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WO2016152706A1 - Agent améliorant la fonction rénale - Google Patents

Agent améliorant la fonction rénale Download PDF

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Publication number
WO2016152706A1
WO2016152706A1 PCT/JP2016/058461 JP2016058461W WO2016152706A1 WO 2016152706 A1 WO2016152706 A1 WO 2016152706A1 JP 2016058461 W JP2016058461 W JP 2016058461W WO 2016152706 A1 WO2016152706 A1 WO 2016152706A1
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WO
WIPO (PCT)
Prior art keywords
renal function
amount
improving agent
function improving
per
Prior art date
Application number
PCT/JP2016/058461
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English (en)
Japanese (ja)
Inventor
真也 永渕
伊藤　健太郎
健人 山地
晃智 粂
Original Assignee
株式会社明治
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by 株式会社明治 filed Critical 株式会社明治
Priority to JP2017508281A priority Critical patent/JPWO2016152706A1/ja
Priority to SG11201704105SA priority patent/SG11201704105SA/en
Priority to CN201680005207.5A priority patent/CN107106684A/zh
Publication of WO2016152706A1 publication Critical patent/WO2016152706A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00

Definitions

  • the present invention relates to a renal function improving agent.
  • the state of renal function is judged based on the blood urea nitrogen concentration. Then, when the blood urea nitrogen concentration or the like is out of the normal value range, for example, a reexamination further examines the state of the renal function to determine whether or not the renal function needs to be treated.
  • Patent Document 1 discloses that a composition having a protein content of 0.5 to 1.5 g per 100 kcal of energy, a phosphorus content of 10 to 40 mg, a sodium content of 10 to 30 mg, and a potassium content of 5 to 50 mg is A, and the protein content is energy.
  • a composition of 3.0 to 4.0 g per 100 kcal, phosphorus content 10 to 40 mg, sodium content 50 to 70 mg, potassium content 5 to 50 mg as B, and these A and B are mixed in a ratio of 4: 1 to 1: 4.
  • It is a fluid nutritional composition for conservative kidney disease patients or dialysis kidney disease patients, and is mixed for conservative kidney disease patients or dialysis kidney disease patients.
  • a fluid nutritional composition for patients with kidney disease which is labeled as being used.
  • improving the diet is only to maintain the health of the person It is also beneficial to curb the increase in medical expenses for the entire population.
  • As a method for improving eating habits for example, when blood urea nitrogen concentration is outside the normal range, change from eating habits concentrated on meat eating to eating habits mainly consisting of vegetables, and intake of protein Reduction. However, it is often difficult or impossible in practice to completely change each meal in order to prevent or suppress deterioration of kidney function.
  • the present invention provides a renal function improving agent that can be used for preventing or suppressing the deterioration of renal function without drastically and drastically changing the conventional diet, and the renal function improving agent,
  • An object of the present invention is to provide a nutritional preparation for improving renal function.
  • the inventor has an abnormally high value for one or more of blood urea nitrogen concentration, blood creatinine concentration, and urinary albumin excretion per day.
  • the amount of protein is 0.5-4 g
  • the amount of phosphorus is 10-40 mg
  • the amount of sodium is 10-70 mg
  • the amount of potassium is 5
  • a renal function improving agent of ⁇ 50 mg is taken as part of a meal, blood urea nitrogen concentration, blood creatinine concentration, urinary albumin per day without greatly changing the conventional diet It has been found that the further increase in the excretion amount can be suppressed and the deterioration of the renal function can be prevented or suppressed, and the present invention has been completed.
  • the present invention provides the following [1] to [8].
  • [1] For those who show abnormal values (oral) to take (administer) one or more of blood urea nitrogen concentration, blood creatinine concentration, and urinary albumin excretion per day
  • a renal function improving agent An agent for improving renal function, wherein the amount of protein is 0.5 to 4 g, the amount of phosphorus is 10 to 40 mg, the amount of sodium is 10 to 70 mg, and the amount of potassium is 5 to 50 mg per 100 kcal of energy.
