CN103997915A - 用于在减肥手术前的术前阶段期间减少内脏脂肪的营养产品 - Google Patents
用于在减肥手术前的术前阶段期间减少内脏脂肪的营养产品 Download PDFInfo
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Abstract
本发明涉及一种口服营养产品,其用于在减肥外科手术介入的术前阶段减少肥胖患者的内脏脂肪,其尤其包括由如下组成的混合物:分子量在200至10000道尔顿的乳清水解产物,乳清的分离产物和/或浓缩产物,以及酪蛋白钙。
Description
技术领域
本发明涉及一种营养产品及其用途,尤其用于在外科手术减肥的手术前阶段减少肥胖患者的内脏脂肪。
背景技术
肥胖患者的数量,尤其在发达国家,不停增长。
肥胖引起的风险是大量的。尤其,已知肥胖增加了心脏代谢风险,其在个体上呈现心脏疾病、心血管意外和II型糖尿病的多个临床和生理症状。
在严重肥胖的情况下,必须借助于手术减肥,其能够限制对食物的吸收,尤其是减少胃容量,同样减少了每天摄入的热量,或者通过引起吸收不良。
现有多种手术减肥的介入类型,诸如放环、套筒、胆汁绕道或分流。所有这些技术,通过在腹壁上切口而用于手术内窥镜而实施,这是难以操作的,因为在肝附近具有内脏脂肪团,而脂肪肝在手术医生介入时对其妨碍,限制到达胃部。
这是必须能够通过手术前减肥而减少内脏脂肪和脂肪肝的程度的原因,因为已知严重肥胖的患者具有非酒精性脂肪肝或NASH。
目前的方法包括对将接受手术的患者进行严格的饮食控制。然而,对于将接受手术的患者而言,该限制饮食难以遵守,并且另外还引起肝狭窄的风险。此外,已经证明了,这种类型的饮食制度增加了强制饮食以及抑制增加肥胖者已经存在的色氨酸功能减退,这是由慢性炎症和应激所引起的。最后,该饮食制度加剧了超重者的症状性机能减退。
此外,肥胖者具有大量微营养素的不足,尤其是抗炎症的微营养素,诸如妨碍愈合的锌、铬、ω3、精氨酸和牛磺酸。此外,由于腹部肥胖,患者的纤维基因比例增高,易于在术后产生血栓。
最后,手术室内的患者压力较大,这也增加了其自然压力。
所有这些与患者的肥胖状况相关的现象,如果不加以治疗并且在,将增加减肥介入手术的困难,而严格的饮食制度,小于800kcal/天,在术前仅使得其加剧。
此外,重要的是在术前减肥并不表现为减少肌肉量,因为在介入手术之后,每周减重数千克将表现为大量减少肌肉量,这影响了基础代谢,并且常常引起体重反弹。此外,在肌肉量的减少也影响诸如心脏的器官,这在麻醉和一般介入手术期间可能是危险的。
因而,需要一种有效的方法,尤其是易于利用,能够特定地减少内脏脂肪,并且解决肥胖患者在减肥手术介入的术前阶段的机能减退和营养不足。
发明内容
为此目的,本发明建议采用一种特别的组合物,包括由至少如下组成的有效原理的混合物:
-分子量在200至10000道尔顿的乳清水解产物,
-乳清的分离产物和/或浓缩产物,以及
-酪蛋白钙。
有利地,可以采用这样的组合物作为营养产品,尤其用于在手术减肥介入的术前阶段减少肥胖患者的内脏脂肪,并且可以减少肝脏体积的25至50%。
此外,一种这样的组合物允许与肥胖患者的特定机能不足和营养缺乏进行抗争,并且还减少了减肥手术的风险。
下文将详细描述本发明。
因而,本发明涉及一种营养组合物,其用作为营养产品或用于制备口服的营养产品,以在减肥手术介入的术前阶段减少肥胖患者的内脏脂肪,其包括由至少如下组成的有效成分的混合物:
-分子量在200至10000道尔顿的乳清水解产物,
-乳清的分离产物和/或浓缩产物,以及
-酪蛋白钙。
本发明所采用的组合物或营养产品,指的是用于特殊饮食供应的产品,作为限制性饮食制度和/或均衡饮食供应的补充。根据本发明的组合物或营养产品尤为适于希望有效地准备进行减肥手术、减少手术风险、且恢复更好的患者。
