Sugar substitute

糖替代品
  • 文章类型: Journal Article
    高糖消耗与心血管疾病和糖尿病有关。目前的糖替代品可能会引起味觉和胃肠道症状。ENSO16是16种不同的糖替代品和植物纤维的组合,已被设计为糖替代品。尚未研究对血浆葡萄糖代谢以及对胃肠道耐受性的影响。17名健康参与者参加了这项随机研究,双盲审判.参与者接受30g葡萄糖或30gENSO16的单次口服剂量,并在7天的冲洗期后交叉进行替代治疗。研究终点是对血浆葡萄糖的影响,胰岛素,C肽浓度和胃肠道疾病。使用有关胃肠道症状的问卷进行个人主观评分。与ENSO16相比,施用葡萄糖后平均基线调整的血浆葡萄糖AUC0-180分钟显著更大(n=15,p=0.0128,配对t检验)。口服葡萄糖或ENSO16后,相对于基线的最大血浆葡萄糖升高分别为117mg*dl-1和20mg*dl-1。与ENSO16摄入相比,在葡萄糖后,胰岛素和C肽AUC0-180分钟显著更大(p<0.01,Wilcoxon秩和检验)。血浆葡萄糖的平均最大浓度,与ENSO16摄入量相比,摄入葡萄糖后的胰岛素和C肽分别为摄入葡萄糖后的1.5、4.6和2.7倍,分别。不良反应大多轻微,治疗之间没有差异。结论。ENSO16对血浆葡萄糖代谢只有很小的影响。这在饮食环境中可能是有意义的,并且可能有助于减少卡路里的摄入。步道注册NCT05457400。首次注册:2022年7月14日。https://clinicaltrials.gov/study/NCT05457400.
    High sugar consumption is associated with cardiovascular diseases and diabetes. Current sugar substitutes may cause taste sensations and gastrointestinal symptoms. ENSO 16 is a combination of 16 different sugar substitutes and plant fibers and has been designed as a sugar alternative. The impact on plasma glucose metabolism as well as on gastrointestinal tolerance has not been investigated yet. 17 healthy participants were enrolled in this randomized, double-blind trial. Participants received a single oral dose of 30 g glucose or 30 g ENSO 16 and crossed over to the alternate treatment after a 7 day wash out period. The study endpoint was the effect on plasma glucose, insulin, C-peptide concentrations and gastrointestinal disorders. A questionnaire regarding gastrointestinal symptoms was used for individual subjective scoring. The mean baseline adjusted plasma glucose AUC0-180 min was significantly greater after glucose administration compared to ENSO 16 (n = 15, p = 0.0128, paired t-test). Maximum plasma glucose elevation over baseline was 117 mg*dl-1 and 20 mg*dl-1 after oral glucose or ENSO 16, respectively. Insulin and C-peptide AUC0-180 min were significantly greater after glucose compared to ENSO 16 intake (p < 0.01, Wilcoxon rank sum test). The mean maximal concentrations of plasma glucose, insulin and C-peptide after glucose intake were 1.5, 4.6 and 2.7-fold greater after glucose intake compared to ENSO 16 intake, respectively. Adverse reactions were mostly mild and not different between treatments. Conclusion. ENSO 16 has only a small impact on plasma glucose metabolism. This may be of interest in a dietary context and may help to reduce calory intake.Trail registration NCT05457400. First registration: 14/07/2022. https://clinicaltrials.gov/study/NCT05457400 .