  • [2] Ingested by those who satisfy at least one of blood urea nitrogen concentration of 25 mg / dL or more, blood creatinine concentration of 1.2 mg / dL or more, and urinary albumin excretion per day of 30 mg or more
  • the above [1] to [4] are for suppressing further increase of one or more of blood urea nitrogen concentration, blood creatinine concentration and urinary albumin excretion per day.
  • the renal function improving agent in any one of.
  • a nutritional preparation for improving renal function comprising a combination of the renal function improving agent according to any one of [1] to [5] above and a nutritional composition other than the renal function improving agent, A nutritional preparation for improving renal function, wherein the protein is 2 to 16%, the lipid is 15 to 37%, the sugar is 55 to 83%, and the dietary fiber is 0 to 3% per 100% of the energy ratio.
  • the nutritional composition other than the above-mentioned renal function improving agent is 0.5 to 4 g of protein, 50 mg or more of phosphorus, 20 mg or more of sodium, and 60 mg or more of potassium per 100 kcal of energy.
  • the nutritional preparation for improving renal function according to the above [6].
  • the weight ratio of the above renal function improving agent and the nutritional composition other than the above renal function improving agent is 0.1 to 10.
  • the nutritional preparation for improving renal function according to the above [6] or [7].
  • Renal function wherein the amount of protein is 0.5 to 4 g, the amount of phosphorus is 10 to 40 mg, the amount of sodium is 10 to 70 mg, and the amount of potassium is 5 to 50 mg per 100 kcal of energy Improver, Renal function including the step of (orally) administering (ingesting) one or more of blood urea nitrogen concentration, blood creatinine concentration, and urinary albumin excretion per day to a person who shows abnormal values How to improve.
  • a pharmaceutical product comprising a composition in which the amount of protein is 0.5 to 4 g, the amount of phosphorus is 10 to 40 mg, the amount of sodium is 10 to 70 mg, and the amount of potassium is 5 to 50 mg per 100 kcal of energy ( Used for addition to pharmaceutical compositions, nutritional pharmaceutical compositions, drugs, etc.) or food and drink (food composition, nutritional composition, special-purpose food, nutritional functional food, health food, etc.), and blood urea nitrogen concentration A composition used for improving renal function of a person who exhibits abnormal values for one or more of creatinine concentration in blood and excretion amount per day of albumin in urine.
  • Medicinal products medicine for ingestion (administration)) of those who show abnormal values for one or more of blood urea nitrogen concentration, blood creatinine concentration, and daily excretion of urinary albumin
  • a composition, a nutritional pharmaceutical composition, a drug, etc.) or a food or drink (a food / beverage composition, a nutritional composition, a special-purpose food, a nutritional functional food, a health food, etc.), A method of imparting a renal function improving effect to the drug or the food or drink.
  • the renal function By gradually reducing the intake of the nutritional composition other than the improving agent and gradually increasing the intake of the renal function improving agent of the present invention, the deterioration of renal function can be prevented without greatly changing the conventional diet. Can be suppressed. That is, abrupt or extreme switching from a normal (conventional) diet to a diet for a kidney disease patient is mentally ill for those who actually take it (such as those with only a slight decrease in kidney function) There were cases where it was difficult or impossible to realize due to a heavy burden.
  • a normal diet is reduced to about 2/3, and a portion corresponding to about 1/3 of the remaining meal is supplemented with the renal function improving agent of the present invention.
  • reducing the normal diet to about 1/2, and supplementing the portion corresponding to about 1/2 of the remaining diet with the renal function improving agent of the present invention
  • the renal function improving agent of the present invention has an abnormal value (abnormally high value) for one or more of blood urea nitrogen concentration, blood creatinine concentration, and urinary albumin excretion per day. It is a renal function improving agent for ingestion, and per 100 kcal of energy, the amount of protein is 0.5-4 g, the amount of phosphorus is 10-40 mg, the amount of sodium is 10-70 mg, the amount of potassium is 5-50 mg It is a renal function improving agent.
