A Study of the MIND Diet for Persons With Multiple Sclerosis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet, Small Group.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis. Базовые параметры: 18 лет — 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Randomized Controlled Trial of MIND Diet for Neuroprotection and Symptom Management in MS
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet
A dietary pattern which promotes the intake of olive oil, fish, leafy greens \& other vegetables, fruits, whole grains, and legumes, and discourages processed foods, red meat, and sugar. - Поведенческое Small Group
Education and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.
Первичные конечные точки
- Changes in plasma neurofilament light chain (NfL) [Срок оценки: Baseline, 6-months, and at 12-months]
Вторичные конечные точки (12)
- Neurological Fatigue Index-MS (NFI-MS) [Срок оценки: Baseline, 6-months, and at 12-months]
- The Expanded Disability Status Scale (EDSS) [Срок оценки: Baseline, 6-months, and at 12-months]
- The Symbol-Digit Modalities Test (SDMT) [Срок оценки: Baseline, 6-months, and at 12-months]
- California Verbal Learning Test (CVLT-II) [Срок оценки: Baseline, 6-months, and at 12-months]
- Brief Visuospatial Memory Test (BVMT-R) [Срок оценки: Baseline, 6-months, and at 12-months]
- The 9-Hole Peg Test (9HPT) [Срок оценки: Baseline, 6-months, and at 12-months]
- Timed 25-Foot Walk (T25FW) [Срок оценки: Baseline, 6-months, and at 12-months]
- The 2-Minute Walk Test [Срок оценки: Baseline, 6-months, and at 12-months]
- Multiple Sclerosis Impact Scale (MSIS-29) [Срок оценки: Baseline, 6-months, and at 12-months]
- Multiple Sclerosis Cognitive Scale (MSCS) [Срок оценки: Baseline, 6-months, and at 12-months]
- MIND Diet Score [Срок оценки: Baseline, 6-months, and at 12-months]
- MIND Diet Adherence Score [Срок оценки: Baseline, 6-months, and at 12-months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Mount Sinai Hospital — New York
Идентификаторы
NCT: NCT06992115 · GCO 23-0300 · RG-2407-43743