A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis (FAST-MS)
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and tolerability of 7-day FMD
研究概览
简要总结
This study is an open-label, single-arm, run-in study in patients with RRMS treated with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate), assessing the feasibility and tolerability of 3 cycles of Fasting-Mimicking Diet (FMD) over 6 months. All eligible patients will receive 3 cycles of the FMD once every 60 days in addition to their standard therapy with first line therapies. The diet provides 1100kcal on day 1 and 800 kcal on days 2-7. The diet consists of ingredients which are Generally Regarded As Safe (GRAS) selected for their fasting mimicking properties.
详细描述
The primary objective of the present study is to evaluate the safety and tolerability of 3 cycles of a 7 days FMD as a potential support to the management of patients affected by RRMS treated with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate). The primary endpoint is the number of serious and/or severe adverse events after the FMD start. A nutritionist will follow the patients for all the 6 months period, with the aim to monitor the FMD effects and to check for any possible problems. The nutritionist will call the patient on day 1 of every FMD cycle to answer any questions and check on the response, and on day 5 of the FMD to check on side effects and adherence.
At scheduled visits, vital signs and adverse events will be recorded from every patient.
Blood samples will be collected at baseline and just before at day 7 before returning to the normal diet on cycle 1 and 1 week after the first, the second and third FMD cycles. Should the patient display abnormal counts, the CBC will be repeated one week later. Additional FMD cycles will not be allowed in patients who do not return to normal levels of White Blood Cells (WBC) and Red Blood Cells (RBC).
At scheduled visits, vital signs and adverse events will be recorded from every patient.
FMD will be administered at month 0, month 2 and month 4 (3 cycles). MRI will be done at baseline and at month 6. At baseline and at month 6 patients will be evaluated with the EDSS and MSFC Functional composite scale. At the same time points, patients will be examined for the presence of cognitive disturbances by the Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS) battery , of anxiety and depressive symptoms by the Hospital Anxiety and Depression Scale (HADS) , of fatigue by the Modified Fatigue Impact Scale (MFIS) , while quality of life will be monitored using the Short Form 36 Health Survey (SF-36) . A nutritional assessment will be carried out at enrollment and before every FMD cycle: patients will be examined evaluating the height and weight, with determination of the BMI; the bodily composition will be measured with a dynamometer and by BIA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of RRMS (Thompson et al. 2018);
- •Disease duration 6 months to 10 years (included);
- •EDSS 0 to 4, 5;
- •Treatment with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate).
排除标准
- •< 6 months since treatment start with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate);
- •Relapse < 60 days;
- •Any active or chronic infection;
- •Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year;
- •Severely limited life expectancy by another co-morbid illness;
- •Nutritional risk screening (NRS 2002) > or = 3;
- •BMI <= 18.5 kg/m2;
- •Bio-impedance phase angle <5.0°;
- •History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts;
结局指标
主要结局
Safety and tolerability of 7-day FMD
时间窗: 6 months
Safety of 7-day FMD in terms of percentage of patients experiencing adverse events and/or worsening of nutritional status. To obtain clinical data on safety of the FMD in MCI or AD patients as assessed by percentage of patients (%) experiencing \> grade 3 adverse events and/or a significant decrease in their lean body mass (kg) and/or with a reduction of phase angle \<5° assessed with bio-impedance measurements. for Adverse Events (CTCAE)
次要结局
- Changes in Body Mass Index (BMI)(6 months)
- Changes in the serum light chain neurofilaments concentration(6 months)
- Efficacy of the FMD in terms of nutritional state(6 months)
- Percentage of patients able to achieve the designated diet regimen(6 months)
- Changes in the Expanded Disability Status Scale (EDSS)(6 months)
- White Blood Cells(6 months)