TWI432207B - 膳食增補劑及其相關方法 - Google Patents
膳食增補劑及其相關方法 Download PDFInfo
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Description
本案係2004年8月11日列案之美國專利申請案No.10/915,784的部分連續申請案,後者係2002年5月7日列案之美專利車請案號No.10/360,789號(如今是是美國專利第6,989,161號)次者又是2001年6月12日列案之美國專利申請案號878,377(如今是美國專利證號6,511,675號)的部分連續申請案,其依據2000年6月12日提出之美國暫時申請案號60/210,746號享有優先審查權,以上各文件均以其整體納入本文為參考。
本發明是關於用來改正膳食營養缺乏的組成物及其相關方法,包括植物化學因子、維生素以及礦物質的營養缺乏。
很多人不能實行健康的飲食習慣,像是攝取適當的食物份量與種類而符合美國每日建議攝取量。美國國家癌症學院的一份研究當中,僅22%的受試者吃夠建議的每日蔬果膳食份量;雖然蔬果的建議攝取量已為眾所周知。舉例來說,加州衛生署的《加州每日食物指引:加州人膳食指導》(一九九○)建議,每人每日最少攝取五至八份的蔬果,包括一份富含維生素A的深綠色或暗橘色蔬果,以及至少一份富含維生素C的蔬果。此外,許多報導均指出每人每週應攝取至少三份的豆類、堅果類或核果類之植物蛋白質。有些研究者建議,400公克(13盎司)的蔬果是每日攝取最佳份量的理想目標。以多類性而論,最好每人每天吃至少三種不同顏色的蔬果。
吃足夠份量以及種類的蔬果有許多好處。舉例來說,已知吃蔬果可減低多種退化性疾病的風險。在一份有41,837位停經婦女的前瞻性同齡族群研究中,調查蔬果攝取與肺癌風險的關連性。研究者發現,若蔬果攝取由每周24份或更少增加至每周超過48份,肺癌的風險幾乎減半。同樣地,若綠葉菜(包括波菜和歐芹等來源)的攝取由每周兩份或更少增加至每周六份或更多,肺癌的風險幾乎減半。參見Steinmetz,K.等人在《癌症研究》五十三期(一九九三),536到543頁的〈愛荷華女性健康研究學當中的蔬菜、水果與肺癌〉。另一研究發現,新鮮番茄(番茄紅素的主要來源)食用增加與所有消化道癌症的保護模式相關。Stahl,W.等人的"番茄紅素:一種人類生物學上重要的類胡蘿蔔素?(Lycopene:A Biologically Important Carotenoid for Humans?)" Arc.Biochem.Biophys.336:1-9(1996).
除了蔬果之外,香草也提供健康益處。舉例來說,迷迭香這種香草包含抗氧化劑,例如像是鼠尾草醇,其可扮演避免膽固醇氧化的角色。同樣地,九層塔也已知具有抗氧化劑活性。然而,和蔬果一樣,有益香草的膳食攝取並不令人滿意。
進一步的研究已顯示典型美式飲食缺乏植物化學因子。植物化學因子一般指的是植物衍生化合物,若每日與維生素和礦物質一同服用,會改善心血管和骨骼健康,改進的抗氧化劑成分曲線,減少的自由基損害,以及身體天然防禦系統的總體改善。
典型的飲食,尤其是美式飲食,包括不當份量及種類的蔬果及香草,以及在這些物質中所存在的植物化學因子以及關連抗氧化劑。一典型的餐食同樣地缺乏與蔬果有關的必需維生素和礦物質。雖然傳統多種維生素可補充西式飲食必需維生素及礦物質,這些多種維生素有許多不能提供以體內自由基為目標的植物化學因子,並因而改善此增補劑的抗氧化劑成分曲線。
本發明提供一種組成物,其包括一獨特的蔬果和香草之乾燥物、濃縮物或萃取物的組合;以及選擇性地包含維生素、礦物質和特殊成份以改正這些物質的膳食營養缺乏。
本發明的組成物提供實質上的健康助益。舉例來說,在一具體實施例中,它可支持食用營養不足膳食者的健康;改善抗氧化劑和營養劑狀況;補充由於不適當膳食所致的血清營養劑和植物化學因子濃度,成為與減少某些退化疾病狀態風險有關的濃度;最小化由於正常老化過程以及暴露於環境壓力所導致的自由基損害;並且(或)改進指示出最佳健康之特定生物指標的狀態,例如像是類胱胺酸、脂質副產品、礦物質狀況以及麩胺基硫過氧化酶。
在一更特定的具體實施例中,本發明的組成物可提供β胡蘿蔔素、α類酯酸、硒,以及維生素C和E,其改進一人的抗氧化劑成分曲線。葉酸和維生素E以心血管健康為目標並予以改善。鈣、鎂和維生素D以骨骼健康為目標並予以改善。維生素B群改進能量代謝。合於本發明的組成物提供100%的所有維生素以及大部分礦物質之美國建議每日攝取量。該組成物也可提供多種植物化學因子以產生一多樣化的抗氧化劑成分曲線。
