Ketogenic

生酮
  • 文章类型: Journal Article
    这项研究旨在描述加拿大青少年和年轻人的节食频率,以及确定节食和饮食失调态度和行为之间的关联。分析了来自加拿大青少年健康行为研究的2762名加拿大青少年和年轻人的数据。使用频率来确定样本中11种不同饮食的患病率,和卡方检验用于评估性别差异。进行了多个改良的Poisson和线性回归分析,以确定任何节食与饮食失调态度和行为之间的关联。在样本中,15.7%的女孩和妇女,10.4%的男孩和男人,13.0%的变性人/性别膨胀(TGE)参与者报告在过去12个月有任何节食,生酮饮食在所有性别中最常见。回归分析的结果表明,在过去的12个月中进行任何节食都与女孩的饮食失调精神病理学有关,女人,男孩们,和男人,但不是TGE参与者。有不同的趋势之间的关联特定类型的节食做法和饮食失调行为的女孩,女人,男孩们,还有男人.节食在加拿大青少年和年轻人的全国样本中相对普遍,参与与更大的进食障碍精神病理学和行为有关。医疗保健和公共卫生专业人员应考虑对报告从事节食活动的青少年和年轻人进行饮食失调筛查。
    This study aimed to describe the frequency of dieting practices among adolescents and young adults in Canada, as well as determine the association between dieting and eating disorder attitudes and behaviors. Data from 2762 Canadian adolescents and young adults from the Canadian Study of Adolescent Health Behaviors were analyzed. Frequencies were used to determine the prevalence of 11 different diets among the sample, and chi-square tests were used to assess gender differences. Multiple modified Poisson and linear regression analyses were conducted to determine the associations between any dieting and eating disorder attitudes and behaviors. Among the sample, 15.7 % of girls and women, 10.4 % of boys and men, and 13.0 % of transgender/gender expansive (TGE) participants reported any dieting in the past 12 months, with the Ketogenic diet being most common among all genders. Results from regression analyses showed that engaging in any dieting in the past 12 months was associated with greater eating disorder psychopathology among girls, women, boys, and men, but not TGE participants. There were varying trends in association between specific types of dieting practices and eating disorder behaviors among girls, women, boys, and men. Dieting is relatively common among a national sample of Canadian adolescents and young adults, and engagement is associated with greater eating disorder psychopathology and behaviors. Healthcare and public health professionals should consider screening for eating disorders among adolescents and young adults who report engaging in dieting practices.
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  • 文章类型: Journal Article
    阿尔茨海默病(AD)的患病率正在增加,但对其认知障碍的有效治疗仍然非常有限。这项研究调查了通过饮食操纵产生酮体对早期AD引起的轻度认知障碍患者记忆的影响,并探讨了潜在的作用机制。
    我们进行了12周,平行组,生酮饮食的受控可行性试验,改良的阿特金斯饮食(MAD),与患有归因于AD的认知障碍的患者的对照饮食相比。我们进行了神经心理学评估,包括记忆测试,并在基线和干预12周后收集血液样本。我们对血浆样品进行非靶向脂质组学和靶向代谢组学分析以检测随时间的变化。
    共筛选了839个人,得到38名随机参与者,其中20人被分配接受MAD,18人被分配接受对照饮食。由于减员,对于主要终点,MAD组中只有13个和对照组中的9个进行了评估,两名参与者达到酮症水平,用于定义MAD依从性标准。与对照组相比,MAD组的记忆综合评分从基线的平均变化为1.37(95%CI:-0.87,4.90)分。干预对基线MAD变化的影响大小中等(Cohen'sD=0.57,95%CI:-0.67,1.33)。在15名参与者中(9名MAD,六个对照)评估脂质组学和代谢组学-脂质组学和代谢组学,从基线到12周,13种代谢物和10种脂质显示出显着变化,包括三酰基甘油(标签,50:5、52:5和52:6),鞘磷脂(SM,44:3、46:0、46:3和48:1),乙酰乙酸酯,脂肪酰基肉碱,甘油-3-磷酸,和羟基脂肪酸。
    在基线和第6周之间磨耗最大。在第6周保留的所有参与者完成研究。尽管按照先验定义的标准,遵守率很低,脂质组学和代谢组学分析显示,在随机化后12周时,MAD和对照参与者之间的循环脂质和代谢物相对于基线有显著变化,MAD参与者表现得更多,尽管不重要,提高记忆力。
    UNASSIGNED: Alzheimer\'s disease (AD) is increasing in prevalence, but effective treatments for its cognitive impairment remain severely limited. This study investigates the impact of ketone body production through dietary manipulation on memory in persons with mild cognitive impairment due to early AD and explores potential mechanisms of action.
