JP6139150B2 - Protein nutritional composition - Google Patents
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- JP6139150B2 JP6139150B2 JP2013017197A JP2013017197A JP6139150B2 JP 6139150 B2 JP6139150 B2 JP 6139150B2 JP 2013017197 A JP2013017197 A JP 2013017197A JP 2013017197 A JP2013017197 A JP 2013017197A JP 6139150 B2 JP6139150 B2 JP 6139150B2
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Description
本発明はタンパク質を補給するための組成物、詳しくは腎機能低下者、特に人工透析患者を対象としたタンパク質栄養補給組成物に関する。人工透析患者は慢性的な栄養不足状態に陥る場合が多く、特にタンパク質栄養が不足しがちである。タンパク質を多量に含有する食品やタンパク質製剤の多くはリンやカリウムを多量に含むが、リンやカリウムは腎臓によって排泄されるため、腎機能が低下するとそれらは体内に蓄積する。したがってそのような患者では、タンパク質の摂取に伴って増大するリンの摂取が動脈硬化・骨病変を引き起こす原因として、カリウムの過剰摂取は不整脈、頻脈等の心疾患リスクの増大を引き起こす原因として、それぞれ問題となっている。 The present invention relates to a composition for supplementing protein, and more particularly, to a protein nutrition supplement composition intended for patients with impaired renal function, particularly artificial dialysis patients. Artificial dialysis patients often fall into a chronic undernourishment, and in particular tend to lack protein nutrition. Many foods and protein preparations containing a large amount of protein contain a large amount of phosphorus and potassium. However, since phosphorus and potassium are excreted by the kidney, they accumulate in the body when the kidney function decreases. Therefore, in such patients, phosphorus intake, which increases with protein intake, causes arteriosclerosis and bone lesions, and excessive potassium intake causes increased risk of cardiac diseases such as arrhythmia and tachycardia. Each is a problem.
米胚乳に含まれるタンパク質の主要成分は易消化性のグルテリン、グロブリン、アルブミンと、難消化性のプロラミンである。米胚乳から抽出されるタンパク質組成物を製造する方法としては、精白米や米粉に耐熱性アミラーゼを作用させ、残存するタンパク質を沈殿として回収する方法(酵素処理米タンパク質)と、精白米や米粉にアルカリ溶液を加えて抽出されるタンパク質を酸沈殿させ、これを回収する方法(アルカリ抽出米タンパク質)が公知であり、栄養素としてのタンパク質利用効率は前者と比べて後者が有意に高く、タンパク質利用効率はカゼインに匹敵することが報告されている(非特許文献1)。 The main components of protein contained in rice endosperm are easily digestible glutelin, globulin, albumin and indigestible prolamin. As a method of producing a protein composition extracted from rice endosperm, heat-resistant amylase is allowed to act on polished rice or rice flour, and the remaining protein is recovered as a precipitate (enzyme-treated rice protein), There is a known method (alkaline-extracted rice protein) for precipitating and recovering the protein extracted by adding an alkaline solution, and the protein utilization efficiency as a nutrient is significantly higher in the latter than in the former. Has been reported to be comparable to casein (Non-patent Document 1).
腎疾患患者、特に人工透析患者は慢性的な栄養不足状態となっている。これは、人工透析に伴ってタンパク質の異化が亢進することに加えて、タンパク質摂取と同時に摂取されるリンやカリウムが血中に蓄積されることにより身体に悪影響を及ぼすことから、リンやカリウムの摂取を制限するためにタンパク質の摂取量が制限されてしまうためである。 Patients with kidney disease, especially those with dialysis, are chronically undernourished. In addition to the increase in protein catabolism associated with artificial dialysis, phosphorus and potassium taken at the same time as protein intake accumulates in the blood, which adversely affects the body. This is because the amount of protein intake is limited in order to limit intake.