在一更特定的具體實施例中,組成物可包括水果、蔬菜和香草成分的組合,其中水果成分是選自西印度櫻桃、蘋果、藍莓、柑橘生物類黃素、蔓越橘、葡萄皮、李和石榴;其中蔬菜成分是選自蘆筍、苜蓿、蕓薹屬植物、甘藍、葉黃素、番茄紅素和水田芥;而且其中香草成分是選自九層塔、牛至、洋芹、
鼠尾草和迷迭香。這些成分可被濃縮,舉例來說他們可能是由原料萃取提煉。視需要地,水果成分、蔬菜成分和香草成分在該組成物中呈現的比例可為其重量的約3.5:1:1。特別的成分,例如像是α類脂酸和肌醇,可添加至該組成物。
在又一具體實施例中,該組成物可包括至少一水果成分選自由柑橘生物類黃素和石榴所構成的組群,以及西印度櫻桃、蘋果、藍莓、越橘、葡萄、李子和覆盆子其中至少一項;至少一蔬菜成分選自以下組群,包括蘆筍、葉黃素、番茄紅素和水田芥,以及選擇性地苜蓿、蕓薹屬植物和甘藍至少其中一項;且至少一香草成分選自以下組群,包括九層塔、牛至和迷迭香,並選擇性地洋芹與鼠尾草其中至少一項。
在另一具體實施例中,提供一方法以用於增進免疫系統,並治療且(或)減輕人體之DNA損壞的風險,該方法包含實施一有效劑量的組成物,該組成物可包括至少一水果成分選自由柑橘生物類黃素和石榴所構成的組群,以及西印度櫻桃、蘋果、藍莓、越橘、葡萄、和李子其中至少一項;至少一蔬菜成分選自以下組群,包括蘆筍、葉黃素、番茄紅素和水田芥,以及選擇性地苜蓿、蕓薹屬植物和甘藍至少其中一項;且至少一香草成分選自以下組群,包括九層塔、牛至和迷迭香,並選擇性地洋芹與鼠尾草其中至少一項。
參考本文之具體實施例的詳細描述以及圖示,將更容易理解並領會本發明的這些和其他目標、優點及特徵。可想而知,前文的一般描述以及隨後的詳細描述僅是示範性及解釋性,且不是要限制本發明之申請專利範圍。
一般而言,本發明是關於含有水果、蔬菜以及香草的組成物。在一具體實施例中,該組成物可包括一水果成分、一蔬菜成分以及一香草成分,其中水果成分是石榴和柑橘生物類黃素其中至少一項,其中蔬菜成分是蘆筍、葉黃素、番茄紅素和水田芥其中至少一項,且其中香草成分是九層塔、牛至和迷迭香其中至少一項。該組成物也可和一能影響染色質穩定度的一已知治療結合,藉此限制此類治療的有害作用。
以下水果成分也可出現在該組成物中:西印度櫻桃、蘋果、越橘、葡萄皮和李子。進一步,以下蔬菜成分也可出現在該組成物中:苜蓿、蕓薹屬植物和甘藍。最後,以下香草成分也可出現在該組成物中:鼠尾草和洋芹。
該組成物在本文所討論的治療中具有協同綜效。因此,該組成物的諸成分合起來比個別成分更有效果。此外,該組成物調節(如本文所討論更明確地說是往上調節)與染色質穩定性有關的基因,像是圖式和示範例中所討論的例子。
基因的例子包括端粒維護,包括(但不限於)Ku、Cdc 13蛋白、催化次單元EST2,以及另三個基因EST1、EST3、EST4/CDC13,MRE11、RAD50、XRS2(酵母菌)/NBS1、p53、hTERT、ATM、TRF2,TERF族的基因。
本發明的組成物可治療或減少染色質損害的發生/風險,並因而支持基因體穩定度,其方法是藉由增加與辨別並修正DNA損傷以及相關之蛋白質結構(例如染色質)有關的基因表
現。染色質損傷之發生/風險的減少,包括關於生物反應或結果的統計顯著之明顯減少。這些基因控制活動包括(但不侷限於)鹼基對配錯修補,雙鏈斷裂修補,或其他維護、修補或監督角色。大部分損害是由於氧化、營養不足、放射線或毒素所導致。有四大類型的DNA損害是出自內生的細胞歷程或外來干擾:鹼基氧化(像是8-oxo-7,8-二氫鳥嘌呤(8-oxoG))以及DNA股的製造由於活性氧化物種而中斷,鹼基的烷化(通常是甲基化),像是形成7-甲基鳥嘌呤、1-甲基腺嘌呤,鹼基的O6甲基鳥嘌呤水解,像是脫胺作用、脫嘌呤作用和脫嘧啶作用,鹼基配錯,由於DNA複製的錯誤,其中錯誤的DNA被接到新形成之DNA股之中,或鹼基被略過或錯誤地插入。人類細胞中有四大類型的DNA修復管道:錯配修復,核苷酸切除修復(NER),鹼基切除修復(BER),以及雙鏈斷裂(DSB)修復。NER途徑主要是移除大片段的DNA加成物。BER途徑負責移除可能內在出現或由外來藥劑所致的已氧化DNA鹼基。DSB途徑負責修復由於各種曝露所導致的雙鏈斷裂,包括離子化放射性、自由基,以及端粒機能不全。此類基因的範例包括(但不侷限於)ERCC、RAD2、RAD6、RAD7、RAD18、RAD23、RAD51、RAD54、CDC7、CDC8、CDC9、MAG1、PHR1、DIN1、DDR48、RNR1、RNR2、RNR3、UB14、repB、repD和APE。這些基因會受本發明之組成物影響,可調節前文所揭示的任何一種損害。
因此該組成物可用來治療與DNA修復問題有關的疾病,包括(但不僅限於)著色性乾皮病、柯凱因氏症候群、髮硫發育障礙、維爾納氏症、布隆氏症候群、共濟失調毛細管擴張症。以上均與不當修復DNA有關。
