US20170135983A1 - Composition for regulating blood sugar - Google Patents
Composition for regulating blood sugar Download PDFInfo
- Publication number
- US20170135983A1 US20170135983A1 US15/246,549 US201615246549A US2017135983A1 US 20170135983 A1 US20170135983 A1 US 20170135983A1 US 201615246549 A US201615246549 A US 201615246549A US 2017135983 A1 US2017135983 A1 US 2017135983A1
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- US
- United States
- Prior art keywords
- composition
- blood sugar
- regulating blood
- daily dosage
- hyperglycemia
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Definitions
- the present invention relates to the technology field of medically-used composition, and more particularly to a composition for regulating blood sugar.
- GLU-AC fasting blood glucose
- 2hPBG concentration of 2 hours postprandial blood glucose
- IGT Impaired Glucose Tolerance
- ROS Reactive Oxygen Species
- T2DM Type 2 diabetes mellitus
- GLUT glucose transporters
- the statistical data made by Ministry of Health and Welfare of Taiwan shows that 90% T2DM patients does simultaneously suffer from obesity.
- the adipose tissue of an obesity patient may releases inflammation factors such as hypoxia-inducible factor 1 ⁇ (HIF-1 ⁇ ), tumor necrosis factor- ⁇ (TNF- ⁇ ) and interleukin (IL), wherein the excessive amount of inflammation factors would induce lipolysis action to produce a large amount of glycerin and free fatty acid (FFA), so as to aggravate the production of Hyperglycemia, fatty liver, and high blood ketone.
- HIF-1 ⁇ hypoxia-inducible factor 1 ⁇
- TNF- ⁇ tumor necrosis factor- ⁇
- IL interleukin
- FFA also inhibits the activity of insulin receptor by activating diacylglycerol (DAG) and protein kinasenk C (PKC), so as to result in the occurrence of insulin resistance.
- DAG diacylglycerol
- PKC protein kinasenk C
- Conventionally-used blood sugar reducing drugs include: non-sulfonylurea insulin secretagogue, sulfonylurea insulin secretagogue, biguanides, alpha-glucohydrolase inhibitor, and DPP-4 inhibitor (inhibitor of dipeptidyl peptidase 4).
- all the above-mentioned blood sugar reducing drugs have side-effects with varying severity, such as diarrhea, anorexia, nausea, and fatal lactic acidosis.
- Insulin sensitizers are also the conventionally-used blood sugar reducing drugs, including troglitazone, rosiglitazone and pioglitazone.
- the insulin sensitizer possesses anti-diabetic activity through activation of a nuclear receptor called PPAR ⁇ (Peroxisome proliferator-activated receptor ⁇ ).
- PPAR ⁇ Peroxisome proliferator-activated receptor ⁇
- over-activation of PPAR ⁇ drives the unwanted and often unacceptable side effects associated with the currently-approved insulin sensitizers, such as edema, weight gain, congestive heart failure, hepatotoxicity.
- the primary objective of the present invention is to provide a composition for regulating blood sugar.
- the composition comprises at least one yellow pigment extracted from a red mold product, wherein the said yellow pigment is Monascin, Ankaflavin, or combination of Monascin and Ankaflavin.
- this blood sugar regulating composition indeed possess the functionalities of: lowering Hyperglycemia induced by high energy diet, alleviating ROS and inflammatory caused by the Hyperglycemia, reduce AST and ALT value of liver as well as sarcosine value of kidney.
- the inventor of the present invention provides a first embodiment of the composition for regulating blood sugar, comprising a yellow pigment extracted from a red mold product, wherein the said yellow pigment is Monascin, and a first daily dosage of the Monascin for an adult user to regulate blood sugar is above 3 mg.
- the inventor of the present invention provides a second embodiment of the composition for regulating blood sugar, comprising yellow pigment extracted from a red mold product, wherein the said yellow pigment is Ankaflavin, and a second daily dosage of the Ankaflavin for an adult user to regulate blood sugar is above 1.5 mg.