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  • 文章类型: Journal Article
    目的:本研究旨在系统评价食用代糖对儿童和青少年恒牙龋齿预防的影响。
    方法:包括比较糖替代品(高和低强度甜味剂)预防6-19岁儿童和青少年恒牙龋齿的临床效果的随机对照试验(RCT)和对照临床试验(CCT)。
    方法:在三个数据库中进行了系统搜索(PubMed,WebofScience和Embase)对出版年份没有任何限制。
    方法:最初的搜索发现了1,859个项目,最后,包括15项研究(11项RCT和4项CCT),共6325名参与者(年龄:6-18岁)。Cochrane偏差风险评估工具用于质量评估。大多数(80%,12/15)被评为“中度”或“高风险”偏倚。所有试验都调查了糖醇,这是一种低强度的甜味剂。木糖醇是最常见的研究(73.3%,11/15),其次是山梨糖醇(46.7%,7/15),和赤藓糖醇(13.3%,2/15).荟萃分析结果显示,木糖醇(标准化平均差[SMD]:-0.50,95%置信区间[CI]-0.85至-0.16,P=0.005)和山梨糖醇(SMD:-0.10,95%CI:-0.19至-0.01,P=0.03)在预防龋齿方面均具有显着效果。没有发现关于高强度甜味剂如阿斯巴甜和糖精的临床试验。
    结论:食用木糖醇或山梨糖醇可能有效预防儿童和青少年恒牙龋齿。没有关于高强度甜味剂在龋齿预防中的作用的临床证据。
    结论:使用木糖醇或山梨糖醇作为糖替代品对预防儿童和青少年龋齿具有有益作用。
    This study aimed to systematically review the effect of sugar substitute consumption on caries prevention in permanent teeth among children and adolescents.
    Randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing the clinical effect of sugar substitutes (both high- and low-intensity sweeteners) in preventing caries in permanent teeth among children and adolescents aged 6-19 were included.
    A systematic search was conducted in three databases (PubMed, Web of Science and Embase) without any restrictions on publication year.
    The initial search found 1,859 items, and finally, 15 studies (11 RCTs and 4 CCTs) with a total of 6325 participants (age: 6-18 years) were included. The Cochrane risk-of-bias assessment tools were used for quality assessment. Most (80%, 12/15) were graded as having a \'moderate\' or \'high\' risk of bias. All trials investigated sugar alcohol, which is a low-intensity sweetener. Xylitol was the most commonly investigated (73.3%, 11/15), followed by sorbitol (46.7%, 7/15), and erythritol (13.3%, 2/15). Results of the meta-analysis showed that both xylitol (standardized mean difference [SMD]: -0.50, 95% confidence interval [CI] -0.85 to -0.16, P = 0.005) and sorbitol (SMD: -0.10, 95% CI: -0.19 to -0.01, P = 0.03) had a significant effect in preventing dental caries compared to no treatment/placebo. No clinical trials on high-intensity sweeteners such as aspartame and saccharin were found.
    The consumption of xylitol or sorbitol is potentially effective in preventing caries in permanent teeth among children and adolescents. No clinical evidence is available regarding the role of high-intensity sweeteners in caries prevention.
    The use of xylitol or sorbitol as sugar substitutes has a beneficial effect in preventing dental caries among children and adolescents.
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  • 文章类型: Journal Article
    甜味蛋白(SP)是最初从热带水果中分离的植物来源的蛋白。它们比蔗糖和大多数人造甜味剂甜数千倍。SP是当与T1R2/T1R3受体相互作用时能够在人类中引起甜味感觉的一类蛋白质。SPthaumatin已经在一些国家的食品工业中引入。其他SP,比如莫内林和布拉泽,是有前途的产品。研究SP的重要阶段,除了证实没有毒性,致突变性,致癌性,和过敏效应,正在研究它们对肠道微生物群的影响。在本文中,我们描述了食用两种重组SP-brazzein或monellin之一六个月后大鼠肠道微生物群组成的变化。全长16S基因测序方法用于DNA文库条形码化。MaAsLin2分析结果表明,在饲喂brazzein的大鼠微生物群中,白蚁的相对丰度出现明显波动,和莫内林喂养的大鼠微生物群中的Anaerutruncusrubiinfantis,which,然而,没有超过标准偏差。蔗糖饲喂组与鼠粪的相对丰度增加有关,这可能会导致肥胖。总的来说,长期食用甜味蛋白brazzein和monellin不会显着改变大鼠的微生物群,也不会导致机会微生物群的出现。这为这些潜在甜味剂的安全性提供了额外的证据。
    Sweet-tasting proteins (SPs) are proteins of plant origin initially isolated from tropical fruits. They are thousands of times sweeter than sucrose and most artificial sweeteners. SPs are a class of proteins capable of causing a sweet taste sensation in humans when interacting with the T1R2/T1R3 receptor. SP thaumatin has already been introduced in the food industry in some countries. Other SPs, such as monellin and brazzein, are promising products. An important stage in researching SPs, in addition to confirming the absence of toxicity, mutagenicity, oncogenicity, and allergenic effects, is studying their influence on gut microbiota. In this paper we describe changes in the composition of rat gut microbiota after six months of consuming one of two recombinant SPs-brazzein or monellin. A full length 16S gene sequencing method was used for DNA library barcoding. The MaAsLin2 analysis results showed noticeable fluctuations in the relative abundances of Anaerocella delicata in brazzein-fed rat microbiota, and of Anaerutruncus rubiinfantis in monellin-fed rat microbiota, which, however, did not exceed the standard deviation. The sucrose-fed group was associated with an increase in the relative abundance of Faecalibaculum rodentium, which may contribute to obesity. Overall, prolonged consumption of the sweet proteins brazzein and monellin did not significantly change rat microbiota and did not result in the appearance of opportunistic microbiota. This provides additional evidence for the safety of these potential sweeteners.
