CN103997914B - 预防心脏代谢风险的营养产品 - Google Patents
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Abstract
本发明涉及一种营养产品,用于预防人类心脏代谢风险,尤其用于减少内脏脂肪和皮下深层脂肪,其尤其包括由如下构成的混合物:‑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以及其特别用于预防心脏代谢风险的应用。
背景技术
心脏代谢风险指的是个人的临床和生物体征,其增长了心脏疾病、心血管意外、2型糖尿病的风险,除非患者自身未强烈地感受到这些体征。
代谢和心血管异常的风险的主要体征是重要的腹围和血液中甘油三酯的升高率。其与至少一个风险因素相关,诸如动脉高血压、高血糖、低用L率等。
心脏代谢风险与体重超标相关,并且在大多数情况下与不健康生活相关。然而,所有体重超标者,同样重要地未必然地引起健康的重大风险。脂肪堆积的定位对于代谢异常风险的出现具有影响。事实上,数年以来,已经注意到心脏代谢问题与内脏脂肪相关,即与全身深处的脂肪。除此之外,最近的研究已经证明,皮下深度的脂肪具有与内脏脂肪相同的病理生理学效应。在两种情况下,内脏脂肪的大小以及巨噬细胞的数量对于心脏代谢风险具有重要影响。
相反地,即使不美观,前两层的皮下脂肪自身并未引起健康问题。
内脏脂肪和皮下深层脂肪包括就荷尔蒙的角度而言非常活跃的巨噬细胞,引起肝脏、胰腺以及脑和肠的能量调节系统机能不良,以及由于组织的轻度和慢性炎症所引起的大量功能减退。该慢性炎症是在血管内形成脂肪片的起因,其沉淀在壁上(心绞痛和下肢动脉炎),并且通过脂肪细胞炎症CRP(“C反应蛋白”C反应蛋白)的作用而破裂。此外,由于形成碎屑,自由基妨碍了细胞层面的交换,引起了葡萄糖不耐受,这是糖尿病后的胰岛素阻力。
为了预防心脏代谢风险,因而重要的是能够作用在内脏脂肪和皮下深层脂肪组织上。
目前,现有的预防心脏代谢风险的方法具有局限性。
自从1980年出现心脏代谢风险以来所推荐的所有均衡、高蛋白、高糖、高脂肪、非常限制或不均衡的饮食制度,均没有解决功能减退的特定问题以及该症状的病理特点。含蛋白质的饮食自身还加重了代谢功能减退。
此外,所推荐的药物作用于代谢综合征的一个病症,例如高血糖、高血压、高甘油三酯或高血胆固醇,而不是作用于代谢综合征的整体。
已知消耗内脏脂肪和皮下深层脂肪是撤销脂肪组织的巨噬细胞的作用的唯一可能性,这是通过减小脂肪细胞的体积以穿过其脂肪分解,然而无需包括调节炎症、脂肪细胞的脂肪分解作用和调节巨噬细胞的炎症信号NF Kappa B之间的关系。临床上证明,脂肪组织的巨噬细胞的NF Kappa B信号随着脂肪细胞的大小的减小而减弱。从尺寸的周长以一定方式从5%减少至10%,心脏代谢风险的因素恢复正常。
在高度限制的饮食制度中(小于800千卡/天),消耗内脏脂肪和不含脂肪的部分是重要的,但是由于与体重回弹效应而常常加剧了代谢综合征的组成部分。除此之外,消耗皮下脂肪非常困难,通常是在非常限制和非常长期的饮食制度后期。
因而需要一种有效、自然和易于采用的方法,其能够减少内脏脂肪和皮下深层脂肪,预防心脏代谢风险。
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。
有利的是,可以使用一种这样的组合物作为营养产品,尤其用于预防心脏代谢风险。根据本发明的组合物尤其可以用于减少内脏脂肪和皮下深层脂肪,预防心脏代谢风险。
下文将详细描述本发明。
因而,本发明涉及一种用于预防心脏代谢风险的营养组合物,包括有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。
本发明意义上的营养组合物或营养产品,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饮食产品尤其适于处于初期或二期预防心脏代谢疾病的医学目的或者美观目的而希望减少内脏脂肪和皮下深层脂肪或者仅减少体重的人。
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和/或乳清制备,以避免破坏β乳球蛋白和α乳清蛋白,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β乳球蛋白和α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,尤其允许加快减少内脏脂肪和减少皮下深层,并模拟饱腹感。至于酪蛋白钙,其尤其具有持续的抑制食欲效果。
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。一个这样的特征也有利于减少内脏脂肪和皮下深层脂肪。
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酪蛋白钙、精氨酸和牛磺酸对肠内激素的作用的补充,尤其是CCK和LP1,有且有利于压力管理。
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,用于引起尤其适于预防心脏代谢风险的效应。
根据一个变化方案,该组合物还可以包括已知的补充组分,用于改善适应压力,并且调节ACTH和氢化可的松的分泌,诸如红景天的洛塞维提取物和/或人参的人参皂苷提取与和/或圣地罗勒的丁子香酚提取物和/或淫羊藿的淫羊藿苷提取物和/或丝氨酸磷脂酰和/或植物甾醇酯。
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(除可能赋形物之外)。
该组合物还可以包括随意添加的成分,诸如氨基酸、维生素和矿物质,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%的色氨酸,
