, it can also be resistant dextrin or modified starch, etc.; it can also be a mixed carbohydrate containing maltodextrin, wherein the content of maltodextrin is greater than 50%, and the remaining carbohydrate is resistant dextrin and / or modified starch.

[0149] In this embodiment, the energy contribution ratio of carbohydrates is 54.86% (typically 45-60%, preferably 50-55%).

[0150] MCT stands for caprylic acid triglyceride, which is 100% pure and does not contain LCT. In addition to caprylic acid triglyceride, it can also be triglycerides with 6-12 carbon atoms, such as trihexanoic acid triglyceride, tridecanoic acid triglyceride, etc.

[0151] In this embodiment, vitamins include fat-soluble vitamins and water-soluble vitamins.

[0152] Fat-soluble vitamins include vitamins A, D, and E; water-soluble vitamins include vitamins B1, B2, B6, B12, C, niacin, pantothenic acid, folic acid, and biotin.

[0153] The fat-soluble and water-soluble vitamins are commercially available fat-soluble vitamin powders and water-soluble vitamin powders. Both fat-soluble and water-soluble vitamin powders contain excipients but do not contain LCT.

[0154] The fat-soluble vitamin powder contains 0.5g of fat-soluble vitamins, and the contents of vitamins A, D, and E are shown in Table 1. The water-soluble vitamin powder contains 0.5g of water-soluble vitamins, and the contents of vitamins B1, B2, B6, B12, C, niacin, pantothenic acid, biotin, and folic acid are shown in Table 1.

[0155] The complex mineral elements include: sodium, iron, calcium, phosphorus, magnesium, potassium, chlorine, iodine, zinc, and selenium.

[0156] The compound mineral elements are derived from commercially available compound mineral powder and sodium chloride. The compound mineral powder contains mineral elements such as iron, calcium, phosphorus, magnesium, potassium, iodine, zinc, and selenium.

[0157] The compound mineral powder and sodium chloride were purchased from the market. The compound mineral powder contained excipients but did not contain LCT; the sodium chloride contained excipients but did not contain LCT.

[0158] The amount of sodium chloride is 1g / 100g; the amount of compound minerals is 0.5g / 100g.

[0159] The content determination results of each component of the complete nutrients in this invention are shown in Table 1.

[0160] The raw materials used in this embodiment—whey protein powder, maltodextrin powder, MCT powder, fat-soluble vitamin powder, water-soluble vitamin powder, compound mineral powder, and sodium chloride—have the following characteristics:

[0161] For example: if the protein content (A) of whey protein is 90% and the carbohydrate content (B) is 8%; the rest is ash, then the amount of whey protein used is 26.7 ÷ 0.9 = 29.667g;

[0162] The amount of carbohydrates in the raw whey protein is 29.667 × 0.08 = 2.373g, which should be included in the total carbohydrate content.

[0163] The calculation of other nutrients can be done by analogy with this method.

[0164] However, if a whey protein powder product contains both protein and carbohydrates, and a carbohydrate product also contains protein, and an MCT powder product also contains both protein and carbohydrates, then a ternary linear equation needs to be solved. Let the amount of whey protein powder be X, the amount of carbohydrate product be Y, and the amount of MCT powder be Z, then:

[0165] Protein equation: X×a1 + Y×a2 + Z×a3 = 26.7

[0166] The carbohydrate equation is: X×b1 + Y×b2 + Z×b3 = 57.05

[0167] MCT equation: X×c1+Y×c2+Z×c3=9

[0168] Where 'a' represents the percentage of protein in the three products; 'b' represents the percentage of carbohydrates in the three products; and 'c' represents the percentage of MCT in the three products. However, products 1, 2, and 3 must not contain long-chain fatty acids.

[0169] At the same time, it is required that the total weight of the three products used does not exceed 100g, so as to ensure the weight of other micronutrients is spare.

[0170] By calculating the values ​​of X, Y, and Z, the amount of raw materials corresponding to the three components of protein, carbohydrates, and MCT can be obtained. Mix them according to the calculated amounts, and then mix them with other micronutrients according to the specific amounts mentioned above, so that the total weight is 100g.

[0171] The energy provided by each 100g of the complete nutritional powder of this invention is 416kcal; the results of the content determination of the components of the complete nutrients are shown in Table 1.