- the inventor of the present invention provides a third embodiment of the composition for regulating blood sugar, comprising yellow pigment extracted from a red mold product, wherein the said yellow pigment is a combination of Monascin and Ankaflavin, and a daily dosage of the combination for an adult user to regulate blood sugar is above 4.5 mg; moreover, a first dose of Monascin in the combination is above 3 mg and a second dose of the Ankaflavin in the combination is above 1.5 mg.
- the inventor of the present invention provides a fourth embodiment of the composition for regulating blood sugar, comprising a red mold product produced by inoculating a Monascus purpureus to a substrate and then subjecting the inoculated substrate with a culturing and drying process; wherein a fourth daily dosage of the red mold product for an adult user to regulate blood sugar is above 1 g.
- FIG. 1 shows a curve plot of time versus blood glucose
- FIG. 2 shows a statistical bar graph of group versus AUC (area under curve) of blood glucose
- FIG. 3 shows a statistical bar graph of adiponectin expression in adipose tissue
- FIG. 4 shows a statistical bar graph of ROS concentration in liver
- FIG. 5 shows a statistical bar graph of TNF- ⁇ expression in adipose tissue
- FIG. 6 shows a statistical bar graph of GLUT-2 expression in adipose tissue
- FIG. 7 shows a statistical bar graph of GLUT-4 expression in adipose tissue
- FIG. 8 shows a statistical bar graph of IL-1 ⁇ expression in adipose tissue
- FIG. 9 shows a statistical bar graph of IL-1 ⁇ expression in adipose tissue
- FIG. 10 shows a statistical bar graph of HIF-1 ⁇ expression in adipose tissue
- FIG. 11 shows histomorphology images of liver slices.
- Monascus species is divided into Monascus pilosus, Monascus purpureus, Monascus ruber, Monascus floridanus, Monascus pallens, and Monascus sanguineus. Moreover, according to culture patterns, growth patterns, olors, and cleistothecia colors, the Monascus species is further divided into Monascus pilosus, Monascus purpureus, and Monascus ruber.
- the present invention provides a composition for regulating blood sugar, wherein the composition comprises at least one yellow pigment extracted from a red mold product, wherein the said yellow pigment is Monascin, Ankaflavin, or combination of Monascin and Ankaflavin.
- the red mold product is produced by inoculating a Monascus purpureus to a substrate and then subjecting the inoculated substrate with a culturing and drying process.
- the process steps for producing the red mold product such as red mold rice (RMR) or red mold Dioscorea (RMD) are full disclosed in the specification of TW patent NO. 1415619.
- a particularly-arranged of animal experiment is completed by inventers. After 1-week pre-feeding, several SD rats are divided into 9 experimental groups for carrying out 10-week animal experiment.
- NOR group consisting of 8 SD rats, wherein the “NOR” means that the SD rats are fed with normal diet. During the animal experiment, the SD rats in NOR group are fed with cornstarch diet unlimitedly. Moreover, RO water is taken as test sample for orally administering to SD rats in NOR group through feeding tubes.
- Second of the 9 experimental group is HFFD group consisting of 8 SD rats, wherein the “HFFD” means the SD rats are fed with high fat and fructose diet. During the animal experiment, the SD rats in HFFD group are fed with chew diet consisting of 73.3% corn starch and 26.7% butter powder.
- MF group consisting of 8 SD rats, wherein the “MF” means that drug of Metformin is taken as test sample for orally administering to SD rats in MF group through feeding tubes. Moreover, during the animal experimental, the SD rats in MF group are fed with high fat and fructose diet unlimitedly.
- RMD group consisting of 8 SD rats, wherein the “RMD” means that powder of red mold Dioscorea (RMD) is taken as test sample for orally administering to SD rats in RMD group through feeding tubes. Moreover, during the animal experimental, the SD rats in RMD group are fed with high fat and fructose diet unlimitedly.
