A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Fatigue
研究概览
简要总结
A randomized, controlled pilot trial of a dietary intervention vs. wait-list control in patients with MS and fatigue for management of their fatigue. The hypothesis of this study is that participants following the low-fat study diet will demonstrate a significant reduction in fatigue after four months compared to wait list controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Diet adherence assessments will be conducted by blinded assessors from OHSU bionutrition team.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-70
- •Diagnosis of MS by 2010 McDonald Criteria
- •EDSS ≤ 7.5
- •Experiencing moderate to severe fatigue (MFIS ≥ 38)
排除标准
- •Current cardiopulmonary disease requiring treatment
- •Pregnancy or breast-feeding
- •MS exacerbation within 30 days of screening visit
- •IV steroids within 30 days of screening visit
- •Dietary fat content of <30% as assessed by food frequency questionnaire (FFQ) at screening visit
- •Fish oil or flax seed oil supplementation within 30 days of screening visit
结局指标
主要结局
Fatigue
时间窗: Baseline to month 4
Measured by Modified Fatigue Impact Scale (MFIS). The MFIS is a 21-item questionnaire that assesses overall self-reported fatigue. Subjects rate agreement with a series of statements on a scale of 0 (rarely) to 4 (almost always), in context of their fatigue over the preceding four weeks. Total possible score of 84. Individuals with an MFIS score of \> 38 are considered to experience moderate to severe "fatigue
次要结局
- Fatigue(Baseline to month 4)
- Disability(Baseline to month 4)
研究者
Vijayshree Yadav
Associate Professor of Neurology
Oregon Health and Science University