汎用されるタンパク質源としては乳タンパク質や大豆タンパク質があるが、これらはリンやカリウムの含有量が高く腎疾患患者のタンパク質栄養源としては好ましくない。乳タンパク質をイオン交換樹脂処理や水酸化アルミニウム処理等によりリンやカリウムを除去する技術が公知であるが(特許文献1および特許文献2)、イオン交換樹脂処理等の煩雑なプロセスを経ているために高価であり、腎疾患患者の負担が大となる。一方、リンやカリウムの含量が低いタンパク質としてゼラチンやコラーゲンおよびコラーゲンペプチドが開示されている(特許文献3)。しかし、これらは動物由来のタンパク質であり、アレルギーを有する患者が摂取することは好ましくない。 Milk protein and soybean protein are widely used as protein sources, but these are not preferable as protein nutrient sources for patients with renal diseases because of their high phosphorus and potassium contents. Although techniques for removing phosphorus and potassium from milk proteins by ion exchange resin treatment or aluminum hydroxide treatment are known (Patent Document 1 and Patent Document 2), they have undergone complicated processes such as ion exchange resin treatment. It is expensive and the burden on patients with kidney disease is large. On the other hand, gelatin, collagen, and collagen peptides are disclosed as proteins having low phosphorus and potassium contents (Patent Document 3). However, these are animal-derived proteins and are not preferred to be taken by patients with allergies.
このような背景より、リンやカリウムの含量が少なく、タンパク質利用効率に優れかつアレルギーのリスクの少ない安全なタンパク質栄養補給源が切望されていた。 Against this background, there has been a strong demand for a safe protein nutrition source with low phosphorus and potassium contents, excellent protein utilization efficiency, and low risk of allergies.
本発明の課題は、リンやカリウムの摂取が制限されている腎疾患患者、特に人工透析患者のリンやカリウムの過剰摂取リスクを増大させることなく、安全に摂取することができるタンパク質利用効率に優れたタンパク質栄養組成物を提供することである。 The subject of the present invention is excellent in the protein utilization efficiency that can be safely ingested without increasing the risk of excessive intake of phosphorus and potassium in patients with renal diseases, particularly those with artificial dialysis, whose intake of phosphorus and potassium is restricted. It is to provide a protein nutritional composition.
本発明者らは、米胚乳由来のタンパク質に関する研究を鋭意行い、米胚乳より抽出されるタンパク質製剤におけるリンやカリウムの含量が他のタンパク質製剤のそれと比較して有意に低く、また、米胚乳より抽出されるタンパク質製剤を動物に投与したところ、尿中又は血液中のリンやカリウムの量が抑制されることを見出し、本発明を完成するに至った。具体的に、本発明は以下のものを提供する。 The inventors of the present invention have intensively conducted research on proteins derived from rice endosperm, and the content of phosphorus and potassium in the protein preparation extracted from rice endosperm is significantly lower than that of other protein preparations. When the extracted protein preparation was administered to animals, it was found that the amounts of phosphorus and potassium in urine or blood were suppressed, and the present invention was completed. Specifically, the present invention provides the following.
(1) 米胚乳タンパク質を有効成分とし、腎機能低下者ならびに人工透析患者を対象としたタンパク質栄養組成物。 (1) A protein nutritional composition comprising rice endosperm protein as an active ingredient and intended for patients with impaired renal function and artificial dialysis patients.
(2) 米胚乳タンパク質の無機リン濃度が純タンパク質100gに対して300mg以下である(1)記載のタンパク質栄養組成物。 (2) The protein nutrition composition according to (1), wherein the concentration of inorganic phosphorus in the rice endosperm protein is 300 mg or less with respect to 100 g of pure protein.
(3) 米胚乳タンパク質の無機カリウム濃度が純タンパク質100gに対して4.0mg以下である(2)記載のタンパク質栄養組成物。 (3) The protein nutrition composition according to (2), wherein the rice endosperm protein has an inorganic potassium concentration of 4.0 mg or less with respect to 100 g of pure protein.
本発明によれば、他の食品タンパク質と比べてリンやカリウムの含量が少なく、これを摂取することによりリンやカリウムの過剰摂取を伴わずにタンパク質栄養の補給が可能である。本発明はかかる米胚乳タンパク質を有効成分とするタンパク質栄養補給剤であり、人工透析患者や、腎機能が低下した慢性腎不全患者、高齢者のタンパク質栄養補給に適する。 According to the present invention, the content of phosphorus and potassium is small compared to other food proteins, and by taking this, protein nutrition can be supplemented without excessive intake of phosphorus or potassium. The present invention is a protein nutritional supplement containing such rice endosperm protein as an active ingredient, and is suitable for protein nutritional supplementation for artificial dialysis patients, chronic renal failure patients with impaired renal function, and the elderly.