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  • 文章类型: Journal Article
    随着对低糖需求的增加,低热量健康饮食,人造甜味剂在食品工业中被广泛用作糖的替代品。因此,开发能够更好地预测糖替代品对人体影响的模型是必要的。这里,我们开发了一种基于微纤维组装体的新型内分泌胰腺芯片,并评估了葡萄糖或糖替代品对胰腺分泌的刺激.这种新的内分泌胰腺芯片使用两个组件组装:(1)通过微流控纺丝制备的细胞负载中空甲基丙烯酸酯明胶(GelMA)/海藻酸钙(CaA)复合微纤维,以实现血管模拟和材料运输,和(2)三维(3D)胰岛培养层,它也用作纤维组装微芯片。利用这个既定的器官芯片,我们调查了五种甜味剂(葡萄糖,赤藓糖醇,木糖醇,甜蜜素,和三氯蔗糖)对胰岛细胞活力以及胰岛素和胰高血糖素分泌的影响。构建的内分泌胰腺芯片具有用于糖替代食品添加剂安全性评估的潜力,可以拓展器官芯片在食品安全领域的应用,为评价各种食品添加剂提供新的平台。本文受版权保护。保留所有权利。
    With the increasing demand for low-sugar, low-calorie healthy diets, artificial sweeteners are widely used as substitutes for sugar in the food industry. Therefore, developing models that can better predict the effects of sugar substitutes on the human body is necessary. Here, a new type of endocrine pancreas-on-a-chip is developed based on a microfiber assembly and its stimulation of pancreatic secretion by glucose or sugar substitutes is evaluated. This new endocrine pancreas-on-a-chip is assembled using two components: (1) a cell-loaded hollow methacrylate gelatin (GelMA)/calcium alginate (CaA) composite microfiber prepared by microfluidic spinning to achieve vascular simulation and material transport, and (2) a 3D pancreatic islet culture layer, which also serves as a fiber assembly microchip. Using this established organ chip, the effects of five sweeteners (glucose, erythritol, xylitol, sodium cyclamate, and sucralose) were investigated on pancreatic islet cell viability and insulin and glucagon secretion. The constructed endocrine pancreas-on-a-chip has potential for the safety evaluation of sugar-substituted food additives, which can expand the application of organ chips in the field of food safety and provide a new platform for evaluating various food additives.