本发明意义上的乳清水解产物,指的是通过包括乳清化学水解或酶水解步骤的方法而获得的所有分子或分子混合物。
本发明意义上的乳清分离产物,指的是含有小于1%的乳糖和脂肪物质的乳清提取液。
本发明意义上的乳清浓缩产物,指的是通过浓缩乳清获得的乳清提取液。
乳清水解产物的分子量在200和10000道尔顿之间,优选在200和3500道尔顿之间。其基本上由二肽和三肽组成。
优选地,其涉及一种乳清水解肽,其包括通过干燥水解产物而获得的肽重量至少占90%。
乳清的分离产物和/或浓缩产物优选分子量在15000和20000道尔顿之间。
乳清分离产物优选通过未对奶进行巴斯德法灭菌的干酪厂商的鲜奶制备,以避免破坏β乳球蛋白和α乳球蛋白,所述厂商通过超过滤或微过滤(过滤尺寸为0.1μm)而提取乳清。通过离子交换获得的分离产物,由于其含微量的乳球蛋白和乳清蛋白而较不合适。分离产物含有少于1%的乳糖和脂肪物质,而其肽浓缩产物优选至少干重量至少90%。
乳清浓缩产物优选通过不采用巴斯德法灭菌的干酪厂商的乳清获得,包括β乳球蛋白、α乳清蛋白和糖巨肽。浓缩产物的肽浓度优选干重量至少占80%。
此外,在根据本发明的组合物中采用的酪蛋白钙优选分子量在20000和35000道尔顿之间。
有利的是,组合物的不同组成成分协同作用。与乳清的分离产物和/或浓缩产物相关的特定水解产物的存在,能够加快减少内脏脂肪,并模拟饱腹感。至于酪蛋白钙,其尤其具有抑制食欲效果。
优选地,酪蛋白钙与水解产物和分离产物和/或乳清浓缩产物所构成的混合物之间的重量比例为0.8至1.2。一种这样的特征还有利于减少内脏脂肪。
根据一个特别合适的实施方式,组合物的有效成分的混合物同样包括氨基酸混合物。存在氨基酸允许改善根据本发明的营养组合物的效用。
组合物中的氨基酸优选至少是色氨酸、谷氨酰胺、亮氨酸、精氨酸和/或牛磺酸,但是该组合物可以包括其他氨基酸,诸如异亮氨酸、缬氨酸、苯丙氨酸或酪氨酸。尤为优选地,根据本发明的组合物包括至少色氨酸、亮氨酸、精氨酸和牛磺酸。
当存在色氨酸时,其占组合物中存在的中性氨基酸(亮氨酸、异亮氨酸、缬氨酸、苯丙氨酸、酪氨酸和色氨酸)的重量的6%-9%,优选大约7%。该特定比例能够确保合适量的色氨酸能够穿过血脑屏障,以能够转变成5-羟色胺,尤其以便于在饱腹感下作为与锌偶联的乳清水解产物、精氨酸和牛磺酸对肠内激素的作用的补充,尤其是CCK和LP1,有且有利于应激管理。
当存在精氨酸和牛磺酸时,精氨酸与牛磺酸的重量比在1.5和2之间。
除了水解产物混合物、分离产物和/或浓缩产物以及氨基酸之外,根据本发明的组合物的活性成分的混合物可以包括选自如下的一种或多种成分:奶钙、镁、维生素B6、维生素B9、维生素E、维生素D、锌和铬。
同样地,该组合物可以包括必需脂肪酸,尤其是ω3。优选地,其值得是植物脂肪酸ω3,其中具有提高的EPA。
根据本发明的组合物的不同组分协同作用,以获得尤为适于在减肥手术介入的术前阶段减少内脏脂肪的意外效果。
根据一个优选实施方式,根据本发明的有效成分的混合物包括至少如下:
-8至12%的乳清水解产物,
-15至20%的乳清分离产物和/或浓缩产物,
-20至25%的酪蛋白钙。
这些百分比为组合物中全部有效成分的干重量(在可能赋形物外部)。
该组合物还可以包括随意添加的成分,诸如氨基酸、维他命和矿物质,其作为乳酸水解产物、乳酸分离产物、乳酸浓缩产物和酪蛋白钙的天然组分的添加物。
根据本发明的组合物优选由至少如下构成:
-1.5至3%色氨酸,
-12至20%的侧链氨基酸,
-6至10%的芳香氨基酸,
-0.8至1.5%的牛磺酸
-1.6至3%的精氨酸,
-1.2至3%的奶钙,
-0.5至1%的镁,
-0.4至1%的ω3,
-对于无赋形剂的50g组合物中,具有1至2mg的维生素B6,
-对于无赋形剂的50g组合物中,具有5至15mg的锌,
-对于无赋形剂的50g组合物中,具有1至3μg的维生素D,
-对于无赋形剂的50g组合物中,具有75至150μg的铬,
-对于无赋形剂的50g组合物中,具有100μg的维生素B9,
-对于无赋形剂的50g组合物中,具有10mg的维生素E。
这些百分比为组合物中全部有效成分的干重量(除可能赋形物之外),一部分组分来自于乳清水解产物、乳清分离产物、乳清浓缩产物和酪蛋白钙,而其余组分为随意添加的氨基酸、维生素和矿物质。
组合物的侧链氨基酸由亮氨酸、异亮氨酸、缬氨酸组成,优选如下:
50-60%的亮氨酸
18至25%的异亮氨酸,以及
20至28%的缬氨酸,
以及色氨酸的芳香氨基酸、酪氨酸的苯丙氨酸,优选如下:
15至24%色氨酸,
38至46%的苯丙氨酸,以及
35至43%的酪氨酸。
根据本发明的组合物可以通过如下所述的方法获得:
-通过如下顺序混合组分而获得第一混合物:酪蛋白钙、乳清分离产物、乳清浓缩产物、乳清水解产物、自由氨基酸、镁和奶钙。pH值应当约为7,并且稳定在该水平。
-向第一混合物添加维生素、矿物质和脂肪酸。
同样获得了一种粉末,其能够被压缩或成为液态,或者以其粉末形态恰当地用于例如药袋、条状物、桶状或胶囊剂。
根据本发明的组合物,由于存在乳清的水解产物和分离产物和/或浓缩产物的混合物,当在通过口腔给药足够量时,能够直接作用以减少脂肪。
其还抑制食欲,并产生饱腹感,尤其借助乳清水解产物的作用。该效果因存在色氨酸而得以改善,并且还可能由于存在其他组分而增强,尤其是奶钙、组氨酸、维生素B6和/或镁,因而不同的组分协同作用。
根据本发明的组合物尤为适于在减肥手术之前减少患者肝脏周围的内脏脂肪,并且减小同样富有脂肪的肝的尺寸。一种尤为适于进行放环、套筒、胆汁绕道或分流的手术介入的准备过程的方法,是6周采用限制饮食,其在DER(睡眠能量消耗)下为20至40%,也称为遵循该方法的人的基础代谢。同样获得的对内脏脂肪的减少,使得外科医生能够更好地准备手术,并且减少5至10%的介入事件。
根据本发明的组合物还允许持续的减少体重,尤其通过提供能够调节饱腹感的色氨酸以及脂肪细胞的巨噬细胞的调节信号NFKappa B的牛磺酸、精氨酸、锌、铬对炎症的作用以及调节内分泌激素,进行协同作用。此外,其减少了尺寸***,均通过维持不含脂肪的部分,尤其是通过提供侧链氨基酸。
根据另一优点,组合物还能够作用于手术风险的其他因素。尤其,其能够:
-减少压力和抑郁,以及使得动脉压力标准化,这是麻醉风险的重要因素,
-减少超感光CRP炎症,这能够改善愈合的时间,
-调节纤维蛋白原凝结的因素,这能够避免形成血栓,
-通过减少与维生素E相关的内脏脂肪而开始治疗可能的脂肪肝,
-抵抗术前的色氨酸功能减退,抑郁的肥胖患者缺乏色氨酸严重的减缓了体重减少和术后体重恢复的基本因素。
根据本发明的组合物可以采用适于口服的任意形式。其尤其能够呈粉末或小丸剂、适于饮用的饮料、小棍或压制物,该组合物添加有赋形剂以及本领域技术人员已知的经典填充物。
优选地,其呈包装在溶于水的药袋中的粉末或小丸剂的形式。
根据本发明的组合物的日剂量(无赋形剂的活性成分的混合物的剂量)优选在66至110g之间,更优选分两次,一次在早上早餐之后或11点,一次在下午,每次服用33至55g。
有利地是,在人体内的组合物中存在的氨基酸、肽和蛋白质在人体内的实际药物吸收量在10分钟至5小时,这允许既快速又继续限制每天摄入的食量。
此外,具有奶钙能够通过尤其掩盖乳清水解产物的苦感而改善根据本发明的饮食产品的口感,以便于有助于大大缩减因该味道而在到限期之前放弃其饮食制度的人的风险
营养组合物能够减少体重超负荷的人的内脏脂肪,尤其通过加快脂肪分解进程、调节三联氧化-炎症-凝血,以及提供有效地减轻肥胖患者的病理性功能减退。
具有奶钙的脂肪酸、尤其是ω3与尤其根据本发明的氨基酸的混合物的组合物同样允许减缓前脂肪细胞转变成内脏脂肪细胞。
已经通过饮食组合物的非限制性实例,示出了本发明,其呈包装在药袋中的55g(有效成分和赋形剂)的粉末的形式。
该组合物由如下的活性成分获得:
-5g分子量在200至3500道尔顿的乳清水解产物,
-10g分子量在15000和20000道尔顿之间的乳清分离产物和/或浓缩产物,
-13g分子量在20000和35000道尔顿之间的酪蛋白钙,
-1mg维生素B6,
-10mg锌,
-0.45g牛磺酸,
-40μg铬,
-10mg维生素E,
-100μg维生素B9,
-2.5μg维生素D,
-270mg植物来源
-足够量4.2g的亮氨酸,
-足够量0.8g的色氨酸,
-足够量0.9g的精氨酸,
-足够量0.75g的奶钙,
-足够量0.36g的镁。
“足够量Xg”的组合物的成分,指的是该成分在组合物中的总量:由蛋白质(酪蛋白钙、乳清分离产物、乳清浓缩产物、乳清水解产物)提供并且由添加任意形态的成分而完成以实现直至Xg的量。
具体实施方式
已经通过一个研究说明了本发明,示出了组合物在减少内脏脂肪和减少减肥手术风险的其他因素而对组合物的影响。
该设计方案已经在一些患者身上实现:
-关于正常的IDF2006(女性80cm,而男性94cm)腰围超标的患者,
-具有选自如下的至少两个心脏代谢风险因素的患者:高动脉血压、高血糖、血脂紊乱(高甘油三酯、总胆固醇和LDL增高,HDL过低)、抽烟、家族病史。
这些患者已经遵循适于他们饮食习惯的的饮食制度,均衡(50%的碳水化合物,35%的脂类,15%的蛋白质;血糖负荷碳水化合物小于10)、低热量(基于计算获得的总能量消耗(DET)限制在700kcal),并且考虑到每天的定量,包括根据本发明(实例中所示)的组合物而每天摄入两次,每次360kcal。规定最少5000步(由计步器测得)的物理运动。在实现腰围10%的减少时,或者其恢复至正常IDF范围内时,该激烈的阶段应当停止。如果该未实现该目标,应该在9个月时中断。
该激烈的阶段之后,应当是稳定阶段,其包括均衡的饮食,而不限制热量,同时每天服用一剂量的根据本发明(实例所示)的组合物。
在研究开始时,已经包括了92名患者:在进入之后28名视力丧失,64名已经终止了密集的营养介入阶段,而34名已经进入稳定阶段。
在下表中示出了包括在内并且已经终止了研究的密集的营养阶段的64名患者的数据:
表1
在下表中示出了已经终止密集营养阶段的64名患者的结果:
表2
这些结果示出了体重减少超过11%。在研究末期,IMC<25的患者数量已经从13人变为包括41人。脂肪质量相对于肌肉质量的减小已经具有优势,使得肌肉质量占总重量的65%至71%。
同样证明了,腰围平均减少约10%。
此外,根据本发明的组合物允许大大地减少减肥手术风险的其他因素,尤其是:
-动脉血压:动脉血压得以改善。其已经被标准化为包括在内的17名高血压患者。
-生理参数:生物参数已经得以改善,尤其是:
●脂类在开始变瘦阶段时,19名患者中的11名标准化了其LDL。
●炎症的这些标记:10个患者,其具有升高的CPR us,其还标准化了四名患者,适于并是不常见的纤维蛋白,
●抗胰岛素的这些标记:10名血糖不正常以及4名胰岛素不正常的患者已经调节了糖尿病风险;此外,对于所有人,已经正面具有特征在于HOMA-IR3的抗胰岛素性下跌35%。
●肌酐已经降低,并且尿素维持稳定,这说明在研究中所采用的营养方案对于肾功能没有可检测得的影响。
腰围减小10%通过减少脂肪肝的体积使得肝体积变小。这允许外科医生最佳地到达胃部,尤其是对患者进行完美地准备,以减少可能引起诸如严重的愈合或浮肿等术后问题的营养缺乏。此外,在术前减少内脏脂肪趋势在介入的一年内具有更大的减少。
此外,有利的是,6个月内,未自发地引起不合需要的效应。
Claims (15)