- MS1X group consisting of 8 SD rats, wherein the “MS1X” means that 1-fold dosage of Monascin is taken as test sample for orally administering to SD rats in MS1X group through feeding tubes. Moreover, during the animal experimental, the SD rats in MS1X group are fed with high fat and fructose diet unlimitedly.
- MS5X group consisting of 8 SD rats, wherein the “MS5X” means that 5-fold dosage of Monascin is taken as test sample for orally administering to SD rats in MS5X group through feeding tubes. Moreover, during the animal experimental, the SD rats in MS5X group are fed with high fat and fructose diet unlimitedly.
- AK1X group consisting of 8 SD rats, wherein the “AK1X” means that 1-fold dosage of Ankaflavin is taken as test sample for orally administering to SD rats in AK1X group through feeding tubes. Moreover, during the animal experimental, the SD rats in AK1X group are fed with high fat and fructose diet unlimitedly.
- AK5X group consisting of 8 SD rats, wherein the “AK5X” means that 5-fold dosage of Ankaflavin is taken as test sample for orally administering to SD rats in AK5X group through feeding tubes. Moreover, during the animal experimental, the SD rats in AK5X group are fed with high fat and fructose diet unlimitedly.
- the last one of the 9 experimental group is MS-AK group consisting of 8 SD rats, wherein the “MS-AK” means that a combination of 1-fold-dose Ankaflavin and 1-fold-dose Monascin is taken as test sample for orally administering to SD rats in MS-AK group through feeding tubes. Moreover, during the animal experimental, the SD rats in MS-AK group are fed with high fat and fructose diet unlimitedly.
- Table 1 the dosage for the above-mentioned different test samples are integrated in following Table 1.
- rat dosage (adult dosage/60 kg)*6.25.
- the daily intake calorie of the rats of all experimental groups are obviously higher than the daily intake calorie of the rats in the NOR group.
- the daily intake calorie of the rats in RMD, MS5X, and MS-AK group are lower.
- the weight of the rats of all experimental groups are obviously heavier than the weight of the rats in the NOR group.
- the weight of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are lighter.
- FIG. 1 where a curve plot of time versus blood glucose.
- FIG. 2 which provides a statistical bar graph of group versus AUC (area under curve) of blood glucose. From FIG. 1 , it can easily find that, the glucose levels of the rats in HFFD group are largely higher than the glucose levels of the rats in NOR group at 0 and 30 minutes. On the other hand, from FIG. 2 , it is able to know that the rats in HFFD group have been suffered from Hyperglycemia because the AUC (area under curve) value of HFFD group is higher than the AUC value of NOR group.
- insulin resistance may be induced in the rats of HFFD group because the beta cells are killed by ROS (Reactive oxygen species) induced by Hyperglycermia. Based on above reasons, it needs to observe the effects provided by the different test samples on the GLU-AC, insulin, insulin resistance, and Fructosamine of the rats.
- the blood collected by capillary tubes are disposed into a 2-mL microcentrifuge tube. After staying for 5 minutes, the microcentrifuge tube carrying with blood is treated with a centrifugation process, and then the serum of the blood is stored in an environment with ⁇ 80 ° C.
- insulin determination is carried out by dropping the serum onto an enzyme-linked immunosorbent assay (ELISA) insulin kit. Thereafter, the insulin resistance is then calculated by using following equation: HOMA-IR 32 [insulin ( ⁇ U/mL)*glucose(mmol/L)]/22.5.
- HOMA-IR 32 Insulin ( ⁇ U/mL)*glucose(mmol/L)]/22.5.
- insulin determination is completed by dropping the serum onto a fructosamine assay kit. Therefore, the determination data of blood glucose, insulin, insulin resistance, and fructosamine are recorded and integrated in following Table 4 and Table 5.
- the GLU-AC concentration of the rats in HFFD group is greater than the GLU-AC concentration of the rats in NOR group.
- the GLU-AC concentrations of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely lowered.
- the GLU-AC level of the rats in MS5X group is almost equal to the GLU-AC level of the rats in NOR group.
- the insulin concentration of the rats in HFFD group is greater than the insulin concentration of the rats in NOR group.