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  • 文章类型: Journal Article
    由于缺乏释放游离和结合挥发物的高性能技术,因此阻碍了充分利用果渣挥发物的努力。这项研究首先确定氯化铁(FeCl3)可以从枸杞果渣中强烈释放甜味增强挥发物(SV),从而将主要香气化合物[MAC;气味活性值(OAV)>1]从9增加到27。潜在的机制包括铁离子作为布朗斯台德酸和路易斯酸对糖苷的特殊水解,亲电铁氧体氧化β-胡萝卜素和β-紫罗兰酮。甜香可以通过27MAC重建和模拟。随后的提取和浓缩使MAC平均增加了2.28倍,提取的香精可以作为特定消费者的绿色和安全的增甜糖替代品。这些研究结果为理解金属盐与风味化学之间的关系奠定了基础。进一步提供了充分利用资源的机会。
    Efforts to fully utilize pomace volatiles have been obstructed by the lack of high-performance technologies to release free and bound volatiles. This study first established that ferric chloride (FeCl3) could strongly release the sweet-enhancing volatiles (SVs) from goji pomace, thus increasing the main aroma compounds [MACs; odor activity value (OAV) > 1] from 9 to 27. The underlying mechanism included the special hydrolysis to glycosides by ferric ions acting as Brønsted and Lewis acids, and the oxidation of β-carotene and β-ionone by electrophilic ferrite. The sweet fragrance could be reconstituted and simulated by the 27 MACs. Subsequent extraction and concentration increased MACs on average by 2.28-fold, and the extracted essence could be used as a green and safe sweet-enhancing sugar substitute for specific consumers. These study findings laid a foundation for understanding the relationship between metal salts and flavor chemistry, further providing an opportunity for the full utilization of resources.
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  • 文章类型: Journal Article
    果糖是通常与葡萄糖分子结合的果糖聚合物的多分散混合物。近年来,对它们使用的兴趣越来越大,作为功能食品的潜在成分或其技术特性。其应用的多样性在于其结构和起源。直到现在,科学方法更侧重于菊粉型果聚糖,而不是像龙舌兰果聚糖那样对混合分支结构的影响。这些具有复杂的结构,存在β(2-1)和β(2-6)键,赋予其益生元特性。在这种情况下,回顾了龙舌兰果聚糖提取的一般过程,以及它们在获得用于食品开发的基础结构方面的技术功能。
    Fructans are a polydisperse mixture of fructose polymers generally bound to a glucose molecule, in recent years, interest in their use has grown, either as a potential ingredient in functional foods or for their technological properties. The diversity of its applications lies in its structure and origin. Until now, the scientific approach has been more focused on inulin-type fructans and not so much on the effect of those of mixed branched structure as agave fructans. These have a complex structure with the presence of β (2 - 1) and β (2 - 6) bonds that give it prebiotic properties. In this context, a review is made of the general processes of extraction of agave fructans, as well as their technological functionality in the obtaining of base structures for the development of food products.
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  • 文章类型: Journal Article
    过量的糖消耗与龋齿等许多疾病之间的关系,肥胖,近年来,糖尿病和冠心病的发病率不断上升。在这项研究中,动物双歧杆菌亚种对天然糖替代品甜菊醇糖苷的利用和双歧杆菌作用。在体外模型系统中测定乳酸。基础培养基(含MRS的非碳水化合物,伙计,罗戈萨和夏普琼脂)补充了0.025%和1%的甜叶菊,0.025%甜叶菊+1%菊粉,%1甜菊糖+1%菊粉。不含碳水化合物的培养基被指定为阴性对照。而含有1%葡萄糖或菊粉的培养基被评估为阳性,并在发酵的0、12、24、36和48小时进行评估。两个系统中的甜菊醇糖苷均显着刺激了动物双歧杆菌亚种的生长。乳酸在不同程度上具有最高的益生元活性评分,短链脂肪酸的生产和生长参数与葡萄糖和益生元菊粉一样多。在生物治疗水平内确定益生菌的生存力,其具有潜在的益生元效应,这取决于益生菌菌株生长和所利用的碳水化合物来源的类型。在研究中,较低浓度的甜叶菊与菊粉的生长速率较高。总之,甜叶菊可用作功能性成分,用于调节肠道微生物群,并设计合生元系统作为益生元底物和糖替代品。
    The relationship between excessive sugar consumption and many diseases such as dental caries, obesity, diabetes and coronary heart has been increasing in recent years. In this study, utilization of natural sugar replacer steviol glycosides and bifidogenic effect by Bifidobacterium animalis subsp. lactis was assayed in vitro model system. The basal medium (non-carbohydrate containing MRS, Man, Rogosa and Sharpe Agar) were supplemented with 0.025% and 1% stevia, 0.025% stevia + 1% inulin, %1 stevia + 1% inulin. The medium which contained no carbohydrate was designated as negative control, whereas the medium containing 1% glucose or inulin were evaluated as positive and evaluated on the 0, 12, 24, 36 and 48 h of fermentation. Steviol glycosides in both system significantly stimulated the growth of Bifidobacterium animalis subsp. lactis to varying degrees with highest prebiotic activity score, short chain fatty acid production and growth parameters as much as glucose and prebiotic inulin. The viability of the probiotic bacteria was determined within the bio-therapeutic level with potential prebiotic effects depending on the probiotic bacterial strain growing and the type of carbohydrate source utilized. In the study, stevia at lower concentration showed a higher growth rate of with inulin. In conclusion, stevia can be used as functional ingredients for the modulation of the gut microbiota and design of synbiotic systems as a prebiotic substrate and sugar substitute.
