A composition with lipid-lowering and weight-reducing functions

Abstract

The present application provides a composition with lipid-lowering and weight-reducing functions, which has clear components and controllable quality. The composition comprises Pu'er tea extract, wherein the Pu'er tea extract contains 10-90% theabrownine by weight, preferably also contains theophylline, the weight ratio of the theabrownine and theophylline is 10:1-60:1, and contains 0-15% tea polyphenols by weight. The theophylline can be selected from exogenous theophylline or theophylline contained in the Pu'er tea extract. The composition with lipid-lowering and weight-reducing functions of the present application also comprises Poria cocos extract; the weight ratio of the Pu'er tea extract to the Poria cocos extract is 1:3-3:1 based on the weight of theabrownine contained in the Pu'er tea extract. The composition of the present application has the advantages of clear effective components, simple preparation process, controllable quality, and stable lipid-lowering and weight-reducing effects.

Description

Technical Field

[0001] This invention relates to a composition, particularly to a composition having auxiliary functions of lowering lipids and losing weight, more specifically to a composition of Pu-erh tea extract and Poria cocos extract, and further to the application of said composition in the pharmaceutical and food industries. Background Technology

[0002] The medicinal effects of Pu-erh tea were recorded as early as in the "Compendium of Materia Medica." Traditional Chinese medicine believes that Pu-erh tea has the effects of clearing heat, relieving summer heat, detoxifying, aiding digestion, removing greasiness, promoting urination, relieving constipation, resolving phlegm, dispelling wind and relieving exterior syndromes, relieving cough and promoting salivation, invigorating energy, and prolonging life. Theabrownin is a water-soluble pigment. It is a general term for a complex product formed by the oxidation and polymerization of polyphenols in Yunnan large-leaf sun-dried green tea during the accelerated oxidation process of sprinkling water and piling or natural oxidation.

[0003] Poria cocos is sweet, bland, and neutral in nature, entering the heart, lung, and spleen meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and stomach, and calming the mind and soothing the nerves. Poria cocos extract mainly contains triterpenes and polysaccharides, which have the effects of strengthening the spleen, calming the nerves, promoting diuresis, and eliminating dampness. It is used to treat spleen deficiency with poor appetite, edema, and oliguria. Modern pharmacological studies have shown that Poria cocos has multiple pharmacological effects, including inhibiting the growth of spleen tumors and enhancing the body's immunity.

[0004] Existing literature has extensively explored the effects of Pu-erh tea and Poria cocos on lipid metabolism and weight loss. A study by SunShan-Shan et al. in their paper "An insoluble polysaccharide from the sclerotium of Poriacocos improves hyperglycemia, hyperlipidemia and hepatic steatosis in ob / obmice via modulation of gut microbiota" (Chinese Journal of Natural Medicines 2019, 17(1): 0003-0014) showed that an insoluble polysaccharide (WIP) was extracted from its sclerotium. After oral administration of WIP to obese mice, glucose and lipid metabolism were significantly improved, and hepatic steatosis was reduced. After ingestion of WIP, the abundance of butyrate-producing bacteria such as Mucor and Clostridium in the cecum of obese mice increased. Ingestion of WIP can increase the butyrate content in the intestine, improve the integrity of the intestinal mucosa, and increase the β-oxidation of fatty acids and reduce the production of nitrates by activating the PPAR-γ pathway. Fecal microbiota transplantation experiments proved that the gut microbiota mediates the health-promoting effects of WIP.

[0005] Chinese patent application CN109157584A discloses a composition with auxiliary lipid-lowering function, its preparation method, and its application. It is made from 20-40 parts ginseng, 40-120 parts Poria cocos, 20-40 parts Pu-erh tea, 20-50 parts gardenia, 50-100 parts lotus leaf, and 20-50 parts ginkgo leaf. CN 111513155A provides a health tea for preventing lipid metabolism abnormalities, composed of the following ingredients: 1-20g Polygonatum sibiricum, 1-20g Angelica sinensis, 1-20g Panax notoginseng, 1-10g Aucklandia lappa, 1-10g Poria cocos, 1-10g red yeast rice, and 1-20g Pu-erh tea. The health tea has a reasonable formula and can effectively prevent and treat symptoms related to lipid metabolism abnormalities. CN 107349292 A provides a weight-loss tea that inhibits lipids, reduces blood sugar, and dissolves oil, and its preparation method, containing: hawthorn extract, tangerine peel extract, kelp extract, lotus leaf extract, wolfberry extract, poria cocos extract, eucommia extract, salvia miltiorrhiza extract, Pu-erh tea extract, winter melon peel extract, stevia extract, watermelon rind juice, lemon juice, honey, lactose, and soluble starch.