以下、アルカリ抽出された米タンパク質組成物を略して、「米胚乳タンパク質」または「米胚乳タンパク質組成物」と称する。米胚乳タンパク質は、精白米または米粉等の米胚乳部分を原料としてアルカリにより抽出することができる。米糠にはフィチン酸等のリンに富んだ成分が含まれているため、精米を充分に行って糠成分を除去するとともに、洗米により肌糠成分も充分に除去しておくことが望ましい。精白米を用いる場合にはアルカリ溶液に浸漬することでタンパク質の一部が抽出されるが、浸漬した米を湿式磨砕等により粉砕して米の組織中に含まれるタンパク質も抽出することにより回収率を高めることができる。米粉を用いる場合にはアルカリ溶液中に1時間〜1昼夜浸漬することでタンパク質が高効率で抽出される。 Hereinafter, the rice protein composition extracted with alkali is abbreviated as “rice endosperm protein” or “rice endosperm protein composition”. Rice endosperm protein can be extracted with alkali using rice endosperm such as polished rice or rice flour as a raw material. Since rice bran contains phosphorus-rich components such as phytic acid, it is desirable that the rice bran component is sufficiently removed by thoroughly polishing the rice bran and the skin wrinkle component is sufficiently removed by washing the rice. When using polished rice, a part of the protein is extracted by soaking in an alkaline solution, but it is recovered by extracting the protein contained in the rice tissue by grinding the soaked rice by wet grinding or the like. The rate can be increased. When using rice flour, protein is extracted with high efficiency by soaking in an alkaline solution for 1 hour to 1 day.
抽出に用いるアルカリの濃度は0.1%〜2%であることが好ましく、より好ましくは0.15〜0.25%である。抽出されるタンパク質溶液にはアルカリ可溶性の繊維質が多量に含まれていることから、これを目開きの細かい篩や濾布等を用いて除去することが好ましい。タンパク質溶液に塩酸等の酸を加えてpH5〜6に調整することにより、凝集するタンパク質を沈殿として回収することができる。タンパク質溶液をあらかじめ50℃程度に加熱した後に中和する場合にはpH7でもタンパク質の凝集体が得られ、またこれを80℃以上に加熱すると凝集体がさらに大きく成長することから、遠心分離を行わずとも篩やフィルタープレス等の濾過によりタンパク質の凝集体を効率良く回収することができる。回収されるタンパク質凝集体を適宜水洗し、これを気流乾燥、流動層乾燥、凍結乾燥等を用いて乾燥することで米胚乳タンパク質組成物を得ることができる。中和時に加熱を行うことにより膨潤したタンパク質凝集物が得られ、この凝集物を乾燥することにより、加熱しない場合に比べて保水性や舌触りに優れた米胚乳タンパク質組成物が得られることから、より広い用途に利用することができる。 The concentration of alkali used for extraction is preferably 0.1% to 2%, more preferably 0.15 to 0.25%. Since the protein solution to be extracted contains a large amount of alkali-soluble fiber, it is preferably removed using a sieve or a filter cloth having a fine mesh. By adding an acid such as hydrochloric acid to the protein solution and adjusting to pH 5-6, the aggregated protein can be recovered as a precipitate. If the protein solution is pre-heated to about 50 ° C and then neutralized, protein aggregates can be obtained even at pH 7, and if this is heated to 80 ° C or higher, the aggregates grow even larger. At least protein aggregates can be efficiently recovered by filtration using a sieve or filter press. A rice endosperm protein composition can be obtained by appropriately washing the recovered protein aggregate and drying it using airflow drying, fluidized bed drying, freeze drying, or the like. By performing heating at the time of neutralization, a swollen protein aggregate is obtained, and by drying this aggregate, a rice endosperm protein composition having excellent water retention and touch compared to the case without heating is obtained. It can be used for a wider range of applications.