- the insulin concentrations of the rats in MF, RMD, MS1x, MS5X, AK1X, AK5X, and MS-AK group are largely lowered.
- the insulin level of the rats in MS5X group is almost equal to the insulin level of the rats in NOR group.
- the insulin resistance value of the rats in HFFD group is greater than the insulin resistance value of the rats in NOR group.
- the insulin resistance value of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely lowered.
- the insulin resistance value of the rats in MS5X group is almost equal to the insulin resistance value of the rats in NOR group.
- the fructosamine concentration of the rats in HFFD group is greater than the fructosamine concentration of the rats in NOR group.
- the fructosamine concentration of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely lowered. So that, the experimental data provided by Table 4 and Table 5 prove that the Monascin and Ankaflavin indeed possess functionality to regulate blood glucose, insulin, insulin resistance, and fructosamine.
- Insulin is used for impelling the absorption and utilization of blood glucose in liver, muscle and adipose tissue.
- WAT white adipose tissue
- TG triglycerides
- a large amount of accumulation of adipocytes would cause the occurrence of inflammatory response so as to induce lipolysis action. Therefore, the inflammatory-induced lipolysis action would produce a large amount of glycerin and free fatty acid (FFA), so as to aggravate the production of Hyperglycemia, fatty liver, and high blood ketone.
- liver, kidney, and adipose tissue weight For carrying out the determination of liver, kidney, and adipose tissue weight, it needs to sacrifice the rats. After sacrificing the rat, blood to be determined is collected from the intraperitoneal of the rat by using syringes, and then the collected blood are disposed into a 2-mL microcentrifuge tube. After staying for 5 minutes, the microcentrifuge tube carrying with blood is treated with a centrifugation process, and then the serum of the blood is stored in an environment with ⁇ 20 ° C. After that, the liver, kidney, and adipose tissue are taken out of the rat.
- the high fat and fructose diet may also cause the rats suffer from Hypertriglyceridemia, so as to damage the liver.
- Table 8 has recorded with data of triglycerides (TG) and total cholesterol (TC). From Table 8, it can easily find that, the concentrations of triglycerides and total cholesterol of the rats in HFFD group are largely higher than the concentrations of triglycerides and total cholesterol of the rats in NOR group. However, comparing to the rats of HFFD group, the concentrations of triglycerides and total cholesterol of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely lowered.
- human serum would include adiponectin of 5-30 ⁇ g/mL for maintaining the balance between glucose and lipids.
- Adiponectin dose not only play an important role in the formation of insulin resistance, but also has close relationship with TG.
- FIG. 3 provides a statistical bar graph of adiponectin expression in adipose tissue. From Table FIG. 3 , it can easily find that, the percentage of adiponectin expression of the rats in HFFD group is lower than the percentage of adiponectin expression of the rats in NOR group. However, comparing to the rats of HFFD group, the percentage of adiponectin expression of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group is largely enhanced. So that, the experimental data provided by FIG. 3 prove that the Monascin and Ankaflavin indeed possess functionality to regulate the adiponectin level in adipose tissue.
- ROS Reactive Oxygen Species
- FIG. 4 provides a statistical bar graph of ROS concentration in liver. From Table FIG. 4 , it can easily find that, the ROS level of the rats in HFFD group is largely higher than the ROS level of the rats in NOR group. However, comparing to the rats of HFFD group, the ROS levels of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely lowered. So that, the experimental data provided by FIG. 4 prove that the Monascin and Ankaflavin indeed possess functionality to reduce the ROS concentration in liver.
- the adipose tissue of an obesity patient may releases inflammation factors such as hypoxia-inducible factor 1 ⁇ (HIF-1 ⁇ ), tumor necrosis factor- ⁇ (TNF- ⁇ ) and interleukin (IL), wherein the excessive amount of inflammation factors would induce lipolysis action to produce a large amount of glycerin and free fatty acid (FFA), so as to aggravate the production of Hyperglycemia, fatty liver, and high blood ketone.