    UNASSIGNED: We conducted a 12-week, parallel-group, controlled feasibility trial of a ketogenic diet, the modified Atkins diet (MAD), compared to a control diet in patients with cognitive impairments attributed to AD. We administered neuropsychological assessments, including memory tests, and collected blood samples at baseline and after 12 weeks of intervention. We performed untargeted lipidomic and targeted metabolomic analyses on plasma samples to detect changes over time.
    UNASSIGNED: A total of 839 individuals were screened to yield 38 randomized participants, with 20 assigned to receive MAD and 18 assigned to receive a control diet. Due to attrition, only 13 in the MAD arm and nine in the control arm were assessed for the primary endpoint, with two participants meeting ketosis levels used to define MAD adherence criteria. The average change from baseline in the Memory Composite Score was 1.37 (95% CI: -0.87, 4.90) points higher in the MAD group compared to the control group. The effect size of the intervention on baseline MAD change was moderate (Cohen\'s D = 0.57, 95% CI: -0.67, 1.33). In the 15 participants (nine MAD, six control) assessed for lipidomic and metabolomic-lipidomics and metabolomics, 13 metabolites and 10 lipids showed significant changes from baseline to 12 weeks, including triacylglycerols (TAGs, 50:5, 52:5, and 52:6), sphingomyelins (SM, 44:3, 46:0, 46:3, and 48:1), acetoacetate, fatty acylcarnitines, glycerol-3-phosphate, and hydroxy fatty acids.
    UNASSIGNED: Attrition was greatest between baseline and week 6. All participants retained at week 6 completed the study. Despite low rates of adherence by criteria defined a priori, lipidomic and metabolomic analyses indicate significant changes from baseline in circulating lipids and metabolites between MAD and control participants at 12-week postrandomization, and MAD participants showed greater, albeit nonsignificant, improvement in memory.
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  • 文章类型: Randomized Controlled Trial
    (1)背景:地中海生酮营养(MKN)可能直接针对与老年人痴呆风险相关的多种神经生物学机制。尽管承诺,这种类型的营养可能是具有挑战性的学习和坚持以健康的方式。我们的团队使用美国国立卫生研究院肥胖相关行为干预试验(NIHORBIT)模型来开发和试点一项计划,以帮助有记忆问题的老年人使用MKN。(2)方法:使用双臂,随机设计,与MKN教育(MKNE)计划相比,我们评估了MKN坚持(MKNA)计划(N=58).研究组之间的主要差异涉及仅在MKNA组中使用动机性访谈(MI)策略和行为改变技术(BCT)。如果参与者在蒙特利尔认知评估(得分19≤26)中证明了主观记忆问题或客观记忆障碍,则将其包括在内。检查的主要结果包括可行性,可接受性,坚持,以及与该计划相关的临床结果。(3)结果:总体上,两组的计划完成度都相对较高,79%的参与者完成了为期6周的课程。招募方案需要调整,但成功达到目标样本量。与MKNE相比,MKNA部门的保留率(82%)和会议出勤率(91%)更高(保留率=72%;出勤率=77%)。总的来说,两组中的大多数参与者使用客户满意度问卷将该计划评为“优秀”。在为期6周的计划中,MKNA小组的参与者证明了对MKN的客观和自我报告依从性更高。Further,有一些证据表明该计划的临床益处,尽管在3个月的随访中,这些影响随着依从性的降低而减弱。(4)讨论:这项试点试验表明,结合MI和BCT策略的MKN计划可能比单独的营养教育计划更好地吸引和留住参与者,尽管两组参与者都报告了很高的满意度。
    (1) Background: Mediterranean ketogenic nutrition (MKN) may directly target multiple neurobiological mechanisms associated with dementia risk in older adults. Despite its promise, this type of nutrition can be challenging to learn and adhere to in a healthy manner. Our team used the National Institutes of Health Obesity Related Behavioral Intervention Trials (NIH ORBIT) model to develop and pilot a program to help older adults with memory concerns use MKN. (2) Methods: Using a two-arm, randomized design, we evaluated an MKN Adherence (MKNA) program compared