-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、酪氨酸和苯丙氨酸,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内脏脂肪和皮下深层脂肪。
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NF KappaB的牛磺酸、精氨酸、锌、铬对炎症的作用以及调节内分泌激素、尤其是CCK和GLP1的调节,进行协同作用。此外,其减少了尺寸外围,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,组合物同样能够作用于心脏代谢风险的大量其他因素上。尤其,其能够减少压力、使得动脉压力正常化、限制氧化作用、减少超感光CRP炎症、限制凝血、调节胆固醇和甘油三酯和/或减少血糖和餐后血糖。
因而,本发明涉及一种如前所述的组合物,用作为营养产物的用途,或者用于制备用于预防人心脏代谢风险的口服营养产品的方法。
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,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和皮下深层脂肪,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超重和腹部肥胖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。
本发明还允许
预防动脉粥样硬化片的形成和断裂,尤其是通过有意义地减少炎症脂肪细胞的分泌物,以便于预防心血管意外,
减少糖尿病风险,尤其通过修复细胞膜的弹性,这有利于葡萄糖和胆固醇的交换并且有助于瘦素、胰岛素和甘油三酯的效应器功能,以及
克制慢性压力,以适应压力者以及控制氢化可的松。
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植物来源的ω3,
-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,以及
-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。
在至少90天、且优选180天期间,对具有与心脏代谢风险相关的征兆的患者每天治疗两次(早上在早餐时或11点一袋,而下午一袋)而服用这种产品时,确认了特征在于大大减少脂肪、尤其是内脏脂肪和皮下深层脂肪的腰围的减少。脂肪量的减少通常比总体重的减少更重要,这意味着不含脂肪的量的增加。根据本发明的组合物尤其允许减少腰围的5至10%的内脏脂肪,该减少对于减少心脏代谢疾病的风险是有效的。其尤其被表达如下:
减少胆固醇T的比例,
减少胆固醇LDL的比例,
稳定胆固醇HDL比例的降低或略升高,
减少抗胰岛素或排斥的患者的空腹血糖以及患有II型糖尿病的患者的HbAlc血糖,
动脉张力的标准化,以及
CRPus和纤维蛋白原的标准化。
具体实施方式
已经通过一个设计方案描述了本发明,其主要目的是示出组合物对于减小腰围和心脏代谢风险的其他因素的效果。
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
这些结果显示了在小于9个月的时间内,平均腰围减少了约10%。
此外,根据本发明的组合物允许大大地减少心脏代谢风险的其他因素,尤其是:
-体重减小:体重减小与腰围减小数量级相同,为9.2kg。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%。
-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。
此外,有利的是,6个月内,未自发地引起不合需要的效应。
Claims (14)
1.一种用于预防心脏代谢风险的营养组合物,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,
-酪蛋白钙,
-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,和
-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。
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.根据权利要求1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.根据权利要求1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.根据权利要求1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.根据权利要求1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.根据权利要求1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。
11.根据权利要求1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。
12.根据权利要求1所述的组合物,其用作口服营养产品,用于预防人类心脏代谢风险。
13.根据权利要求1所述的组合物,其用作口服营养产品,用于减少体重过重者的内脏脂肪和皮下深层脂肪。
14.根据权利要求1所述的组合物,其用作口服营养产品,用于减小腰围、降低压力、标准化动脉血压、限制氧化、减少超感光CRP炎症、限制凝血、调节胆固醇和甘油三酯,和/或减少血糖和/或餐后血糖。
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