- HIF-1 ⁇ hypoxia-inducible factor 1 ⁇
- TNF- ⁇ tumor necrosis factor- ⁇
- IL interleukin
- FIG. 5 provides a statistical bar graph of TNF- ⁇ expression in adipose tissue. From Table FIG.
- the percentage of TNF- ⁇ expression of the rats in HFFD group is largely higher than the percentage of TNF- ⁇ expression of the rats in NOR group.
- the percentages of TNF- ⁇ expression of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely reduced.
- FIG. 6 and FIG. 7 where a statistical bar graph of GLUT-2 expression in adipose tissue and a statistical bar graph of GLUT-4 expression in adipose tissue are shown.
- Table FIG. 6 it can easily find that, the percentage of GLUT-2 expression of the rats in HFFD group is largely lower than the percentage of GLUT-2 expression of the rats in NOR group.
- the percentages of GLUT-2 expression of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely enhanced.
- Table FIG. 6 shows a statistical bar graph of GLUT-2 expression in adipose tissue and a statistical bar graph of GLUT-4 expression in adipose tissue.
- FIG. 8 and FIG. 9 where a statistical bar graph of IL-6 expression in adipose tissue and a statistical bar graph of IL-1 ⁇ expression in adipose tissue are provided.
- Table FIG. 8 it can easily find that, the percentage of IL-6 expression of the rats in HFFD group is largely higher than the percentage of IL-6 expression of the rats in NOR group.
- the percentages of IL-6 expression of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely lowered.
- Table FIG. 8 shows that the percentage of IL-6 expression of the rats in HFFD group is largely higher than the percentage of IL-6 expression of the rats in NOR group.
- MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely lowered.
- the percentage of IL-1 ⁇ expression of the rats in HFFD group is largely higher than the percentage of IL-1 ⁇ expression of the rats in NOR group.
- the percentages of IL-1 ⁇ expression of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely lowered.
- FIG. 10 illustrates a statistical bar graph of HIF-1 ⁇ expression in adipose tissue. From Table FIG. 10 , it can easily find that, the percentage of HIF-1 ⁇ expression of the rats in HFFD group is largely higher than the percentage of HIF- ⁇ expression of the rats in NOR group. However, comparing to the rats of HFFD group, the percentages of HIF-1 ⁇ expression of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group are largely lowered. So that, the experimental data provided by FIG. 8 , FIG. 9 and FIG. 10 prove that the Monascin and Ankaflavin indeed possess functionality to reduce the ROS concentration produced in liver.
- Liver is rich in various enzyme, such as aspartate aminotransferase (AST) and alanine aminotransferase (ALT).
- AST aspartate aminotransferase
- ALT alanine aminotransferase
- FIG. 11 histomorphology images of liver slices are provided. From FIG. 11 , it can find that, the liver tissue taken out from the rats of HFFD group has become fatty liver (indicated by arrow in FIG. 11 ) due to excessive amount of fat accumulation.
- the formation of fatty liver of the rats in MF, RMD, MS1X, MS5X, AK1X, AK5X, and MS-AK group has been alleviated or solved.
- composition for regulating blood sugar provided by the present invention has been introduced completely and clearly; in summary, the present invention includes the advantages of:
- This blood sugar regulating composition merely comprises at least one yellow pigment extracted from a red mold product, wherein the said yellow pigment is Monascin, Ankaflavin, or combination of Monascin and Ankaflavin.
- this blood sugar regulating composition indeed possess the functionalities of: lowering Hyperglycemia induced by high energy diet, alleviating ROS and inflammatory caused by the Hyperglycemia, reduce AST and ALT value of liver as well as sarcosine value of kidney.
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AS | Assignment |
Owner name: SUNWAY BIOTECH CO., LTD., TAIWAN Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:PAN, TZU-MING;LEE, CHUN-LIN;HSU, YA-WEN;SIGNING DATES FROM 20160606 TO 20160609;REEL/FRAME:039532/0256 |
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |