CN107115414A - 用于预防及治疗第2型糖尿病的营养品组合 - Google Patents
用于预防及治疗第2型糖尿病的营养品组合 Download PDFInfo
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Abstract
本发明是关于一种呈胶囊或锭剂形式的膳食增补剂,其包括等效于6mg至40mg氯化锌的量的锌源;视情况存在的等效于100微克至1000微克吡啶甲酸铬的量的铬源;视情况存在的4微克至100微克维生素B12;视情况存在的呈萃取物或粉末形式的西洋参(American Ginseng),其量提供20mg至200mg人参皂苷或20mg至200mg经分离或合成之人参皂苷;视情况存在的呈油、萃取物或粉末形式的肉桂皮,其量提供1000mg至5000mg甲基羟基查耳酮聚合物;视情况存在的2mg至50mg叶黄素;及视情况存在的绿茶萃取物,其量提供200mg至4000mg表没食子儿茶素没食子酸酯或200mg至4000mg经分离或合成的表没食子儿茶素没食子酸酯。
Description
相关申请案之交叉参考
本案为部分接续申请案,本案主张2014年8月18日申请的PCT申请案第PCT/US2014/051441号的权益,且也主张2014年8月18日申请的美国申请案第14/461,533号及2013年8月26日申请的美国临时申请案第61/959,495号的优先权。这些申请案都以全文引用的方式并入本文中。
技术领域
本发明是关于一种用于控制人类及其它哺乳动物的血液葡萄糖含量的膳食增补剂,及用于预防、改善或治疗第2型糖尿病的方法。
背景技术
糖尿病为其中身体不产生或不恰当地使用胰岛素的疾病。胰岛素将糖转化成能量,因此其对每个器官的健康是至关重要的。糖尿病可导致广泛范围的其它严重健康并发症,包括心脏病、高血压、失明及肾脏疾病。第2型糖尿病占所有糖尿病个案的90-95%且通常与肥胖、家族史、缺乏锻炼及年龄相关。第1型糖尿病,占所有个案的5-10%,起源于遗传且此类别中的大部分患者被投予胰岛素。所揭示的增补剂并非针对此受众。在美国,经诊断患有第2型糖尿病的人为2100万且未诊断者至少有700万。其为美国增长最快的疾病且为死亡之第五大原因。据估计,33%美国白种人将发展糖尿病。亚太及非洲裔美国人具有较高风险。
估计治疗糖尿病的成本在全球范围内、在2013年为$5480亿且在美国、在2012年为$2450亿。糖尿病治疗在美国医疗支出中占约11%的且预期会随着更多人转移至较高风险段而增长。虽然医疗专家相信大部分第2型糖尿病为可预防及可逆的,但暴饮暴食及经加工的制剂与久坐生活方式的组合使得预防及逆转困难。
当前糖尿病药物仅10%被视为一线药物,其使糖化血色素(Hb A1c)降低1%或大于1%。Hb A1c(血糖含量指标)每降低1%可将因糖尿病所致的死亡影响降低20%。大部分处方药物的局限处在于,其昂贵(每月$150或大于$150),药物功效随时间降低,副作用成问题(若干个集体诉讼),且许多药物不支持运动所需的能量-50%药物最多呈体重中性及约50%将引起体重增加。肥胖阻碍糖尿病治疗的有效性。
发明内容
用于治疗、预防或改善第2型糖尿病的膳食增补剂可以每日两次剂型包括等效于10mg至400mg氯化镁的量的口服镁源;等效于3mg至20mg氯化锌的量的口服锌源;视情况存在的等效于多达500微克吡啶甲酸铬的量的口服铬源;视情况存在的多达100微克的量的维生素B12;视情况存在的呈萃取物或粉末形式的西洋参,其量提供多达100mg人参皂苷;视情况存在的呈油、萃取物或粉末形式的肉桂皮,其量提供多达2500mg甲基羟基查耳酮聚合物;视情况存在的多达25mg的量的叶黄素;以及视情况存在的绿茶萃取物,其量提供多达2000mg表没食子儿茶素没食子酸酯。
在本发明的某些态样中,可用经分离或合成的人参皂苷取代呈天然萃取物或粉末形式的西洋参。
在本发明的某些态样中,可用经分离或合成的甲基羟基查耳酮聚合物取代呈油、萃取物或粉末形式的肉桂皮。
在本发明的某些态样中,可用经分离或合成的表没食子儿茶素没食子酸酯取代绿茶萃取物。
用于治疗、预防或改善第2型糖尿病的方法可包括每日经由一或多个锭剂或胶囊向患者经口投予(一天单次或多次)等效于20mg至800mg氯化镁的量的镁源;等效于6mg至40mg氯化锌的量的锌源;视情况存在的等效于100微克至1000微克吡啶甲酸铬的量的铬源;视情况存在的4微克至200微克维生素B12;视情况存在的呈萃取物或粉末形式的西洋参,其量提供20mg至200mg人参皂苷或20mg至200mg经分离或合成的人参皂苷的量;视情况存在的呈油、萃取物或粉末形式的肉桂皮,其量提供1000mg至5000mg甲基羟基查耳酮聚合物或1000mg至5000mg经分离或合成的甲基羟基查耳酮聚合物;视情况存在的2mg至50mg叶黄素;以及视情况存在的绿茶萃取物,其量提供200mg至4000mg表没食子儿茶素没食子酸酯或200mg至4000mg经分离或合成的表没食子儿茶素没食子酸酯。
参照以下说明书及申请专利范围将更好地理解各种具体实例的此等及其它特征、优点及目标。
附图说明
图1显示胶囊内胶囊,其用于将二甲双胍与膳食增补剂分隔以便共投予。
图2显示三层锭剂,其用于将二甲双胍与膳食增补剂分隔以便共投予。
图3图示用所揭示的增补剂治疗及用安慰剂治疗的个别HbA1c反应。
图4图示根据所揭示的增补剂的治疗使得糖尿病患者HbA1c显著降低。
具体实施方式
在约50岁或大于50岁时已诊断患有前期糖尿病或完全糖尿病的男性及女性有可能受益于所揭示的膳食增补剂的投药。建议此类个体改变其膳食且增强运动。一般而言,仅向诊断有完全糖尿病的个体指定药物处方,通常为二甲双胍。然而,近期研究已证实二甲双胍对于处于心脏病(糖尿病患者中的常见病状)风险中的男性而言并非有效药物。因此,替代或较低二甲双胍剂量疗法对于男性而言可能特别有帮助。
前期糖尿病患者可安全使用所揭示的膳食增补剂延迟或中止症状进展。增补剂可作为辅助疗法给予处方、推荐或自投予,或经由适当调节葡萄糖代谢来促进更佳的健康。基于I期临床测试结果,估计所揭示的膳食增补剂当添加至现有治疗方案中时,可使Hb A1c降至0.10-1.00范围内,且将向患者提供其它有利且可量测的结果,诸如体重减轻、血压降低及体能增加。
对于第2型糖尿病而言,可向患者投予所揭示的膳食增补剂调配物来增加体能、改善视力、增强免疫系统、促进糖代谢及增加瘦体质。该调配物可包含吡啶甲酸铬、氯化镁、维生素B12、氯化锌以及包含西洋参、肉桂皮、叶黄素及绿茶的萃取物。可每日服用两次的单剂量锭剂或胶囊的实例可包含50-500mcg吡啶甲酸铬、10-100mg氯化镁、2-10mcg维生素B12、3-20mg氯化锌以及250mg-2000mg包含西洋参、肉桂皮、叶黄素与绿茶的萃取物。含有特定范围量的所有这些组分的此类组成物已命名,且预期以名称「DiabetainC」市售。调配物包含当与二甲双胍以一个锭剂或胶囊形式组合时随时间展现稳定性的成分。为了最大化处方效果或最小化副作用,草本植物与二甲双胍或用于治疗糖尿病的任何其它处方药物以锭剂或胶囊形式组合被认为是新颖的。调配物可作为辅助疗法用于延迟糖尿病进展且帮助控制血糖。其可作为二甲双胍的辅助疗法用于帮助控制血糖且延迟第二辅助处方药物的添加。调配物可投予处于患有心脏病风险中的逾50岁个体,且尤其可有益于治疗男性以降低二甲双胍剂量负荷。
虽然对于非处方药(over the counter;OTC)增补剂通常不进行临床试验,但Charles Liu致力于为患者及健康照护专业人员提供保证:所揭示的膳食增补剂(预期其以名称「Diabetian C」市售)为糖尿病及前期糖尿病患者的安全及有效增补剂。基于迄今为止的两个研究的结果,DiabetainC有效降低Hb Alc、空腹血糖及胆固醇。结果由临床药师Charles Liu利用最近3年的原始数据汇编而得。
在本发明的另一态样中,用于改善健康及降低第2型糖尿病相关风险的膳食增补剂包括镁源及锌源。一般而言,等效于参考化合物的量的金属或矿物源是指矿物或金属的莫耳当量且包括参考化合物。
镁离子为基本生命核酸化学必需的且为所有已知活有机体中的所有细胞必需的。处于诊断有第2型糖尿病风险中或已诊断患有第2型糖尿病的个体典型地缺乏镁。因此,需要生物学上可利用的镁源。镁源可为可安全口服以向适当细胞功能提供镁离子的任何镁化合物。实例包括氯化镁、氧化镁、葡糖酸镁、苹果酸镁、乳清酸镁、甘胺酸镁及柠檬酸镁。每日投予两次的单次剂量可含有10mg至400mg氯化镁的等效物(亦即,所提供镁等效于氯化镁的镁源的量或莫耳当量)。举例而言,每日投予两次的单次剂量可含有10mg、20mg、50mg、100mg、200mg、300mg或400mg氯化镁的等效物。
锌具有抗氧化特性,帮助加速愈合过程且有益于加强及保护人类及其它哺乳动物的免疫系统。糖尿病患者通常缺乏锌。因此,生物学上可利用的锌源亦视为必需的。锌源可为可安全口服以提供全身吸收的任何锌化合物。实例包括氯化锌、氧化锌、硫酸锌、吡啶甲酸锌、葡糖酸锌、柠檬酸锌及甘胺酸锌。每日投予两次的单次剂量可含有3mg至20mg氯化锌的等效物(亦即,提供全身吸收的锌等效于氯化锌的锌化合物的量)。举例而言,每日投予两次的单次剂量可含有3mg、5mg、10mg、15mg或20mg氯化锌的等效物。
在本发明的某些态样中,膳食增补剂中包括铬源以及镁及锌。有迹象表明,铬为产生葡萄糖耐受因子所必要或需要的,发现该因子可发挥有益的胰岛素模拟作用及胰岛素增强作用,其可适用于校正糖尿病患者的葡萄糖代谢与治疗的不平衡。因此,根据本发明的某些膳食增补剂可含有可安全地每日口服两次的铬化合物,以提供等效于约50微克(mcg)至约500微克(例如50mcg、75mcg、100mcg、200mcg、300mcg、400mcg或5mcg)吡啶甲酸铬的量的铬的全身吸收。除了吡啶甲酸铬自身之外,实例亦包括聚烟酸铬、柠檬酸铬、氯化铬及烟酸铬。
在本发明的某些态样中,除了镁源、锌源及视情况存在的铬源之外,膳食增补剂也包括维生素B12。维生素B12对于维持大脑及神经系统的正常功能而言及对于血液形成而言为重要的。其通常涉及人体的每一细胞的代谢,尤其影响DNA合成及调节,且也涉及脂肪酸代谢及胺基酸代谢。相信,二甲双胍的投药降低血清维生素B12含量且长期使用二甲双胍实质上增加了维生素B12缺乏症及高同型半胱胺酸血症的风险,其为心血管疾病的独立风险因素,尤其在患有第2型糖尿病的个体中。因此,根据本发明的某些膳食增补剂可含有有效校正二甲双胍诱发性缺乏症的量的维生素B12。每日投予两次的单次剂型的适合量为约2mcg至约100mcg,例如2mcg、3meg、4mcg、5mcg、10mcg、20mcg、25mcg、50mcg或100mcg。
根据本发明的某些态样,除了镁源及锌源以外且除了视情况存在的维生素B12及视情况存在的铬源以外,膳食增补剂也可包括一或多种草本植物粉末或植物萃取物。
可将来自西洋参的萃取物或粉末添加至本文所揭示的膳食增补剂中以有助于降低患有第2型糖尿病的人的血糖含量。相信,西洋参减缓来自膳食的糖的吸收。也有证据表明,西洋参可使得胰岛素耐受者的细胞更接受胰岛素。西洋参亦被认为可减轻压力、增强免疫系统及降低血压。西洋参萃取物或粉末的量可足以在预定每日投予两次的单一剂型中提供约10mg至约100mg人参皂苷。适合的粉末状西洋参及萃取物(水、酒精或水与酒精)可市购或可使用制备草本植物粉末及萃取物的习知方法来制备。乙醇及水萃取物(例如50-70%乙醇及30%至50%水)可与膳食增补剂的其它组分及视情况存在的赋形剂(诸如黏合剂)掺合且压制成锭剂剂型或填入硬壳或软壳胶囊中。
可将肉桂皮的油萃取物或粉末添加至所揭示的膳食增补剂中以单独或与胰岛素及/或二甲双胍协同起作用,从而降低血糖含量,由此减少对胰岛素的需要及/或更好地控制血糖含量。可添加至每日两次剂型中的肉桂皮、油或萃取物的适合量为提供约500mg至约2500mg甲基羟基查耳酮聚合物的量,相信甲基羟基查耳酮聚合物为胰岛素模拟物。举例而言,甲基羟基查耳酮聚合物可以500mg、1000mg、1500mg、2000mg或2500mg的量、以每日两次剂型提供。
可将叶黄素添加至所揭示的膳食增补剂中以预防糖尿病并发症。糖尿病往往与并发症相关,诸如白内障及对频繁且经预防的感染的敏感性增强。与糖尿病相关的较高葡萄糖含量诱导免疫系统细胞中出现氧化压力且增加与癌症、发炎疾病、自体免疫疾病、败血性休克及病毒感染有关的核因子κB活性。可添加至每日投予两次的膳食增补剂剂型中的叶黄素的适合量为约1mg至约25mg,例如5mg、10mg或20mg。