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  • 文章类型: Review
    出于健康和安全考虑,传统的高热量甜味剂和人造甜味剂在食品工业中逐渐被天然和低热量甜味剂所取代。作为天然优质的糖替代品,甜菊醇糖苷(SvGls)就其安全性和应用进行了持续的审查。最近,在欧洲和亚洲的许多地方,有机甜叶菊的种植一直在增加,很明显,未来糖替代品的市场广阔。莱鲍迪甙A,SvGls的主要组成部分,由于其安全性而逐渐被消费者接受,零卡路里,clear,和甜味,没有明显的不良特征。因此,它可以作为甜味剂用于各种食品或膳食补充剂。此外,莱鲍迪甙A已被证明具有许多生理功能,如抗高血压,抗糖尿病,和反病毒。但到目前为止,关于莱鲍迪甙A的全面评论很少,在这篇评论文章中,我们讨论物理化学性质,代谢过程,安全,监管,健康益处,和莱鲍迪甙A的生物合成途径,并总结了莱鲍迪甙A的修饰方法和最先进的生产和纯化技术。此外,分析了当前阻碍莱鲍迪苷A未来生产和应用的问题,并提出了建议。
    For health and safety concerns, traditional high-calorie sweeteners and artificial sweeteners are gradually replaced in food industries by natural and low-calorie sweeteners. As a natural and high-quality sugar substitute, steviol glycosides (SvGls) are continually scrutinized regarding their safety and application. Recently, the cultivation of organic stevia has been increasing in many parts of Europe and Asia, and it is obvious that there is a vast market for sugar substitutes in the future. Rebaudioside A, the main component of SvGls, is gradually accepted by consumers due to its safe, zero calories, clear, and sweet taste with no significant undesirable characteristics. Hence, it can be used in various foods or dietary supplements as a sweetener. In addition, rebaudioside A has been demonstrated to have many physiological functions, such as antihypertension, anti-diabetes, and anticaries. But so far, there are few comprehensive reviews of rebaudioside A. In this review article, we discuss the physicochemical properties, metabolic process, safety, regulatory, health benefits, and biosynthetic pathway of rebaudioside A and summarize the modification methods and state-of-the-art production and purification techniques of rebaudioside A. Furthermore, the current problems hindering the future production and application of rebaudioside A are analyzed, and suggestions are provided.
