Randomized Controlled Trial on Intermittent Fasting in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Leptin
研究概览
简要总结
This is a randomized controlled trial that will test the effects of intermittent fasting (IF) in subjects with relapsing-remitting MS (RRMS). The goal of this clinical trial is to acquire objective evidence regarding whether an IF diet has beneficial effects in MS patients.Two dietary regimens, IF and western diet, will be compared in a randomized, controlled, single-blinded 12 week trial in RRMS patients. This is a single-center study.
详细描述
RRMS patients will be enrolled in a randomized, controlled, single-blinded 12 week trial in which IF will be compared to a standard western diet. Patients will be recruited at the John L. Trotter MS center and randomly assigned to either a standard western diet or an IF diet (1:1). Enrolled subjects will complete a clinical and laboratory assessment before starting the diet (baseline), at week 6 and at end of the study (week 12). The primary outcome will be leptin at week 12 measured in the peripheral blood. Secondary outcomes will be: 1) peripheral blood metabolic profiling; 2) anthropometric (body mass index and waist circumference) and total body fat measures; 3) gut microbiota richness and composition.
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)
盲法说明
Outcome assessors will be blinded to the intervention because they will not know the group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RRMS (2010 Mc Donald criteria).
- •EDSS <6.0 and disease duration ≤ 15 years.
- •On an injectable therapy for MS, glatiramer acetate (GA) or beta-interferon (beta-IFN) for at least 3 months prior to the study and with no anticipated changes of the medication for the 12 week study duration.
- •Age ≥18 years.
- •BMI > 22 and < 35 kg/m2 with stable weight in the 3 months prior to screening.
排除标准
- •History of any chronic disease process (excluding MS) that could interfere with interpretation of results.
- •Diagnosis in the past of an eating disorder (anorexia, bulimia, or binge eating).
- •Relapsing at the time of enrollment.
- •On corticosteroid treatment (oral or intravenous) in the past month. Nasal corticosteroid treatments are allowed.
- •Diagnosis of diabetes or at time of OGTT (fasting glucose >126 mg/dl or > 200 mg/dl at 2 hours with a load of 75 g of glucose
- •History of food allergies or food intolerance that would interfere with the study.
- •History of antibiotic treatment within the past 3 months prior to enrollment
- •Use of anticoagulant drugs (like Warfarin or Coumadin) that need to monitor their intake of vegetables containing high levels of vitamin K.
- •Currently on a special diet and not willing to stop at least one month prior to enrollment
- •Currently taking omega 3/fish oil supplements and not willing to stop administration one month prior to enrollment
- •Currently pregnant or plan to become pregnant within 6 months
- •Current tobacco or e-cigarette smoker
研究组 & 干预措施
Intermittent fasting
The subjects randomized to this group will do IF by restricting their diet and consuming few calories two days per week. During the days of fasting, subjects will be allowed to drink water, calorie-free beverages, and eat fresh, steamed or roasted non-starchy vegetables.
干预措施: Intermittent fasting (Other)
Western diet
The subjects randomized to this group will eat a standard western style diet.
结局指标
主要结局
Leptin
时间窗: 12 weeks
Leptin at week 12 measured in the peripheral blood
次要结局
- Anthropometric measure(12 weeks)
- Gut microbiota(12 weeks)
- Peripheral metabolic and inflammatory profiling(12 weeks)