該組成物可用來影響/調節粒線體功能專一基因的功能,此類基因的範例在以下的表格八提出。這些基因一般可分為四類。第一類,用於粒線體轉錄/轉譯的基因,其範例包括(但不僅限於)MTRF1L,與粒線體轉譯機構有關;GFM2,與蛋白質伸長有關的一種蛋白質,此為一粒線體的核糖體蛋白質;TOMM20,一特定受體的主成分,該受體負責細胞溶質合成之粒線體蛋白質的辨識及易位,並和TOM22一起發揮作用作為粒線體外膜表面的導引訊息,並促進先驅蛋白移入TOM40易位孔,COX15,主要出現在和原血紅素生物合成有關之高度氧化磷酸化(OxPhs)為特徵的組織中;POLG2,由DNA聚合酶γ準確複製的粒線體DNA;以及MRPS10,其係粒線體28S核糖體蛋白質的某部分。第二類,用於粒線體結構的基因,此類基因的範例包括(但不僅限於):DNMIL,維護粒線體形態極為重要;OPA1,粒線體內膜的主要組織者,並是內褶膜維護所需;MFN1,基本的跨膜GPT酶,其中介粒線體融合(MFN1獨立於細胞骨架作用);BNIP3,提供粒線體通透性的調節;COX18,將整體的膜蛋白插入粒線體所需,且是組裝細胞色素C氧化酶活性所必需,並在將COX2蛋白質的碳端易位並輸出至粒線體膜間空間扮演重要角色;還有DNM1L,其在粒線體和過氧化體劃分時作用,其方法可能是調節膜的分裂以及以酶水解GTP使之單聚化以形成環狀結構並可以重塑胞膜。第三類,各式粒線體蛋白質,此類基因的範例包括(但不僅限於):WWOX,一腫瘤抑制基因;PPIF,用於蛋白質褶疊;10GB,與CoQ合成的最後步驟有關;SLC25A37,是一粒線體離子運輸子,其特別專一於中介發展紅血球細胞時的離子攝取,因此在原血紅素的生物合成扮演一重要角色;ABCB7,與原血紅素
由粒線體運輸至細胞溶質有關;還有SLC25A36,用於粒線體的一運輸子。第四類,用於粒線體酶的基因,此類基因的範例包括(但不僅限於):SDHD,係呼吸作用的一部分;ATPAF1製造ATP極重要的酵素;NARS2、IARS2、EARS2、LARS2、HARS2,分別是和胺基酸ASN、ILE和GLN、LEU及HIS之製造有關的酶;HIBADH,為TCA循環提供琥珀基coA的一種酵素,催化脂肪酸β氧化作用步驟之一的酵素;MIB1,其係蛋白質泛素化作用(消去致命者)所需的E3接合酶;BCKDHB和ACAD8,用於為TCA製造丁二醯CoA;AFG3L2,其係保護氧化性壓力的AAA蛋白脢;PEO1,一種DNA解旋酶,粒線體DNA整合度的長期維護以及粒線體DNA複本數量的維護極為重要;HK2(己醣激酶)和HADHB,其係與脂肪酸的β氧化作用有關。
該組成物也可與已知的治療結合,以創造一組合療法。這主要可用於具有會損及DNA穩定性之已知不良副作用的已知治療,例如像是化學治療以及放射線治療。其他化合物也可用於不良受損DNA的修復和穩定。
本發明也是關於用於改正膳食引發之水果、蔬菜以及香草缺乏,並改正在此等物質中所出現的營養素。本發明的組成物可額外包含植物化學因子、維生素以及礦物質,已知能改進身體對抗氧化劑、自由基和疾病之自然防禦力。
組成物可包括水果、蔬菜、香草和明顯有益健康的其他成分。以下的表格示範的是可包括在該組合中之適當水果、蔬菜、香草和礦物質的代表性每日份量。劑量和施實方法可依應
用例所需而有所不同。舉例來說,劑量A表示適用於表發明之個別成分的一劑量範圍。劑量B表示一特定具體實施例的劑量。表格一至表格五的單位「毫克」表示所述份量是以該數目的毫克,以每日兩顆藥的劑量,除非另有註記,例如像是聲明為「國際單位」。因此,為決定每一個藥片的特定成分之份量,各個表格中所提及的數量必須減半。
該柑橘類生物類黃素得由密西根州,亞達市(Ada)的通路實業集團國際公司(Access Business Group International LLC)購得。此成分可能是濃縮型式,並可包括(但不僅限於):柚皮素、橘皮苷、柚皮芸香苷、香葉木苷、芸香苷、橘皮素、香葉木素、新橘皮苷、陳黃皮酮和槲皮素。
紐崔萊水田芥可向Access Business Group International LCC購得。蕓薹屬植物和/或甘藍可以是乾燥、粉末的型式。本文中所稱蕓薹屬植物成分可包括由蕓薹屬植物所衍生的物質,舉例來說像是青花菜。組成物中所使用的葉黃素酯可以是商品名為Xangold的10%微粒散劑之型式,其可向俄亥俄州辛辛那堤的Cognis Nutrition & Health購得。組成物中所使用的番茄紅素可能是商品名為Lycobeads 5%的型式,其可向紐澤西州奧倫吉的H.Reisman Corp.購得。
