JP5762396B2 - 糖尿病療法の支援のためのα−ケト酸を含有する栄養補助剤 - Google Patents
糖尿病療法の支援のためのα−ケト酸を含有する栄養補助剤 Download PDFInfo
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- JP5762396B2 JP5762396B2 JP2012502570A JP2012502570A JP5762396B2 JP 5762396 B2 JP5762396 B2 JP 5762396B2 JP 2012502570 A JP2012502570 A JP 2012502570A JP 2012502570 A JP2012502570 A JP 2012502570A JP 5762396 B2 JP5762396 B2 JP 5762396B2
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS, COOKING OILS
- A23D9/00—Other edible oils or fats, e.g. shortenings, cooking oils
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
- A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Diabetes (AREA)
- Nutrition Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Mycology (AREA)
- Endocrinology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Emergency Medicine (AREA)
- Obesity (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
10〜500mg ナトリウム、
10〜500mg カリウム、
50〜500mg カルシウム、
10〜300mg マグネシウム、
1〜20mg 亜鉛、
5〜50mg 鉄、
0.1〜1mg ヨウ素、
5〜100μg セレン、
5〜100μg クロム、
100mgまでのビタミンB1、
100mgまでのビタミンB2、
100mgまでのビタミンB6、
200μgまでのビタミンB12、
5gまでのビタミンC、
500mgまでのビタミンE、
300mgまでのパントテン酸、
1gまでのナイアシン、
10mgまでの葉酸、
1mgまでのビオチン。
持続力(Ausdauerfaehigkeit)の改善の決定のために、個々の嫌気性−好気性−閾値(IAAS)を算出する。これは、走行ベルト試験(Laufbandtest)を用いた乳酸−パフォーマンス−曲線の測定に基づき行われる(トレーニング相−プロトコル:開始6km/h、増加2km/h、これは約25〜50ワット/分の増加に相応する、段階期間3分)。この場合に、トレーニング段階の前及び後に30秒間の休止時間において血液試料を取り出し、このグルコース値及び乳酸値をYSI Life Sciences社(Yellow Springs, USA)のYSI 2300 STAT plus Analyzerを用いて、そして、最大酸素吸収(VO2max値)を肺活量によりCosmed (Rom、イタリア)社のK4測定装置を用いて測定した。
(Brunetti, A. and I. D. Goldfine. "RoIe of myogenin in myoblast differentiation and its regulation by fibroblast growth factor." J.Biol.Chem. 265.11 (1990): 5960-63. Fernandez, A. M., et al . "Muscle-specific inactivation of the IGF-I receptor induces compensatory hyperplasia in skeletal muscle." J. Clin. Invest 109.3 (2002): 347-55. Ragolia, L., Q. Zuo, and N. Begum. "Inhibition of myogenesis by depletion of the glycogen-associated regulatory subunit of protein phosphatase-1 in rat skeletal muscle cells." J.Biol.Chem. 275.34 (2000): 26102-08. Sun, Z., et al . "Muscular response and adaptation to diabetes mellitus." Front Biosci. 13 (2008): 4765-94)。
研究の実施:
身体トレーニングと組み合わせた分枝鎖状α−ケト酸(BCKAs)及びAKGの混合物の、グルコース−及びインスリン代謝、筋肉増強、筋力増加、窒素物質代謝の増加並びに一般的な健康の改善に対する作用を、II型糖尿病患者で試験するために、以下のヒト研究を実施した:
被験者:
それぞれ15人の被験者を有する2つの群を募集した。この30人の被験者を研究プランの組み入れ基準(Einschlusskriterium)に相応して評価し、かつ、臨床的又は人体計測的データに基づき任命した。引き続き、被験者を「ダブルブラインド」手法によりランダム化した(第1表)。性別分布、年齢及び身長に関してこの両群の間に統計学的に有意な差は存在しない。