  • the actual intake person (subject who takes the renal function improving agent of the present invention) is abnormal in one or more of blood urea nitrogen concentration, blood creatinine concentration, and daily excretion of urinary albumin. The person who shows the value.
  • the actual ingestor is preferably a person who satisfies the following conditions from the viewpoint of increasing the effect and action of ingesting the renal function improving agent of the present invention.
  • the actual intaker preferably has a blood urea nitrogen concentration of 25 mg / dL or more, more preferably 28 mg / dL or more, and further preferably 30 mg / dL or more.
  • the actual intaker preferably has a blood creatinine concentration of 1.2 mg / dL or more, more preferably 1.4 mg / dL or more, and further preferably 1.6 mg / dL or more.
  • the actual intake of the urinary albumin per day is preferably 30 mg or more, more preferably 40 mg or more, and even more preferably 50 mg or more.
  • the actual ingestor is more preferable among blood urea nitrogen concentration, blood creatinine concentration, and urinary albumin excretion per day.
  • two items (variables) satisfy the above conditions, and more preferably, three items (all items) satisfy the above conditions.
  • the renal function improving agent of the present invention contains protein, phosphorus, sodium, and potassium.
  • it is necessary to restrict intake of phosphorus, sodium, and potassium in patients with kidney disease, and it is also necessary to restrict intake of protein in patients with kidney disease in the preservation period (chronic).
  • phosphorus, sodium, and potassium are essential elements of the human body. If protein, including protein, is not consumed at all, deficiency may occur, and health may be adversely affected. Therefore, in the renal function improving agent of the present invention, the lower limit of the content of protein, phosphorus, sodium, and potassium is set to avoid the risk of deficiency, the upper limit is set to avoid the risk of overdose, and the upper limit and In the content of the lower limit range, the improvement effect of renal function is shown.
  • the renal function improving agent of the present invention can contain lipids, carbohydrates, other minerals (other than phosphorus, sodium, potassium), vitamins, and dietary fiber. That is, a nutritionally balanced composition can be prepared by containing lipids and sugars. And the composition which provided the health function derived from each component can be prepared by including another mineral (things other than phosphorus, sodium, potassium), a vitamin, and a dietary fiber.
  • the protein preferably includes milk proteins such as casein and whey protein, and more preferably casein.
  • the amount of protein per 100 kcal of energy is, for example, 0.5 to 4 g, preferably 0.5 to 3 g, more preferably 0.5 to 2 g, still more preferably 0.5. ⁇ 1.5 g.
  • the amount of phosphorus (P) per 100 kcal of energy is, for example, 8 to 45 mg, preferably 10 to 40 mg, more preferably 10 to 38 mg, and further preferably 10 to 35 mg.
  • the amount of sodium (Na) per 100 kcal of energy is, for example, 8 to 75 mg, preferably 10 to 70 mg, more preferably 10 to 65 mg, and further preferably 10 to 60 mg.
  • the amount of potassium (K) per 100 kcal of energy is, for example, 5 to 50 mg, preferably 5 to 45 mg, more preferably 5 to 40 mg, and further preferably 5 to 35 mg.
  • the amount of each component of protein, phosphorus, sodium, and potassium is below the lower limit of the above numerical range, it becomes difficult to give each of these components sufficiently to the actual ingestor. It may cause harmful effects due to shortage.
  • lipids include medium chain fatty acid triglycerides and long chain fatty acid triglycerides.
  • the amount of lipid per 100 kcal of energy is, for example, 0.5-6 g, preferably 1-5 g, more preferably 1.5-4.5 g, still more preferably 2 ⁇ 4g.
  • preferable examples of the carbohydrate include soluble polysaccharides (for example, starches such as dextrin and corn starch, and oligosaccharides).
  • the amount of carbohydrate per 100 kcal of energy is, for example, 8 to 24 g, preferably 10 to 22 g, more preferably 12 to 20 g, still more preferably 14 to 18 g.
  • the amount of each component of lipid and carbohydrate is below the lower limit of the above numerical range, it will be difficult to give these components sufficiently to the actual ingestor, and there will be an adverse effect due to the lack of these components. May be incurred.
  • the amount of each component of lipid and carbohydrate exceeds the upper limit of the above numerical range, it will be difficult to provide the actual intake with sufficient nutrients that are well-balanced. May cause harmful effects.