紐崔萊洋芹可向Access Business Group International LCC購得。該組成物也可包括上述水果、蔬菜和香草成分之外的成分。舉例來說,適合用於本發明之組成物及方法的維生素可包括維生素A、維生素B1維生素B6、維生素B12、菸鹼酸/菸鹼醯胺、泛酸、葉酸、生物素、膽鹼、維生素C、維生素D、維生素E。以下的表格四是一適合的維生素組成。
除了上述的維生素,用於本發明之組成物與方法的礦物質包括(舉例來說)硼、鈣、鉻、銅、碘、鎂、錳、鉬、鉀、硒、釩和鋅。也可使用其他維生素和礦物質。以下的表格五包括適
合本發明之組成物的礦物質組成。
以表格一至表格三的成分,以及選擇性地表格四至表格五的成分,本發明的組成物可提供多種維生素及礦物質的很大一部分(在許多例子中還會超過)每日所需建議攝取量。以下的表格六及表格七顯示組成物的效力,是以上述每日攝取量,是以表列維生素和礦物質之每日所需的百分率表示。
可用於該組成物的額外特殊成分包括(舉例來說)甲基磺醯基甲烷(MSM)、α-類脂酸(10mg/每日)、兒茶素類、聚酚類、黃酮類、番茄紅素、葉黃素、酵母、肌醇,以及對胺苯甲酸(PABA)。
本發明的組成物可用個別水果濃縮劑、蔬菜濃縮劑、香草濃縮劑、植物化學因子、維生素、礦物質和其他營養素的藥學上可接受之型式調製而成,包括上述成分的鹽類。組成物可形成錠劑、粉劑、膠狀劑或(為本發明之目的並在整個申請案中通篇使用,一錠劑包括但並不限於藥片、藥丸、膠囊、藥粉等等)。舉例來說,該組成物可形成藥粉,以用於和可食用的液體像是牛奶、果汁、水或可食用的膠狀液或糖漿混合,以混入其他液體或食物。該組成物可和其他食物或液體形成製劑,以提供預先度量好的組合食品,舉例來說像是一人份的食用棒。若有需要可添加調味劑、黏劑、蛋白質、碳水化合物,以及類
似物。
依據本發明的一觀點,該組成物是以三個獨立錠劑投藥,每天實施兩次;不過,該組成物可依需要以其他型式或單位劑量投藥。
本發明的組成物將在以下的範例中說明,但並非要設限。
可準備三個錠劑以提供a)水果、蔬菜和香草成分,b)維生素,c)礦物質。第一錠劑包括表格一至表格三的水果、蔬菜和香草成分。此第一錠劑中各個成分的分量是該等表格中所列出劑量B的一半,因為表中所列數量是以兩個此種錠劑的分量呈現。第一錠劑也可包含載劑和其他製藥助劑,像是二氧化矽、氧化鎂、碳酸鈣、交聯羧甲纖維素鈉、微晶纖維素和硬脂酸鎂,熟悉本技藝的人士應知其份量可隨使用目的而有所不同。
第二錠劑包含表格四的維生素。此第二錠劑中各個成分的分量是表格中所列出份量的一半,因為表中所列數量是以兩個此種錠劑的份量呈現。第二錠劑也可包含載劑和其他製藥助劑,像是微晶纖維素、碳酸鈣、交聯羧甲基纖維素鈉、硬脂酸鎂,以及二氧化矽。
第三錠劑包含表格五的礦物質。此第三錠劑中各個成分的分量是表格中所列出份量的一半,因為表中所列數量是以兩個此種錠劑的份量呈現。第三錠劑也可包含載劑和其他製藥助劑,像是微晶纖維素、碳酸鈣、交聯羧甲基纖維素鈉、硬脂酸鎂,以及二氧化矽。
此三粒錠劑,若每日投藥兩次,補足典型膳食中所出現的
植物化學因子空缺。
以下例子是關於製備上述三種錠劑的方法。該等成分和以上表格一至表格五中所指出的成分一樣。然而,為了以下例子,包含由表格一至表格三之水果、蔬菜和香草成分的錠劑稱為「錠劑一」;包含由表格四之水果、蔬菜和香草成分的錠劑稱為「錠劑一」;包括表格四之維生素成分的錠劑稱為「錠劑二」;而且包含表格五之礦物質成分的錠劑稱為「錠劑三」。可知若有所需可用其他製備錠劑的方法以及其他適合的輸送載體。
混合的生育酚、D-α-生育酚(琥珀酸鹽),以及二氧化矽(經奈米級過濾之極微粉末)通過一備有20網孔(mesh)篩網的SWECO分離機,倒入100立方呎的PK摻合機。該等成分摻合十分鐘氧化鎂(D.C.heavy)、西印度櫻桃濃縮劑、柑橘生物類黃素複合物、李子萃取物、蘋果萃取物、迷迭香萃取物、九層塔萃取物、葡萄皮萃取物、越橘萃取物、甘藍萃取物、蘆筍萃取物、藍莓萃取物、洋芹萃取物、牛至萃取物、鼠尾草萃取物、石榴萃取物,以及肌醇,通過一備有20網孔篩網的SWECO分離機,倒入100立方呎的PK摻合機。該等成分摻合十分鐘。
番茄紅素(5%)、酯化型葉黃素(散劑)、綜合生育酚、碳酸鈣(顆粒)、交聯羧甲基纖維素鈉和微晶纖維素(矽化),通過一備有20網孔篩網的SWECO分離機,直接倒入100立方呎的PK摻合機。該混合物摻合十分鐘接下來,硬脂酸鎂(Kosher)
通過一備有20網孔篩網的SWECO分離機,直接倒入100立方呎的PK摻合機。該等成分再額外摻合五分鐘所得混合物裝入布袋或大型貨料袋中,並壓製成錠劑。
