Specific total-nutrient formula food for tumor patients and preparation method of specific total-nutrient formula food

Abstract

The invention relates to the technical field of specific total nutrient formula foods, and discloses a specific total nutrient formula food for tumor patients and a preparation method thereof, 1000 g of the specific total nutrient formula food comprises 187-280.5 g of proteins, 265-397 g of fat, 200-300.28 g of carbohydrates, 41-62 g of dietary fibers, 1.42-2.15 g of composite vitamins, 15.9-24.0 g of composite minerals, and 57.4-85.2 g of immune nutrition nutritional factors. The health-care food has the characteristics of high fat, high energy, low carbohydrate and comprehensive nutrition, accords with the related recommendation of the nutrition treatment guide of malignant tumors in modern medicine, can meet the special nutritional requirements of tumor patients, and improves the nutritional status of the tumor patients.

Description

Technical Field

[0001] The present invention relates to the technical field of specific complete nutritional formula foods, in particular to a specific complete nutritional formula food for tumor patients and a preparation method thereof. Background Art

[0002] Cancer is a wasting disease. Patients suffer from malnutrition due to the rapid loss of fat stored in their body tissues. Malnutrition is an independent risk factor for death in cancer patients. It is reported that the incidence of malnutrition in outpatient and inpatient cancer patients is 32.0% to 34% and 47.7% to 49.0%, respectively, while the malnutrition rate in patients with malignant or advanced tumors is as high as 68.0% to 80.5%. Severe malnutrition causes a decline in the patient's quality of life, organ dysfunction and increased complications, and threatens life.

[0003] In developed Western countries, nutritional therapy has a history of more than 30 years and is an important part of the treatment system. Nutritional therapy determines the final treatment effect. Therefore, nutritional therapy, especially enteral nutrition therapy, plays a very important role in the comprehensive treatment of cancer patients. Studies have shown that the human body's immunity and the biological characteristics of tumors are the main factors that determine the prognosis of tumors.

[0004] Foods for Special Medical Purpose (FSMP), also known as FSMP for short, are specially processed and prepared to meet the special needs of people with limited food intake, digestive and absorption disorders, metabolic disorders or specific disease states for nutrients or diets. Most of the products currently available on the market that provide nutritional support for cancer patients are health foods or ordinary foods, or nutritional meals prepared by the nutrition department themselves. Most of them are made by simply mixing a variety of active substances with anti-tumor functions and immunity-enhancing properties or other ingredients that are both medicinal and edible. Currently, the only complete nutritional formula food for special medical purposes for cancer that has been launched in China is Nestle's liquid product, Suyisu, and Nestle's similar product abroad is the powder product of Suyusu, but the nutrition of this product is not very comprehensive and does not conform to the eating habits of Chinese people.

[0005] To this end, the present invention provides a specific complete nutritional formula food for tumor patients and a preparation method thereof. Summary of the invention

[0006] In view of the above problems, the present invention provides a specific complete nutritional formula food for tumor patients and a preparation method thereof, which complies with the provisions of the "Items and Requirements for Registration Application Materials for Special Medical Purpose Formula Foods (Trial)" that "no other biologically active substances other than the nutrients and optional ingredients specified in the standard shall be added", that is, raw materials that are both medicinal and edible and have biological activity cannot be used in special medical purpose formula foods, and strictly follow the "General Rules for Special Medical Purpose Formula Foods" (GB29922) when designing the formula and selecting the raw materials, select ordinary food raw materials, raw and auxiliary materials that comply with the provisions of GB14880 "Hygiene Standards for the Use of Food Nutrition Fortifiers" and GB2760 "Standards for the Use of Food Additives", and at the same time, according to the metabolic and nutritional needs and pathological and physiological characteristics of tumor patients, through the combination of different raw materials, nutrient ratios are carried out to develop a specific complete nutritional formula food that conforms to the dietary habits of Chinese people and is suitable for tumor patients, which can provide comprehensive and balanced nutrition for tumor patients, improve their immunity, effectively improve prognosis, improve the quality of life of patients, and be used for adjuvant treatment of tumors.