[0006] In existing technologies for the application of Pu-erh tea and Poria cocos, traditional Chinese medicinal materials or processed medicinal slices are typically used as ingredients, and the products are prepared by weight-based formulations. However, research on their effective components and mechanisms of action is limited. Furthermore, the effective components of raw materials or processed medicinal slices often fluctuate significantly due to differences in origin or processing methods. Therefore, in existing technologies using raw materials or processed medicinal slices, the effective components are unclear, making it difficult to control the content and proportion of these components to ensure the expected health or medical effects.

[0007] This invention aims to overcome the shortcomings of existing technologies by studying the composition and mechanism of action of Pu-erh tea extract and Poria cocos extract, clarifying the effective components, and providing a composition with simple formulation, clear effective components, controllable quality, and clear and reliable lipid-lowering and weight-loss effects. Furthermore, it provides its preparation method and uses in food and medicine. Summary of the Invention

[0008] In view of the shortcomings of the prior art, the present invention provides a composition with clearly defined components and controllable quality that has the function of reducing lipids and losing weight.

[0009] The composition of this invention has the outstanding advantages of clearly defined active ingredients, simple preparation process, controllable quality, and stable lipid-lowering and weight-loss effects.

[0010] This invention is achieved through the following technical solution: The inventors have conducted a systematic study on the chemical composition of Pu-erh tea, the changes in chemical composition after storage for different years, the dynamic changes in the absorption, distribution, and transformation of its chemical composition in the human body after drinking Pu-erh tea, and its impact on the human metabolic network, and proposed a composition with lipid-lowering and weight-loss functions in this invention.

[0011] The present invention provides a composition having lipid-lowering and weight-loss functions, the composition comprising Pu-erh tea extract, wherein the Pu-erh tea extract contains 10-90% theabrownin by weight.

[0012] The composition with lipid-lowering and weight-loss functions further includes theophylline, theabrownin, and theophylline in a weight ratio of 10:1-60:1, preferably 30:1, and tea polyphenols comprising 0-15% by weight. The theophylline may be selected from exogenously added theophylline or theophylline contained in Pu-erh tea extract.

[0013] The composition having lipid-lowering and weight-loss functions further includes Poria cocos extract; the weight ratio of Pu-erh tea extract to Poria cocos extract, based on the weight of theabrownins contained therein, is 1:3-3:1.

[0014] The composition having lipid-lowering and weight-loss functions is characterized in that the weight ratio of the Pu-erh tea extract to the poria cocos extract, based on the weight of theabrownins contained therein, is 1:2-2:1.

[0015] The above-mentioned composition with lipid-lowering and weight-loss functions can be prepared into various product forms. For example, the composition may include food-grade additives and be prepared as a solid beverage, liquid beverage, semi-solid beverage, solid food, liquid food, or semi-solid food; or the composition with lipid-lowering and weight-loss functions may include pharmaceutically applicable excipients and be prepared as a powder, granules, capsules, tablets, oral liquid, or syrup. As a specific embodiment, the composition may include food-grade additives and be prepared as a solid beverage, liquid beverage, or semi-solid food, or may include pharmaceutically applicable excipients and be prepared as a granule, capsule, tablet, oral liquid, or syrup dosage form. The pharmaceutically applicable excipients include excipients, disintegrants, dispersants, lubricants, flavoring agents, sweeteners, and other excipients suitable for pharmaceutical purposes.

[0016] The present invention further provides a solid beverage with lipid-lowering and weight-loss functions, comprising individually packaged compositions as described above, and optionally including individually packaged drinking liquids.

[0017] The present invention further provides a liquid beverage with lipid-lowering and weight-loss functions, comprising individually packaged compositions as described above and a liquid dispersant, wherein the liquid dispersant is selected from drinking water and optionally includes one or more of stabilizers, flavoring agents, sweeteners and preservatives.