1.一种营养组合物,其用作口服营养产品,用于在减肥外科手术介入的术前阶段减少肥胖患者的内脏脂肪,包括由至少如下构成的有效成分的混合物:
-分子量在200至10000道尔顿的乳清水解产物,
-乳清的分离产物和/或浓缩产物,以及
-酪蛋白钙。
2.根据权利要求1所述的组合物,其特征在于分离产物和/或浓缩产物的分子量在15000和20000道尔顿之间。
3.根据前述任意一项权利要求所述的组合物,其特征在于酪蛋白钙的分子量在20000至35000道尔顿之间。
4.根据前述任意一项权利要求所述的组合物,其特征在于乳清水解产物的分子量在200至3500道尔顿之间。
5.根据前述任意一项权利要求所述的组合物,其特征在于酪蛋白钙与水解产物和分离产物和/或乳清浓缩产物所构成的混合物之间的重量比例为0.8至1.2。
6.根据前述任意一项权利要求所述的组合物,其特征在于有效成分的混合物还包括氨基酸的混合物。
7.根据权利要求6所述的组合物,其特征在于氨基酸包括选自如下的至少一种氨基酸:色氨酸、谷氨酰胺、亮氨酸、精氨酸和牛磺酸。
8.根据权利要求7所述的组合物,其特征在于色氨酸占组合物中的中性氨基酸重量的6%至9%。
9.根据权利要求7或8所述的组合物,其特征在于精氨酸与牛磺酸的重量比例在1.5和2之间。
10.根据前述任意一项权利要求所述的组合物,其特征在于有效成分的混合物还包括选自如下的至少一种成分:奶钙、镁、维生素B6、维生素B9、维生素E、维生素D、锌和铬。
11.根据前述任意一项权利要求所述的组合物,其特征在于有效成分的混合物还包括基本脂肪酸。
12.根据权利要求11所述的组合物,其特征在于基本脂肪酸是ω3。
13.根据前述任意一项权利要求所述的组合物,其特征在于乳清水解产物占8至12%,乳清的分离产物和/或浓缩产物占15至20%,而酪蛋白钙占20至25%,这些百分比是组合物中全部有效成分干重量。
14.根据前述任意一项权利要求所述的组合物,其特征在于其还包括至少如下:
-1.5至3%色氨酸,
-12至20%的侧链氨基酸,
-6至10%的芳香氨基酸,
-0.8至1.5%的牛磺酸
-1.6至3%的精氨酸,
-1.2至3%的奶钙,
-0.5至1%的镁,
-0.4至1%的ω3,
-对于无赋形剂的50g组合物中,具有1至2mg的维生素B6,
-对于无赋形剂的50g组合物中,具有5至15mg的锌,
-对于无赋形剂的50g组合物中,具有1至3μg的维生素D,
-对于无赋形剂的50g组合物中,具有75至150μg的铬,
-对于无赋形剂的50g组合物中,具有100μg的B9,
-对于无赋形剂的50g组合物中,具有10mg的维生素E,
这些百分比为组合物中全部有效成分的干重量。
15.根据前述任意一项权利要求所述的组合物,其特征在于其呈粉末或小丸剂、易于服用的饮料、饮食棒或压制物的形式。
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FR3007987A1 (fr) * | 2013-07-02 | 2015-01-09 | Internat Nutrition Res Company | Medicament pour la prevention et le traitement de l'atherosclerose et du survieillissement metabolique |
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ES2536661B1 (es) * | 2013-11-27 | 2016-03-09 | Moreno Martín, S.L. | Composición proteínica |
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