[0007] On the one hand, the embodiment of the present application provides a specific complete nutritional formula food for tumor patients, wherein 1000g of the specific complete nutritional formula food comprises: 187-280.5g of protein, 265-397g of fat, 200-300.28g of carbohydrates, 41-62g of dietary fiber, 1.42-2.15g of complex vitamins, 15.9-24.0g of complex minerals, and 57.4-85.2g of immunonutritional nutritional factors, wherein:

[0008] The protein comprises 93.5-140.25 g of isolated soy protein and 93.5-140.25 g of whey protein.

[0009] Preferably, the fat includes 265-397 g of compound fat powder, and the compound fat powder includes 190.8-285.8 g of low-erucic acid rapeseed oil, 53-79.4 g of medium-chain triglycerides, and 21.2-31.8 g of fish oil.

[0010] Preferably, the carbohydrate comprises 200-300.28 g of maltodextrin.

[0011] Preferably, the complex vitamin contains vitamin A 1.7-2.6 mg, vitamin C 242-363 mg, vitamin D3 35-53 μg, vitamin E 35-53 mg, vitamin K1 194-292 μg, vitamin B1 4.5-6.7 mg, vitamin B2 4.5-6.7 mg, VB6 4.5-6.7 mg, pantothenic acid 13-19.5 mg, biotin 94-140 mg, folic acid 1.0-1.5 mg, niacinamide 20-44 mg, vitamin B12 5.8-8.7 μg, and choline 1.0-1.5 g.

[0012] Preferably, the composite mineral comprises 5.0-7.5 g potassium citrate, 3.7-5.6 g sodium citrate, 2.4-3.6 g calcium carbonate, 1.8-2.7 g dipotassium hydrogen phosphate, 0.8-1.2 g magnesium sulfate, 2.2-3.4 g sodium chloride, 74-110 μg chromium chloride, 2.0-3.0 mg copper gluconate, 37-56 mg iron pyrophosphate, 8.8-13.3 mg manganese sulfate, 0.24-0.36 mg sodium molybdate, 0.15-0.22 mg sodium selenite, 24.7-37 mg zinc gluconate, and 0.3-4.5 mg potassium iodide.

[0013] Preferably, the dietary fiber includes 26-39 g of galacto-oligosaccharide and 15-23 g of fructo-oligosaccharide.

[0014] Preferably, the immunonutritional nutritional factors include 40-59g of L-arginine, 5.4-8.2g of nucleotides, and 12-18g of n-3 fatty acids.

[0015] Preferably, the energy supply ratio of protein, fat and carbohydrates is 25%:35%:40%.

[0016] Preferably, the specific nutritionally complete formula food further comprises 11-17 g of citric acid as an acidity regulator and 8-12 g of icing sugar as a sweetener.

[0017] On the other hand, the present invention provides a method for preparing a specific nutritionally complete formula food for tumor patients, wherein the formula food comprises the following preparation steps:

[0018] (1) Weighing: Weigh the ingredients accurately according to the formula;

[0019] (2) Premixing: Add multivitamins, multiminerals, immune nutrition factors, and carbohydrates into a mixer for premixing, with a mixing time of 220 s and a mixing speed of 30 rpm;

[0020] (3) Total mixing: protein, fat and dietary fiber were added into the mixer in sequence, with a mixing time of 240 s and a mixing speed of 45 rpm;

[0021] (4) Inner packaging filling: Net content 50g / bag, aluminum-plastic film bag packaging, sealing test strength not less than 30kPa.

[0022] Compared with the prior art, the technical solution of this application has the following beneficial effects:

[0023] The specific complete nutritional formula food of the present invention is used for nutritional supplementation of cancer patients, and contains seven nutrients required by the human body, namely carbohydrates, fats, proteins, vitamins, minerals, water and dietary fiber. The present invention has the characteristics of high fat, high energy, low carbohydrates and comprehensive nutrition, conforms to the relevant recommendations of the modern medical nutritional treatment guidelines for malignant tumors, can meet the special nutritional needs of cancer patients, and improve the nutritional status of cancer patients.

[0024] Currently, enteral nutrition products on the market mostly use casein and whey protein as protein sources, ignoring the role of plant protein in the application support of tumor patients. The protein in the specific complete nutritional formula food of the present invention comes from animal protein and plant protein, namely whey protein and soy protein isolate. Studies have shown that whey protein combined with enteral nutrition preparations can significantly improve the patient's TP, HGB change, ALB level, and significantly reduce the probability of adverse reactions in patients. In recent years, people have conducted extensive research on maintaining nutritional needs, and there has been a global trend of transition from animal protein to plant protein, especially in Western countries. Soy protein isolate (SPI) is the most refined form of soy protein, containing a protein content of >90%, and a significantly improved digestibility. The production process of SPI can remove hard cell walls and anti-nutritional factors, which can significantly improve the digestibility of soy protein. At the end of intestinal digestion, higher levels of free amino acids released from SPI are conducive to better absorption. All normal cell lines except lymphocytes, including fibroblasts, hepatocytes, kidney cells and epithelial cells, are methionine-independent cells. Many malignant tumor cells, such as breast cancer, lung cancer, colon cancer, kidney cancer, bladder cancer, melanoma, and glioma, are dependent on methionine. Compared with normal cells, tumor cells have a higher transmethylation rate and require more methionine. Therefore, in an environment with low methionine concentration, the restriction of nucleotide methylation may be the rate-limiting step in inhibiting tumor cell growth. According to a report by Hawry Lewicz et al., the incidence of breast cancer in rats induced by N-methylnitrosourea was lower in those who consumed soy protein foods than in those who consumed casein foods, and soy protein foods can inhibit tumor expansion. Soy protein isolate has an advantage in protein selection for tumor patients due to its low methionine amino acid pattern.

[0025] The fat in the specific complete nutritional formula food of the present invention comes from low-erucic acid rapeseed oil, medium-chain triglycerides, and fish oil. Among them, the oleic acid content in low-erucic acid rapeseed oil is more than 60%. Compared with peanut oil, corn oil, soybean oil, olive oil, etc., it has the lowest saturated fatty acid content and contains reasonable linoleic acid and linolenic acid. It is known as the "healthiest edible vegetable oil" internationally. The rapeseed polyphenols in low-erucic acid rapeseed oil are a type of secondary metabolite unique to rapeseed, which has biological activities such as anti-tumor, hypoglycemic, antibacterial, and free radical scavenging, which helps cancer patients improve their immunity. Medium-chain triglycerides are easily oxidized to provide energy, which is beneficial to improving the energy metabolism of cancer patients.

[0026] The immunonutrients in the specific complete nutrition formula food described in the present invention include L-arginine, nucleotides and n-3 fatty acids. The Guidelines for Nutritional Treatment of Patients with Malignant Tumors 2021 point out that for patients undergoing major cervical or abdominal surgery, it is recommended to use enteral nutrition containing immunomodulatory ingredients (arginine, n-3PUFA and nucleotides) during perioperative period; ESPEN Practical Guidelines: Clinical Nutrition for Cancer 2021 point out that oral / enteral immunonutrients (arginine, n-3 fatty acids, nucleotides) are recommended for perioperative patients undergoing surgical resection of upper gastrointestinal tumors; ESPEN Enteral Nutrition Guidelines: Non-surgical Oncology 2006: For perioperative tumor patients, it is best to use immunonutrients (arginine, n-3 fatty acids, nucleotides) during preoperative enteral nutrition for 5 to 7 days, regardless of the patient's nutritional status.

[0027] The invention adds appropriate amounts of vitamins and minerals in the formula, including macroelements, essential trace elements, fat-soluble vitamins and water-soluble vitamins. The combined use of multiple vitamins and minerals can play an important role in regulating the body's material and energy metabolism. DETAILED DESCRIPTION

[0028] The present invention will be further described below in conjunction with the embodiments, but they are not intended to limit the present invention.

[0029] Example 1

[0030] 1. The raw materials are shown in Table 1:

[0031] Table 1 is the raw materials for preparing the nutrient agent of the present invention

[0032]

[0033]

[0034] Example 2

[0035] 1. The raw materials are shown in Table 2:

[0036] Table 2 is the raw materials for preparing the nutrient agent of the present invention

[0037] Material Name Feeding amount / 1000g effect Soy Protein Isolate 116.87 Provides required protein Whey Protein Isolate 116.87 Provides required protein Maltodextrin 255.93 Provides needed carbohydrates Fat powder 330.86 Provides the required fat Frosting 10.15 Provides needed carbohydrates Complex minerals 21.2 Provides minerals needed by the human body Multivitamins 1.92 Provides vitamins needed by the human body n-3 fatty acids 16 Provides n-3 fatty acids needed by the human body Arginine 52 Provides arginine needed by the human body Nucleotides 7.2 Provides nucleotides needed by the human body Galacto-oligosaccharides 35 Provide dietary fiber needed by the human body Fructo-oligosaccharides 21 Provide dietary fiber needed by the human body Citric acid 15 Acidity regulator

[0038] Example 3

[0039] 1. The raw materials are shown in Table 3:

[0040] Table 3 is the raw materials for preparing the nutrient agent of the present invention

[0041] Material Name Feeding amount / 1000g effect Soy Protein Isolate 140.25 Provides required protein Whey Protein Isolate 140.25 Provides required protein Maltodextrin 255.93 Provides needed carbohydrates Fat powder 317.15 Provides the required fat Frosting 12 Provides needed carbohydrates Complex minerals 24.0 Provides minerals needed by the human body Multivitamins 2.15 Provides vitamins needed by the human body n-3 fatty acids 18 Provides n-3 fatty acids needed by the human body Arginine 59 Provides arginine needed by the human body Nucleotides 8.2 Provides nucleotides needed by the human body Galacto-oligosaccharides 39 Provide dietary fiber needed by the human body Fructo-oligosaccharides 23 Provide dietary fiber needed by the human body Citric acid 17 Acidity regulator

[0042] The formula food comprises the following preparation steps:

[0043] (1) Weighing: Weigh the ingredients accurately according to the formula;

[0044] (2) Premixing: Add multivitamins, multiminerals, immune nutrition factors, and carbohydrates into a mixer for premixing, with a mixing time of 220 s and a mixing speed of 30 rpm;

[0045] (3) Total mixing: protein, fat and dietary fiber were added into the mixer in sequence, with a mixing time of 240 s and a mixing speed of 45 rpm;

[0046] (4) Inner packaging filling: Net content 50g / bag, aluminum-plastic film bag packaging, sealing test strength not less than 30kPa.

[0047] The present invention is suitable for cancer patients over 10 years old who are at nutritional risk or malnourished, including cancer patients whose existing or potential nutritional metabolic conditions may have a negative impact on their disease or treatment-related clinical outcomes (infection-related complications, hospital stay, etc.), and also cancer patients with hunger-related low body weight, cachexia / disease-related malnutrition, sarcopenia and asthenia whose body functions and even clinical outcomes are adversely affected by lack of energy, protein and other nutrients. The clinical effects of the product after relevant cancer patients consumed it are as follows:

[0048] 60 patients with gastric cancer were randomly divided into two groups: the experimental group took this product (immune enhancement diet group, n = 30); the control group took a standard formula (conventional complete nutrition product group, n = 30) and received nutritional supplements 7 days before surgery. The groups were well matched in terms of age, gender, cancer stage, and intraoperative variables. After surgery, clinical variables were evaluated, including postoperative infectious complications, non-infectious complications, and SIRS duration. The postoperative comparison results are detailed in the table below

[0049] Table 1 shows the postoperative results:

[0050]

[0051]

[0052] From the comparison of the data in the above table, it can be seen that nutritional supplementation with tumor-specific complete nutrition products before surgery can significantly reduce the number of patients receiving antibiotic treatment, infectious complications, and abdominal abscesses or effusions.