绿茶萃取物可依足以提供约100mg至约2000mg表没食子儿茶素没食子酸酯的单次剂量(每日投予两次)的量添加至所揭示的膳食增补剂中以降低胰岛素抗性及/或预防、延迟或阻滞第2型糖尿病的发展。举例而言,表没食子儿茶素没食子酸酯可以100mg、200mg、300mg、400mg、500mg、1000mg、1500mg及2000mg之量、以每日两次剂型提供。
镁源及锌源连同视情况存在的铬III源、维生素B12、西洋参、肉桂皮、叶黄素及绿茶可与填充剂及/或赋形剂(诸如调味剂、着色剂、遮光剂、黏合剂、崩解剂、润滑剂等)合并且压制成锭剂或囊片,或填入硬壳或软壳胶囊(例如明胶胶囊)中。虽然所揭示的剂型已描述为每日投予两次,但该等剂型可调配成每日投予超过两次,或每日投予少于两次(例如每日投予一次),其中各组成成分的量适当地加以调整(不一定依比例)。
本文所揭示的膳食增补剂不希望作为通用营养增补剂,而是靶向第2型糖尿病的治疗、预防及/或改善。因此,所揭示的增补剂可由镁源及锌源组成或基本上由其组成,且视情况由铬源、维生素B12、西洋参、肉桂皮、叶黄素、绿茶萃取物及用于治疗第2型糖尿病的医药活性剂(例如胰岛素)组成或基本上由其组成。因此,可调配本发明的锭剂及胶囊以使得其不含有通常添加至通用营养增补所用的多种维生素及矿物质锭剂与胶囊中的其它维生素或矿物质。此允许糖尿病患者及处于发展糖尿病风险中的彼等者在必要或需要时服用所揭示的增补剂且视情况服用其它增补剂,通常无需考虑过度给予营养品。
虽然上述植物的天然萃取物、粉末形式及油被认为非常有益且经济的,但有可能的是,所选活性剂可自植物材料分离或合成。因此,在本发明的某些态样中,膳食增补剂可包含以下各者、基本上由以下各者组成或由以下各者组成:镁源、锌源、视情况存在之铬源、视情况存在之维生素B12、视情况存在的人参皂苷(10mg-100mg,对于每日两次锭剂而言)、视情况存在的甲基羟基查耳酮聚合物(500mg-2500mg,对于每日两次锭剂而言)、视情况存在的叶黄素及视情况存在的表没食子儿茶素没食子酸酯(100mg-2000mg,对于每日两次锭剂而言)。
临床试验已显示,根据本发明的「DiabetainC」增补剂当投予第2型糖尿病患者时,与二甲双胍共投予时使Hb A1c平均降低1.7%,相比之下,当单独使用二甲双胍时,Hb A1c降低1.2%。此为显著的改善。Hb Alc降低0.5%至1%与罹病率降低20%相关。临床试验亦已显示,平均而言,「DiabetainC」与其它口服抗糖尿病药物的共投予使Hb A1c降低1.25%,相比之下,单独使用其它抗糖尿病药物时,Hb A1c降低0.75%。
临床试验已显示,与二甲双胍共投予时,空腹血糖(fasting blood glucose;FBG)有利地减少72mg/dL,相比之下,单独投予二甲双胍时,降低48mg/dL。临床试验亦已证明,与其它抗糖尿病药物共投予时,FBG降低45mg/dL,相比之下,单独投予其它糖尿病药物时,FBG降低30mg/dL。此等改善为显著的,因为FBG每减少15mg/dL至40mg/dL使得糖尿病相关心脏病降低高达50%。
在本发明的另一态样中,锭剂及胶囊可进一步包含熟知有效量的抗糖尿病药物,诸如二甲双胍。举例而言,二甲双胍可以500mg的量并入每日投予两次的单次剂量中。
本文所揭示的用于调节葡萄糖代谢及治疗或预防第2型糖尿病或前期糖尿病的膳食增补剂可在具有或不具有胰岛素的情况下、在具有或不具有二甲双胍及/或其它抗糖尿病药物的情况下投予,且可通过处方膳食及/或生活方式改变来增强或提高。可降低第2型糖尿病相关风险的此类改变包括达到且维持合理或正常的体重(例如BMI低于25或低于20)、每日或有规律的身体活动(例如一周大部分天数运动至少20或30分钟)及将脂肪摄入量限制至每日总热量的约25%。