  • the renal function improving agent of the present invention includes calcium, magnesium, iron, zinc and the like as other minerals (other than phosphorus, sodium and potassium).
  • the amount of calcium (Ca) per 100 kcal of energy is, for example, 5 to 55 mg, preferably 10 to 50 mg, more preferably 15 to 45 mg, and further preferably 20 to 40 mg.
  • the amount of magnesium (Mg) per 100 kcal of energy is, for example, 1 to 35 mg, preferably 3 to 30 mg, more preferably 5 to 25 mg, and still more preferably 10 to 20 mg.
  • the amount of iron (Fe) per 100 kcal of energy is, for example, 0.1 to 2.5 mg, preferably 0.2 to 2 mg, more preferably 0.3 to 1.5 mg. More preferably, it is 0.5 to 1.2 mg.
  • the amount of zinc (Zn) per 100 kcal of energy is, for example, 0.1 to 2.5 mg, preferably 0.2 to 2 mg, more preferably 0.3 to 1.5 mg. More preferably, it is 0.5 to 1.2 mg.
  • the amount of each component of these minerals is below the lower limit of the above numerical range, it will be difficult to give these components sufficiently to the actual ingestor, and the disadvantage caused by the lack of these components will be adversely affected. There is a possibility of inviting.
  • the amount of each component of these minerals exceeds the upper limit of the above numerical range, it will be difficult to give the actual intake sufficient necessary minerals that are well-balanced. It may cause harmful effects.
  • examples of vitamins include vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, and vitamin C.
  • the amount of vitamin A per 100 kcal of energy is, for example, 5 to 120 ⁇ g RE (retinol equivalent), preferably 10 to 100 ⁇ g RE, more preferably 20 to 90 ⁇ g RE, still more preferably 40 to 80 ⁇ g RE. is there.
  • the amount of vitamin A is below the lower limit of the above numerical range, there is a possibility of causing adverse effects due to lack of vitamin A.
  • the amount of vitamin D per 100 kcal of energy is, for example, 0.03 to 0.7 ⁇ g, preferably 0.05 to 0.5 ⁇ g, more preferably 0.07 to 0.3 ⁇ g. More preferably, it is 0.1 to 0.2 ⁇ g.
  • the amount of vitamin D is below the lower limit of the above numerical range, there is a possibility that a harmful effect due to lack of vitamin D may be caused.
  • the degree of improvement in renal function or the like in cases where the actual intake person is a renal failure patient whose vitamin D intake is restricted, etc. May be lower.
  • the amount of vitamin E, vitamin B1, vitamin B2, vitamin C, etc. per 100 kcal of energy may be appropriately determined with reference to normal amounts considered necessary for the human body. .
  • the amount of vitamin E per 100 kcal of energy is, for example, 0.5 to 2 mg.
  • the amount of vitamin B1 per 100 kcal of energy is, for example, 0.05 to 0.2 mg.
  • the amount of vitamin B2 per 100 kcal of energy is, for example, 0.05 to 0.2 mg.
  • the amount of vitamin C per 100 kcal of energy is, for example, 2 to 20 mg.
  • the renal function improving agent of the present invention may further contain carnitine, a sweetener, dietary fiber, an emulsifier, and the like as necessary as a component constituting the solid content.
  • Carnitine is a nutrient contained in meat and has effects such as promotion of fat burning.
  • the amount of protein blended is small, and the nutritional composition that can be used in combination with the renal function improving agent of the present invention also tends to lack carnitine because the blended amount of protein is small. For this reason, carnitine is preferably used in the renal function improving agent of the present invention.
  • the amount of carnitine per 100 kcal of energy is, for example, 0.5 to 70 mg, preferably 1 to 50 mg, more preferably 3 to 40 mg, and further preferably 5 to 40 mg.
  • the amount of carnitine falls below the lower limit of the above numerical range, it is difficult to sufficiently give an actual intaker effects such as promotion of fat burning.
  • the amount of carnitine exceeds the upper limit of the above numerical range, there is a possibility that it will be disadvantageous in price competition from the viewpoint of increasing the production cost of the renal function improving agent of the present invention.
  • preferred dietary fibers include indigestible dextrin, reduced indigestible dextrin, and cellulose, and more preferred are indigestible dextrin and cellulose.
  • dietary fiber is an indigestible component contained in food.
  • indigestible dextrin is known to have an action of suppressing a rapid increase in blood glucose level after meals and an action of suppressing absorption of cholesterol.