[0018] The present invention further provides a health food with auxiliary lipid-lowering and weight-loss functions, comprising the composition and food additives as described above, wherein the health food is in one of the forms of solid, liquid, semi-solid and gel.

[0019] The present invention further provides the use of the composition having lipid-lowering and weight-loss functions as described above and any product form thereof in the preparation of pharmaceuticals for treating hyperlipidemia, fatty liver or obesity and health foods for assisting in lipid-lowering or weight loss.

[0020] The present invention also provides a method for preparing the composition or its product form, including raw material quality inspection, mixing of raw materials, and packaging.

[0021] All references cited in this article are incorporated herein by reference in their entirety and for all purposes to the extent that each publication or patent or patent application is explicitly and separately cited herein by reference in its entirety and for all purposes.

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. As used in this specification and the appended claims, the singular forms “a” and “the” include more than one of the referenced objects, unless the context clearly indicates a different meaning. For example, reference to “component” includes a combination of one or more components.

[0023] To make the objectives, technical solutions, and effects of this invention clearer and more explicit, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. Attached Figure Description

[0024] Figure 1 Comparison of theabrownin content in Pu-erh tea, black tea, and green tea

[0025] Figure 2 PCA trajectory diagram of urine changes over time before, during and after drinking Pu-erh tea

[0026] Figure 3 Serum total cholesterol and triglyceride levels in subjects before and after drinking Pu-erh tea

[0027] Figure 4 Changes in body weight in mice treated with Pu-erh tea and on high-fat diets

[0028] Figure 5 Changes in serum (a) and liver (b) lipids in mice after Pu-erh tea intervention

[0029] Figure 6. Changes in body weight (a) and blood lipids (b) in high-fat induced obese mice treated with Pu-erh tea.

[0030] Figure 7 Pu-erh tea and theaflavins regulate serum (a) and liver (b) TC and TG levels in mice on a high-fat diet.

[0031] Figure 8The mechanism by which theaflavins in Pu-erh tea lower cholesterol.

[0032] Figure 9 Theabrownins regulate gut microbiota and bile acid metabolism in mice.

[0033] Figure 10 Bile acid metabolism and lipid metabolism in microbial transplantation mice

[0034] Figure 11 Poria cocos Pu-erh tea solid beverage intervention on mouse body weight changes

[0035] Figure 12 The combination of Poria cocos and Pu-erh tea intervened in the changes of liver, epididymal perifat, subcutaneous fat, and perirenal fat in mice.

[0036] Figure 13 Intervention of Blood Lipid Changes in Mice with a Combination of Poria and Pu-erh Tea

[0037] Figure 14 The combination of Poria cocos and Pu-erh tea intervened in the total triglyceride and total cholesterol levels in mouse livers.

[0038] Figure 15 Pathological staining of liver (HE staining) in mice with a fatty liver model.

[0039] Figure 16 Oral glucose tolerance test (OGTT) in mice with a fatty liver model

[0040] Figure 17 Area under the curve (AUC) of oral glucose tolerance test in mice with fatty liver model intervention

[0041] Figure 18 Insulin Tolerance Test (ITT) in a Fatty Liver Model

[0042] Figure 19 Study on the regulatory effects of different Pu-erh tea extracts on blood lipids

[0043] Figure 20 Study on the regulatory effects of different proportions of Pu-erh tea extract and Poria cocos extract on blood lipids

[0044] In the accompanying drawings of this invention, parallel experiments involve multiple substances. Due to the limitations of grayscale image display, these substances may be displayed as colors with similar grayscale levels. To overcome this problem, the inventors hereby state that the order of experimental results in the accompanying drawings is the same as the order of the illustrated figures. For example, see the attached figures. Figure 13The four sets of experimental results represent the effects of different substances on the levels of TG, TC, HDL-C, and LDL-C. The order of the bar charts for each indicator is the same as the order of the example charts, i.e., from left to right: control, HFHS, Theabrownin, Poria, CAPE, Polymer, Theabrownin+Poria, Theabrownin+CAPE, Theabrownin+Polymer, Poria+CAPE, Poria+Polymer, CAPE+Polymer. Detailed Implementation

[0045] The inventors discovered that existing technologies lacked research disclosing the clearly defined chemical components and efficacy of Pu-erh tea extracts. Through extensive experimental research, they explored the effective components in Pu-erh tea extracts possessing health-promoting and / or pharmacological effects, and systematically studied their mechanisms of action and clinical efficacy. Based on this, they proposed a composition with clearly defined components and controllable quality, possessing lipid-lowering and weight-loss functions. The composition of this invention has the outstanding advantages of clearly defined effective components, simple preparation process, controllable quality, and stable lipid-lowering and weight-loss effects. The following examples illustrate this.