アルカリ抽出法により得られる米胚乳タンパク質は消化性に優れ、タンパク質栄養としての利用効率も高いことから、腎疾患患者のタンパク質補給源として優れている。また、米胚乳タンパク質組成物では米胚乳組織中のリンやカリウムが効率良く除去されており、これらの含量が少なく、リンは標品100g当たり100〜250mg(純タンパク質100gに対して120〜300mg)、カリウムは標品100gに対して1.0〜5.0mg(純タンパク質100gに対して2.0〜4.0mg)であり、透析患者等の腎疾患患者が摂取してもリンやカリウムの血中濃度上昇を危惧することなく安心してタンパク質摂取が可能である。尚、透析患者に推奨されるリンの摂取上限は標準体重50kgあたり約600mg/日、カリウムは1,500mg/日であり、タンパク質補給剤として追加摂取可能な範囲をそれぞれの10%と設定した場合には、後述の米胚乳タンパク質標品Aの場合に純タンパク質として23g、米胚乳タンパク質標品Bの場合50gまでの摂取が可能と計算される。これらの値は体重50kgの成人におけるタンパク質必要摂取量の42.5gに対して54%および118%に相当し、これらの米胚乳タンパク質標品は透析患者等の腎疾患患者や腎機能低下者に対する追加的タンパク質補給源として優れていることが解る。以上より、透析患者等の腎疾患患者や腎機能低下者のタンパク質補給源としては、純タンパク質100gに対するリンの含量が300mg以下、好ましくは150mg以下、純タンパク質100gに対するカリウムの含量が4.0mg以下、好ましくは3.0mg以下のタンパク質製剤が適しており、米胚乳タンパク質はこれらの条件を充分に満足するものである。なお、純タンパク質100gにおけるリン含量はICP発光分析法により、カリウムの含量は、原子吸光分析法により測定される。 Rice endosperm protein obtained by the alkali extraction method is excellent as a protein supplement source for kidney disease patients because of its excellent digestibility and high utilization efficiency as protein nutrition. Moreover, in the rice endosperm protein composition, phosphorus and potassium in the rice endosperm tissue are efficiently removed, and their content is small, and phosphorus is 100 to 250 mg per 100 g of the sample (120 to 300 mg with respect to 100 g of pure protein). , Potassium is 1.0 to 5.0 mg per 100 g sample (2.0 to 4.0 mg per 100 g pure protein), and even if taken by a renal disease patient such as a dialysis patient, Protein intake is possible without worrying about an increase in blood concentration. The upper limit of phosphorus intake recommended for dialysis patients is approximately 600 mg / day per 50 kg of standard body weight, and potassium is 1,500 mg / day, and the range of additional intake as a protein supplement is set to 10% of each. In the case of the rice endosperm protein preparation A, which will be described later, it is calculated that it is possible to ingest up to 23 g as pure protein and in the case of the rice endosperm protein preparation B up to 50 g. These values correspond to 54% and 118% of the required protein intake of 42.5 g in an adult weighing 50 kg. These rice endosperm protein preparations are used for patients with renal diseases such as dialysis patients and those with impaired renal function. It turns out to be an excellent source of additional protein supplements. From the above, as a protein supply source for renal disease patients such as dialysis patients and those with impaired renal function, the content of phosphorus with respect to 100 g of pure protein is 300 mg or less, preferably 150 mg or less, and the content of potassium with respect to 100 g of pure protein is 4.0 mg or less. Preferably, a protein preparation of 3.0 mg or less is suitable, and the rice endosperm protein sufficiently satisfies these conditions. The phosphorus content in 100 g of pure protein is measured by ICP emission spectrometry, and the potassium content is measured by atomic absorption spectrometry.
米胚乳タンパク質組成物を配合した加工食品としては、飲料、焼き菓子、ゼリー状食品、スープ類、お粥等への利用が可能であり、腎疾患患者の病態により好適な食品形態に加工することも可能である。尚、加工食品に使用する副原料として、リンやカリウムの含量が低いものを用いるべきであることは言うまでもない。 Processed foods containing rice endosperm protein composition can be used for beverages, baked goods, jelly-like foods, soups, porridges, etc., and processed into suitable food forms according to the pathology of patients with kidney disease Is also possible. Needless to say, a low content of phosphorus or potassium should be used as an auxiliary material used in processed foods.