  • the amount of dietary fiber per 100 kcal of energy is, for example, 0.1 to 5 g, preferably 0.2 to 2 g, more preferably 0.3 to 1.8 g, still more preferably. 0.5 to 1.5 g.
  • the amount of dietary fiber is below the lower limit of the above numerical range, it is difficult to sufficiently give the actual intake person the health promoting effect caused by dietary fiber.
  • the amount of dietary fiber exceeds the upper limit of the above numerical range, there is a possibility that it is disadvantageous in terms of price from the viewpoint of increasing the manufacturing cost of the renal function improving agent of the present invention.
  • the protein is 2 to 6%
  • the lipid is 15 to 37%
  • the sugar is 55 to 83%
  • the dietary fiber is 0 to 3% per 100% of the energy ratio.
  • renal function improving agents include renal function improving agents.
  • the renal function improving agent of the present invention can be made into a property that can be taken as, for example, a liquid food or an enteral nutrient.
  • the volume of a single dose of the renal function improving agent of the present invention (dose for each administration) is preferably 50 to 1000 mL, more preferably 100 to 250 mL, still more preferably 100 to 200 mL, and particularly preferably 100 to 200 mL. 150 mL. If the volume is less than 50 mL, the amount of water may be too small for patients with renal failure whose water intake is limited, and it may be difficult to maintain good body function. When the volume exceeds 1000 mL, the burden on the kidney is increased for patients with renal insufficiency in which the amount of water intake is restricted, which may not be preferable for improving the medical condition.
  • the renal function-improving agent of the present invention can be administered to the intake person at one time or in divided doses (dose for each administration) at any time before meal, after meal, between meals, and before going to bed. Alternatively, it can be administered at two or more times selected from these (for example, before meals and before going to bed).
  • the dosage of the renal function improving agent of the present invention can be determined individually according to the age and weight of the intaker.
  • the renal function improving agent of the present invention can be administered preferably for 1 week or longer, more preferably for 1 month or longer, and still more preferably for 1 year or longer.
  • the renal function improving agent of the present invention can be packaged in a unit amount per meal from the viewpoint of hygiene during intake and ease of handling during transportation and storage. Therefore, this invention can provide the renal function improving agent which consists of a unit package form per meal.
  • the “renal function improving agent consisting of a unit package form per meal” means a renal function improving agent packaged in a unit amount per meal. Specifically, for example, a package produced by using a four-side seal packaging machine or the like, in which the edges of two films are fixed together, or a package in which the opening of a cup-shaped soft container is closed with a film.
  • the unit amount per serving of the renal function improving agent of the present invention is preferably 50 to 1000 mL, more preferably 100 to 250 mL, still more preferably 100 to 200 mL, and particularly preferably 100 to 150 mL.
  • the “unit amount per meal” means a predetermined amount (a single intake) that is assumed to be ingested once.
  • the “predetermined amount that is supposed to be ingested at one time” may be an amount that is expected to complete the entire amount in a relatively short time, for example, oral ingestion. In the case of, it is not limited to the amount that can be ingested in one mouth or continuously.
  • the “unit amount per meal” may be, for example, the volume of one administration of the renal function improving agent of the present invention (the dose for each administration), or the one administration dose. May be divided into small amounts (for example, 1/2 to 1/10 of the volume of a single dose).
  • the renal function improving agent of the present invention is preferably ingested by a person who shows an abnormal value of blood urea nitrogen concentration, so that further increase in the blood urea nitrogen concentration of the intake person is preferably suppressed compared to before intake. More preferably, the blood urea nitrogen concentration of the intake person is reduced by 3% or more, more preferably, the blood urea nitrogen concentration of the intake person is reduced by 5% or more, and particularly preferably, the blood concentration of the intake person is reduced. The urea nitrogen concentration is reduced by 7% or more.
