Meal replacement compositions, methods of making the same, and uses thereof

Abstract

Meal replacement composition, its preparation method and its use. The meal replacement composition comprises by weight parts: oat 16-24 parts, gordon euryale 16-24 parts, red jujube meat 16-24 parts, highland barley 16-24 parts, low-lactose milk powder 160-240 parts, fried rice 40-60 parts, coconut meat 16-24 parts, peanut 40-60 parts, almond 32-48 parts, apple 32-48 parts, radix astragali 4-6 parts, baked polygonatum 4-6 parts, papaya 2-4 parts, yam 2-4 parts, poria 2-4 parts and radix codonopsis 2-4 parts. The meal replacement composition of the present application can supplement the daily required nutrients, at the same time, by acting on the intestinal flora, the content of beneficial bacteria is increased, and the content of harmful bacteria is inhibited, so as to achieve the effects of tonifying spleen, protecting liver, invigorating kidney and benefiting lung, and slowing down the progression of amyotrophic lateral sclerosis (ALS).

Description

Technical Field

[0001] This application generally relates to the field of food technology, particularly to a meal replacement composition, a preparation method thereof, and uses thereof. Background Art

[0002] Amyotrophic lateral sclerosis (ALS), also known as "Lou Gehrig's disease", is a chronic, progressive neurodegenerative disease. According to clinical symptoms, it can be divided into three types: primary amyotrophic lateral sclerosis, mainly manifested as weakness and muscle atrophy of the upper and lower limbs, and finally respiratory failure; bulbar amyotrophic lateral sclerosis, patients do not have obvious symptoms of peripheral spinal cord damage within half a year before the onset, but afterwards, symptoms such as unclear speech, slurred pronunciation, inability to speak, difficulty swallowing, fasciculation, and tongue atrophy will significantly appear; pyramidal amyotrophic lateral sclerosis, manifested as severe muscle spasm, paraplegia, or quadriplegia and other symptoms.

[0003] ALS is a rare disease with an incidence rate of about 3 to 7 per 100,000, mostly occurring between the ages of 30 and 60, and most cases occur after the age of 45, with more males than females. Although the pathogenesis of ALS is currently unclear, it is generally believed to be related to genetic environmental factors, oxidative stress, mitochondrial dysfunction, toxic effects of excitatory amino acids, imbalance of calcium homeostasis, abnormal aggregation of proteins, etc. 10% of patients have familial ALS (fALS), and 90% have sporadic ALS (sALS). ALS cannot be cured, and the prognosis is poor. In traditional Chinese medicine, it is mostly classified into the category of "flaccidity syndrome".

[0004] Different from common neurological diseases such as Alzheimer's disease (AD), Parkinson's disease (PD), and senile cerebrovascular diseases, ALS has relatively low social attention, less investment, and less output, and the development of its treatment methods is relatively slow. Summary of the Invention

[0005] Based on the above background, this application provides a meal replacement composition, wherein, in parts by weight, the meal replacement composition comprises: 16 - 24 parts of oats, 16 - 24 parts of euryale ferox seeds, 16 - 24 parts of red date flesh, 16 - 24 parts of highland barley, 160 - 240 parts of low-lactose milk powder, 40 - 60 parts of fried rice, 16 - 24 parts of coconut meat, 40 - 60 parts of peanuts, 32 - 48 parts of almonds, 32 - 48 parts of apples, 4 - 6 parts of astragalus membranaceus, 4 - 6 parts of stewed polygonatum sibiricum, 2 - 4 parts of papaya, 2 - 4 parts of Chinese yam, 2 - 4 parts of poria cocos, and 2 - 4 parts of codonopsis pilosula.

[0006] On the other hand, this application also provides a preparation method of the meal replacement composition described herein, comprising the following steps: The raw materials of each component in the meal replacement composition are removed from impurities, purified, dried, and then pulverized using a pulverizer; The crushed peanuts and almonds were sieved through a 40-mesh sieve, and the remaining crushed raw materials were sieved through a 60-mesh sieve to obtain dry powders of each component. Weigh each component according to its respective weight percentage and mix them thoroughly.

[0007] On the other hand, this application also provides the use of the meal replacement compositions described herein in the preparation of a medicament for the treatment of amyotrophic lateral sclerosis (ALS).

[0008] On the other hand, this application also provides the use of the meal replacement compositions described herein in the preparation of health products.

[0009] On the other hand, this application also provides the use of the meal replacement compositions described herein in the preparation of food.

[0010] On the other hand, this application also provides pharmaceuticals, health products, or food products that include the meal replacement compositions described herein.