to an MKN education (MKNE) program (N = 58). The primary difference between study arms involved the use of motivational interviewing (MI) strategies and behavior change techniques (BCT) only in the MKNA arm. Participants were included if they evidenced subjective memory concerns or objective memory impairment on the Montreal Cognitive Assessment (Score 19 ≤ 26). Primary outcomes examined included feasibility, acceptability, adherence, and clinical outcomes associated with the program. (3) Results: Overall, there was relatively high program completion in both groups, with 79% of participants completing the 6-week program. The recruitment protocol required adjustment but was successful in reaching the target sample size. Retention (82%) and session attendance (91%) were higher in the MKNA arm compared to the MKNE (retention = 72%; attendance = 77%). Overall, most participants in both groups rated the program as \"excellent\" using the client satisfaction questionnaire. Participants in the MKNA arm evidenced higher objective and self-reported adherence to MKN during the 6-week program. Further, there was some evidence of clinical benefits of the program, although these effects diminished as adherence decreased in the 3 months follow-up. (4) Discussion: This pilot trial demonstrated that the MKN program incorporating MI and BCT strategies may better engage and retain participants than a nutrition education program alone, although participants in both groups reported high satisfaction.
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  • 文章类型: Randomized Controlled Trial
    目的:为了确定饮食中糖或碳水化合物限制对身体活动能量消耗的影响,能量摄入,和24小时的生理结果。
    方法:在随机分组中,开放标签交叉设计,25名健康男性(n=10)和女性(n=15)在24小时内食用三种饮食:适度的碳水化合物和糖含量(MODSUG=50%碳水化合物[20%糖],15%蛋白质,35%脂肪);低糖含量(LOWSUG=50%碳水化合物[<5%糖],15%蛋白质,35%脂肪);和低碳水化合物含量(LOWCHO=8%碳水化合物[<5%糖],15%蛋白质,77%的脂肪)。在随意测试午餐之前,在实验室条件下监测餐后对规定早餐(20%EI)的代谢反应,随后在自由生活条件下进行饮食和身体活动监测,直到第二天早上收集血液样本。
    结果:MODSUG,LOWSUG和LOWCHO饮食导致两种身体活动能量消耗的平均[95CI]率相似(771[624,919]与677[565,789]vs.802[614,991]kcal·d-1;p=0.29]和能量摄入(2071[1794,2347]与2195[1918,2473]vs.2194[1890,2498]千卡·d-1;P=0.34),分别。LOWCHO条件引起最低的血糖和胰岛素对早餐的反应(P<0.01),但最高的24小时LDL-胆固醇浓度增加(P<0.001),MODSUG和LOWSUG治疗之间没有差异。瘦素浓度在消耗LOWCHO的24小时内相对于LOWSUG降低(p<0.01)。
    结论:当能量密度被控制时,尽管代谢发生了实质性变化,但限制糖或总饮食碳水化合物并不能调节24小时(〜19小时自由生活)的身体活动水平或能量摄入。
    UNASSIGNED:NCT03509610,https://clinicaltrials.gov/show/NCT03509610。
    OBJECTIVE: To determine the effects of dietary sugar or carbohydrate restriction on physical activity energy expenditure, energy intake, and physiological outcomes across 24 h.
    METHODS: In a randomized, open-label crossover design, twenty-five healthy men (n = 10) and women (n = 15) consumed three diets over a 24-h period: moderate carbohydrate and sugar content (MODSUG = 50% carbohydrate [20% sugars], 15% protein, 35% fat); low sugar content (LOWSUG = 50% carbohydrate [< 5% sugars], 15% protein, 35% fat); and low carbohydrate content (LOWCHO = 8% carbohydrate [< 5% sugars], 15% protein, 77% fat). Postprandial metabolic responses to a prescribed breakfast (20% EI) were monitored under laboratory conditions before an ad libitum test lunch, with subsequent diet and physical activity monitoring under free-living conditions until blood sample collection the following morning.
