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General Clinical Research Center

全科临床研究中心

基本信息

批准号：
7015779
负责人：
STEVEN M ALTSCHULER
金额：
$ 96.24万
依托单位：
CHILDREN'S HOSP OF PHILADELPHIA
依托单位国家：
美国
项目类别：
财政年份：
1997
资助国家：
美国
起止时间：
1997-02-24 至 2006-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7015779
关键词：
clinical research human subject

项目摘要

and investigate the usefulness of the EEC as a predictor of the subjects response to the KD, In Phase 1, the current practices for initiation of the ketogenic diet and its efficacy (defined as >50% reduction of seizure frequency at the 3-month interval compared to baseline) will be investigated. We propose that a gradual introduction of the KD, without a 24 to 48 hour preceding fast (Grad-KD), is as safe and efficacious as the currently recommended initiation of the KD (CR-KD) with fast. Safety of the two protocols will be evaluated during a six-day inpatient admission and the first three months of exposure. Efficacy will be determined at three months. Baseline and 1- month changes in the routine electroencephalogram (EEG) will be examined simultaneously. The predictive power of the changes between the baseline and 1-month EEG for the 3-month response (defined above) will be shown in those EEG records that have diminished background slowing or reduction of potentially epileptogenic discharges. In a pilot study we will investigate the mechanistic hypothesis that the antiepileptic properties of the KD is dueto anincrease in CNS-Gamma Amino Butyric Acid (GABA), asmeasured by MRI Spectroscopy at baseline, 0.5-month and3- month in the CR-KD therapy. We will also examine the association between changes in CNS-GABA at 0.5- month andresponse to KD therapy (defined above). In Phase 2, subjects who have demonstrated a positive response at 3 months will be followed. The maintenance KD in responders on two caloric intakes will be evaluated. The currently recommended KD is hypocaloric, providing only 75% of subject's caloric needs, and does not allow any weight gain for the 12 months duration of treatment. The necessity of semi-starvation to maintain a positive clinical response has not been evaluated scientifically. We will examine if a Eucaloric KD (Eu-KD), with adequate calories for the subject allowing for normal weight gain, is as effective as the currently recommended Hypocaloric KD (Hypo-KD) with no weight gain or loss over 12 months. As part of this evaluation, comparisons of two methods used to estimate caloric needs, Recommended Daily Allowance (RDA) tables and Resting Energy Expenditure (by indirect calorimetry), will be made. In addition, the effect of the KD on several nutritional Darameters including anthropometry, body composition and bone mineral status, will be evaluated, allowing the 12-month impact of the Eu-KD versus Hypo-KD diets on nutritional status to be compared.

并研究EEC作为受试者预测指标的有用性对KD的反应，在第1阶段，研究生酮饮食开始的现行做法及其疗效（定义为生酮饮食减少>50%）。与基线相比，将研究3个月间隔时的癫痫发作频率）。我们建议，在没有24至48小时禁食（Grad-KD）的情况下，KD的引入与目前的建议用快速启动KD（CR-KD）。两种方案的安全性将在为期六天的住院和接触的前三个月。将在3个月时确定疗效。基线和1- 同时检查常规脑电图（EEG）的月变化。的预测能力基线和1个月EEG之间3个月应答（定义见上文）的变化将在这些EEG中显示记录有减少背景减慢或减少潜在的致癫痫放电。在一项初探性研究中我们将研究KD的抗癫痫特性是由于增加 CNS-γ-氨基丁酸（GABA），通过MRI光谱在基线、0.5个月和3个月时测量在CR-KD治疗中，我们还将研究在0.5- 1000 mg/kg剂量下CNS-GABA变化之间的关联。月和对KD治疗的反应（定义见上文）。在II期研究中，将对3个月时表现出阳性应答的受试者进行随访。维护KD 将评估两次热量摄入的应答者。目前推荐的KD是低热量的，仅提供75% 受试者的热量需求，并且在12个月的治疗持续时间内不允许任何体重增加。的必要性维持积极临床反应的半饥饿尚未得到科学评估。我们将研究如果一个 Eucaloric KD（Eu-KD），具有足够的热量，允许受试者正常体重增加，与Eucaloric KD（Eu-KD）一样有效。目前推荐的低热量KD（Hypo-KD）在12个月内没有体重增加或减轻。作为评估的一部分，比较两种用于估计热量需求的方法，推荐每日摄入量（RDA）表和休息能量消耗（通过间接量热法），将作出。此外，KD对几种营养物质的影响也是如此。将对包括人体测量、身体成分和骨矿物质状态在内的参数进行评估，比较Eu-KD与Hypo-KD饮食对营养状况的影响。