A Randomised Controlled Pilot Study to Compare the Effects of Prolonged Fasting and Ketogenic Low Glycemic Load Treatment on Health Related Quality of Life in Relapsing-remitting Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months.
研究概览
简要总结
It is well accepted that nutrition as an environmental factor is involved in the pathogenesis of multiple sclerosis. But is there a role for prolonged fasting and ketogenic low glycemic load treatment to alter the course of multiple sclerosis (MS)? The investigators think yes there is. Primarily the investigators want to detect if these diets are feasible for MS patients. Therefore the investigators examine the impact of this dietary intervention on the health related quality of life for individuals after 7 days, 3 months and 6 months in compare to baseline. Secondarily the investigators focus on endocrinological and immunological changes after 7 days, 3 months and 6 months in compare to baseline.
详细描述
In this controlled randomised pilot study the patients are allocated to 1. a ketogenic low glycemic load treatment from the outset of the study for 24 weeks or 2. enhance their regular diet with an initial 7-day fasting followed by a Mediterranean diet pattern until the study end or 3. stay on their regular diet (control group) from the outset of the study for 24 weeks. The investigators will then assess the differences between the groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing remitting MS
- •Stable immunomodulatory treatment or no treatment at least 6 months prior to inclusion
- •Expanded disability status scale < 7
- •Body mass index (BMI) > or = 18,5 OR BMI > or = 45 with no risk factors
- •Not pregnant or breast-feeding
- •No serious mental health illness such as dementia or schizophrenia;
- •No use of a weight loss therapy in the month prior to screening.
排除标准
- •Start or changes if immunomodulatory treatment < 7 months prior to screening
- •SPMS or PPMS
- •Relapse or corticosteroid use < 30 days prior to screening
- •Diabetes or any metabolic defects
- •Drug abuse
结局指标
主要结局
Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months.
时间窗: Visit: Baseline, month 1, month 3 and month 6
Two summary scores: physical health und mental health, 12 subscales and 2 single item scales.
次要结局
- Adherence rates, number of participants with adverse events and laboratory parameters at 6 months.(Visits: Baseline, month 1, month 3 and month 6)
研究者
Markus Bock, MD
Principal Investigator
Charite University, Berlin, Germany