    RESULTS: The MODSUG, LOWSUG and LOWCHO diets resulted in similar mean [95%CI] rates of both physical activity energy expenditure (771 [624, 919] vs. 677 [565, 789] vs. 802 [614, 991] kcal·d-1; p = 0.29] and energy intake (2071 [1794, 2347] vs. 2195 [1918, 2473] vs. 2194 [1890, 2498] kcal·d-1; P = 0.34), respectively. The LOWCHO condition elicited the lowest glycaemic and insulinaemic responses to breakfast (P < 0.01) but the highest 24-h increase in LDL-cholesterol concentrations (P < 0.001), with no differences between the MODSUG and LOWSUG treatments. Leptin concentrations decreased over 24-h of consuming LOWCHO relative to LOWSUG (p < 0.01).
    CONCLUSIONS: When energy density is controlled for, restricting either sugar or total dietary carbohydrate does not modulate physical activity level or energy intake over a 24-h period (~ 19-h free-living) despite substantial metabolic changes.
    UNASSIGNED: NCT03509610, https://clinicaltrials.gov/show/NCT03509610.
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  • 文章类型: Journal Article
    关于糖尿病前期和2型糖尿病(T2DM)患者的最佳饮食尚未达成共识。尤其是在低碳水化合物选项之间。
    我们比较了2种低碳水化合物饮食与3个关键相似性(加入非淀粉蔬菜,避免添加糖和精制谷物)和3个关键差异(与避免豆类相比,水果,和整体,完整的谷物)对糖尿病前期和T2DM患者的血糖控制和心脏代谢危险因素的影响。
    Keto-Med是随机的,交叉,介入试验。40名年龄≥18岁的糖尿病前期或T2DM患者遵循配方良好的生酮饮食(WFKD)和地中海加饮食(Med-Plus),每组12周,以随机顺序。饮食共享上述3个关键相似性。Med-Plus融合了豆类,水果,和整体,完整的谷物,而WFKD避开了他们。主要结果是每种饮食12周后糖化血红蛋白(HbA1c)的百分比变化。次要和探索性结果包括体重变化百分比,空腹胰岛素,葡萄糖,和血脂;来自连续葡萄糖监测仪(CGM)的平均葡萄糖,和营养摄入。
    主要分析了33名具有完整数据的参与者。12周时不同饮食的HbA1c值没有差异。WFKD的甘油三酯下降更多[百分比变化,-16%(SEM,4%)与-5%(SEM,6%);P=0.02]和LDL胆固醇较高的WFKD[百分比变化,+10%(SEM,4%)与-5%(SEM,5%)为Med-Plus;P=0.01]。体重减轻8%(SEM,1%)与7%(SEM,1%)和HDL胆固醇增加11%(SEM,2%)与7%(SEM,3%)的WFKD与Med-Plus相比,分别;然而,两者的饮食×顺序有显著的交互作用。与Med-Plus相比,WFKD参与者的纤维和3种营养素摄入量较低。12周的随访数据表明,Med-Plus更具可持续性。
    12周后不同饮食阶段的HbA1c值没有差异,但是两种饮食都从基线有所改善,可能是由于几个共同的饮食方面。WFKD导致甘油三酯的更大下降,但也有潜在的不良风险,因为低密度脂蛋白胆固醇升高和减少营养摄入量,避免豆类,水果,和整体,完整的谷物,以及不那么可持续。该试验在clinicaltrials.gov注册为NCT03810378。
    Consensus has not been reached on what constitutes an optimal diet in individuals with prediabetes and type 2 diabetes mellitus (T2DM), especially between low-carbohydrate options.
    We compared 2 low-carbohydrate diets with 3 key similarities (incorporating nonstarchy vegetables and avoiding added sugars and refined grains) and 3 key differences (incorporating compared with avoiding legumes, fruits, and whole, intact grains) for their effects on glucose control and cardiometabolic risk factors in individuals with prediabetes and T2DM.
