A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
2017年11月14日 更新者：Ellen M. Mowry、Johns Hopkins University
Experimental studies of the experimental autoimmune encephalomyelitis (EAE), a mouse model of multiple sclerosis, indicate that the number of calories fed to mice prevent EAE and are also associated with less severe disease in mice who do develop the disease.
Currently, whether these results translate favorably in humans is unknown.
This is a pilot trial of testing two caloric restriction (CR) diets versus a control diet in multiple sclerosis (MS) patients: one continuous caloric restriction (CR) diet where a small number of calories will be restricted every day or another intermittent CR diet where a caloric intake will be restricted more severely 2 days per week.
Participants are randomized to one of the diets, and for the first 8 weeks, will receive standardized, prepared meals tailored to the specific diet.
At the conclusion of the controlled feeding study, all participants will transition to an unblinded phase for an additional 40 weeks where they are provided with instructions to follow an intermittent CR diet.
研究概览
研究类型
介入性
注册 (实际的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Aged 18-50
- Capable of storing food safely, willing to follow diet/eat provided food, and able to receive shipments at home or work
- Meets 2010 criteria for McDonald MS;
- Relapse or new lesion in previous 2 years
- Expanded disability status score (EDSS) < 6
- Disease duration ≤15 years
- Untreated or on stable on first-line MS therapy [injectable] for at least 6 months, with no anticipated changes in the next 10 weeks
- Unchanged vitamin D dose or thyroid replacement dose (for those on it) with no anticipated changes or in supplement use for the next 10 weeks.
- Non-regular smoker (average no more than 1 cigarette/day) for at least 2 months
- Stable weight, by self report, for past 3 months (± 8 lbs)
- Body mass index (BMI) > 23 kg/m2
Exclusion Criteria:
Pregnant or nursing, or unwilling to prevent pregnancy (if of childbearing to potential)
- History of gastrointestinal disease causing malabsorption
- History of diabetes requiring medication
- History of stage IV/V chronic kidney disease or vascular disease
- History of major surgery in past 3 months
- Current use of warfarin
- History of eating disorder
- Currently on a special diet for MS/other diet (provided diet will be pork free)
- Chemotherapy within the past year
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Continuous calorie restriction
Participants will be provided with a diet that includes approximately 78% of calories each day that would be needed to maintain current BMI.
|
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
|
|
实验性的：Intermittent calorie restriction
Participants will be provided a diet that with a daily calorie intake required to maintain current BMI, except only 25% of this calorie intake will be provided for 2 days a week.
|
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
|
|
安慰剂比较：Control calorie intake
Participants will be assigned to consume enough calories each day required to maintain current BMI
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Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
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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 |
|---|---|---|
|
Adverse events
大体时间：8 weeks
|
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
|
8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adherence to Calories Assigned
大体时间：8 weeks
|
Adherence will be assessed by comparing the total caloric intake provided to the patients through the assigned diet to the total energy intake determined by the research dieticians.
|
8 weeks
|
|
Adherence to Calories Assigned
大体时间：48 weeks
|
Adherence during the "advice-only" phase will be compared to adherence in each diet group during the first 8 weeks using paired t-tests, where the grouping is done naturally by subject.
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48 weeks
|
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Adverse Events
大体时间：48 weeks
|
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
|
48 weeks
|
|
Quality of Life Questionnaire
大体时间：48 weeks
|
"Functional Assessment in MS" results will be assessed during the study
|
48 weeks
|
|
NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire
大体时间：48 weeks
|
PROMIS Fatigue results will be assessed during the study
|
48 weeks
|
|
Change in metabolite ratios
大体时间：8 weeks
|
The impact of each calorie restriction diet versus control diet on the metabolomics profile will be assessed.
|
8 weeks
|
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Immune cell subsets/cytokines
大体时间：8 weeks
|
The impact of each calorie restriction diet versus control diet on ratios of immune cell subsets (e.g.
T-helper (TH)17, TH1, TH2, T regulatory) and related cytokines will be assessed.
|
8 weeks
|
|
Change in concentration of measures of metabolism
大体时间：8 weeks
|
The impact of each calorie restriction diet versus control diet on fasting glucose, insulin, leptin, ghrelin, C-reactive protein, lipids, and long-chain ceramides will be assessed.
|
8 weeks
|
|
Change in serum lipid concentration
大体时间：8 weeks
|
The impact of each calorie restriction diet versus control diet on fasting lipids and long-chain ceramides will be assessed.
|
8 weeks
|
|
Change in serum brain-derived neurotrophic factor concentration (BDNF)
大体时间：8 weeks
|
The impact of each calorie restriction diet versus control diet on fasting BDNF will be assessed.
|
8 weeks
|
|
Change in levels of oxidative stress biomarkers
大体时间：8 weeks
|
The impact of each calorie restriction diet versus control diet on protein carbonyls, 8-isoprostane, nitrotyrosine, and 4-hydroxynonenal adducts will be assessed.
|
8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ellen Mowry, MD、Johns Hopkins University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年12月1日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2015年12月28日
首先提交符合 QC 标准的
2016年1月4日
首次发布 (估计)
2016年1月6日
研究记录更新
最后更新发布 (实际的)
2017年11月17日
上次提交的符合 QC 标准的更新
2017年11月14日
最后验证
2017年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB00065806
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.