  • the renal function improving agent of the present invention is preferably ingested by a person who exhibits an abnormal value of blood creatinine concentration, compared to before ingestion, preferably further increasing the blood creatinine concentration of the user, Preferably, the blood creatinine concentration of the intake person is reduced by 3% or more, more preferably the blood creatinine concentration of the intake person is reduced by 5% or more, and particularly preferably, the blood creatinine concentration of the intake person is 7 % Is reduced.
  • the renal function-improving agent of the present invention is preferably ingested by a person who shows an abnormal excretion amount of urinary albumin per day, as compared with that before ingestion.
  • the daily excretion of urinary albumin of the intake person is reduced by 3% or more, and further preferably, the daily intake of urinary albumin of the intake person is reduced.
  • the amount of excretion of urinary albumin is reduced by 5% or more, and particularly preferably, the daily excretion of urinary albumin of the intake person is reduced by 7% or more.
  • the renal function improving agent of the present invention can be produced by a known method in the field of liquid food or enteral nutrition.
  • it can be manufactured by appropriately combining a raw material mixing step (preparation step), a sterilization step, a cooling step, a homogenization step, a packaging step, and the like.
  • a raw material mixing step preparation step
  • sterilization step sterilization step
  • cooling step a homogenization step
  • packaging step and the like.
  • aseptically for example, a can container or the above-described soft package.
  • UHT sterilization method about 120 to 145 ° C., about 1 to 10 seconds and aseptic packaging method
  • a method for example, a retort method, an autoclave method, etc.
  • a method such as heat sterilization can be used as necessary after the container is cooled and filled into a container.
  • a nutritional preparation for improving renal function can be prepared by combining the above-mentioned renal function improving agent and a nutritional composition other than the above renal function improving agent.
  • the nutritional preparation for improving renal function of the present invention has a protein amount of preferably 0 in a nutritional composition other than the renal function improving agent per 100 kcal of energy.
  • 0.5 to 4 g, more preferably 0.5 to 3 g the amount of phosphorus is preferably 50 mg or more, more preferably 60 to 150 mg, and the amount of sodium is preferably 20 mg or more, more preferably 25 to 50 mg.
  • the amount of potassium is preferably 60 mg or more, more preferably 70 to 160 mg.
  • the nutritional adjustment product for improving kidney function as a whole may cause adverse effects due to the lack of these components. Conversely, if the amount of each component such as protein exceeds the upper limit of the above numerical range, it will be difficult to sufficiently prevent or suppress the decrease in renal function to the actual ingestor. May cause harmful effects due to excess.
  • the nutritional preparation for improving renal function of the present invention is a weight ratio of the above renal function improving agent and a nutritional composition other than the above renal function improving agent (renal function improving agent).
  • / Nutrient composition other than the renal function improving agent is preferably 0.1 to 10, more preferably 0.3 to 5, and still more preferably 0.5 to 3. If this weight ratio falls below the lower limit of the above numerical range, it will be difficult to give the actual intake sufficient prevention and suppression effects on renal function, which may cause adverse effects due to the lack of these components. There is. If this weight ratio exceeds the upper limit of the above numerical range, it will be difficult to prevent or suppress the deterioration of renal function without greatly changing the dietary habits so far, and it may cause adverse effects due to excess of each of these components There is sex.
  • renal function with 2 to 16% protein, 15 to 37% lipid, 55 to 83% carbohydrate, and 0 to 3% dietary fiber per 100% of the energy ratio Mention nutritional preparations for improvement.
  • nutritional adjustments for improving renal function are not limited to 2 to 16% protein, 15 to 37% lipid, 55 to 83% carbohydrate, and 0 to 3% dietary fiber per 100% of the energy ratio.