[0053] One of the most common complications after surgery in malnourished cancer patients is delayed and failed wound healing. This study investigated the effect of early postoperative administration of this product, which contains the immunonutrients arginine, omega-3 fatty acids and nucleotides, combined with increased hydroxyproline synthesis to improve wound healing in patients undergoing gastrectomy for gastric cancer. This study selected 66 patients with gastric cancer and randomly divided them into two groups: one group received early postoperative enteral immunonutrition (this product) and the other group received an equal energy and nitrogen intake control group; the wound healing process was evaluated by: (1) quantification of hydroxyproline and (2) postoperative complications. The local hydroxyproline level in the experimental group (59.6 nmol (5.0-201.8)) was higher than that in the control group (28.1 nmol (5.8-89.6) P=0.0018). Details of postoperative complications are shown in the table below.

[0054] Table 2 summarizes the results of postoperative complications:

[0055]

[0056]

[0057] The results showed that 60 patients were analyzed. The number of surgical wound healing times was significantly reduced (0 vs. 8 (26.7%) P = 0.005) compared with the formula (n 1 / 430). Malnourished cancer patients who use this product early after surgery can increase the synthesis of hydroxyproline and improve the healing of surgical wounds in patients undergoing gastrectomy for gastric cancer.

[0058] The present invention uses whey protein and soy protein isolate as the protein sources of this product, and the protein sources of the present invention are all high-quality proteins; the compound of animal and plant proteins is selected, and its amino acid score is increased by about 10% compared with a single protein. The compound of animal and plant proteins follows the principle of food complementarity (the farther the biological species of the food, the better), which is more in line with the eating habits of Chinese people. A large number of studies have shown that the compound of animal and plant proteins can further exert its nutritional value and efficacy compared with single proteins. As a new type of nutritious and healthy food, dual-protein food can significantly improve the basic state and quality of life of patients, shorten the treatment time, reduce the infection rate and mortality rate, reduce medical expenses, and has a significant medical intervention effect. Combined with the results of dual-protein animal efficacy evaluation experiments and clinical nutritional intervention, it is believed that the body may have an immune interaction of the "intestinal-liver-spleen axis" and a potential mechanism of action of dual proteins regulating the intestinal-liver-spleen axis to promote immune reconstruction. Studies have shown that reducing animal protein and increasing plant protein at the same time show obvious advantages in insulin sensitivity. Tumor patients have a certain degree of insulin resistance, and appropriately increasing the intake of plant protein is beneficial to blood sugar control.

[0059] The combined use of three immunonutrients, arginine, ribonucleic acid, and n-3 fatty acids, can help reduce postoperative inflammatory responses and the occurrence of complications such as infection compared to patients using standard EN preparations.

[0060] This product uses two soluble dietary fibers, oligofructose and oligogalactose, as the source of dietary fiber, which is beneficial for improving the anti-inflammatory ability and immunity of cancer patients. In addition to multiple physiological functions such as protecting intestinal health, participating in immune regulation, inhibiting tumor cell generation, improving human mineral absorption, and improving cardiovascular diseases, studies have shown that oligogalactose has good anti-inflammatory activity; oligofructose is a proliferation factor for bifidobacteria. Bifidobacteria and their metabolites can increase the activity of macrophages and NK cells, promote the production of antibodies and the secretion of other immune factors, thereby improving the body's defense capabilities. Eating oligofructose can enhance the body's immunity. Oligofructose can also promote the synthesis of B vitamins, thereby improving the body's metabolic level, and enhancing the body's immunity and resistance to disease. Animal experiments have shown that the large-scale reproduction of bifidobacteria in the intestine can play an anti-cancer role because the cells, cell wall components and extracellular secretions of bifidobacteria can improve the body's immunity.