<実施例1> 米胚乳タンパク質(動物用)の調製とミネラル含量
コシヒカリ米粉(新潟製粉株式会社より購入)25kgを100Lの0.2%水酸化ナトリウム溶液に懸濁して20℃で一夜放置した。コクサン社製遠心分離機「H−130I」に上記懸濁液を約5L/分の流速で給液した。回転数は1,400rpmとした。流出する遠心上清を集め、これを再度同一条件にて遠心分離を行うことにより澱粉粒が除去されたタンパク質抽出液を得た。このタンパク質抽出液のpHを5.5に調整して凝集するタンパク質を上記と同様に遠心分離を用いて回収した。タンパク質の沈殿を約50Lの水に懸濁した後に再度遠心分離を行い、回収された沈殿を凍結乾燥した。同様の操作を8回繰り返すことにより、約6kgの米胚乳タンパク質標品Aを得た。
<Example 1> Preparation and Mineral Content of Rice Endosperm Protein (for Animal) 25 kg of Koshihikari rice flour (purchased from Niigata Flour Milling Co., Ltd.) was suspended in 100 L of 0.2% sodium hydroxide solution and left overnight at 20 ° C. The suspension was supplied to a centrifuge “H-130I” manufactured by Kokusan Co., Ltd. at a flow rate of about 5 L / min. The rotation speed was 1,400 rpm. The centrifugal supernatant flowing out was collected and centrifuged again under the same conditions to obtain a protein extract from which the starch granules were removed. The protein that was aggregated by adjusting the pH of the protein extract to 5.5 was recovered using centrifugation as described above. The protein precipitate was suspended in about 50 L of water and then centrifuged again, and the recovered precipitate was lyophilized. By repeating the
住化分析センター社製スミグラフNC−900を用いた酸素循環燃焼・TCDガスクロマトグラフ検出法により本標品の窒素含量を求め、これに米胚乳タンパク質の窒素係数である5.95を乗じることによりタンパク質純度を求めた。標品Aのタンパク質純度は90%と計算された。標品Aのミネラル含量は日本食品分析センターに委託することにより分析した。結果を表1に示した。また、カゼイン(日本新薬社製カゼインナトリウムCW)ならびに大豆タンパク質(不二精油製フジプロ−F)のミネラル含量と比較した。この結果、標品Aはカゼインや大豆タンパク質と比較してリンやカリウムの含量が大幅に低いことが分かった。 The nitrogen content of this sample is obtained by oxygen circulation combustion and TCD gas chromatographic detection method using Sumika NC-900 made by Sumika Chemical Analysis Co., Ltd., and this is multiplied by 5.95 which is the nitrogen coefficient of rice endosperm protein. Purity was determined. The protein purity of sample A was calculated to be 90%. The mineral content of sample A was analyzed by entrusting it to the Japan Food Analysis Center. The results are shown in Table 1. Moreover, it compared with the mineral content of casein (Nippon Shinyaku Co., Ltd. casein sodium CW) and soybean protein (Fuji Pro-F made from Fuji essential oil). As a result, it was found that the sample A had a significantly lower phosphorus and potassium content than casein and soy protein.
<実施例2> 臨床試験用米胚乳タンパク質の調製と試験食製造
実施例1と同様に25kgのコシヒカリ米粉を100Lの0.2%水酸化ナトリウム溶液で処理し、2回遠心分離を行うことによりタンパク質抽出液を得た。この抽出液を285メッシュ(目開き53μm)の篩を通過させることにより繊維質を除去した。この液を50℃に加熱し、6N塩酸を添加してpHを7.0に調整した。この液を80℃で30分保温することによりタンパク質の凝集体を大きく成長させ、これを冷却した後に285メッシュの篩を用いて篩上としてタンパク質を回収した。タンパク質を約50Lの水に懸濁して同様の篩処理を行い、この操作を3回繰り返してタンパク質の水洗を行った。得られた湿タンパク質は絞り袋に入れて圧搾することにより水分を除去し、その後凍結乾燥した。同様の操作を20回反復し、約15kgの米胚乳タンパク質標品Bを得た。標品Bのタンパク質純度は92%であった。標品Bのミネラル分析結果を表1に示したが、標品Aと同様にリンやカリウムの含量は低かった。
<Example 2> Preparation of rice endosperm protein for clinical test and test food production 25 kg of Koshihikari rice flour was treated with 100 L of 0.2% sodium hydroxide solution and centrifuged twice as in Example 1. A protein extract was obtained. The extract was passed through a 285 mesh (aperture 53 μm) sieve to remove the fibrous material. This solution was heated to 50 ° C., and 6N hydrochloric acid was added to adjust the pH to 7.0. The solution was incubated at 80 ° C. for 30 minutes to grow a large protein aggregate. After cooling this, the protein was recovered on a sieve using a 285 mesh sieve. The protein was suspended in about 50 L of water and subjected to the same sieving treatment, and this operation was repeated three times to wash the protein with water. The obtained wet protein was squeezed into a squeezed bag to remove moisture, and then freeze-dried. The same operation was repeated 20 times to obtain about 15 kg of rice endosperm protein preparation B. The protein purity of sample B was 92%. The mineral analysis results of the sample B are shown in Table 1. As with the sample A, the contents of phosphorus and potassium were low.