[0011] This meal replacement composition is the first enteral nutrition agent utilizing food-grade ingredients. Its ingredient ratios meet the recommended energy intake for ALS patients, specifically tailored for them and addressing the issue of high basal energy expenditure in ALS patients (product energy value: 2033kcal / 500g). The nutrient ratios are compliant and meet the dietary needs of ALS patients, which require high protein, high fat, and high energy. Furthermore, the excipients are highly nutritious and have synergistic protective effects on multiple systems in the body (containing vitamins, dietary fiber, etc., regulating immunity, protecting the cardiovascular and nervous systems, etc.). After the initial product production was successful, team members personally tasted it; the product's flavor design is nutritionally balanced with a moderate sweetness. It demonstrates humanistic care, considering both taste and texture to provide a pleasant consumption experience, offering balanced nutrition and convenient daily meal preparation for patients and their families, reducing life stress.

[0012] The meal replacement composition of this application is suitable not only for ALS patients but also for other patients who require nutritional supplementation. While supplementing daily nutritional needs, it works on the gut microbiota, increasing the content of beneficial bacteria and inhibiting the content of harmful bacteria, thereby achieving the effects of strengthening the spleen, protecting the liver, invigorating the kidneys, and benefiting the lungs, and slowing the progression of ALS.

[0013] In addition, the meal replacement composition of this application uses readily available raw materials that are cheaper than all enteral nutrition products on the market, ensuring taste while providing the body with basic daily nutrition; the powdered product is prepared for reconstitution, making it convenient for patients with swallowing difficulties while overcoming the problem of short shelf life.

[0014] Other features and advantages of this application will be set forth in the following description, and will be apparent in part from the description, or may be learned by practicing the application. Other advantages of this application can be realized and obtained by means of the solutions described in the description and the accompanying drawings. Attached Figure Description

[0015] The accompanying drawings are used to provide an understanding of the technical solutions of this application and constitute a part of the specification. They are used together with the embodiments of this application to explain the technical solutions of this application and do not constitute a limitation on the technical solutions of this application.

[0016] Figure 1 A schematic diagram illustrating the mechanism of action of this application is shown.

[0017] Figure 2 The nutritional components of the meal replacement composition of this application are shown.

[0018] Figure 3 A schematic diagram of the clinical trial protocol for the meal replacement composition of this application is shown.

[0019] Figure 4 This illustration shows a comparison of the ALSFRS-R and MMT (Manual Muscle Strength Assessment Scale) scores of six patients at different time points in Example 2 of this application. The data for each bar in the left figure represents the average score of the six patients.

[0020] Figure 5 The results of the Kruskal-Wallis H rank-sum test for the gut microbiota in Example 2 of this application are shown, where ALS_0 is the patient before treatment and ALS_1 is the patient after treatment.

[0021] Figure 6 A heatmap showing the correlation between clinical efficacy and gut microbiota in Example 2 of this application is presented.

[0022] Figure 7 The results of animal experiments on the meal replacement composition of this application are shown in the figure.

[0023] Figure 8 An internal packaging diagram of the meal replacement composition of this application is shown. Detailed Implementation

[0024] Unless otherwise stated, the technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this application pertains. When a quantity, concentration, or other value or parameter is expressed as a range, preferred range, or preferred upper and lower numerical limits, it should be understood that this is equivalent to specifically disclosing any range by combining any pair of upper or preferred values ​​with any lower or preferred value, regardless of whether the range is specifically disclosed. Unless otherwise stated, the numerical ranges listed herein are intended to include the endpoints of the range and all integers and fractions (decimals) within that range.

[0025] When used with a numerical variable, the terms "about" or "approximately" usually mean that the value of the variable and all values ​​of the variable are within the experimental error (e.g., within a 95% confidence interval for the mean) or within ±10% of the specified value, or a wider range.

[0026] The expression "comprising," or similar expressions such as "including," "containing," and "having," is open-ended and does not exclude additional unlisted elements, steps, or components. The expression "consisting of," excludes any unspecified elements, steps, or components. The expression "substantially consisting of," limits the scope to the specified elements, steps, or components, plus optional elements, steps, or components that do not materially affect the essential and novel features of the claimed subject matter. It should be understood that the expression "comprising" encompasses both the expressions "substantially consisting of" and "consisting of."

[0027] The expression "at least one" or "one or more" indicates 1, 2, 3, 4, 5, 6, 7, 8, 9 or more kinds.