在某些实施例中,膳食增补剂与二甲双胍以胶囊10或锭剂12共投予,其中二甲双胍与膳食增补剂(例如镁源、锌源、视情况存在的铬源、视情况存在的维生素B12、视情况存在的呈萃取物或粉末形式的西洋参、视情况存在的肉桂皮、视情况存在的叶黄素及视情况存在的绿茶萃取物)实体上分隔。此可如下达成:使二甲双胍粒化且用医药学上安全的溴物质(诸如脂肪酸、蜡、虫胶或植物纤维)涂布粒化二甲双胍。有包衣障壁的二甲双胍颗粒可与膳食增补剂一起压制成锭剂,或与膳食增补剂合并于明胶胶囊中。或者,障壁材料可在分层锭剂中构成二甲双胍层16与膳食增补剂层18之间的障壁层14。作为又一替代例,可将二甲双胍(或膳食增补剂)并入另一个明胶胶囊10内所含的明胶胶囊20中,明胶胶囊10亦含有位于胶囊内壁的外表面与胶囊外壁的内表面之间的膳食增补剂(或二甲双胍)。
安全(研究1)
在对29岁至72岁之30名第2型糖尿病患者的6个月研究中,发现DiabetainC或Diabetain安全。未侦测到不良反应或长期副作用。研究不包括需要胰岛素来控制葡萄糖含量的个体或第2型糖尿病患病时间长于10年的个体。研究亦排除服用血液稀释剂或抗抑郁剂的个体。
DIABETAINCTM联合OMNIWAFERTM作为替换餐对于在30天内服用抗糖尿病药物的患者的空腹血糖(FBG)、体重及血脂的影响
在此先期研究中,研究DiabetainC营养增补剂以针对总共9名患者的体重减轻进行核实。利用较大数目个正参加糖尿病临床试验的患者(N=20)起始研究。在能够参与研究的9名患者中,6名完成此过程且记录体重变化。除体重变化之外,亦与患者晤谈其体能水平。体能水平的变化与体重相对于基线的变化程度良好相关。
表1.DiabetainC与Omniwafer共投予之后的体重减轻
表1
编号 | 基线体重(1b) | 体重减轻(1b) |
1 | 106.2 | 0 |
2 | 88.1 | 2 |
3 | 112 | 0 |
4 | 197.6 | 7 |
5 | 107.4 | nd |
6 | 91.3 | 3.1 |
7 | 111.5 | nd |
8 | 121.7 | nd |
9 | 118.9 | 2.6 |
平均值 | 117 | 2.5 |
sd | 32 | 2.6 |
总之,研究测定67%顺应率,67%报导体重减轻(平均值±SD:2.5±2.6lb)。同样,67%患者报导体能水平增加,同时体重减轻。已观测到,Diabetain与Omniwafer共投予对于大部分参与者的体重减轻及体能水平增加具有显著的影响。在此先期研究中,观测到体重减轻平均逾2%。此研究的结果确保更大的研究及更长的随访时间。
基于此先期研究进行动力计算之后,已确定主要研究的样本大小,在对照组及研究组的每个组中使用26位参与者进行。另外,患者将被追踪3个月且在干预之前及之后确定进行HbAlc分析。在主要研究中,2016年自同一研究群体中随机募集参与者。
DIABETAINCTM对服用二甲双胍之患者之血红蛋白A1C及血脂的影响
年龄在14岁至69岁范围内的总共52名糖尿病患者参与研究以评价Diabetain-C的抗糖尿病作用。虽然大部分参与者为女性,但其个体特征(亦即年龄、脂质特征及血压或HbA1c含量)在性别之间无统计学差异,但其中女性参与者体重通常大于男性。
虽然服用安慰剂的个体大多(52.2%)显示A1c增加,但服用Diabetain-C的所有个体显示HbA1c含量降低,然发现服用Diabetain-C的一名患者(#45)的HbA1c自6.5%升高至6.8%。
治疗组的血脂未发生显著变化,但安慰剂组的HDL含量稍微降低。
向患者给予安慰剂或Diabetain-C持续90天。治疗组与安慰剂组的基线平均HbA1c为约7.0%,表明就A1c而言,随机分组为有效的。所呈现的资料包括参与研究的所有52位个体且统计学分析中包括所有的非缺失量测结果(N=48)。治疗之后,安慰剂组的HbA1c自基线升高7.1%且治疗组的HbA1c自基线降低8.5%(HbA1c 0.6)(p<0.05)。治疗之后的结果显示,服用Diabetain-C的个体的HbA1c比安慰剂组患者小1.1个单位(p<0.005)。此相当于HbA1c降低14.7%。
表2–个体特征**