    Keto-Med was a randomized, crossover, interventional trial. Forty participants aged ≥18 years with prediabetes or T2DM followed the well-formulated ketogenic diet (WFKD) and the Mediterranean-plus diet (Med-Plus) for 12 weeks each, in random order. The diets shared the 3 key similarities noted above. The Med-Plus incorporated legumes, fruits, and whole, intact grains, while the WFKD avoided them. The primary outcome was the percentage change in glycated hemoglobin (HbA1c) after 12 weeks on each diet. Secondary and exploratory outcomes included percentage changes in body weight, fasting insulin, glucose, and blood lipids; average glucose from continuous glucose monitor (CGM), and nutrient intake.
    The primary analysis was of 33 participants with complete data. The HbA1c values did not differ between diets at 12 weeks. Triglycerides decreased more for the WFKD [percentage changes, -16% (SEM, 4%) compared with -5% (SEM, 6%) for the Med-Plus; P = 0.02] and LDL cholesterol was higher for the WFKD [percentage changes, +10% (SEM, 4%) compared with -5% (SEM, 5%) for the Med-Plus; P = 0.01]. Weight decreased 8% (SEM, 1%) compared with 7% (SEM, 1%) and HDL cholesterol increased 11% (SEM, 2%) compared with 7% (SEM, 3%) for the WFKD compared with the Med-Plus, respectively; however, there was a significant interaction of diet × order for both. Participants had lower intakes of fiber and 3 nutrients on the WFKD compared with the Med-Plus. Twelve-week follow-up data suggest the Med-Plus is more sustainable.
    HbA1c values were not different between diet phases after 12 weeks, but improved from baseline on both diets, likely due to several shared dietary aspects. The WFKD led to a greater decrease in triglycerides, but also had potential untoward risks from elevated LDL cholesterol and lower nutrient intakes from avoiding legumes, fruits, and whole, intact grains, as well as being less sustainable. This trial was registered at clinicaltrials.gov as NCT03810378.
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  • 文章类型: Journal Article
    低碳水化合物生酮饮食是一种可行的减肥方法,近年来已重新流行。移动健康(mHealth)应用程序形式的技术允许可扩展和远程提供此类饮食干预措施,并且在没有直接医疗监督的情况下越来越多地被普通人群使用。然而,目前尚不清楚与应用程序使用和用户行为相关的哪些因素与成功减肥相关。
    首先,描述和表征用户行为,我们的目标是检查参与者的特征和用户行为随时间的变化,这些参与者参与了一项远程实施的临床减肥试验,该试验测试了mHealth生酮饮食应用与呼吸丙酮生物反馈装置配对的应用.第二,确定12周时对减肥重要的变量,这些变量可能为饮食干预措施的未来发展提供见解,我们旨在探讨哪些与应用和依从性相关的用户行为是成功减肥的特征。
    我们分析了参与先前减肥研究干预组的75名超重或肥胖成年人的应用程序使用情况和自我报告的问卷调查数据。我们通过线性混合模型检查了一段时间内的数据模式,并进行了相关性,线性回归,和因果中介分析来表征饮食-,weight-,以及与减肥相关的应用程序相关的用户行为。
    在通过mHealth应用程序与呼吸丙酮生物反馈装置配对远程提供低碳水化合物生酮饮食干预的背景下,自我报告的饮食依从性似乎是预测体重减轻的最重要因素(β=-.31;t54=-2.366;P=.02)。此外,自我报告的依从性介导了更高的应用参与度(从c=-0.008,95%CI-0.014至-0.0019到c\'=-0.0035,95%CI-0.0094至0.0024)或更高的呼吸丙酮水平(从c=-1.34,95%CI-2.28至-0.40到c\'=-0.40,95%CI-1.42至0.62)与更高的体重减轻之间的解释了总共27.8%和28.8%的体重减轻差异,分别。随着时间的推移,用户行为(体重测量和应用程序参与度的依从性)和与依从性相关的方面(呼吸丙酮值和自我报告的饮食依从性)在实现临床显着体重减轻>5%的个体和未实现的个体之间存在差异。
    我们对与应用和依从性相关的用户行为的深入检查提供了在mHealth干预背景下与成功减肥相关的因素的见解。特别是,我们发现,自我报告的饮食依从性是预测体重减轻的最重要指标,这可能有助于制定未来的mHealth饮食干预措施.