[0028] ALS is incurable and has a poor prognosis. In Traditional Chinese Medicine (TCM), it is often categorized as "atrophy syndrome." Modern medicine, based on theories left by ancient physicians, classifies the pathogenesis of atrophy syndrome into approximately eleven types: lung heat and leaf scorching, spleen and stomach weakness, liver and kidney deficiency, excessive stomach heat, yin deficiency and fire excess, deficiency of essence and blood, deficiency of vital energy, deficiency of extraordinary meridians, internal accumulation of damp heat, invasion of wind, cold and dampness, and mixed deficiency and excess patterns. Clinically, the survival time of ALS patients is 3 to 5 years, and death often results from extreme respiratory distress and severe muscle atrophy.

[0029] Currently published papers on traditional Chinese medicine compound prescriptions for treating ALS include: "Clinical Study of Modified Sijunzi Decoction in the Treatment of Amyotrophic Lateral Sclerosis" (Medical Guide, August 2016, Vol. 35, Supplement, pp. 43-45); "Clinical Observation of Modified Guilu Erxian Jiao in the Treatment of Amyotrophic Lateral Sclerosis" (Journal of Clinical Traditional Chinese Medicine, 2013, Vol. 5, No. 24, pp. 28-30); "Clinical Observation of the Efficacy of Fuyuan Shengji Granules in Improving the Syndrome of Amyotrophic Lateral Sclerosis Patients" (Journal of Neurology and Neurorehabilitation, September 2009, Vol. 6, No. 3, pp. 173-175); and "Treatment of 25 Cases of Amyotrophic Lateral Sclerosis with Yiqi Qiangji Decoction" (Journal of Integrated Traditional and Western Medicine on Cardiovascular and Cerebrovascular Diseases, May 2006, Vol. 4, No. 5, pp. 452-453). These compound prescriptions have a certain therapeutic effect on ALS, but they cannot function as a meal replacement.

[0030] Nutritional meal replacements used for amyotrophic lateral sclerosis (ALS) include Peptamen, Nexium Enteral Nutrition Suspension (manufactured by Nutricia Pharmaceutical (Wuxi) Co., Ltd.), Reliton, Reliton (manufactured by Huarui Pharmaceutical Co., Ltd.), Reliton (manufactured by Fresenius Kabi Huarui Pharmaceutical Co., Ltd.), and Ensure (ABBOTT LABORATORIES BV). These nutritional meal replacements have drawbacks including high price, inconvenient administration, poor taste, low dietary content, inconvenient storage, and lack of application of food-medicine homology principles. Most existing enteral nutrition products are composed directly of small molecules such as proteins and carbohydrates, neglecting the taste issue.

[0031] The *Suwen* (Plain Questions) chapter on flaccid paralysis states, "The Yangming meridian is the sea of ​​the five viscera and six bowels, responsible for nourishing the tendons… When the Yangming is deficient, the tendons become lax, and the belt meridian fails to provide support, thus causing flaccid paralysis of the feet." The Foot Yangming Stomach Meridian is indeed the sea of ​​the five viscera and six bowels; deficiency of the Yangming leads to malnourishment of these organs, which is one of the pathogenesis mechanisms of flaccid paralysis. Based on the ancient medical view that "treating flaccid paralysis solely relies on the Yangming meridian," and combined with the "gut-muscle axis" theory, this application explores and develops an enteral nutrition agent that treats amyotrophic lateral sclerosis (ALS) by regulating the gut microbiota in patients with muscle atrophy, while simultaneously functioning as a nutritional meal replacement.

[0032] Based on this, this application provides a meal replacement composition for treating amyotrophic lateral sclerosis (ALS) composed of Chinese medicinal herbs that are both food and medicine. While supplementing daily nutritional needs, it also works on the intestinal flora, increasing the content of beneficial bacteria and inhibiting the content of harmful bacteria, thereby achieving the effects of tonifying the spleen, protecting the liver, strengthening the kidneys, and benefiting the lungs, and slowing the progression of ALS.

[0033] In one aspect, this application provides a meal replacement composition, wherein, by weight, the meal replacement composition comprises: 16-24 parts oats, 16-24 parts fox nuts, 16-24 parts red date flesh, 16-24 parts highland barley, 160-240 parts low-lactose milk powder, 40-60 parts roasted rice, 16-24 parts coconut meat, 40-60 parts peanuts, 32-48 parts almonds, 32-48 parts apples, 4-6 parts astragalus, 4-6 parts roasted polygonatum, 2-4 parts papaya, 2-4 parts yam, 2-4 parts poria cocos, and 2-4 parts codonopsis.