[0046] Example 1: Study on the Chemical Composition of Pu-erh Tea

[0047] Tea is a traditional Chinese beverage, primarily categorized into green tea, black tea, and Pu-erh tea. It is well known that one of the main active ingredients in tea is polyphenols, especially in unfermented green tea, while black tea and Pu-erh tea undergo semi-fermentation and full fermentation processes, respectively. Studies comparing the fat-reducing effects of green tea, black tea, and Pu-erh tea have shown that Pu-erh tea is significantly more effective than green tea and black tea in lowering serum total cholesterol (TC) and total triglycerides (TG), suggesting that Pu-erh tea contains characteristic active ingredients that distinguish it from black and green tea.

[0048] Pu-erh tea is famous for its unique pile fermentation process. During the pile fermentation process, polyphenolic components, mainly flavonoids and tea polyphenols, undergo complex chemical reactions such as microbial transformation, enzymatic oxidation, non-enzymatic auto-oxidation, degradation, and condensation under the action of humid heat and microorganisms, forming the more complex polymer theabrownin.

[0049] The inventors employed chemomics methods to investigate the main components of green tea, black tea, and Pu-erh tea, including quantitative studies of polyphenols and tea pigments, thereby exploring the main metabolic characteristics of Pu-erh tea. The tea polyphenols are primarily catechins, including theanine, catechinic acid (C), gallic acid (GA), catechin gallate (CG), epicatechin (EC), epigallocatechin (EGC), epigallocatechin gallate (EGCG), epicatechin gallate (ECG), gallocatechin (GC), and gallocatechin gallate (GCG), etc. The tea pigments include theabrownins (TB), thearubigins (TR), and theaflavins (TF).

[0050] Quantitative analysis results showed that the content of major tea polyphenols in green tea was significantly higher than that in Pu-erh tea and black tea (see attached). Figure 1 Quantitative analysis of tea pigments showed that the content of theabrownin in Pu-erh tea was significantly higher than that in black tea and green tea, indicating that theabrownin is a characteristic component of Pu-erh tea.

[0051] Example 2: Clinical Study of Pu-erh Tea

[0052] The inventors conducted a six-week human experiment involving the consumption of Pu-erh tea. Each healthy volunteer ate a prescribed diet three times a day, drank a fixed amount of Pu-erh tea at specified times, and had urine samples collected at specified times. The experiment revealed some interesting results, such as Pu-erh tea causing significant fluctuations in the levels of a series of endogenous metabolites, including inositol and 3-chlorotyrosine (in a direction beneficial to lipid metabolism). However, two weeks after participants stopped drinking Pu-erh tea, their urinary metabolic profiles did not return to the pre-consumption state as the inventors had expected.

[0053] Multivariate statistical analysis revealed that the differential metabolites leading to this abnormal "metabolic state" were mostly products related to gut microbiota metabolism. In other words, drinking Pu-erh tea significantly altered the gut microbiota structure of the subjects, causing their metabolic profile to remain in a "different" state even after tea consumption ceased. Combining the results of several other experiments, the inventors speculate that a key reason why tea consumption, and even many "dietary interventions," are beneficial to their health is the structural adjustments they exert on the human gut microbiota, helping them maintain a better microecological balance.

[0054] Example 3: Study on the impact of Pu-erh tea on microbial communities

[0055] The inventors further recruited 13 male volunteers to drink Pu-erh tea powder rich in theaflavins. Significant changes were observed in the subjects' blood lipids, gut microbiota, and endogenous metabolite profiles before and after a 4-week tea-drinking intervention. Results showed that after 4 weeks of Pu-erh tea consumption (Post-PTea), serum total cholesterol (TC) and triglyceride (TG) levels were significantly lower than before tea consumption (Pre-PTea). (See attached image) Figure 3 ).

[0056] Analysis of fecal intestinal flora in subjects before and after tea consumption using 16S rRNA gene sequencing showed that the abundance of Bacilli and Clostridia was significantly reduced after tea consumption. Among them, Lactobacillus, Bacillus, Streptococcus, Lactococcus, Clostridium, Bifidobacterium, and Bacteroides, which are related to BSH enzymes, all showed a decreasing trend. Lactobacillus, Streptococcus, Clostridium, Bifidobacterium, and Bacteroides showed significant differences (p<0.05).

[0057] These bacteria contain bile salt hydrolase (BSH), and the main function of intestinal bacteria BSH is to degrade conjugated bile acids. Reduced BSH activity leads to a significant increase in the level of conjugated bile acids flowing from the gallbladder into the small intestine. These conjugated bile acids can inhibit intestinal FXR-FGF15, thereby promoting hepatic bile acid synthesis and reducing liver cholesterol levels. The inventors used bioinformatics correlation analysis techniques to study the correlation between chemical components in tea and intestinal bacteria, finding a high correlation between theabrownins, a polyphenolic polymer abundant in Pu-erh tea, and BSH bacteria.

[0058] Example 4: Study on the mechanism of Pu-erh tea in lowering cholesterol

[0059] To verify the findings of the clinical trials, the inventors further investigated the mechanism of Pu-erh tea in weight loss and lipid reduction through animal experiments. In the Pu-erh tea intervention experiment, mice were divided into a control group (ND group); a normal tea-drinking group (ND+PTea group); a high-fat diet group (HFD group); and a high-fat tea-drinking group (HFD+PTea group), for a period of 26 weeks. The results showed that compared with the normal diet and high-fat diet groups, Pu-erh tea could significantly reduce the weight of mice, and the weight of mice in the high-fat tea-drinking group was reduced to a level close to that of the normal group (see appendix). Figure 4 ).

[0060] To confirm the effects of Pu-erh tea on blood lipids, the inventors tested biochemical indicators in the serum and liver of mice. The results showed that the serum levels of total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) in high-fat diet-induced obese mice were significantly higher than those in the control diet group, indicating the successful establishment of the high-fat diet-induced obese mouse model. Furthermore, Pu-erh tea intervention significantly reduced the serum levels of TC, TG, HDL, and LDL in both normal and obese mice, and also reduced the liver levels of TC and TG (see appendix). Figure 5 The results above show that feeding mice a high-fat diet while simultaneously drinking Pu-erh tea has a preventive effect on high-fat-induced obesity phenotype and hyperlipidemia.

[0061] Example 5: Study on the weight loss mechanism of Pu-erh tea

[0062] The inventors further verified that Pu-erh tea can significantly regulate the weight and blood lipids of obese animals. Mice fed a high-fat diet for 4 weeks, 22 weeks, and 42 weeks were further treated with Pu-erh tea for 4 weeks, respectively, as the HFD4+PTea group, HFD22+PTea group, and HFD42+PTea group. The results showed (Figure 6) that in short-term (4 weeks), medium-term (22 weeks), and long-term (42 weeks) high-fat diet-induced obese mouse models, after Pu-erh tea intervention, the weight of obese mice began to decrease significantly from the second week after drinking tea, and serum TC and TG levels also decreased significantly, indicating that Pu-erh tea also has a significant therapeutic effect on high-fat diet-induced obesity and hyperlipidemia.

[0063] To further clarify the changes in gut microbiota in high-fat diet-induced obese mice after Pu-erh tea intervention, the inventors analyzed the gut microbiota structure in the ileum contents of mice after 26 weeks of Pu-erh tea intervention using 16S rRNA sequencing technology. The results showed that the gut microbiota of mice in both the normal diet / tea-drinking group and the high-fat diet / tea-drinking group exhibited significant clustering trends, indicating that Pu-erh tea significantly altered the gut microbiota structure of mice on both diets. Differential microbiota analysis revealed a significant decrease in the abundance of BSH-related Lactobacillus, Bacillus, Enterococcus, Streptococcus, and Leuconostoc, which is consistent with the changes in gut microbiota after human consumption of Pu-erh tea, suggesting that Pu-erh tea significantly reduces the abundance of BSH bacteria.