西印度櫻桃濃縮劑、微晶纖維素(矽化)和α-類脂酸通過一備有20網孔篩網的SWECO分離機,直接倒入100立方呎的PK摻合機。該等成分摻合十分鐘接下來,將以下成分通過一備有20網孔篩網的SWECO分離機,直接倒入該100立方呎的PK摻合機:硝酸噻胺(97%)、核黃素、菸鹼醯胺、生物素研製劑(1%)、維生素B12(1.1%)、泛酸鈣顆粒、葉酸、鹽酸吡哆醇(95%),以及重酒石酸膽鹼。該等成分摻合十分鐘接著,以下各項通過一備有20網孔篩網的SWECO分離機,直接倒入100立方呎的PK摻合機:β-胡蘿蔔素(散劑)、維生素D3(散劑),酵母(標準化)以及維生素A(醋酸鹽)。該混合物摻合十分鐘。
接下來,將以下成分通過一備有20網孔篩網的SWECO分離機,直接倒入該1.00立方呎的PK摻合機:抗壞血酸(97%)、碳酸鈣(顆粒)、交聯羧甲基纖維素鈉、d-α-琥珀酸生育酚酯、二氧化矽(經奈米級過濾之極微粉末)。該混合物摻合十分鐘
接下來,硬脂酸鎂(Kosher)通過一備有20網孔篩網的SWECO分離機,直接倒入該100立方呎的PK摻合機。該混合物摻合十分鐘所得混合物裝入布袋或大型貨料袋中,並壓製成錠劑。
胺基酸螯合鋅、綜合生育酚,以及二氧化矽(經奈米級過濾之極微粉末)通過一備有20網孔篩網的SWECO分離機,倒入100立方呎的PK摻合機。該等成分摻合十分鐘共同處理的苜蓿濃縮劑/微晶纖維素/碳酸鈣、硒酵母、微晶纖維素、胺基酸螯合銅、胺基酸螯合錳、碘化鉀碎末、胺基酸螯合鉻、胺基酸螯合鉬、脫水蕓薹屬植物、脫水水田芥,以及交聯羧甲基纖維素鈉,通過一備有20網孔篩網的SWECO分離機,倒入100立方呎的PK摻合機。該等成分摻合十分鐘。
氯化鉀、氧化錳(D.C.heavy)和碳酸鈣(顆粒),通過一備有20網孔篩網的SWECO分離機,倒入100立方呎的PK摻合機。該等成分摻合十分鐘接下來,硬脂酸鎂(Kosher)通過一備有20網孔篩網的SWECO分離機,直接倒入100立方呎的PK摻合機。該等成分再額外摻合十分鐘接下來,硬脂酸鎂(Kosher)通過一備有20網孔篩網的SWECO分離機,直接倒入該100立方呎的PK摻合機。該混合物摻合五分鐘所得混合物裝入布袋或大型貨料袋中,並壓製成錠劑。
臨床研究是獨立審查委員會認可、雙盲、加入安慰劑做為對照的平行分組研究。
受測者是加州和夏威夷州的120位健康成年日裔美人。受測者是日本血統(雙親和四位祖輩尊親均是日本血統)且大部分是食用日式食物。
受測者被要求不是接受組成物就是接受安慰劑(每日12片錠劑),共八周。該組成物和日本Alticor以Triplex XTM
為名販售者為相同配方。所產品均覆膜並以編有號碼的鋁箔包裝提出,以確保雙盲。
所得結果可區分為四大類;(1)一代表性水溶抗氧化營養素〔維生素C〕,以及一代表性脂溶性抗氧化劑營養素〔β-胡蘿蔔素〕的血漿中濃度,(2)「抗-高半胱胺酸三巨頭」:維生素B6、維生素B12和葉酸鹽的血漿中濃度,以及高半胱胺酸的血漿中濃度,(3)染色體組穩定的營養基因組機制,以及(4)血漿代謝體成分分布的改變。
依據由120位受試者(60位以Triple X治療,且60位以安慰劑治療)所得的血液樣本,分別在基準量、第四周和第八周,進行血漿營養素和高半胱胺酸濃度的分析。
在基準值和第二周,依據由14位受試者而來的血液樣本(7位以Triple X治療,且7位以安慰劑治療)進行營養基因組分析。
血漿營養素和高半胱胺酸改變計數結果是以用於組間比較的獨立群組t檢定檢測。P值小於0.05即視為具有顯著差異。
營養基因體資料首先僅以組成物治療組內的配對t檢定進行分析,以辨識出44,000基因當中有哪些測出在治療之後表現出表現位準的顯著變化。P值小於0.05即視為具有顯著差異。
0.4的Q值(錯誤發現率)用來控制錯誤的陽性結果。此分析辨認出約2,000個基因,這些又接著接受生物相關型態改變檢查。
由臨床研究而來的結果如下。相較於服用安慰劑的受測者,服用組成物的受測者顯示出葉酸鹽、維生素B6、維生素B12和維生素C的濃度增加,以及高半胱胺酸濃度減少,全都是治療四周之內發生,其結果在第八周仍維持。代謝體的分析指出,氧化壓力減少。營養基因體分析指出,基因體完整性和腫瘤抑制機制、高半胱胺酸代謝、抗氧化壓力以及脂肪過氧化作用增加。
營養基因體資料的臨床解讀顯示出預期之外的結果,相較於安慰劑組,已知會發揮功能支持基因體穩定(藉由染色質維護、損害偵測和修護)約150個基因,在Triple X組顯著增加。其後分析安慰劑治療組的這些基因,顯示安慰劑治療之後並無改變。相較於基準值,攝取本發明的組成物導致與DNA維持、複製或修護有關的基因表現有統計上顯著的增加(第七圖)。
代謝體資料的解讀顯示出預期之外的結果,攝取Triple X導致2-羥基丁酸顯著減少的現象增加,這是和氧化壓力有關的代謝物(第八圖),並且有5-氧脯胺酸減少的傾向,這也是與氧化壓力有關的代謝物(第九圖)。如此顯示組合物的攝取會導致抗氧化營養素在血漿中的濃度增加,染色質維護與修護因基的表現增加,高半胱胺酸減少,以及氧化壓力代謝體指示物的減少。
臨床測試是要確定本發明之組成物的效能。可期待攝取該組成物將會:改正植物化學因子的膳食營養缺乏;改進體內的
抗氧化劑含量;減少自由基損害;增加血漿維生素、礦物質和植物化學因子濃度;並且改進血漿和系統抗氧化能力,舉其大者。
此研究所用的包含判準是健康男子和女子,由18至80歲,他們攝取少於12項每周建議膳食檢查表上記載的項目。這些受測者的選擇是在實施一食品食用頻率問卷並得到建議膳食分數(RFS)之後。RFS是由23種食物組成,其中14項是水果和蔬菜,若每周按建議攝取已知會和減低的死亡率有關。這現像是在由42,254位婦女所做的同齡層研究中顯示出。相較於平均RFS為6.4(最低四分位)的人,RFS平均為16(最高四分位)的人不分原因死亡率相對風險為0.69,而前者的不分原因死亡率相對風險為。可發現,與最低四分位之中的人相比,最高四分位的人攝取明顯較多卡洛里(131%)、纖維(200%)、維生素C(230%)、葉酸鹽(181%)以及前-維生素A類胡蘿蔔素(253%)。
臨床研究包含120受測者的雙盲研究(也就是對受測者及研究者)持續六周的期間。在此六周期間,受測者被告知要服用三種藥丸,不是組成物就是安慰劑,每日兩次,像是早晨和傍晚。受測者的測量是藉由採集血液及尿液樣本並進行以下檢驗:總多酚類、血漿ORAC(氧自由基吸收能力)、CP450酶誘導、細胞質分裂阻滯微核檢驗、彗星電泳檢驗、生物能量檢驗,尿液膽酸類、B6、B12、葉酸鹽、維生素C、高半胱胺酸、α-生育酚及β-生育酚類、β-胡蘿蔔素、C反應蛋白和尿液8-表-前列腺素F2α,這些都是在基準值以及開始研究後的兩周、四周以及第六周進行檢驗。依據以下測量判定上述指標的改進,也就是組成物的效率:維生素類、礦物質類和植物化學因子類的血清中濃度;血清與體內抗氧化能力;排毒能力;細胞能量動力學;基因組穩定度;其他風險因子以及主觀作用。
可想而知研究結果會顯示攝取該組成物六周之後,受測者的生育酚類、B12、B6、葉酸鹽、維生素C和其他抗氧化劑血清中濃度會有顯著增加,此現象指出體內抗氧化劑的數量改進,而且此現象和維生素、營養素和植物化學因子的膳食營養缺乏有顯著改進有關,並且和自由基損害還有減少的基因組基因組穩定度(例如像是減少的DNA損害)有關,以上僅舉其大者。
臨床研究的結果如下。與服用安慰劑的受測者比較,服用本發明之組成物的受測者顯示出血清中的β-胡蘿蔔素、α-生育酚、葉酸鹽和維生素B6及B12濃度增加。服用本發明之組成物的受測者也顯示出顯著減少的高半胱胺酸,以及減量的DNA損害,此係如細胞質分裂阻滯微核檢驗所示。此現象顯示該組成物的攝取可增加抗氧化營養素的血清中濃度,減少高半胱胺酸,並減少DNA損害。
以上的係本發明的較佳具體實施例之描述。可有許多變異及改變而不會偏離文後隨附申請專利範圍所定義之本發明的精神及其更寬廣觀點,申請專利範圍應以包括均等論在內的專利法原則加以解釋。以單數指稱的任何申請專利範圍之元素,例如用「一個(a、an)」、「該(the)」、「所稱(said)」,不應解讀為是要限制該元素為單數。
第一圖顯示組成物對於維生素C濃度的作用。
第二圖顯示組成物對於β胡蘿蔔素濃度的作用。
第三圖顯示組成物對於維生素B6濃度的作用。
第四圖顯示組成物對於維生素B12濃度的作用。
第五圖顯示組成物對於葉酸鹽濃度的作用。
第五圖顯示組成物對於高半胱胺酸濃度的作用。
第六圖顯示組成物對於高半胱胺酸濃度的作用。
第七圖是一圖表,顯示與DNA或染色質維護或修補有關,藉由攝取該組成物所調節之基因的數目。
第八A圖和第八B圖分別是一圖表和一圖示,顯示以使用本發明之組成物治療的減少氧化壓力,是以2-羥基丁酸濃度的減少指示。
第九A圖和第九B圖分別是一圖表和一圖示,顯示以使用本發明之組成物治療的減少氧化壓力,是以5-氧合脯氨酸濃度的減少指示。
第十圖顯示在治療之後血漿中β胡蘿蔔素的濃度改變。
第十一圖顯示在治療之後血漿中葉酸鹽的濃度改變。
第十二圖顯示在治療之後血漿中維生素B6的濃度改變。
第十三圖顯示在治療之後血漿中維生素B12的濃度改變。
第十四圖顯示在治療之後血漿中高半胱胺酸的濃度改變。
第十五圖顯示在治療之後DNA損傷的改變。
第十六圖顯示在治療之後與DNA維護基因有關之基因的基本表現活動。
Claims (9)
- 一種組成物之用途,其係用於製備用以調節一所需主體中與染色質穩定度相關之基因表現的治療物質,該組成物包含一水果成分、一蔬菜成分以及一香草成分,其中該水果成分是劑量介於約5毫克/每日至約500毫克/每日的石榴,和劑量介於約25毫克/每日至約1000毫克/每日的柑橘生物類黃素,其中該蔬菜成分是劑量介於約25毫克/每日至約1000毫克/每日的蘆筍,和劑量介於約5毫克/每日至約500毫克/每日的水田芥,且其中該香草成分是劑量介於約25毫克/每日至約1000毫克/每日的牛至,和劑量介於約25毫克/每日至約1000毫克/每日的迷迭香,藉此增進與染色質穩定性相關之基因的表現。