[0034] In some implementations, the meal replacement composition, by weight, comprises: 18-22 parts oats, 18-22 parts fox nuts, 18-22 parts red date flesh, 18-22 parts highland barley, 180-220 parts low-lactose milk powder, 45-55 parts roasted rice, 18-22 parts coconut meat, 45-55 parts peanuts, 37-42 parts almonds, 37-42 parts apples, 4-6 parts astragalus, 4-6 parts roasted polygonatum, 2-3 parts papaya, 2-3 parts yam, 2-3 parts poria cocos, and 2-3 parts codonopsis.

[0035] In some implementations, the meal replacement composition, by weight, comprises: 20 parts oats, 20 parts fox nuts, 20 parts red date flesh, 20 parts highland barley, 200 parts low-lactose milk powder, 50 parts roasted rice, 20 parts coconut meat, 50 parts peanuts, 40 parts almonds, 40 parts apples, 5 parts astragalus, 5 parts roasted polygonatum, 2.5 parts papaya, 2.5 parts yam, 2.5 parts poria cocos, and 2.5 parts codonopsis.

[0036] The sources and effects of each component in the meal replacement composition of this application are as follows: Six main ingredients that are both food and medicine: Astragalus: The root of *Astragalus memeranaceus* (Fisch.) Bge. var. *mongholicus* (Bge.) Hsiao or *A. membranaceus* (Fisch.) Bge., belonging to the genus *Astragalus* of the legume family. It has a sweet taste and slightly warm nature, and enters the spleen and lung meridians. It tonifies qi and raises yang, generates fluids and nourishes blood, promotes circulation and relieves pain, and promotes tissue regeneration and detoxification. It is mainly used to treat spleen qi deficiency, lung qi deficiency, spontaneous sweating due to qi deficiency, qi and blood deficiency, and sores that are difficult to ulcerate or heal.

[0037] Codonopsis pilosula: The dried root of Codonopsis pilosula, Codonopsis lanceolata, or Codonopsis chuanxiong, all belonging to the Campanulaceae family. It is sweet in taste and neutral in nature, entering the liver and spleen meridians. It tonifies the spleen and lungs, nourishes blood and generates fluids. It is used for spleen and lung qi deficiency, poor appetite and fatigue, cough and wheezing, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to fluid depletion, and internal heat with thirst.

[0038] Poria cocos: The dried sclerotium of the fungus Poria cocos (Schw.) Wolf (family Polyporaceae). It has a sweet and bland taste, is neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. It is used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia. It also promotes diuresis and eliminates dampness, strengthens the spleen and resolves phlegm, calms the mind and soothes the nerves; it tonifies the spleen, transports nutrients into the blood, replenishes blood deficiency, and aids digestion; it also transports fluids and eliminates phlegm and dampness. It is neutral in nature and can be used for both cold and hot conditions.

[0039] Yam: This product is the dried rhizome of Dioscorea opposita, a plant in the Dioscoreaceae family. Also known as yam, wild yam, mountain yam, Huai yam, and white yam, it is a medicinal herb recorded in the *Chinese Materia Medica*. It has a sweet taste and neutral properties, and enters the spleen, lung, and kidney meridians. It nourishes qi and yin, tonifies the spleen, lungs, and kidneys, and astringes essence to stop leukorrhea. It is used for spleen deficiency with poor appetite, chronic diarrhea, lung deficiency with cough and asthma, kidney deficiency with seminal emission, leukorrhea, frequent urination, and thirst due to deficiency heat.

[0040] Papaya: The dried, nearly mature fruit of *Chaenomeles speciosa* (Sweet) Nakai, a plant in the Rosaceae family. It has a sour taste and warm properties, and enters the liver and spleen meridians. It relaxes muscles and tendons, resolves dampness, and harmonizes the middle jiao (digestive system). It is used for damp-heat arthralgia, lower back and knee pain, summer-heat vomiting and diarrhea, muscle spasms and cramps, and beriberi with edema.

[0041] Stewed Polygonatum: Polygonatum is the dried rhizome of Polygonatum yunnanensis, Polygonatum sibiricum, or Polygonatum multiflorum, all belonging to the Liliaceae family. It is sweet in taste and neutral in nature, and enters the spleen, lung, and kidney meridians. It tonifies qi and nourishes yin, strengthens the spleen, moistens the lungs, and benefits the kidneys. It is used for symptoms such as spleen and stomach qi deficiency, fatigue, stomach yin deficiency, dry mouth and poor appetite, lung deficiency and dry cough, consumptive cough with hemoptysis, deficiency of essence and blood, soreness and weakness of the lower back and knees, premature graying of hair, and internal heat and thirst.