  • the renal function improving agent of the present invention is for ingestion by a person showing an abnormal value, for example, about one or more of blood urea nitrogen concentration, blood creatinine concentration, and urinary albumin excretion per day.
  • An agent for improving or preventing renal failure, an agent for improving or preventing nephritis, an agent for improving or preventing diabetic nephropathy, and the amount of protein is 0 per 100 kcal of energy.
  • renal failure includes acute renal failure and chronic renal failure
  • nephritis includes glomerulonephritis, interstitial nephritis, and the like.
  • Non-diabetic model As a non-diabetic model mouse, the wild type “C57BLKS / JInvent-m + / m + mouse” (hereinafter abbreviated as “m + / m + mouse”) of db / db mouse was used.
  • Feed 1 to 2 of the present invention As a feed having a low protein content corresponding to the present invention, a feed having the composition shown in Table 1 (the feeds 1 and 2 of the present invention) was used.
  • B Modified standard feed (modified AIN93M) A feed (modified AIN 93M) having the composition shown in Table 1 was used as a feed having a low protein content to be used in combination with the feeds 1 and 2 of the present invention.
  • C Comparative feed A feed having a composition shown in Table 1 (a comparative feed) was used as a feed having a high protein content not corresponding to the present invention.
  • Standard feed (AIN93M) A feed (AIN93M) having the composition shown in Table 1 was used as a feed having a high protein content to be used in combination with a comparative feed.
  • the energy ratio of nutrients (protein, lipid, carbohydrate, dietary fiber) in each feed in Table 1 is as shown in Table 2.
  • mice Eight week old female db / db mice (12) were used. For 4 weeks from 8 weeks to 12 weeks of age, the mice were acclimated with a standard diet (AIN93M) ad libitum. At 12 weeks of age, each value such as body weight shown in Table 3 was measured. At the age of 12 weeks, the mice were fed with a feed prepared by mixing “the feed 1 of the present invention” and “modified AIN93M” at a weight ratio of 1: 2, and then for 4 days, A feed prepared by mixing Inventive Feed 1 ”and“ Modified AIN 93M ”at a weight ratio of 1: 1 was fed.
  • AIN93M standard diet
  • the measuring method of each item of Table 3 is as follows.
  • Example 2 An experiment was conducted in the same manner as in Example 1 except that “Feed 2 of the present invention” was used instead of “Feed 1 of the present invention”.
  • “Comparative Example 1] Implemented except that “feed for comparison” was used instead of “feed 1 of the present invention”, “AIN 93M” was used instead of “modified AIN 93M”, and the number of mice was changed from 12 to 10 The experiment was performed in the same manner as in Example 1. In each of the groups of Examples 1 and 2 and Comparative Example 1, each feed was fed so that the intake amount was the same.
  • Example 1 and 2 the evaluation of the renal function of the intake person is excellent in all of the blood creatinine concentration, blood urea nitrogen concentration and urine albumin concentration as compared with Comparative Example 1. I understand. Also, in Examples 1 and 2, compared with Reference Example 1, the renal function of the intake person is evaluated very well to some extent in the blood urea nitrogen concentration, and the blood creatinine concentration and urine concentration are significantly higher. It can be seen that the evaluation of the renal function of the intake person is excellent to the extent that there is no significant difference in the albumin concentration. Further, in Examples 1 and 2, the blood albumin concentration is comparable to that in Comparative Example 1, and the blood albumin concentration is higher than that in Reference Example 1, so that the nutritional state of the intake person is excellent. You can see that
  • the present invention is excellent in the effect of improving renal function, and in particular, among the urea urea concentration in blood, the blood creatinine concentration, and the excretion amount of urinary albumin per day.
  • the present invention provides a renal function for a person (subject) showing an abnormal value to ingest one or more of blood urea nitrogen concentration, blood creatinine concentration, and urinary albumin excretion per day.
  • an improving agent an improving agent, a preventive agent or a therapeutic agent for renal failure, an improving agent, a preventive agent or a therapeutic agent for nephritis, an improving agent, a preventive agent or a therapeutic agent for diabetic nephropathy.