- 如申請專利範圍第1項之組成物的用途,其中施予該治療物質的步驟包括以三個藥片、各藥片每天服用兩次的型式,將該組成物施予一主體。
- 如申請專利範圍第1項之組成物的用途,其中該調節的步驟包括向上調升該染色質穩定性相關基因的表現。
- 一種組成物之用途,其係用於製備用以調節一所需主體中與DNA修護相關基因之表現的治療藥物,該組成物包含一水果成分、一蔬菜成分以及一香草成分,其中該水果成分是劑量介於約5毫克/每日至約500毫克/每日的石榴,和劑量介於約25毫克/每日至約1000毫克/每日的柑橘生物類黃素,其中該蔬菜成分是劑量介於約25毫克/每日至約1000毫克/每日的蘆筍,和劑量介於約5毫克/每日至約500毫克/每日的水田芥,且其中該香草成分是劑量介於約25毫克/每日至約1000毫克/每日的牛至,和劑量介於約25毫克/每日至約1000毫克/每日的迷迭 香,藉此增進與DNA修護相關之基因的表現。
- 如申請專利範圍第4項之組成物的用途,其中施予該治療藥物的步驟包括以三個藥片、各藥片每天服用兩次的型式,將該組成物施予一主體。
- 如申請專利範圍第4項之組成物的用途,其中該調節的步驟包括向上調升與DNA修護相關基因之表現。
- 一種組成物之用途,其係用於製備用以減少染色質損害之風險的治療藥物,該組成物包含一水果成分、一蔬菜成分以及一香草成分,其中該水果成分是劑量介於約5毫克/每日至約500毫克/每日的石榴,和劑量介於約25毫克/每日至約1000毫克/每日的柑橘生物類黃素,其中該蔬菜成分是劑量介於約25毫克/每日至約1000毫克/每日的蘆筍,和劑量介於約5毫克/每日至約500毫克/每日的水田芥,且其中該香草成分是劑量介於約25毫克/每日至約1000毫克/每日的牛至,和劑量介於約25毫克/每日至約1000毫克/每日的迷迭香,且以一有效劑量的組成物增進基因的表現,進而減少染色質損害的風險。
- 如申請專利範圍第7項之組成物的用途,其中施予該治療藥物的步驟包括以三個藥片、各藥片每天服用兩次的型式,將該組成物施予一主體。
- 如申請專利範圍第7項之組成物的用途,其中該減少染色質損害之風險的步驟包括向上調升與染色質穩定性相關基因之表現。
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EP1136073A1 (en) * | 2000-03-22 | 2001-09-26 | N.V. Nutricia | Compositions suitable for the treatment of damage caused by ischemia/reperfusion or oxidative stress |
US6579544B1 (en) * | 2000-05-31 | 2003-06-17 | Nutriex, L.L.C. | Method for supplementing the diet |
US7438936B2 (en) * | 2000-06-12 | 2008-10-21 | Access Business Group International Llc | Dietary supplement and related method |
US7939115B2 (en) | 2000-06-12 | 2011-05-10 | Access Business Group International Llc | Dietary supplement and related method |
US7416749B2 (en) * | 2000-06-12 | 2008-08-26 | Access Business Group International Llc | Dietary supplement and related method |
JP2002051732A (ja) * | 2000-06-12 | 2002-02-19 | Access Business Group Llc | 食事による植物性化学物質欠乏症を矯正する組成物及び方法 |
JP4257022B2 (ja) * | 2000-06-27 | 2009-04-22 | 小川香料株式会社 | 食品の香味劣化抑制剤並びに抑制方法 |
US7128933B2 (en) * | 2000-09-01 | 2006-10-31 | Mitchell Kurk | Composition and method for the treatment of personal odors |