[0042] Top Ten Auxiliary Ingredients: Oats: The stems and leaves of the oat plant (Oatella sativa), a member of the Poaceae family. They have a sweet taste and neutral properties, and are beneficial to the spleen and stomach, promote bowel movements and induce labor, and have astringent and hemostatic effects. They are rich in vitamins and minerals and have strong antioxidant properties.

[0043] Euryale ferox: The dried, mature seed kernel of the Euryale ferox plant (family Nymphaeaceae). It has a sweet and astringent taste, is neutral in nature, and enters the spleen and kidney meridians. It invigorates the stomach and qi, and tonifies the spleen and kidneys.

[0044] Red date flesh: The pulp of the fruit of the jujube plant (Ziziphus jujuba), a member of the Rhamnaceae family. It is sweet in taste and warm in nature. It enters the heart, spleen, and stomach meridians. It tonifies the middle energizer, replenishes qi, and strengthens the spleen and stomach.

[0045] Highland barley: The kernel of the barley plant *Avena chinensis* (Fisch. ex Roem. et Schult.) Metzg. [*A. nuda L. var. chinensis* Fisch. ex Roem. et Schult.; *A. nuda auct. non L.] It has a salty taste, neutral properties, and enters the liver, spleen, and lung meridians. It dispels dampness and promotes sweating, regulates qi and relieves chest congestion, and strengthens essence and boosts energy.

[0046] Low-lactose milk powder: Made from skimmed milk produced by dehydrating the milk of cattle or buffalo. It has a sweet taste and neutral properties, and enters the heart, lung, and stomach meridians. It nourishes qi and blood, strengthens the lungs and stomach, and promotes the production of body fluids and moistens the intestines. It is rich in protein and amino acids and is suitable for patients with lactose intolerance.

[0047] Fried millet (sorghum): Belonging to the genus Millet of the Poaceae family, it is an annual herbaceous cereal crop. It nourishes the stomach, replenishes qi, strengthens the spleen and lungs.

[0048] Coconut meat: The flesh of the fruit of the palm tree (Cocos spp.). It has a sweet taste, neutral properties, and enters the heart and spleen meridians. It nourishes and strengthens the body, replenishes qi, and dispels wind.

[0049] Peanuts: The seeds of the peanut plant, a legume. They are sweet in taste, neutral in nature, and enter the spleen and lung meridians. They soothe the spleen and stomach, moisten the lungs and resolve phlegm, nourish and regulate qi, and clear the throat and stop malaria.

[0050] Apple: The fruit of the apple tree, a plant in the Rosaceae family. It has a sweet taste and cool properties, and enters the spleen, stomach, and heart meridians. It promotes a healthy gut microbiota, reduces inflammation, generates fluids and moistens the lungs, and strengthens the spleen and stomach.

[0051] Almonds: The mature, bitter seeds of the apricot or other bitter-tasting trees (Prunus armeniaca, Prunus armeniaca, etc.) belonging to the Rosaceae family. They are bitter in taste, slightly warm in nature, and enter the lung and large intestine meridians. They moisten the lungs, soothe the stomach, and relieve phlegm and cough.

[0052] The above-mentioned 6 kinds of natural plant materials that are both food and medicine, along with 10 kinds of excipients, work synergistically to alleviate the symptoms of ALS while supplementing the daily nutritional needs.

[0053] On the other hand, this application also provides a method for preparing the meal replacement composition described herein, comprising the following steps: The raw materials of each component in the meal replacement composition are removed from impurities, purified, dried, and then pulverized using a pulverizer; The crushed peanuts and almonds were sieved through a 40-mesh sieve, and the remaining crushed raw materials were sieved through a 60-mesh sieve to obtain dry powders of each component. Weigh each component according to its respective weight percentage and mix them thoroughly.

[0054] On the other hand, this application also provides the use of the meal replacement compositions described herein in the preparation of a medicament for the treatment of amyotrophic lateral sclerosis (ALS).

[0055] On the other hand, this application also provides the use of the meal replacement compositions described herein in the preparation of health products.

[0056] On the other hand, this application also provides the use of the meal replacement compositions described herein in the preparation of food.

[0057] On the other hand, this application also provides internal packaging diagrams of the meal replacement compositions described herein, such as... Figure 8 As shown.

[0058] On the other hand, this application also provides pharmaceuticals, health products, or food products that include the meal replacement compositions described herein.

[0059] In some implementations, the dosage form of the drug, health product, or food is an oral preparation; preferably, the oral preparation is a powder, tablet, capsule, granule, powder, effervescent tablet, blister pack, or solution.

[0060] In some embodiments, the medicines, health products, or food products described herein can be prepared into suitable oral formulations, including powders and granules, as needed. Granules are obtained by mixing the powder of the meal replacement compositions described herein with hot or warm water.

[0061] In some implementations, the food or health product may also contain edible excipients acceptable for use in the food or health product.

[0062] This application describes several embodiments, but these descriptions are exemplary and not restrictive, and it will be apparent to those skilled in the art that many more embodiments and implementations are possible within the scope of the embodiments described herein. Although many possible combinations of features are shown in the accompanying drawings and discussed in the detailed description, many other combinations of the disclosed features are also possible. Unless specifically limited, any feature of any embodiment may be used in combination with any other feature in any other embodiment, or may replace any other feature in any other embodiment.

[0063] This application includes and contemplates combinations of features known to those skilled in the art. The embodiments and features disclosed in this application can also be combined with any conventional features to form a unique inventive scheme as defined by the claims. Any feature of any embodiment can also be combined with features from other inventive schemes to form another unique inventive scheme as defined by the claims. Therefore, it should be understood that any feature shown and / or discussed in this application can be implemented individually or in any suitable combination. Therefore, the embodiments are not limited except by the limitations imposed by the appended claims and their equivalents. Furthermore, various modifications and changes can be made within the scope of the appended claims.

[0064] Furthermore, in describing representative embodiments, the specification may have presented methods and / or processes as a specific sequence of steps. However, the method or process should not be limited to the specific order of steps described herein, to the extent that it does not depend on such a specific order. As will be understood by those skilled in the art, other sequences of steps are also possible. Therefore, the specific order of steps set forth in the specification should not be construed as a limitation of the claims. Moreover, the claims concerning the method and / or process should not be limited to the steps performed in the written order, and those skilled in the art will readily understand that these orders can be varied and still remain within the spirit and scope of the embodiments of this application.

[0065] Experimental methods in the following embodiments without specific conditions are generally determined according to national standards. Experimental materials in the following embodiments without specified sources are all commercially available raw materials. The equipment used in each step of the following embodiments is conventional equipment. If there is no corresponding national standard, then generally accepted international standards, conventional conditions, or conditions recommended by the manufacturer are followed. Unless otherwise defined or stated, all technical and scientific terms used in this application have the same meaning as those skilled in the art. Furthermore, any methods and materials similar or equivalent to those described herein may be applied to the methods of this application.

[0066] Example 1. Preparation of Meal Replacement Composition The meal replacement composition of this application uses the following proportions: 20g oats, 20g fox nuts, 20g red date flesh, 20g highland barley, 200g low lactose milk powder, 50g roasted rice, 20g coconut meat, 50g peanuts, 40g almonds, 40g apples, 5g astragalus, 5g roasted polygonatum, 2.5g papaya, 2.5g yam, 2.5g poria cocos, and 2.5g codonopsis pilosula.

[0067] The preparation method includes the following steps: The raw materials were cleaned, purified, dried, and pulverized using a pulverizer. Peanuts and almonds were sieved through a 40-mesh sieve, while the remaining materials were sieved through a 60-mesh sieve. After drying, the powders were weighed according to the above proportions and mixed evenly to obtain the meal replacement composition of this application. Table 1 below shows the various material compositions of the meal replacement composition: Table 1 The composition is rich in crude fiber, vitamins B1 and B2, and various essential amino acids, making it highly nutritious and possessing functions such as regulating immunity and protecting the cardiovascular and nervous systems.

[0068] Among them, the content ratio of nutrients meets the standard and conforms to the dietary requirements of patients with amyotrophic lateral sclerosis. The protein content is 23%, the fat content is 25%, and the carbohydrate content is 52%. Every 500 g can provide 2,000 kcal of energy, which can meet the daily energy intake of a 60-kg healthy person.

[0069] Example 2. Clinical trial This clinical trial is part of the clinical trials approved by the Capital Medical University School-level Cultivation Fund (Natural Sciences) in 2022, with the approval number: PYZ22034.

[0070] In this example, the meal replacement composition prepared in Example 1 of the present application was used, and this meal replacement composition is also referred to as Yiqi Shengji Drink hereinafter.

[0071] In this study, 10 patients with amyotrophic lateral sclerosis who had known and consented to participate in the exploration of the "gut-muscle" axis mechanism of the long-term effect of Yiqi Shengji Drink on amyotrophic lateral sclerosis (this disease is a rare disease and recruitment is extremely difficult) and 10 healthy subjects were taken as examples. The 10 patients were divided into the Yiqi Shengji Drink group (6 cases, only taking Yiqi Shengji Drink, three times a day, 100 g each time) and the control group (4 cases, normal diet, without any intervention). At week 0, feces were collected from 10 patients and 10 healthy subjects respectively to measure the intestinal flora, so as to compare the differences in intestinal flora biodiversity between ALS patients and healthy subjects. In addition, the ALSFRS-R and MMT (Manual Muscle Test) of 10 ALS patients were also evaluated to facilitate the comparison of the changes in ALS patients before and after taking Yiqi Shengji Drink. At week 4 (±3 days), feces were collected from the Yiqi Shengji Drink group and the control group respectively to measure the intestinal flora, and then compared to find out the changes in the main pathogenic flora before and after taking the Yiqi Shengji Drink meal replacement and the correlation between the changes in intestinal flora and clinical efficacy.

[0072] Evaluation indicators Refer to the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS FRS) to evaluate the general condition of patients. Observe the general state of patients and score, including speech, salivation, swallowing, writing, using tableware, dressing and washing, turning over and adjusting bedding, walking, climbing stairs, and breathing. Each index accounts for a 10% weight, and the scoring criteria are shown in Table 2.

[0073] Table 2 General state scoring criteria for ALS patients After 6 patients who entered the clinical study took the meal replacement composition of the present application for 4 weeks, 5 patients had varying degrees of improvement in functions such as breathing, speech, swallowing, and salivation. The specific situation is as Figure 4 shown.

[0074] The gut microbiota of the subjects was studied, and the results showed that: like Figure 5 As shown (ALS_0 represents patients before treatment; ALS_1 represents patients after treatment), at the genus level, the abundance of 11 bacterial genera changed between ALS patients and healthy subjects using the Kruskal-Wallis H rank-sum test (left figure). The three genera with the largest changes in abundance were... Ruminococcus (P=0.03167) Eisenbergiella (P=0.03473) Klebsiella (P=0.04709). After one month of drinking a Qi-boosting and muscle-regenerating beverage as a meal replacement, the number of rumen cocci ( Ruminococcus The relative abundance of ) increased significantly; Sarcopenia is a biomarker genus for the diagnosis of sarcopenia. Eisenbergiella The relative abundance of these elements decreased significantly (P<0.05).

[0075] The Kruskal-Wallis H rank-sum test revealed differences in 10 KEGG metabolic function predictions between ALS patients and healthy subjects (right figure). The pathways with significant differences in functional prediction were ko01501-lactam resistance (P=0.02751), ko05200-transketolase (P=0.01206), and ko01524-platinum resistance (P=0.01574).

[0076] To better investigate the correlation between clinical efficacy and gut microbiota, we analyzed the relationship using Spearman Correlation Heatmap. Figure 6 It can be seen that beneficial bacteria—Ruminococcus spp.—are closely related to the clinical efficacy of ALS patients. Ruminococcus It was significantly positively correlated with the improvement of respiratory function (Breath) in the primary outcome measure (P<0.01); and contributed to the alleviation of inflammatory and metabolic diseases. Blautia The fungal species were significantly negatively correlated with both cut food and handing equipment (both P<0.01).

[0077] Example 3. Mouse Experiment This animal experiment is part of the animal mechanism research approved by the Capital Medical University School-level Cultivation Fund (Natural Science) in 2023, approval number: PYZ23032.

[0078] I. This experiment used SOD1, an internationally recognized animal model of ALS. G93AUsing mice as the research subjects, study whether this product can slow down the progression of ALS, supplement the nutrients required by the living body, and has no toxic effect on the living body.

[0079] The usage ratio of the meal replacement composition (Qi-Yi Sheng-Ji Drink) in this application in the experiment: 20 g of oats, 20 g of Euryale ferox, 20 g of red date flesh, 20 g of hulless barley, 200 g of low-lactose milk powder, 50 g of fried rice, 20 g of coconut meat, 50 g of peanuts, 40 g of almonds, 40 g of apples, 5 g of Astragalus membranaceus, 5 g of processed Polygonatum sibiricum, 2.5 g of papaya, 2.5 g of Chinese yam, 2.5 g of Poria cocos, 2.5 g of Codonopsis pilosula.

[0080] According to the calculation formula: dose for human (60 kg) ÷ 7.7 = dose for mice per kg, calculate the grams of Qi-Yi Sheng-Ji Drink required for each meal of the experimental mice. According to the dose obtained from this calculation and the actual experimental situation, adjust the dose of Qi-Yi Sheng-Ji Drink to 5 g of Qi-Yi Sheng-Ji Drink per meal for each mouse.