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  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

L'invention concerne un agent améliorant la fonction rénale qui est utilisable pour prévenir ou supprimer une détérioration de la fonction rénale sans modifier grandement les habitudes alimentaires antérieures. Un agent améliorant la fonction rénale à prendre par une personne qui montre une valeur anormale d'au moins un facteur choisi parmi la concentration sanguine en azote uréique, la concentration sanguine en créatinine et l'excrétion urinaire d'albumine quotidienne, ledit agent améliorant la fonction rénale comprenant, pour 100 kcal d'énergie, 0,5-4 g de protéine, 10-40 mg de phosphore, 10-70 mg de sodium et 5-50 mg de potassium.
PCT/JP2016/058461 2015-03-20 2016-03-17 Agent améliorant la fonction rénale WO2016152706A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2017508281A JPWO2016152706A1 (ja) 2015-03-20 2016-03-17 腎機能改善剤
SG11201704105SA SG11201704105SA (en) 2015-03-20 2016-03-17 Renal function improving agent
CN201680005207.5A CN107106684A (zh) 2015-03-20 2016-03-17 肾功能改善剂

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2015057374 2015-03-20
JP2015-057374 2015-03-20

Publications (1)

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WO2016152706A1 true WO2016152706A1 (fr) 2016-09-29

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Country Status (5)

Country Link
JP (1) JPWO2016152706A1 (fr)
CN (1) CN107106684A (fr)
SG (1) SG11201704105SA (fr)
TW (1) TW201701773A (fr)
WO (1) WO2016152706A1 (fr)

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JPH1066541A (ja) * 1996-08-27 1998-03-10 Meiji Milk Prod Co Ltd 腎臓病患者の各症状に適応した液状調整 栄養組成物
WO2006019187A1 (fr) * 2004-08-18 2006-02-23 The University Of Tokyo Remède pour une néphropathie
JP2008063234A (ja) * 2006-09-04 2008-03-21 Pharma Foods International Co Ltd 慢性腎不全予防・改善組成物
JP2012236820A (ja) * 2011-04-28 2012-12-06 Sakai Chem Ind Co Ltd 慢性腎臓病の予防又は治療用組成物

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JP2000264844A (ja) * 1999-01-11 2000-09-26 Otsuka Pharmaceut Factory Inc 腎疾患患者用栄養組成物
US8647660B2 (en) * 2004-12-29 2014-02-11 Hill's Pet Nutrition, Inc. Combination of limited nutrients and enhanced dietary antioxidants to impart improved kidney health
EP1874131A2 (fr) * 2005-04-29 2008-01-09 Hill's Pet Nutrition Inc. Methodes permettant de prolonger la vie des felins
CA2613788C (fr) * 2005-06-29 2016-08-23 Hill's Pet Nutrition, Inc. Procedes et compositions pour la prevention et le traitement de maladie renale
WO2007022344A2 (fr) * 2005-08-17 2007-02-22 Hill's Pet Nutrition, Inc. Procedes et compositions permettant de prevenir et de traiter les maladies renales
CA2636039C (fr) * 2006-01-19 2013-03-19 Hill's Pet Nutrition, Inc. Compositions et procedes destines a prevenir ou a traiter une maladie renale chronique chez les felins
SG11201408601PA (en) * 2012-06-28 2015-01-29 Meiji Co Ltd Nutritional composition
CN105530947A (zh) * 2013-09-13 2016-04-27 株式会社明治 用于减轻蛋白质异化或促进蛋白质同化的制剂

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH1066541A (ja) * 1996-08-27 1998-03-10 Meiji Milk Prod Co Ltd 腎臓病患者の各症状に適応した液状調整 栄養組成物
WO2006019187A1 (fr) * 2004-08-18 2006-02-23 The University Of Tokyo Remède pour une néphropathie
JP2008063234A (ja) * 2006-09-04 2008-03-21 Pharma Foods International Co Ltd 慢性腎不全予防・改善組成物
JP2012236820A (ja) * 2011-04-28 2012-12-06 Sakai Chem Ind Co Ltd 慢性腎臓病の予防又は治療用組成物

Also Published As

Publication number Publication date
SG11201704105SA (en) 2017-06-29
TW201701773A (zh) 2017-01-16
CN107106684A (zh) 2017-08-29
JPWO2016152706A1 (ja) 2017-12-28

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