標品Bを用いて臨床試験用試験食を製造した(表3参照)。本試験食品1包には純タンパク質として5gの米胚乳タンパク質が含まれるよう、配合を決定した。 A test meal for clinical trials was prepared using the preparation B (see Table 3). The formulation was determined so that 1 g of the test food contained 5 g of rice endosperm protein as a pure protein.
<実施例3>
非肥満性糖尿病モデル動物であるGKラット(雄)を日本エス・エル・シー社から7週齢で購入した。7日間の馴化飼育後にコンベンショナル条件下で飼育した。飼料として、AIN−93Gに準じた高スクロース食(20%スクロース)を用い、タンパク質として実施例1で調製した米胚乳タンパク質、米糠タンパク質、大豆タンパク質、またはカゼインを用い、タンパク質含量は20%となる様に調製した。各飼料の成分分析結果を表2に示した。
<Example 3>
A GK rat (male), a non-obese diabetic model animal, was purchased from Japan SLC at 7 weeks of age. After 7 days of acclimatization, the animals were reared under conventional conditions. A high sucrose diet (20% sucrose) according to AIN-93G is used as the feed, and the rice endosperm protein, rice bran protein, soybean protein, or casein prepared in Example 1 is used as the protein, and the protein content is 20%. Prepared in the same manner. Table 2 shows the component analysis results of each feed.
代謝ケージ下にトレイを設置し、3日間毎日尿を採取した。3日分の尿を合わせ、バナドモリブデン酸吸光光度法により尿中のリン濃度を求め、1日当たりの尿中無機リン排泄量を算出した。尚、リン濃度の分析は財団法人日本食品分析センターに委託した。 A tray was placed under the metabolic cage, and urine was collected daily for 3 days. Three days of urine were combined, the urinary phosphorus concentration was determined by the vanadomolybdic acid absorptiometry, and the amount of inorganic phosphorus excreted in urine per day was calculated. The analysis of phosphorus concentration was entrusted to the Japan Food Analysis Center.
図1に示した通り、1日当たり尿無機リン排泄量はカゼイン食で高く、米胚乳タンパク質食で最少であった。 As shown in FIG. 1, the amount of urinary inorganic phosphorus excreted per day was high in the casein diet and the minimum in the rice endosperm protein diet.
<実施例4>
肥満型糖尿病モデルラットであるZDFラット(雄)を日本チャールス・リバー社より6週齢で購入した。10日間の予備飼育の後、AIN−93Gに準じた標準飼料(10%スクロース)で飼育した。飼育開始時より2週間間隔で実施例3と同様に尿を採取し、尿中無機リン排泄量を測定した。図2に示した通り、このモデル動物を用いた場合でも尿中無機リン排泄量はカゼイン食群で高く、米胚乳タンパク質食群で低かった。
<Example 4>
ZDF rats (male), an obese diabetic model rat, were purchased at 6 weeks of age from Charles River Japan. After 10 days of preliminary breeding, the animals were raised with a standard feed (10% sucrose) according to AIN-93G. Urine was collected at intervals of 2 weeks from the start of breeding in the same manner as in Example 3, and the amount of inorganic phosphorus excreted in urine was measured. As shown in FIG. 2, even when this model animal was used, urinary inorganic phosphorus excretion was high in the casein diet group and low in the rice endosperm protein diet group.