**年龄在14岁至69岁范围内的总共52名糖尿病患者参与研究以评价Diabetain-C的抗糖尿病作用。虽然大部分参与者为女性,但其个体特征(亦即年龄、脂质特征及血压或HbA1c含量)在性别之间无统计学差异,然而其中女性参与者体重通常大于男性。
图3说明对Diabetain-C或安慰剂治疗的个别HbA1c反应。虽然服用安慰剂的个体大多(52.2%)显示A1c增加,但服用Diabetain-C的所有个体显示HbA1c含量降低,然发现服用Diabetain-C的一名患者(#45)的HbA1c自6.5%升高至6.8%。
图4显示Diabetain-C疗法使糖尿病患者的HbA1c显著降低。向患者给予安慰剂或Diabetain-C持续90天。治疗组与安慰剂组的基线平均HbA1c为约7.0%,表明就A1c而言,随机分组为有效的。所呈现的资料包括参与研究的所有52位个体且统计学分析中包括所有的非缺失量测结果(N=48)。治疗之后,安慰剂组的HbA1c升高7.1%且治疗组的HbA1c降低8.5%。结果显示,服用Diabetain-C的个体的HbA1c比安慰剂组患者小1.1个单位。此相当于HbA1c降低14.7%。
ap<0.05,药物相对于相应基线
bp<0.005,药物相对于相应安慰剂
以上描述视为仅针对较佳实施例的描述。熟习此项技术者及制作或使用所说明的具体实例的彼等者将想到此等具体实例的修改。因此,应了解,上述具体实例仅具例示性且不意欲限制本发明的范畴,本发明的范畴由以下权利要求限定,如根据专利法的原则(包括均等论)所解释。
Claims (8)
1.一种呈胶囊或锭剂剂型的膳食增补剂,其包含:
可口服的镁源,其量为10mg至400mg氯化镁的莫耳当量;
可口服的锌源,其量为3mg至20mg氯化锌的莫耳当量;
可口服的铬源,其量为40微克至500微克吡啶甲酸铬的莫耳当量;
2微克至100微克的量的维生素B12;
呈萃取物或粉末形式的西洋参(American Ginseng),其量提供10mg至100mg人参皂苷;
呈油、萃取物或粉末形式的肉桂皮,其量提供500mg至2500mg甲基羟基查耳酮聚合物;
1mg至25mg的量的叶黄素;以及
绿茶萃取物,其量提供100mg至2000mg表没食子儿茶素没食子酸酯(epigallocatechingallate)。
2.根据权利要求1所述的膳食增补剂,其进一步包含2微克至100微克的量的维生素B12。
3.一种呈胶囊或锭剂剂型的膳食增补剂,其由以下各者组成:
可口服的镁源,其量为10mg至400mg氯化镁的莫耳当量;
可口服的锌源,其量为3mg至20mg氯化锌的莫耳当量;
可口服的铬源,其量为40微克至500微克吡啶甲酸铬的莫耳当量;
2微克至100微克的量的维生素B12;
呈萃取物或粉末形式的西洋参,其量提供:
10mg至100mg的至少一种人参皂苷;
500mg至2500mg的甲基羟基查耳酮聚合物;
1mg至25mg叶黄素;
100mg至2000mg表没食子儿茶素没食子酸酯;以及
视情况存在的赋形剂。
4.一种呈胶囊或锭剂剂型的膳食增补剂,其包含:
治疗有效量的二甲双胍;以及
膳食增补剂,其包括可口服的镁源,其量为10mg至400mg氯化镁的莫耳当量;可口服的锌源,其量为3mg至20mg氯化锌的莫耳当量;可口服的铬源,其量为40微克至500微克吡啶甲酸铬的莫耳当量;2微克至100微克的量的维生素B12;呈萃取物或粉末形式的西洋参,其量提供10mg至100mg的至少一种人参皂苷;500mg至2500mg的甲基羟基查耳酮聚合物;以及1mg至25mg叶黄素;100mg至2000mg表没食子儿茶素没食子酸酯。
5.根据权利要求4所述的锭剂或胶囊,其中该二甲双胍与该膳食增补剂藉由障壁分隔。
6.根据权利要求5所述的锭剂,其包括含二甲双胍层、膳食增补剂层,以及位于该二甲双胍层与该膳食增补剂层之间的障壁层。
7.根据权利要求5所述的胶囊,其包括含有二甲双胍的内胶囊以及含有该内胶囊及该膳食增补剂的外胶囊,该膳食增补剂位于该内胶囊与该外胶囊之壁的内表面之间。
8.根据权利要求5所述的胶囊,其包括含有膳食增补剂的内胶囊以及含有该内胶囊及该二甲双胍的外胶囊,该二甲双胍位于该内胶囊与该外胶囊之壁的内表面之间。