[0172] Table 1. Ingredients of Complete Nutritional Powder (100g) from Example 1

[0173]

[0174] 2. Add the different raw materials from step 1) to the different hoppers of the fully automatic enteral nutrition preparation machine. Set the dosage of each raw material according to Table 1 on the computer to generate a specific formula. Perform ultraviolet disinfection and closed preparation in a 300,000-level cleanroom.

[0175] Each raw material can be weighed separately by a precision electronic scale, or it can be automatically weighed and added by a configuration machine (accuracy 0.1g or less).

[0176] 3. After all raw materials have been added according to the formula dosage, mix thoroughly, seal, and store.

[0177] When using, open the sealed cap, mix with warm water, and administer orally or via nasogastric tube.

[0178] Example 2

[0179] Except for copper and chromium, each 100g of the complete nutritional powder is the same as in Example 1, with copper at 0.16mg / 100g and chromium at 6μg / 100g.

[0180] The composition of the complete nutritional powder (100g) is shown in Table 2.

[0181] Table 2. Ingredients of the Complete Nutritional Powder (100g) from Example 2

[0182]

[0183] Different raw materials are added to different hoppers of the fully automatic enteral nutrition preparation machine. A specific formula is generated on the computer according to the amount of each raw material. The formula is then prepared in a 300,000-level cleanroom with ultraviolet disinfection and airtight preparation.

[0184] Each raw material can be weighed separately by a precision electronic scale, or it can be automatically weighed and added by a configuration machine (accuracy 0.1g or less).

[0185] After all ingredients have been added according to the formula, mix them thoroughly, seal, and store.

[0186] Example 3

[0187] Each 100g of the complete nutritional powder contains dietary fiber and other dietary nutrients, and the remaining components are the same as in Example 1, including:

[0188] Dietary fiber includes soluble and insoluble dietary fiber. The dietary fiber provided is commercially available dietary fiber powder, which contains excipients but not LCT (soluble dietary fiber). Specifically:

[0189] The composition content of the complete nutritional powder (100g) is shown in Table 3.

[0190] The dietary fiber content is (2-6) g / 100g, preferably 4 g / 100g. The specific components of dietary fiber (g / 100g) are shown in Table 3.

[0191] Other dietary nutrients include taurine and carnitine. In this example, the other dietary nutrient is commercially available taurine powder, which contains excipients but does not contain LCT.

[0192] Table 3. Dosage of dietary fiber and dietary nutrients in the complete nutritional powder of this invention.

[0193]

[0194] Dietary fiber can also contain pectin, with a dosage of 0.1-2 (g / 100g).

[0195] The different raw materials mentioned above are added to different hoppers of the fully automatic enteral nutrition preparation machine. The specific formula is generated on the computer according to the above settings for the dosage of each raw material. The formula is then prepared in a 300,000-level cleanroom with ultraviolet disinfection and airtight preparation.

[0196] Each raw material can be weighed separately by a precision electronic scale, or it can be automatically weighed and added by a configuration machine (accuracy 0.1g or less).

[0197] After all ingredients have been added according to the formula, mix them thoroughly, seal, and store.

[0198] When using, open the sealed cap, mix with warm water, and administer orally or via nasogastric tube.

[0199] Example 4

[0200] Each 100g of the complete nutritional powder also contains water-soluble dietary fiber. The remaining components are the same as in Example 1, including:

[0201] The water-soluble dietary fiber was purchased as dietary fiber powder from the market. It contains excipients but does not contain LCT; among which:

[0202] The composition content of the complete nutritional powder (100g) is shown in Table 4.

[0203] Table 4 Dietary Fiber of the Complete Nutritional Powder of the Present Invention

[0204]

[0205] The different raw materials mentioned above are added to different hoppers of the fully automatic enteral nutrition preparation machine. The specific formula is generated on the computer according to the above settings for the dosage of each raw material. The formula is then prepared in a 300,000-level cleanroom with ultraviolet disinfection and airtight preparation.

[0206] Each raw material can be weighed separately by a precision electronic scale, or it can be automatically weighed and added by a configuration machine (accuracy 0.1g or less).

[0207] After all ingredients have been added according to the formula, mix them thoroughly, seal, and store.