[0061] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A specific complete nutritional formula food for cancer patients, characterized in that: The specific complete nutritional formula food, calculated on a 1000g scale, comprises: 187-280.5g of protein, 265-397g of fat, 200-300.28g of carbohydrates, 41-62g of dietary fiber, 1.42-2.15g of complex vitamins, 15.9-24.0g of complex minerals, and 57.4-85.2g of immunonutritional nutritional factors, wherein: The protein comprises 93.5-140.25 g of isolated soy protein and 93.5-140.25 g of whey protein.

2. The specific complete nutritional formula food for cancer patients according to claim 1, characterized in that: The fat comprises 265-397 g of compound fat powder, and the compound fat powder comprises 190.8-285.8 g of low-erucic acid rapeseed oil, 53-79.4 g of medium-chain triglycerides, and 21.2-31.8 g of fish oil.

3. The specific complete nutritional formula food for cancer patients according to claim 1, characterized in that: The carbohydrates include 200-300.28 g of maltodextrin.

4. The specific complete nutritional formula food for cancer patients according to claim 1, characterized in that: The complex vitamin comprises vitamin A 1.7-2.6 mg, vitamin C 242-363 mg, vitamin D3 35-53 μg, vitamin E 35-53 mg, vitamin K1 194-292 μg, vitamin B1 4.5-6.7 mg, vitamin B2 4.5-6.7 mg, VB6 4.5-6.7 mg, pantothenic acid 13-19.5 mg, biotin 94-140 mg, folic acid 1.0-1.5 mg, niacinamide 20-44 mg, vitamin B12 5.8-8.7 μg, and choline 1.0-1.5 g.

5. The specific complete nutritional formula food for cancer patients according to claim 1, characterized in that: The composite mineral comprises 5.0-7.5 g potassium citrate, 3.7-5.6 g sodium citrate, 2.4-3.6 g calcium carbonate, 1.8-2.7 g dipotassium hydrogen phosphate, 0.8-1.2 g magnesium sulfate, 2.2-3.4 g sodium chloride, 74-110 μg chromium chloride, 2.0-3.0 mg copper gluconate, 37-56 mg iron pyrophosphate, 8.8-13.3 mg manganese sulfate, 0.24-0.36 mg sodium molybdate, 0.15-0.22 mg sodium selenite, 24.7-37 mg zinc gluconate, and 0.3-4.5 mg potassium iodide.

6. The specific complete nutritional formula food for cancer patients according to claim 1, characterized in that: The dietary fiber comprises 26-39 g of galacto-oligosaccharide and 15-23 g of fructo-oligosaccharide.

7. The specific complete nutritional formula food for cancer patients according to claim 1, characterized in that: The immunonutritional nutritional factors include 40-59g of L-arginine, 5.4-8.2g of nucleotides, and 12-18g of n-3 fatty acids.

8. The specific complete nutritional formula food for cancer patients according to claim 1, characterized in that: The energy supply ratio of protein, fat and carbohydrates is 25%:35%:40%.

9. The specific complete nutritional formula food for cancer patients according to claim 1, characterized in that: The specific nutritionally complete formula food further comprises 11-17 g of citric acid as an acidity regulator and 8-12 g of icing sugar as a sweetener.

10. A method for preparing a specific nutritionally complete formula food for tumor patients as claimed in any one of claims 1 to 9, characterized in that: The formula food comprises the following preparation steps: (1) Weighing: Weigh the ingredients accurately according to the formula; (2) Premixing: Add multivitamins, multiminerals, immune nutrition factors, and carbohydrates into the mixer for premixing. The mixing time is 220 seconds and the mixing speed is 30 rpm. (3) Total mixing: Add protein, fat and dietary fiber into the mixer in sequence, with a mixing time of 240 s and a mixing speed of 45 rpm; (4) Inner packaging filling: Net content 50g / bag, aluminum-plastic film bag packaging, sealing test strength not less than 30kPa.

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