Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy (MITOX)
The aim of the present study is to compare Resting Energy Expenditure (REE) between normal fat diet (NFD) as a control vs high fat diet (HFD) as a treatment in Mitochondrial cytopathies disorders ( MID's ) patients. Secondary objectives is to compare diet induced thermogenesis (DIT) and body composition between NFD vs HFD.
This study is a randomized cross-over study. Normal fat diet (ie 10 % proteins, 45 % lipids, 45 % carbohydrates) is the imposed diet at baseline, high fat diet (ie 10 % proteins, 30 % lipids, 60 % carbohydrates is used according to the cross-over design trial. Main evaluation criteria is REE and second evaluation criteria is DIT both measured by indirect calorimetry ). 36 included MID subjects will be included in this study. Main evaluation criteria and second evaluation criteria will be measured at baseline, 1 month, 2 month and 3 month.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Lille、法国、59037
- Centre d'Investigation Clinique
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Paris、法国、75000
- Centre d'Investigation Clinique
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
5 to 21 years-old children,
- Children with a proven mitochondrial cytopathy documented on biopsies by histology, histoenzymology, ultrastructure and enzyme assay and/or on body fluids by laboratory markers including lactacidemia, metabolic acidosis, increased CSF lactate, lactate/pyruvate and beta-hydroxybutyrate/acetoacetate ratios, paradoxical postprandial ketonemia, alaninemia, citrullinemia, plasma acylcarnitines.
- Children on the usual diet (30% lipids, 60% glucides and 10% proteins) for at least 1 month.
- Informed consent of the 2 parents and from the child when in age to express a consent.
- Child with a social security cover.
Exclusion Criteria:
- Acute infection (fever > 38.5°C for more than 6h) within 7 days prior to the study.
- Disability for understanding and following the protocol
- Rejection of the study by the patient or failure to comply to the protocol
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：high fat diet
10 % proteins, 30 % lipids, 60 % carbohydrates
|
high fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates
|
|
安慰剂比较：Normal fat diet
10 % proteins, 45 % lipids, 45 % carbohydrates
|
high fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
resting energy expenditure
大体时间：up to 3 months
|
resting energy expenditure measured by indirect calorimetry
|
up to 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
diet induced thermogenesis
大体时间：baseline, 1 month, 2 months, 3 months
|
diet induced thermogenesis measured by indirect calorimetry
|
baseline, 1 month, 2 months, 3 months
|
|
body composition
大体时间：baseline, 1 month, 2 months, 3 months
|
body composition by DEXA
|
baseline, 1 month, 2 months, 3 months
|
合作者和调查者
调查人员
- 首席研究员：Dries DOBBELAERE, MD、University Hospital, Lille
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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