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  • 文章类型: Journal Article
    这项研究是为了研究低聚半乳糖与酶修饰的罗汉果苷(mMV-GOS)组合的甜味强度和潜在的粪便微生物组调节,两者都是通过专利的单锅合成产生的。甜度强度由受过训练的感觉小组成员在体内进行。通过体外pH控制分批发酵评估对人粪便微生物组的影响,通过qPCR和GC-FID测量细菌种群和有机酸浓度,分别。在10小时的细菌种群发酵期间的显着生长(p≤0.05)包括双歧杆菌(8.49±0.44CFU/mL),拟杆菌(9.73±0.32CFU/mL),肠球菌(8.17±0.42CFU/mL),与每个细菌组的阴性对照计数(7.94±0.27、7.84±1.11、7.52±0.37和5.81±0.08CFU/mL)相比,分别)在发酵的同时。同样,发酵10小时时,mMV-GOS中SCFA的产量相应显着增加,与阴性对照(8.15±1.97和1.86±0.24mM)相比,主要见于乙酸盐(20.32±2.56mM)和丙酸盐(9.49±1.44mM)的产生,符合阳性对照(短链低聚果糖;46.74±12.13和6.51±1.91mM,分别)揭示了选择性发酵。总之,这些底物可以被认为是新的候选益生元甜味剂,预见一种可行和创新的方法,以降低食品中的蔗糖含量为目标。在人体研究中通过结合甜味和益生元纤维功能进行评估时,这种新成分可以提供健康益处。
    This study was conducted to investigate the sweetness intensity and the potential fecal microbiome modulation of galactooligosaccharides in combination with enzymatically modified mogrosides (mMV-GOS), both generated through a patented single-pot synthesis. Sweetness intensity was performed in vivo by trained sensory panelists. The impact on the human fecal microbiome was evaluated by in vitro pH-controlled batch fermentation, and bacterial populations and organic acid concentrations were measured by qPCR and GC-FID, respectively. Significant growth (p ≤ 0.05) during the fermentation at 10 h of bacterial populations includes Bifidobacterium (8.49 ± 0.44 CFU/mL), Bacteroides (9.73 ± 0.32 CFU/mL), Enterococcus (8.17 ± 0.42 CFU/mL), and Clostridium coccoides (6.15 ± 0.11 CFU/mL) as compared to the negative control counts for each bacterial group (7.94 ± 0.27, 7.84 ± 1.11, 7.52 ± 0.37, and 5.81 ± 0.08 CFU/mL, respectively) at the same time of fermentation. Likewise, the corresponding significant increase in production of SCFA in mMV-GOS at 10 h of fermentation, mainly seen in acetate (20.32 ± 2.56 mM) and propionate (9.49 ± 1.44 mM) production compared to a negative control at the same time (8.15 ± 1.97 and 1.86 ± 0.24 mM), is in line with a positive control (short-chain fructooligosaccharides; 46.74 ± 12.13 and 6.51 ± 1.91 mM, respectively) revealing a selective fermentation. In conclusion, these substrates could be considered as novel candidate prebiotic sweeteners, foreseeing a feasible and innovative approach targeting the sucrose content reduction in food. This new ingredient could provide health benefits when evaluated in human studies by combining sweetness and prebiotic fiber functionality.
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  • 文章类型: Journal Article
    背景:乳果糖被批准用于便秘的对症治疗,糖尿病患者常见的胃肠道(GI)并发症。乳果糖产品含有碳水化合物杂质(例如,乳糖,果糖,半乳糖),这发生在乳果糖制造过程中。这些杂质可能会影响使用乳果糖治疗轻度便秘的2型糖尿病(T2DM)患者的血糖水平。先前对健康受试者的研究显示,口服乳果糖摄入后血糖水平没有增加。然而,目前尚不清楚摄入乳果糖是否会增加糖尿病患者的血糖水平。
    目的:评估轻度便秘患者口服乳果糖后的血糖分布,门诊非胰岛素依赖型T2DM患者。
    方法:这种前瞻性,双盲,随机化,控制,单中心试验在格拉茨医科大学临床研究中心进行,奥地利,在24名成年白人轻度便秘中,非胰岛素依赖型T2DM患者。符合条件的受试者被随机分配到六个治疗序列之一。每个由4种按性别分层的治疗方法组成,采用不完全区组设计。受试者接受单剂量20g或30g乳果糖(晶体和液体制剂),水作为阴性对照或30g葡萄糖作为阳性对照。在给药后180分钟的时间段内测量毛细管血糖浓度。主要终点是在整个评估期间的血糖浓度曲线下的基线校正面积[AUCbaseline_c(0-180分钟)]。对乳果糖剂量和制剂与水进行定量比较,以相等的乳果糖剂量与葡萄糖。以及液体乳果糖与晶体乳果糖。安全参数包括胃肠道耐受性,在给药后180分钟和24小时评估,和不良事件发生长达24小时后的剂量。
    结果:在24名随机和分析的受试者中,摄入20g和30g乳果糖后的血糖浓度-时间曲线与两种乳果糖制剂的水摄入后的血糖浓度-时间曲线几乎相同,尽管碳水化合物杂质的含量不同(晶体和约≤3.0%。30%为液体)。无论乳果糖剂量和制剂如何,乳果糖和水之间的主要终点[AUCbaseline_c(0-180分钟)]没有显著差异。此外,关于所有次要终点,乳果糖制剂显示出与水相当的结果,其中一个例外涉及最大葡萄糖水平。30g剂量后观察到最大血糖略有增加,液体乳果糖,与水相比,平均治疗差异为0.63mmol/L(95%置信区间:0.19,1.07)。与30g液体和结晶乳果糖相比,摄入30g葡萄糖显着增加所有血糖终点,分别(所有P<0.0001)。在不同乳果糖制剂之间没有观察到血糖响应的差异。不出所料,乳果糖可增加排便次数,一般耐受性良好.由于乳果糖的泻药作用,受试者仅经历轻度至中度的GI症状。
    结论:轻度便秘患者的血糖AUCbaseline_c(0-180分钟)水平,非胰岛素依赖型T2DM患者不受20g和30g结晶或液体乳果糖制剂中碳水化合物杂质的影响.