US20020119173A1 (en) * | 2000-12-22 | 2002-08-29 | Lin Samuel Qcheng | Cosmetic compositions for preventing skin irritation |
US6387370B1 (en) * | 2001-01-19 | 2002-05-14 | A. Glenn Braswell | Compositions containing extracts of Morinda citrifolia, red wine, prune, blueberry, pomegranate, apple and enzyme mixture |
US20020192314A1 (en) * | 2001-03-06 | 2002-12-19 | Cho Suk H. | Dietary supplement compositions |
US20020182270A1 (en) * | 2001-05-31 | 2002-12-05 | Stier Roger E. | Edible compositions comprising freeze-dried flavoring agents |
US6586018B1 (en) * | 2001-08-31 | 2003-07-01 | Sabina Fasano | Herbal composition |
US20030108627A1 (en) * | 2001-09-25 | 2003-06-12 | Jonathan Selzer | Cranberry based dietary supplement and dental hygiene product |
US6551628B1 (en) * | 2001-11-30 | 2003-04-22 | Renew Life Formulas, Inc. | Herbal intestinal tract cleanser |
US7132296B2 (en) * | 2002-02-15 | 2006-11-07 | Medical Products Manufacturing, Llc | Method for assaying the antioxidant capacity of a sample |
JP4149836B2 (ja) * | 2003-02-27 | 2008-09-17 | 独立行政法人科学技術振興機構 | ジヒドロキシベンゾエート誘導体、その製造方法およびその利用 |
JP2004269415A (ja) * | 2003-03-07 | 2004-09-30 | Japan Research & Development Association For New Functional Foods | 抗酸化剤 |
WO2005087208A2 (en) | 2004-03-10 | 2005-09-22 | Trustees Of Tufts College | Synergistic effect of compositions comprising carotenoids selected from lutein, beta-carotene and lycopene |
TWI342780B (en) * | 2004-08-11 | 2011-06-01 | Access Business Group Int Llc | Dietary supplement |
MX2008015299A (es) * | 2006-06-01 | 2009-02-06 | Sakura Properties Llc | Composiciones de fucoidano y métodos. |
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2014
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US7939115B2 (en) | 2011-05-10 |
JP2014156474A (ja) | 2014-08-28 |
TW201002336A (en) | 2010-01-16 |
WO2009123821A3 (en) | 2009-11-26 |
WO2009123821A2 (en) | 2009-10-08 |
US20080226744A1 (en) | 2008-09-18 |
JP2011516480A (ja) | 2011-05-26 |
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