    ClinicalTrials.govNCT04165707;https://clinicaltrials.gov/ct2/show/NCT04165707。
    RR2-10.2196/19053。
    Low-carbohydrate ketogenic diets are a viable method to lose weight that have regained popularity in recent years. Technology in the form of mobile health (mHealth) apps allows for scalable and remote delivery of such dietary interventions and are increasingly being used by the general population without direct medical supervision. However, it is currently unknown which factors related to app use and user behavior are associated with successful weight loss.
    First, to describe and characterize user behavior, we aim to examine characteristics and user behaviors over time of participants who were enrolled in a remotely delivered clinical weight loss trial that tested an mHealth ketogenic diet app paired with a breath acetone biofeedback device. Second, to identify variables of importance to weight loss at 12 weeks that may offer insight for future development of dietary mHealth interventions, we aim to explore which app- and adherence-related user behaviors characterized successful weight loss.
    We analyzed app use and self-reported questionnaire data from 75 adults with overweight or obesity who participated in the intervention arm of a previous weight loss study. We examined data patterns over time through linear mixed models and performed correlation, linear regression, and causal mediation analyses to characterize diet-, weight-, and app-related user behavior associated with weight loss.
    In the context of a low-carbohydrate ketogenic diet intervention delivered remotely through an mHealth app paired with a breath acetone biofeedback device, self-reported dietary adherence seemed to be the most important factor to predict weight loss (β=-.31; t54=-2.366; P=.02). Furthermore, self-reported adherence mediated the relationship between greater app engagement (from c=-0.008, 95% CI -0.014 to -0.0019 to c\'=-0.0035, 95% CI -0.0094 to 0.0024) or higher breath acetone levels (from c=-1.34, 95% CI -2.28 to -0.40 to c\'=-0.40, 95% CI -1.42 to 0.62) and greater weight loss, explaining a total of 27.8% and 28.8% of the variance in weight loss, respectively. User behavior (compliance with weight measurements and app engagement) and adherence-related aspects (breath acetone values and self-reported dietary adherence) over time differed between individuals who achieved a clinically significant weight loss of >5% and those who did not.
    Our in-depth examination of app- and adherence-related user behaviors offers insight into factors associated with successful weight loss in the context of mHealth interventions. In particular, our finding that self-reported dietary adherence was the most important metric predicting weight loss may aid in the development of future mHealth dietary interventions.
    ClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707.
    RR2-10.2196/19053.
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  • 文章类型: Journal Article
    This prospective open-label feasibility study aimed to evaluate acceptability, tolerability and compliance with dietary intervention with K.Vita, a medical food containing a unique ratio of decanoic acid to octanoic acid, in individuals with drug-resistant epilepsy. Adults and children aged 3-18 years with drug-resistant epilepsy took K.Vita daily whilst limiting high-refined sugar food and beverages. K.Vita was introduced incrementally with the aim of achieving ≤35% energy requirements for children or 240 ml for adults. Primary outcome measures were assessed by study completion, participant diary, acceptability questionnaire and K.Vita intake. Reduction in seizures or paroxysmal events was a secondary outcome. 23/35 (66%) children and 18/26 (69%) adults completed the study; completion rates were higher when K.Vita was introduced more gradually. Gastrointestinal disturbances were the primary reason for discontinuation, but symptoms were similar to those reported from ketogenic diets and incidence decreased over time. At least three-quarters of participants/caregivers reported favourably on sensory attributes of K.Vita, such as taste, texture and appearance, and ease of use. Adults achieved a median intake of 240 ml K.Vita, and children 120 ml (19% daily energy). Three children and one adult had ß-hydroxybutyrate >1 mmol/l. There was 50% (95% CI 39-61%) reduction in mean frequency of seizures/events. Reduction in seizures or paroxysmal events correlated significantly with blood concentrations of medium chain fatty acids (C10 and C8) but not ß-hydroxybutyrate. K.Vita was well accepted and tolerated. Side effects were mild and resolved with dietetic support. Individuals who completed the study complied with K.Vita and additional dietary modifications. Dietary intervention had a beneficial effect on frequency of seizures or paroxysmal events, despite absent or very low levels of ketosis. We suggest that K.Vita may be valuable to those with drug-resistant epilepsy, particularly those who cannot tolerate or do not have access to ketogenic diets, and may allow for more liberal dietary intake compared to ketogenic diets, with mechanisms of action perhaps unrelated to ketosis. Further studies of effectiveness of K.Vita are warranted.