[0081] In this experiment, male ALS-SOD1 mice at 8 weeks old G93A were divided into a model group of 10 mice and a Qi-Yi Sheng-Ji Drink group of 10 mice, and both were raised in an environment with constant temperature (25 - 27 °C), constant humidity and specific pathogen free (SPF). The mice in the Qi-Yi Sheng-Ji Drink group were intragastrically administered 5 g of this Qi-Yi Sheng-Ji Drink product, and the model group was fed with an equal amount of sterilized SPF-grade granular rodent feed, three times a day, and an equal amount of sufficient water supply was ensured. According to the growth characteristics of ALS-SOD1 mice, the mice in the Qi-Yi Sheng-Ji Drink group were continuously intragastrically administered for 7 days. Observe the status of the mice during the 0-day and 7-day intragastric administration experiments, and weigh the body weight and muscle strength once a day. After 7 days of intragastric administration, the body weight and muscle strength of the model mice and the mice in the Qi-Yi Sheng-Ji Drink group were measured before and after intragastric administration, and the results are as shown in G93A the left figure below. Figure 7 as shown in the left figure below.

[0082] II. Evaluation indicators 1. Refer to the "Clinical Research Index Principles for Traditional Chinese Medicine in Treating Spleen Deficiency Syndrome" to evaluate the general condition of the mice. Every day, the mice were separated into the observation cage, and the general status of the mice was observed and scored, including mental state, activity state, hair state, and feces condition. Each index accounted for a 25% weight, and the scoring criteria are shown in Table 3.

[0083] 2. Table 3 Scoring criteria for the general status of mice The results are as shown in Figure 7 the right figure below.

[0084] The above experiments conclude that modifying the gut microbiota to improve the clinical symptoms of amyotrophic lateral sclerosis (ALS) is feasible. The Qi-Boosting and Muscle-Regenerating Decoction of this application can increase the content of beneficial bacteria in the gut and inhibit the growth of harmful bacteria, thereby alleviating the progression of symptoms such as muscle atrophy, dysphagia, and fasciculations in ALS patients. Traditional Chinese medicine is used to tonify the spleen, protect the liver, strengthen the kidneys, and benefit the lungs, improving the quality of life for ALS patients and supporting their vital energy. The excipients supplement daily nutritional needs, achieving a meal replacement effect.

Claims

1. A meal replacement composition, wherein, By weight, the meal replacement composition comprises: 16-24 parts oats, 16-24 parts fox nuts, 16-24 parts red date flesh, 16-24 parts highland barley, 160-240 parts low-lactose milk powder, 40-60 parts roasted rice, 16-24 parts coconut meat, 40-60 parts peanuts, 32-48 parts almonds, 32-48 parts apples, 4-6 parts astragalus, 4-6 parts roasted polygonatum, 2-4 parts papaya, 2-4 parts yam, 2-4 parts poria cocos, and 2-4 parts codonopsis.

2. The meal replacement composition according to claim 1, wherein, By weight, the meal replacement composition comprises: 18-22 parts oats, 18-22 parts fox nuts, 18-22 parts red date flesh, 18-22 parts highland barley, 180-220 parts low-lactose milk powder, 45-55 parts roasted rice, 18-22 parts coconut meat, 45-55 parts peanuts, 37-42 parts almonds, 37-42 parts apples, 4-6 parts astragalus, 4-6 parts roasted polygonatum, 2-3 parts papaya, 2-3 parts yam, 2-3 parts poria cocos, and 2-3 parts codonopsis.

3. The meal replacement composition according to claim 1, wherein, By weight, the meal replacement composition comprises: 20 parts oats, 20 parts fox nuts, 20 parts red date flesh, 20 parts highland barley, 200 parts low-lactose milk powder, 50 parts roasted rice, 20 parts coconut meat, 50 parts peanuts, 40 parts almonds, 40 parts apples, 5 parts astragalus, 5 parts roasted polygonatum, 2.5 parts papaya, 2.5 parts yam, 2.5 parts poria cocos, and 2.5 parts codonopsis pilosula.

4. A method for preparing the meal replacement composition according to any one of claims 1-3, comprising the following steps: The raw materials of each component in the meal replacement composition are removed from impurities, purified, dried, and then pulverized using a pulverizer; The crushed peanuts and almonds were sieved through a 40-mesh sieve, and the remaining crushed raw materials were sieved through a 60-mesh sieve to obtain dry powders of each component. Weigh each component according to its respective weight percentage and mix them thoroughly.

5. Use of the meal replacement composition according to any one of claims 1-3 in the preparation of health food products.

6. A health food comprising the meal replacement composition of any one of claims 1-3.

Images