    BACKGROUND: Lactulose is approved for the symptomatic treatment of constipation, a gastrointestinal (GI) complication common in individuals with diabetes. Lactulose products contain carbohydrate impurities (e.g., lactose, fructose, galactose), which occur during the lactulose manufacturing process. These impurities may affect the blood glucose levels of individuals with type 2 diabetes mellitus (T2DM) using lactulose for the treatment of mild constipation. A previous study in healthy subjects revealed no increase in blood glucose levels after oral lactulose intake. However, it is still unclear whether the intake of lactulose increases blood glucose levels in individuals with diabetes.
    OBJECTIVE: To evaluate the blood glucose profile after oral lactulose intake in mildly constipated, non-insulin-dependent subjects with T2DM in an outpatient setting.
    METHODS: This prospective, double-blind, randomized, controlled, single-center trial was conducted at the Clinical Research Center at the Medical University of Graz, Austria, in 24 adult Caucasian mildly constipated, non-insulin-dependent subjects with T2DM. Eligible subjects were randomized and assigned to one of six treatment sequences, each consisting of four treatments stratified by sex using an incomplete block design. Subjects received a single dose of 20 g or 30 g lactulose (crystal and liquid formulation), water as negative control or 30 g glucose as positive control. Capillary blood glucose concentrations were measured over a period of 180 min post dose. The primary endpoint was the baseline-corrected area under the curve of blood glucose concentrations over the complete assessment period [AUCbaseline_c (0-180 min)]. Quantitative comparisons were performed for both lactulose doses and formulations vs water for the equal lactulose dose vs glucose, as well as for liquid lactulose vs crystal lactulose. Safety parameters included GI tolerability, which was assessed at 180 min and 24 h post dose, and adverse events occurring up to 24 h post dose.
    RESULTS: In 24 randomized and analyzed subjects blood glucose concentration-time curves after intake of 20 g and 30 g lactulose were almost identical to those after water intake for both lactulose formulations despite the different amounts of carbohydrate impurities (≤ 3.0% for crystals and approx. 30% for liquid). The primary endpoint [AUCbaseline_c (0-180 min)] was not significantly different between lactulose and water regardless of lactulose dose and formulation. Also with regard to all secondary endpoints lactulose formulations showed comparable results to water with one exception concerning maximum glucose level. A minor increase in maximum blood glucose was observed after the 30 g dose, liquid lactulose, in comparison to water with a mean treatment difference of 0.63 mmol/L (95% confidence intervals: 0.19, 1.07). Intake of 30 g glucose significantly increased all blood glucose endpoints vs 30 g liquid and crystal lactulose, respectively (all P < 0.0001). No differences in blood glucose response were observed between the different lactulose formulations. As expected, lactulose increased the number of bowel movements and was generally well tolerated. Subjects experienced only mild to moderate GI symptoms due to the laxative action of lactulose.
    CONCLUSIONS: Blood glucose AUCbaseline_c (0-180 min) levels in mildly constipated, non-insulin dependent subjects with T2DM are not affected by the carbohydrate impurities contained in 20 g and 30 g crystal or liquid lactulose formulations.
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