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  • 文章类型: Clinical Trial Protocol
    背景:实体瘤化疗耐药的根本原因是肿瘤血液供应减少,导致缺氧的微环境,依赖厌氧能量代谢,和静脉治疗的传递受损。临床前数据表明,热量限制和低碳水化合物摄入的饮食策略可以抑制糖酵解,而急性运动可以短暂增加肿瘤的血流量,减少缺氧。转移性乳腺癌(DREAM)的饮食限制和运动诱导的适应研究将比较短期,在静脉化疗治疗期间进行50%热量限制和生酮饮食结合有氧运动,以常规护理改变肿瘤负担,治疗副作用,和生活质量。
    方法:50名开始新的静脉化疗的可测量转移和原发性乳腺癌患者将被随机分配到常规护理或联合饮食和运动干预。在每次化疗前48-72小时,分配到干预组的参与者将获得由50%的测量卡路里需求组成的食物,其中80%的卡路里来自脂肪,≤10%来自碳水化合物,并将在每次化疗输注期间进行30-60分钟的中等强度周期测功机锻炼。多达六个治疗周期。饮食和运动持续时间将适应每个化疗方案。肿瘤负荷将通过使用轴向计算机断层扫描(主要结果)和磁共振成像(MRI)得出的表观扩散系数(次要结果)的目标病变大小的变化进行评估。三级结果将包括对心脏的治疗毒性的定量MRI标记,大腿骨骼肌,还有肝脏,以及患者报告的症状和生活质量。探索性结果指标包括无进展生存期和总生存期。
    结论:DREAM研究将测试一种新颖的,针对肿瘤化疗耐药机制的短期饮食和运动干预。病变大小的减少可能会转化为改善的癌症结果,包括疾病进展和总生存期。此外,生活方式干预可能使转移性乳腺癌患者积极参与他们在治疗中发挥关键作用.
    背景:ClinicalTrials.gov,NCT03795493,1月7日登记,2019.
    BACKGROUND: An underlying cause of solid tumor resistance to chemotherapy treatment is diminished tumor blood supply, which leads to a hypoxic microenvironment, dependence on anaerobic energy metabolism, and impaired delivery of intravenous treatments. Preclinical data suggest that dietary strategies of caloric restriction and low-carbohydrate intake can inhibit glycolysis, while acute exercise can transiently enhance blood flow to the tumor and reduce hypoxia. The Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer (DREAM) study will compare the effects of a short-term, 50% calorie-restricted and ketogenic diet combined with aerobic exercise performed during intravenous chemotherapy treatment to usual care on changes in tumor burden, treatment side effects, and quality of life.
    METHODS: Fifty patients with measurable metastases and primary breast cancer starting a new line of intravenous chemotherapy will be randomly assigned to usual care or the combined diet and exercise intervention. Participants assigned to the intervention group will be provided with food consisting of 50% of measured calorie needs with 80% of calories from fat and ≤ 10% from carbohydrates for 48-72 h prior to each chemotherapy treatment and will perform 30-60 min of moderate-intensity cycle ergometer exercise during each chemotherapy infusion, for up to six treatment cycles. The diet and exercise durations will be adapted for each chemotherapy protocol. Tumor burden will be assessed by change in target lesion size using axial computed tomography (primary outcome) and magnetic resonance imaging (MRI)-derived apparent diffusion coefficient (secondary outcome) after up to six treatments. Tertiary outcomes will include quantitative MRI markers of treatment toxicity to the heart, thigh skeletal muscle, and liver, and patient-reported symptoms and quality of life. Exploratory outcome measures include progression-free and overall survival.
    CONCLUSIONS: The DREAM study will test a novel, short-term diet and exercise intervention that is targeted to mechanisms of tumor resistance to chemotherapy. A reduction in lesion size is likely to translate to improved cancer outcomes including disease progression and overall survival. Furthermore, a lifestyle intervention may empower patients with metastatic breast cancer by actively engaging them to play a key role in their treatment.
    BACKGROUND: ClinicalTrials.gov, NCT03795493 , registered 7 January, 2019.