<実施例5>
新潟大学医学部倫理委員会の承認の下に、維持透析患者を対象とした臨床試験を実施した。維持透析通院患者10名をリクルートし、米胚乳タンパク質を含む試験食を2週間摂取させる試験を行った。試験食の組成を表3に示す。試験食は11gずつ(米胚乳タンパク質純品としては5g)アルミ包材に充填し、これを1日1回少量の水または湯に溶いて飲用させた。試験期間中は通常の食生活を継続するように指導し、試験食は通常摂取している食品に追加する形とした。
<Example 5>
Under the approval of the Niigata University School of Medicine Ethics Committee, a clinical trial was conducted on maintenance dialysis patients. A test was conducted in which 10 patients on maintenance dialysis were recruited and a test meal containing rice endosperm protein was ingested for 2 weeks. Table 3 shows the composition of the test meal. Each 11 g of the test meal (5 g as a rice endosperm protein pure product) was filled in an aluminum wrapping material, and this was dissolved in a small amount of water or hot water once a day for drinking. Instructions were given to continue the normal diet during the test period, and the test meal was added to the foods normally consumed.
被験者として、全身状態が安定した低栄養傾向のある成人の維持血液透析患者をリクルートした。選択基準は、血清アルブミン値が3.8mg/dl以下を示して低栄養傾向が認められ、かつ本臨床試験の趣旨を理解し文書同意が得られた者(性別不問)とした。心臓、肝臓等に重篤な疾患のある者、重症感染症、手術前後、重篤な外傷のある者、食物アレルギーを有する者、その他、担当医が研究参画に不適切と判断した者は除外した。リクルートした10名は、年齢75.4±7.8歳、男性3名、女性7名であった。 As subjects, we recruited adult maintenance hemodialysis patients with stable general condition and tending to undernutrition. The selection criteria were those who showed a serum albumin level of 3.8 mg / dl or less, showed a tendency toward malnutrition, understood the gist of this clinical study, and obtained written consent (gender-independent). Excludes persons with serious diseases in the heart, liver, etc., severe infections, before and after surgery, persons with severe trauma, persons with food allergies, and other persons judged inappropriate by the attending physician. did. The 10 people recruited were 75.4 ± 7.8 years of age, 3 men and 7 women.
試験開始2週間前、1週間前、開始直前、米胚乳タンパク質食摂取1週間後および2週間後に採血を行い、血液検査、血液生化学検査および血中ミネラル分析を行った。米胚乳タンパク質食品摂取前後(開始直前および2週間後)の血中無機リンおよびカリウムの分析結果を表4に示した。尚、2番の被験者は試験期間中の感冒により米胚乳タンパク質食品を5日間摂取しなかったため、解析対象からは除外し、9名での解析を行った。 Two weeks before the start of the test, one week before, just before the start, blood was collected 1 week and 2 weeks after the intake of the rice endosperm protein diet, and blood tests, blood biochemical tests, and blood mineral analysis were performed. Table 4 shows the analysis results of blood inorganic phosphorus and potassium before and after the rice endosperm protein food intake (immediately before and after 2 weeks). In addition, since the 2nd test subject did not ingest the rice endosperm protein food for 5 days due to the cold during the test period, it was excluded from the analysis target, and analysis was performed by 9 subjects.
維持透析患者が2週間にわたり毎日5gの米胚乳タンパク質を摂取しても血中無機リンやカリウムの濃度は上昇しなかったことから、この用量での米胚乳タンパク質の摂取は維持透析患者にとって問題がないことが確認された。また、2番の被験者の感冒以外に有害事象は観察されず、維持透析患者が米胚乳タンパク質を5g/日の用量で摂取しても安全であると判断された。 Even if maintenance dialysis patients ingested 5 g of rice endosperm protein every day for 2 weeks, the concentration of inorganic phosphorus and potassium in the blood did not increase, so intake of rice endosperm protein at this dose was problematic for maintenance dialysis patients Not confirmed. In addition, no adverse events were observed other than the common cold of No. 2 test subject, and it was judged that it was safe for maintenance dialysis patients to take rice endosperm protein at a dose of 5 g / day.
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CA2150571C (en) * | 1992-11-30 | 1998-09-29 | Seiichi Shimamura | Low-phosphorus whey protein, manufacturing method thereof, low-phosphorus purified whey hydrolysate and manufacturing method thereof |
JP2706888B2 (en) * | 1993-01-25 | 1998-01-28 | 新潟県 | Method for processing rice using lactic acid bacteria, processed food using the rice, and method for producing low-protein cooked rice |
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