[0208] When using, open the sealed cap, mix with warm water, and administer orally or via nasogastric tube.

[0209] Example 5

[0210] Each 100g of the complete nutritional powder contains dietary fiber (including soluble and insoluble dietary fiber), and the remaining components are the same as in Example 1, wherein:

[0211] The dietary fiber was purchased from the market as dietary fiber powder. It contains excipients but does not contain LCT; among which:

[0212] The composition content of the complete nutritional powder (100g) is shown in Table 5.

[0213] Table 5. Dosage of Dietary Fiber in the Complete Nutritional Powder of the Present Invention

[0214]

[0215] The different raw materials mentioned above are added to different hoppers of the fully automatic enteral nutrition preparation machine. The specific formula is generated on the computer according to the above settings for the dosage of each raw material. The formula is then prepared in a 300,000-level cleanroom with ultraviolet disinfection and airtight preparation.

[0216] Each raw material can be weighed separately by a precision electronic scale, or it can be automatically weighed and added by a configuration machine (accuracy 0.1g or less).

[0217] After all ingredients have been added according to the formula, mix them thoroughly, seal, and store.

[0218] When using, open the sealed cap, mix with warm water, and administer orally or via nasogastric tube.

[0219] Experimental Case 1: Clinical observation of the efficacy of MCT nutritional powder in patients with chylous fistula

[0220] The MCT complete nutrition powder prepared in Example 1 of this invention has been used in a prospective controlled trial in patients with chylothorax who met the inclusion and exclusion criteria at Peking University First Hospital.

[0221] Study Title: A prospective cohort study on the treatment of chylothorax after radical resection of lung cancer using a diet of medium-chain triglycerides and oral complete nutritional supplements (Project No.: 2024YC28).

[0222] 1. Research Subjects

[0223] Inpatients admitted to the Department of Thoracic Surgery at Peking University First Hospital from January 2024 to December 2025 were selected. They were diagnosed with chylothorax after lung cancer surgery, met the diagnostic and inclusion / exclusion criteria, were aged 18-80 years, and voluntarily accepted observation and treatment.

[0224] The subjects were given the MCT diet according to the actual needs of clinical diagnosis and treatment. Patients whose intake was deemed insufficient by the nutritionist (such as poor appetite, small food intake, etc., resulting in insufficient energy and protein intake to support postoperative recovery) were also supplemented with the MCT complete nutritional powder prepared in Example 1 of this invention to reach the appropriate range of energy and protein requirements. Among them, there were 5 patients in the MCT diet group (diet group) and 4 patients who used the MCT complete nutritional powder (MCT-ONS group). All subjects had undergone lung cancer resection and lymph node dissection. After resuming eating after surgery, they showed a significant increase in drainage volume and hypoproteinemia. The daily drainage volume reached more than 300 ml (normal postoperative drainage volume is generally around 200 ml or less), and sometimes more than 1000 ml. The triglyceride level of the pleural drainage fluid was >1.24 mmol / L, and chylothorax was diagnosed.

[0225] Patients in the diet group directly consumed the MCT meals provided by the meal delivery staff according to the doctor's orders; patients in the MCT-ONS group took the complete nutritional powder prepared in Example 1 with warm water, 2-8 times a day, 30-60 grams each time (i.e., the amount of complete nutritional powder given per meal according to the degree of insufficient food intake of the patient).

[0226] The MCT diet refers to the specific implementation of the patent application "A dietary combination to promote lymphatic vessel healing".

[0227] The study observed the treatment effects, time to removal of chest drainage tubes after surgery, weight changes, and improvement in nutritional indicators in the two groups of patients. The results are shown in Table 4.

[0228] Table 4. Observation results of treatment effects in patients with chylothorax

[0229]

[0230] in:

[0231] Case 3 was not effective after 2 days of treatment with MCT diet + MCT-ONS. After switching to full MCT-ONS, the patient was successfully extubated and discharged after 5 days of treatment.

[0232] Case 6 was discharged after extubation following an 8-day fast after the MCT diet proved ineffective.

[0233] Case 7 was originally expected to be extubated and discharged in 4 days, but the extubation was delayed by 3 days due to subcutaneous emphysema.