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US20150056297A1 (en) * | 2013-08-26 | 2015-02-26 | Charles H. Liu | Nutraceutical combination for prevention and treatment of type 2 diabetes |
CN109640704A (zh) * | 2016-08-04 | 2019-04-16 | 西雅图咖米公司 | 用于运动后恢复的组合物及其制造和使用方法 |
US11357250B2 (en) | 2016-08-15 | 2022-06-14 | Summit Innovation Labs LLC | Treatment and prevention of diabetes and obesity |
CN108126055A (zh) * | 2018-01-26 | 2018-06-08 | 广东省农业科学院茶叶研究所 | 茶叶提取物组合物在缓解和治疗糖尿病中的应用 |
WO2020058817A1 (en) * | 2018-09-17 | 2020-03-26 | Piramal Retail Private Limited | Pharmaceutical composition and process for its preparation |
US11185565B2 (en) * | 2019-01-02 | 2021-11-30 | Gm Pharmaceuticals, Inc. | Compositions including milk thistle and methods of use |
PL429726A1 (pl) | 2019-04-24 | 2020-11-02 | Instytut Biotechnologii I Badań Medycznych Biolamed Spółka Z Ograniczoną Odpowiedzialnością | Preparat o działaniu hipoglikemicznym |
CN110302196A (zh) * | 2019-07-30 | 2019-10-08 | 安徽农业大学 | 多酚氧化产物治疗糖尿病 |
US11484610B2 (en) | 2019-11-22 | 2022-11-01 | Vector Vitale Ip Llc | Method of treating melanoma |
US11596650B2 (en) * | 2019-12-20 | 2023-03-07 | Vector Vitale Ip Llc | Composition and method for the treatment of type 2 diabetes |
US10799530B1 (en) | 2019-12-20 | 2020-10-13 | Vector Vitale Ip Llc | Composition and method for the prevention and treatment of obesity |
US10933091B1 (en) | 2019-12-20 | 2021-03-02 | Vector Vitale Ip Llc | Composition and method for the treatment of type I diabetes |
WO2021216562A1 (en) * | 2020-04-21 | 2021-10-28 | Finzi Eric | Zinc for treating covid-19 |
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US20160166631A1 (en) | 2016-06-16 |
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WO2015031089A1 (en) | 2015-03-05 |
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