[0064] Example 6: Study on the effective components of Pu-erh tea in lowering cholesterol

[0065] During the fermentation process of Pu-erh tea, tea polyphenols such as catechins and their gallic acid ester derivatives undergo complex oxidation and polymerization under the action of specific bacterial communities to form complex phenolic tea pigments—theaflavins. Theaflavins are the main characteristic components of Pu-erh tea. To further clarify the role of theaflavins in lowering cholesterol in Pu-erh tea, the inventors intervened with Pu-erh tea powder and theaflavins in obese mice induced by a high-fat diet. The results showed that, compared with the control diet group, drinking Pu-erh tea and theaflavins significantly reduced the levels of total cholesterol and triglycerides in the serum and liver of mice. Notably, the reduction in cholesterol and triglycerides was more significant in the theaflavin group than in the Pu-erh tea group (see appendix). Figure 7 This indicates that theabrownin is the active ingredient that causes phenotypic changes in Pu-erh tea.

[0066] Based on the above research results, the molecular mechanism by which the active ingredient theaflavins in Pu-erh tea lowers serum and liver cholesterol is as follows:

[0067] (1) Theabrownins inhibit BSH bacteria in the small intestine, leading to a decrease in BSH enzyme activity and an increase in terminal ileal conjugated bile acids, including TCDCA and TUDCA. Ileal conjugated bile acids inhibit the intestinal FXR-FGF15 signaling pathway, weakening its inhibition of hepatic bile acid synthases and causing an upregulation of hepatic bile acid synthesis;

[0068] (2) During the dynamic changes in the body, bile acid synthesis increases, especially CDCA, which is a strong agonist of FXR. It promotes the expression of liver FXR in the cell nucleus, thereby activating the FXR-SHP pathway. Since intestinal FXR-FGF15 inhibits liver bile acid synthases CYP7A1, CYP8B1, CYP27A1, and CYP7B1 without selectivity, while the liver FXR-SHP pathway selectively inhibits the expression of the classical pathway CYP8B1, CA synthesis is reduced relative to CDCA.

[0069] (3) Ultimately, the downregulation of intestinal FXR-FGF15 and the upregulation of hepatic FXR-SHP work together to affect bile acid synthase, leading to an increase in CYP7B1 in the alternative pathway and a decrease in CYP8B1 in the classical pathway. CDCA synthesis is significantly upregulated relative to CD synthesis, thereby increasing hepatic bile acid synthesis and promoting bile acid excretion through feces, thus lowering cholesterol levels. (Appendix) Figure 8 ).

[0070] Example 7: Study on the mechanism by which Pu-erh tea promotes fat metabolism

[0071] To clarify the scientific basis for the weight-loss effect of Pu-erh tea, the inventors fed mice a high-fat diet while also giving them a solution containing theaflavins. The results showed that the gut microbiota of the mice that drank theaflavins underwent significant changes, with a substantial increase in the levels of bacteria that have been proven to have beneficial effects on health, such as Akkermansia muciniphila, Clostridium scindens, Streptococcus thermophilus, and Parabacteroides distasonis. (See attached image) Figure 9 (ae). Along with the changes in gut bacteria, the composition and structure of bile acids involved in energy metabolism also changed, among which the level of non-12-hydroxybile acids, a type of bile acid that plays a key role in promoting "fat burning," increased accordingly (see appendix). Figure 9 f), and enhanced the expression of genes for brown adipose tissue and white adipose tissue reduction, resulting in a significant reduction in the size, number, and fusion of oil droplets (white adipose tissue) in the liver and fat of mice.

[0072] More importantly, in experiments involving germ-free mice transplanted with a high-fat diet and given theabrownin-infused water, the inventors also observed a "slimming" effect in obese mice, proving that theabrownin's fat-burning effect is achieved by altering the structure of intestinal bacteria, aided by the power of non-12-hydroxybile acids (see appendix). Figure 10 ).

[0073] Example 8: A study of the application of a Poria cocos and Pu-erh tea composition in a high-sugar, high-lipid-induced fatty liver animal model. Fungal polysaccharides possess various biological activities, including antitumor, antiviral, anti-inflammatory, hypoglycemic, cholesterol-lowering, and lipid-lowering effects. They inhibit the growth of tumors or cancer cells through immunomodulatory effects and have no toxic side effects on normal cells. Poria cocos, as a traditional Chinese medicine, plays an important role in improving immunity, antitumor activity, sedation, and diuresis, and is increasingly valued by researchers. Poria cocos contains various components, mainly including poria cocos polysaccharides, xylan, acidic polysaccharides, mannan, and poria cocos acid, among which poria cocos polysaccharides are the most abundant.

