Randomized Controlled Trial of MIND Diet for Neuroprotection and Symptom Management in MS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in plasma neurofilament light chain (NfL)
研究概览
简要总结
This study will assess the impact of a MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) diet on brain health and MS symptoms. Participants will be randomly assigned to one of two arms: the diet intervention arm or the "continue current diet"/control arm. Participants randomized to the dietary intervention arm will change their diet to follow a MIND dietary pattern for one year; diet-related education and programming is provided to support this change. Participants randomized to the continue/control arm will be asked to continue their current dietary habits, without major change for one year; multiple sclerosis (MS) MS-related related education and programming (unrelated to diet) is provided. All participants will be asked to provide blood & stool samples and to complete online questionnaires & three in-person assessments.
详细描述
The goal of this study is to evaluate the effects of a Mediterranean-style dietary intervention on neuroprotection and symptom management in MS with an early phase II, randomized, controlled clinical trial. Participants will be randomized-stratified by MS phenotype and treatment type-to the diet intervention arm (change current diet to a MIND diet) or the continue/control arm (no major change in current dietary habits).
All patients will participate in a baseline visit, and 6 month visit, a 12 month (end of study visit), and meet with small support groups between study visits.
Participants will also complete online questionnaires, undergo functional & cognitive assessments, and contribute blood & stool samples while on protocol.
The diet intervention arm will receive MIND diet-related education and support from the study dietitian and the principal investigator; virtual small group environments will facilitate discussion about participants' experience and potential challenges with MIND diet adherence and ways to overcome them. Virtual groups will meet weekly for the first month, then monthly through month 12.
The continue current dietary habits /control arm will receive MS-related education and support unrelated to diet from members of the study team and the principal investigator. Group meeting topics and schedules will be provided in advance to offer flexibility; participants are required to attend 6 virtual small group meetings but are invited to join as many as desired.
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
Neurological exams and functional & cognitive assessments will be conducted by trained staff who are masked from the participant's diet assignment.
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
- 否
入选标准
- •Ages 18-70 years, inclusive
- •MS diagnosis, on any treatment (including no treatment)
- •MIND diet score of ≤8 at baseline
- •NfL parameters determined by age
排除标准
- •Diagnosis of an additional neurodegenerative disease (e.g. Alzheimer's) or other serious neurological condition (e.g. stroke)
- •Current serious medical condition that could impact the ability to participate or influence study results (e.g. cancer, HIV)
- •Pregnancy/planning during study period
研究组 & 干预措施
MIND Diet
Participants randomized to the intervention arm will change their dietary patterns to adhere to the MIND diet for one year after randomization.
干预措施: Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet (Behavioral)
MIND Diet
Participants randomized to the intervention arm will change their dietary patterns to adhere to the MIND diet for one year after randomization.
干预措施: Small Group (Behavioral)
Continue Diet
Participants randomized to the control arm will continue their current dietary habits, without major changes, for one year after randomization. Participants will not receive diet education in small group.
干预措施: Small Group (Behavioral)
结局指标
主要结局
Changes in plasma neurofilament light chain (NfL)
时间窗: Baseline, 6-months, and at 12-months
Plasma NfL quantification will be reported in units of pg/ml.
次要结局
- Neurological Fatigue Index-MS (NFI-MS)(Baseline, 6-months, and at 12-months)
- The Expanded Disability Status Scale (EDSS)(Baseline, 6-months, and at 12-months)
- The Symbol-Digit Modalities Test (SDMT)(Baseline, 6-months, and at 12-months)
- California Verbal Learning Test (CVLT-II)(Baseline, 6-months, and at 12-months)
- Brief Visuospatial Memory Test (BVMT-R)(Baseline, 6-months, and at 12-months)
- The 9-Hole Peg Test (9HPT)(Baseline, 6-months, and at 12-months)
- Timed 25-Foot Walk (T25FW)(Baseline, 6-months, and at 12-months)
- The 2-Minute Walk Test(Baseline, 6-months, and at 12-months)
- Multiple Sclerosis Impact Scale (MSIS-29)(Baseline, 6-months, and at 12-months)
- Multiple Sclerosis Cognitive Scale (MSCS)(Baseline, 6-months, and at 12-months)
- MIND Diet Score(Baseline, 6-months, and at 12-months)
- MIND Diet Adherence Score(Baseline, 6-months, and at 12-months)
- The Diet History Questionnaire (DHQ)(Baseline, 6-months, and at 12-months)
- The Insomnia Severity Index (ISI)(Baseline, 6-months, and at 12-months)
- The Godin Leisure-Time Exercise Questionnaire (GLTEQ)(Baseline, 6-months, and at 12-months)
- Glial fibrillary acidic protein (GFAP) level(Baseline, 6-months, and at 12-months)
- Lipid panel(Baseline, 6-months, and at 12-months)
- Apolipoproteins level(Baseline, 6-months, and at 12-months)
- Hemoglobin A1C Test(Baseline, 6-months, and at 12-months)
- The NHANES biological aging index (BAI)(Baseline, 6-months, and at 12-months)
- Leukocyte telomere length (LTL)(Baseline, 6-months, and at 12-months)
- Neurological Fatigue Index-MS (NFI-MS)(Baseline, 6-months, and at 12-months)
- The Expanded Disability Status Scale (EDSS)(Baseline, 6-months, and at 12-months)
- The Symbol-Digit Modalities Test (SDMT)(Baseline, 6-months, and at 12-months)
- California Verbal Learning Test (CVLT-II)(Baseline, 6-months, and at 12-months)
- The 9-Hole Peg Test (9HPT)(Baseline, 6-months, and at 12-months)
- Brief Visuospatial Memory Test (BVMT-R)(Baseline, 6-months, and at 12-months)
- Timed 25-Foot Walk (T25FW)(Baseline, 6-months, and at 12-months)
- The 2-Minute Walk Test(Baseline, 6-months, and at 12-months)
- The Diet History Questionnaire (DHQ)(Baseline, 6-months, and at 12-months)
- Multiple Sclerosis Impact Scale (MSIS-29)(Baseline, 6-months, and at 12-months)
- Multiple Sclerosis Cognitive Scale (MSCS)(Baseline, 6-months, and at 12-months)
- MIND Diet Score(Baseline, 6-months, and at 12-months)
- MIND Diet Adherence Score(Baseline, 6-months, and at 12-months)
- The Insomnia Severity Index (ISI)(Baseline, 6-months, and at 12-months)
- The Godin Leisure-Time Exercise Questionnaire (GLTEQ)(Baseline, 6-months, and at 12-months)
- Glial fibrillary acidic protein (GFAP) level(Baseline, 6-months, and at 12-months)
- Lipid panel(Baseline, 6-months, and at 12-months)
- Apolipoproteins level(Baseline, 6-months, and at 12-months)
- Hemoglobin A1C Test(Baseline, 6-months, and at 12-months)
- The NHANES biological aging index (BAI)(Baseline, 6-months, and at 12-months)
- Leukocyte telomere length (LTL)(Baseline, 6-months, and at 12-months)
研究者
Ilana Katz Sand
Associate Professor, Neurology; Associate Director, CGD Center for MS
Icahn School of Medicine at Mount Sinai