[0234] In addition, MCT powder has the advantages of being easy to carry, having a stable formula, being able to be prepared and used at home, and not relying on professional nutritional knowledge. As a fixed formula, it can reduce the risk of relapse and re-hospitalization due to improper diet.

[0235] The MCT complete nutritional powder of the present invention is rich in energy, protein and carbohydrates. When patients are not eating normally, taking the complete nutritional powder of the present invention can help maintain a better nutritional status, heal wounds faster and recover better after surgery.

[0236] The complete nutritional powder of this invention contains a full range of micronutrients that help postoperative recovery and wound healing, such as zinc, vitamin A, vitamin D, magnesium, calcium, and vitamin C. It can not only ensure good healing of lymphatic vessel damage, but also facilitate the overall functional recovery of patients after surgery, and significantly reduce the incidence of postoperative malnutrition and hypoproteinemia.

[0237] The components of the complete nutritional powder of this invention are scientifically proportioned, which can ensure nutritional balance. According to the postoperative energy needs of patients, the daily intake of MCT is less than 45g, usually 36-45g, which is far below the safe limit of MCT (60g). This significantly improves safety and tolerability and reduces tolerance problems such as ketosis, nausea, vomiting, and indigestion caused by excessive intake of MCT.

[0238] The above embodiments of the present invention are merely exemplary and do not constitute any limitation on the scope of the present invention. Those skilled in the art should understand that modifications or substitutions can be made to the details and form of the technical solutions of the present invention without departing from the spirit and scope thereof, but all such modifications and substitutions fall within the protection scope of the present invention.

Claims

1. A whole nutrition powder for promoting lymphatic vessel healing, characterized in that, It comprises the following components: protein, carbohydrates, medium-chain triglycerides (MCT), complex mineral elements, and complex vitamins, wherein the complex mineral elements include at least sodium, iron, calcium, phosphorus, magnesium, potassium, chlorine, iodine, zinc, or selenium; the complex vitamins include fat-soluble vitamins and water-soluble vitamins; and all the fat in the complete nutritional powder is derived from MCT.

2. The complete nutritional powder of claim 1, wherein The amounts of the constituent ingredients are as follows, per 100g of complete nutritional powder: Protein 15-32g / 100g Carbohydrates 46.8-62.4g / 100g Medium-chain triglycerides (MCT) 9-20g / 100g Complex mineral elements 0.8-3g / 100g Multivitamins 7-75mg / 100g.

3. The complete nutritional powder according to claim 1 or 2, wherein Each 100g of the complete nutritional powder also contains other auxiliary ingredients, including coenzyme Q10 and / or proanthocyanidins.

4. The complete nutritional powder of claim 3, wherein, The amounts of the other auxiliary ingredients are: Coenzyme Q10 40-100mg / 100g Proanthocyanidins 40-100mg / 100g.

5. The complete nutritional powder according to any one of claims 1 to 4, wherein, Each 100g of the complete nutritional powder also contains dietary fiber, wherein the dietary fiber includes soluble dietary fiber and / or insoluble dietary fiber.

6. The complete nutritional powder of claim 5, wherein, The amount of dietary fiber is 2-6g / 100g.

7. The nutritionally complete powder of any one of claims 1-3, wherein the powder is a liquid when reconstituted with water. Each 100g of the complete nutritional powder also contains dietary nutrients, including taurine and carnitine.

8. The complete nutritional powder of claim 7, wherein The amounts of the dietary nutrients are: Taurine 10-100mg / 100g Carnitine 2-40mg / 100g.

9. A method for preparing a whole nutrition powder for promoting lymphatic vessel healing, characterized by, The steps are performed in the following order: 1) Prepare the ingredients according to the following composition: protein; carbohydrates; medium-chain triglycerides (MCT); complex minerals; complex vitamins; 2) Mix the protein, carbohydrates, medium-chain triglycerides (MCT), complex mineral elements, and complex vitamins as described in step 1) until homogeneous to obtain the final product; Specifically, per 100g of complete nutritional powder: protein 15-32g; carbohydrates 46.8-62.4g; medium-chain triglycerides (MCT) 9-20g.

10. The preparation method according to claim 9, characterized in that, The amounts of the composite mineral elements are as follows: The amounts of the multivitamins are as follows:

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