METHODS: A 6-month prospective, randomised, double-blinded, placebo-controlled, crossover, multicentre dietary trial is designed comparing a 9% metabolic energy based calculated medium-chain triglyceride (MCT) oil supplement to a conventional \'control\' DS. Only dogs which will have an International Veterinary Epilepsy Task Force Tier II level like diagnosis of IE which satisfied the following inclusion criteria are included: age between 6 months and ≤ 12 years; weighing between 4 and ≤ 65 kg; unremarkable interictal neurological examinations; no clinically significant findings on routine laboratory diagnostics; unremarkable brain MRI scan; have had at least 3 seizures in the previous 3 months prior to enrolment; treated with at least one ASD and being classified as resistant. All dogs are fed initially for 90 ± 2 days with either the control oil or the MCT oil alongside their normal diet, followed by 97 ± 2 days with the other supplement including a 7-day washout period. Overall, the aim is to recruit thirty-six patients at five different centres and to investigate the effect of MCTs as DS on seizure activity, tolerability, behavioural comorbidities and quality of life (QoL).
CONCLUSIONS: Dietary interventions are rarely studied in a standardised form in veterinary medicine. The background diet, the cohort of animals and ASD received is standardised in this prospective diet trial to ensure representative data about the potential effect of MCT DS. If the study data confirms former findings, this would provide further evidence for the efficacy of MCTs as a management option for canine epilepsy. This publication should offer a repository of trial conditions and variable description with forecasted statistical analysis.
方法:6个月的前瞻性,随机化,双盲,安慰剂对照,交叉,多中心饮食试验旨在比较基于9%代谢能的计算中链甘油三酸酯(MCT)油补充剂与常规“对照”DS。仅包括具有符合以下纳入标准的国际兽医癫痫工作组TierII级IE诊断的狗:年龄在6个月至≤12岁之间;体重在4至≤65kg之间;不明显的发作间神经系统检查;在常规实验室诊断中没有临床显着发现;不明显的脑MRI扫描;在入组前的前3个月中至少有3次癫痫发作;接受过至少一种ASD治疗并被归类为耐药性。所有的狗最初用对照油或MCT油与正常饮食一起喂养90±2天。然后是97±2天,其他补充剂包括7天的洗脱期。总的来说,目的是在五个不同的中心招募36名患者,并研究MCT作为DS对癫痫发作活动的影响,耐受性,行为合并症和生活质量(QoL)。
结论:饮食干预在兽医学中很少以标准化形式进行研究。背景饮食,本前瞻性饮食试验对接受的动物和ASD队列进行了标准化,以确保有关MCTDS潜在效应的代表性数据.如果研究数据证实了以前的发现,这将为MCT作为犬癫痫治疗选择的有效性提供进一步的证据.本出版物应提供试验条件和变量描述的存储库,并进行预测的统计分析。