[0074] To further investigate the weight loss and lipid-lowering effects of the Poria cocos and Pu-erh tea combination, the inventors conducted a 12-week mouse experiment, divided into 12 groups: a control diet group, a high-sugar, high-fat diet group (HFHS group), a high-sugar, high-fat diet plus Pu-erh tea group (HFHS+Theabrownin group), a high-sugar, high-fat diet plus Poria cocos group (HFHS+Poria group), a high-sugar, high-fat diet plus propolis extract group (HFHS+CAPE group), a high-sugar, high-fat diet plus resin group (HFHS+Polymer group), and a high-sugar, high-fat diet plus Pu-erh tea and Poria cocos group (HFHS+Theabrownin group). The experiment included four groups: HFHS+Theabrownin+CAPE group (high sugar, high fat plus Pu-erh tea and propolis extract), HFHS+Theabrownin+Polymer group (high sugar, high fat plus theabrownin and resin), HFHS+Poria+CAPE group (high sugar, high fat plus Poria and resin), HFHS+Poria+Polymer group (high sugar, high fat plus Poria and resin), and HFHS+CAPE+Polymer group (high sugar, high fat plus propolis extract and resin). The intervention lasted for 12 weeks.

[0075] The experimental results showed that a high-sugar, high-fat diet significantly increased the body weight of mice. However, intervention with Pu-erh tea, Poria cocos, propolis extract, and resin while on a high-sugar, high-fat diet significantly regulated the body weight of mice. The most significant effect was observed in the group receiving both Pu-erh tea and Poria cocos as intervention (see attached). Figure 11 Meanwhile, the inventors measured the weight of the liver, epididymal fat (EAT), inguinal subcutaneous fat (AAT), and perirenal fat in mice. They found that Pu-erh tea, Poria cocos, Pu-erh tea combined with Poria cocos, and Pu-erh tea combined with resin could significantly reverse the increase in liver and fat weight caused by high sugar and high fat intake. The Pu-erh tea combined with Poria cocos group showed the most significant effect. (See attached image) Figure 12 Further studies on serum and liver lipids in mice revealed that a high-sugar, high-fat diet significantly increased the levels of total triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol esters (HDL-C), low-density lipoprotein cholesterol esters (LDL-C) in the serum of mice, as well as total triglycerides and total cholesterol in the liver. Intervention with Pu-erh tea, Poria cocos, Pu-erh tea combined with Poria cocos, Pu-erh tea combined with propolis extract, and Pu-erh tea combined with resin significantly reduced the levels of blood lipids and liver lipids in mice, with the Pu-erh tea combined with Poria cocos group showing the lowest lipid levels. (See attached image) Figure 13 , attached Figure 14 ). As attached Figure 15As shown, the staining of mouse liver pathological sections (HE staining) indicated that high sugar and high fat caused lipid droplet deposition in the mouse liver, indicating that the fatty liver model was successfully established. The intervention with Pu-erh tea and Poria cocos significantly improved the pathological changes of fatty liver. Among them, the Pu-erh tea and Poria cocos intervention group was close to the normal control group, indicating that the Pu-erh tea and Poria cocos intervention group was the most effective in improving the fatty liver phenotype, and also verified the finding that serum and liver lipids were the lowest in this group.

[0076] Furthermore, the inventors conducted oral glucose tolerance tests (OGTT) and insulin tolerance tests (ITT) on the above-interventioned mice. The OGTT results showed (see attached...). Figure 16 A high-sugar, high-fat diet induced impaired glucose tolerance in mice. Pu-erh tea, Poria cocos, propolis extract, resin, and combinations thereof significantly improved glucose tolerance in mice. The group receiving both Pu-erh tea and Poria cocos showed the smallest area under the curve, indicating that the combined intervention was significantly more effective than any single component. (See appendix) Figure 17 Meanwhile, by plotting ITT curves, the inventors discovered that a high-sugar, high-fat diet induced impaired insulin tolerance in mice, and the group receiving both Pu-erh tea and Poria cocos intervention showed the most significant improvement in insulin tolerance (see appendix). Figure 18 ).