身体トレーニングを2つの変法において実施した。一変法をスポーツ科学者又はドクトラントの指導下でSektion Sport und Rehabilitation der Uniklinik Ulmにおいて、又は資格を有するトレーナーの監督下でフィットネススタジオ/物理療法営業所において実施した。他の変法は、被験者自身により制御されるいわゆる「自由なトレーニング」であった。プロフェッショナルにより指導されるトレーニングは「研究義務のあるトレーニング」とみなされ、すなわち、1週間あたり3つのトレーニングユニット、「補助トレーニング」としての自由トレーニングである。この研究義務のあるトレーニングは、持続トレーニング(Ausdauertraining)及び力持続トレーニング(Kraftausdauertraining)からなり、その際、トレーニングユニットはそれぞれ15分間及び約5分間の中間休止を有する3回の繰り返しを有する持続トレーニング及び5分間にわたる力持続トレーニングを包含する。したがって、このトレーニング時間はトレーニングユニットあたり45分間を有する持続期間及び5分間を有する力持続トレーニングにわたる研究期間に相応し、したがって1週間あたり135分間の持続トレーニング及び15分間の力持続トレーニングに相応する。このトレーニングを6週間にわたり実施した。これに続き、トレーニングしていない1週間の再生相が続いた。
7週間(6週間のトレーニング週及び1週間の再生週)の全研究相の間、この2つの被験者群は毎日その体重により定められた量のミックス2(以下記載の組成におけるケト酸)又はプラセボ−ミックスを摂取し、その際、被験者は全期間にわたり常に同じミックスを摂取した。我々は、栄養補助剤の以下の組成を選択した:
500mgタブレットあたりのケト酸:
C Gel LM 03411 6.25mg
C Pharma Gel 12012 12.5mg
Avicel PH101 141.2mg
Avicel PH200 80.7mg
Kolliidon 25 7.8mg
ステアリン酸マグネシウム 1.6mg。
図1には、傾斜路試験(Rampentest)の際の最大達成される身体パフォーマンスがまとめられる。この最大達成される身体パフォーマンスはトレーニングの開始前にKAS群においてはプラセボ群におけるのに比較していくらかより高いように見え、これはしかし統計学的に有意な差ではない(P>0.05)。全体して、身体トレーニングによるこの最大の能力の顕著な増加が、この研究期間の間に示された。全被験者で、この最大に達成される身体パフォーマンスはトレーニングプログラム後並びに再生後に顕著な増加が記録される(P<0.01又はP<0.05)。
持続力のために、個々の嫌気性−好気性−乳酸閾値で多段階試験で測定された身体パフォーマンスを評価のために考慮した。但し、このパラメーターは身体的に比較的弱い被験者では常に算出可能でなく、そのため、この症例数はさらに変動した(第2表)。
図3には、血漿中のグルコース濃度についての結果が示される。
グルコース物質代謝のための長期パラメーターはHbA1cである(図4)。被験者ではこのHbA1c割合は研究開始前にはいくらか高められており、但し、KAS群においてはより顕著であった。トレーニングにより、両群において、これは有意にほぼ正常水準に低下した。したがって、HbA1cの低下の場合の「正味−利得」はKAS群において、プラセボ群におけるよりも顕著により高く、このことは、より大きな作用を説明する。
QUICKI(量的インスリン感受性検査指数)は、インスリン感受性のための広く知られたパラメーターであり、かつ、基礎インスリンレベル及びグルコースレベルに基づく。増加するQUICKIは改善されたインスリン感受性を示す。すなわち、所定のグルコースレベルでインスリンレベルがより低いほど、このインスリン感受性はより高い。この値は以下の式により算出される
Wallace TM, Levy JC and Matthew DR. Use and Abuse of HOMA Modeling, Diabetes Care 27: 1487-1495, 2004。
Claims (16)
- α−ケト酸としてα−ケトグルタラート、α−ケトイソカプロアート、α−ケトイソバレラート及びα−ケト−β−メチルバレラート(前記α−ケト酸はその塩の形にあってもよい)を含有し、栄養補助剤でありかつ調製物の全質量に対して6質量%未満の窒素含有量を有する、身体的活動と組み合わせて、糖尿病性物質代謝状態の正常化及びHbA1cの減少を生じるための調製物。
- 前述のα−ケト酸の塩としてアルカリ−又はアルカリ土類金属塩が含まれている請求項1記載の調製物。
- AKG/BCKAsの量比が5:1〜1:5である請求項1記載の調製物。
- α−ケト酸の全量に関して一日量0.5g〜50gを含有する請求項1又は2記載の調製物。
- さらに、L−オルニチン、L−リシン、L−ヒスチジン又はL−アルギニンを含有する請求項1から4のいずれか1項記載の調製物。
- アミノ酸を前述のα−ケト酸の塩として含有する請求項5記載の調製物。
- さらにクレアチンを含有する請求項1から6のいずれか1項記載の調製物。
- 炭水化物、脂肪及び油、ビタミン、酸化防止剤、ミネラル及び微量元素、保存剤、食品着色剤、甘味剤、風味増強剤及び芳香剤の群から選択される更なる添加剤を含有することを特徴とする請求項1から7のいずれか1項記載の調製物。
- 処方のために更なる助剤を含有する請求項1から8のいずれか1項記載の調製物。
- コーティング助剤としてメタクリラート−コポリマーを含有する請求項1から9のいずれか1項記載の調製物。
- 請求項1から10のいずれか1項記載の調製物を含有する食品。
- 糖尿病療法の支援のための経口吸収可能な製品の製造のための請求項1から10のいずれか1項記載の調製物又は請求項11記載の食品の使用。
- II型糖尿病患者での身体トレーニングの支援のための製品の製造のための請求項1から10のいずれか1項記載の調製物又は請求項11記載の食品の使用。
- 身体的活動と組み合わせて、糖尿病性物質代謝状態の正常化を、血液グルコースレベルの低下によってもたらす製品の製造のための請求項1から10のいずれか1項記載の調製物又は請求項11記載の食品の使用。
- インスリン感受性を増加させる製品の製造のための請求項1から10のいずれか1項記載の調製物又は請求項11記載の食品の使用。
- 哺乳類の糖尿病療法の支援のための請求項1から10のいずれか1項記載の調製物。
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PCT/EP2010/053704 WO2010112362A1 (de) | 2009-04-03 | 2010-03-22 | Nahrungsergänzungsmittel enthaltend alpha-ketosäuren zur unterstützung der diabetestherapie |
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