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  • 文章类型: Journal Article
    目的:生酮代谢疗法(KMT)已证明在减少癫痫发作方面有效。然而,患者的依从性和不良反应限制了其使用。即食(RTF)生酮配方可提高依从性,并包含减轻不良反应的成分。这项研究是第一个评估RTF的疗效和耐受性,乳清基,中链甘油三酯增强(WBME)生酮配方。
    方法:对2015年1月1日至2018年2月28日期间接受KMT治疗的患者的回顾性资料进行分析。包括接受来自WBME配方的总卡路里的≥75%且监测3个月的患者。结果指标是胃肠道问题,酸中毒,血清血糖和β-羟丁酸水平,无意的体重变化,饮食反应(癫痫发作减少≥50%),癫痫发作自由,改变配方或停止治疗。结果数据不完整或从配方中接受<75%总卡路里的患者被排除。
    结果:26例患者(13例男性;平均[SD]年龄,6.1[5.8]年)符合纳入标准。13名患者是已确定的患者,他们在更改为WBME配方之前接受了标准生酮配方;13名是KMT的新患者,其治疗是使用WBME配方开始的。该配方具有良好的耐受性;两组中都没有患者停止治疗或需要改变配方。已建立和新患者的联合饮食反应率(95%CI)为96%(80-100%)。治疗后3个月,两组的癫痫发作自由度(95%CI)为20%(7-41%)。最常见的不良反应是便秘(69%[95%CI,48-86%])。
    结论:WBME生酮配方似乎对儿童难治性癫痫患者有效且耐受性良好。
    OBJECTIVE: Ketogenic metabolic therapy (KMT) has demonstrated effectiveness in seizure reduction. However, patient compliance and adverse effects limit its use. Ready-to-feed (RTF) ketogenic formulas improve compliance and include components that mitigate adverse effects. This study is the first to evaluate the efficacy and tolerability of an RTF, whey-based, medium-chain triglyceride-enhanced (WBME) ketogenic formula.
    METHODS: Retrospective data from patients who received KMT between January 1, 2015, and February 28, 2018, were analyzed. Patients who received ≥75% of their total calories from the WBME formula and who were monitored for 3 months were included. Outcome measures were gastrointestinal issues, acidosis, serum blood glucose and beta-hydroxybutyrate levels, unintentional weight changes, diet response (≥50% reduction in seizures), seizure freedom, and change in formula or discontinuation of therapy. Patients with incomplete outcome data or who received <75% of total calories from the formula were excluded.
    RESULTS: Twenty-six patients (13 males; mean [SD] age, 6.1 [5.8] years) met the inclusion criteria. Thirteen patients were established patients who received a standard ketogenic formula before changing to the WBME formula; 13 were patients new to KMT whose therapy was initiated using the WBME formula. This formula was well tolerated; no patient in either group discontinued therapy or required a change in formula. The combined diet response rate (95% CI) for established and new patients was 96% (80-100%). Seizure-freedom (95% CI) for both groups at 3 months posttreatment was 20% (7-41%). The most prevalent adverse effect was constipation (69% [95% CI, 48-86%]).
    CONCLUSIONS: The WBME ketogenic formula appears to be effective and well tolerated by pediatric patients with refractory epilepsy.
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  • 文章类型: Journal Article
    Adherence is a critical factor to consider when interpreting study results from randomized clinical trials (RCTs) comparing one diet to another, but it is frequently not reported by researchers. The purpose of this secondary analysis of the Keto-Med randomized trial was to provide a detailed examination and comparison of the adherence to the two study diets (Well Formulated Ketogenic Diet (WFKD) and Mediterranean Plus (Med-Plus)) under the two conditions: all food being provided (delivered) and all food being obtained by individual participants (self-provided). Diet was assessed at six time points including baseline (×1), week 4 of each phase when participants were receiving food deliveries (×2), week 12 of each phase when participants were preparing and providing food on their own (×2), and 12 weeks after participants completed both diet phases and were free to choose their own diet pattern (×1). The adherence scores for WFKD and Med-Plus were developed specifically for this study. Average adherence to the two diet patterns was very similar during both on-study time points of the intervention. Throughout the study, a wide range of adherence was observed among participants-for both diet types and during both the delivery phase and self-provided phase. Insight from this assessment of adherence may aid other researchers when answering the important question of how to improve behavioral adherence during dietary trials. This study is registered at clinicaltrials.gov NCT03810378.
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