[0077] The above results indicate that the combined intervention of Pu-erh tea and Poria cocos can significantly inhibit the obesity and hyperlipidemia phenotype induced by a high-sugar and high-fat diet in mice, and can also significantly improve the impaired glucose tolerance and insulin tolerance caused by a high-sugar and high-fat diet. It is worth emphasizing that the combined intervention of Pu-erh tea and Poria cocos is significantly better than other intervention groups, indicating that the combination of Pu-erh tea and Poria cocos has better weight loss and lipid-lowering effects.

[0078] Example 9: Study on the lipid-lowering and weight-loss effects of different Pu-erh tea extracts

[0079] The inventors further verified the regulatory effects of different Pu-erh tea extracts on blood lipids. Mice fed a high-fat diet for 22 weeks were further treated with Pu-erh tea for 4 weeks, in the following order: high-fat diet control group, Pu-erh tea extract with 98% theabrownin content, 50% theabrownin content, 30% theabrownin content, and theabrownin:theophylline (10:1), theabrownin:theophylline (30:1), and theabrownin:theophylline (60:1) ratios. The theabrownin and theophylline ratios were their weight ratios. The results showed (see attached...). Figure 19 After intervention with Pu-erh tea, serum cholesterol and triglycerides were reduced, especially the theabrownin:theophylline (30:1) content of Pu-erh tea extract, which showed the most significant effect.

[0080] Example 10: The regulatory effect of different proportions of Pu-erh tea extract and Poria cocos extract on blood lipids.

[0081] The inventors further investigated the regulatory effects of different ratios of Pu-erh tea extract and Poria cocos extract on blood lipids. Mice fed a high-fat diet for 22 weeks were further treated with Pu-erh tea extract and Poria cocos extract for 4 weeks. The Pu-erh tea extract was calculated based on theaflavins, and the weight ratio of Pu-erh tea extract to Poria cocos extract was used. The ratios were as follows: high-fat diet control group, Pu-erh tea extract: Poria cocos extract (1:3), Pu-erh tea extract: Poria cocos extract (1:2), Pu-erh tea extract: Poria cocos extract (1:1), Pu-erh tea extract: Poria cocos extract (2:1), and Pu-erh tea extract: Poria cocos extract (3:1). The results showed (see attached). Figure 20 After intervention with Pu-erh tea extract and Poria cocos extract, serum cholesterol and triglycerides were reduced, especially the mixture of Pu-erh tea extract and Poria cocos extract (1:1) had the most obvious effect.

[0082] Example 11: Preparation of Solid Beverage

[0083] Take 10g of Pu-erh tea extract (theabrownin content 30%) and 10g of Poria cocos extract, pulverize them through a 40-mesh sieve, mix them thoroughly, and package them into 20 bags to obtain Poria cocos Pu-erh tea solid beverage.

[0084] Example 12: Preparation of Solid Beverage

[0085] Take 10g of Pu-erh tea extract (theabrownin content 30%, theophylline 1%) and 10g of Poria cocos extract, pulverize them through a 40-mesh sieve, mix them thoroughly, and package them into 20 bags to obtain Poria cocos Pu-erh tea solid beverage.

Claims

1. A composition having a lipid-lowering function, characterized by comprising, The composition is made of Pu'er tea extract and Poria cocos extract, the Pu'er tea extract contains 30-90% theaflavins by weight, the weight ratio of theaflavins to theophylline in the Pu'er tea extract is 30:1; the weight ratio of the Pu'er tea extract to the Poria cocos extract is 1:1 based on the weight of theaflavins contained in the Pu'er tea extract.

2. The composition with lipid-lowering function as described in claim 1, characterized in that, The composition is further added with food suitable additives to be prepared into one of solid food, liquid food and semi-solid food.

3. The composition having lipid-lowering and weight-reducing functions according to claim 1, wherein the composition is a food or a drink. The composition is further added with pharmaceutically suitable excipients to be prepared into one of powder, granules, capsules, tablets, oral liquid and syrup.

4. Use of the composition with lipid-lowering function according to claim 1 in the preparation of health food for assisting lipid-lowering.

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