A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Diet (Other)
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.
干预措施: Diet (Other)
Control calorie intake
Participants will be assigned to consume enough calories each day required to maintain current BMI
干预措施: Diet (Other)
结局指标
主要结局
Adverse events
时间窗: 8 weeks
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
次要结局
- Quality of Life Questionnaire(48 weeks)
- Change in concentration of measures of metabolism(8 weeks)
- Adverse Events(48 weeks)
- Change in metabolite ratios(8 weeks)
- NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire(48 weeks)
- Change in serum brain-derived neurotrophic factor concentration (BDNF)(8 weeks)
- Adherence to Calories Assigned(48 weeks)
- Immune cell subsets/cytokines(8 weeks)
- Change in serum lipid concentration(8 weeks)
- Change in levels of oxidative stress biomarkers(8 weeks)
- Adherence to Calories Assigned(8 weeks)
研究者
Ellen M. Mowry
Associate Professor of Neurology and Epidemiology
Johns Hopkins University