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Идёт набор NCT06450977

Remote Evaluation of MIND Diet

Без фазы С лечением Multiple Sclerosis Cognitive Change Nutrition, Healthy

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: MIND Diet, Control Diet.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Cognitive Change, Nutrition, Healthy. Базовые параметры: 18 лет — 64 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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Обзор

The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves thinking ability and memory compared to a healthy control diet in persons with Multiple Sclerosis (MS). The main question it aims to answer is: Does the MIND diet improve cognitive performance relative to a control diet in persons with MS? Participants will: Consume one meal that follows the MIND diet or a control meal every day for 3 months, complete online surveys and cognitive testing before and after, and keep a record of the food they eat during the study.

Подробное описание

The purpose of this study is to understand how a healthy diet is related to thinking ability and memory in people with multiple sclerosis (MS). This study is fully remote consisting of meals being delivered to participant homes using Daily Harvest meal delivery service. Participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks. The study meals and smoothies will follow either a dietary pattern thought to improve brain health (Mediterranean-DASH Intervention for Neurodegenerative Delay; MIND), or a control diet, and will include foods commonly found in grocery stores. Participants will not know which diet they are assigned to (active or control). Participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided. Participants will complete a series of online forms or surveys. Additionally, participants will complete an online cognitive battery from Cambridge Neuropsychological Test Automated Battery (CANTAB) at the beginning and end of the study.

Вмешательства

  • Другое MIND Diet
    Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.
  • Другое Control Diet
    Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.

Первичные конечные точки

  • Information Processing [Срок оценки: 12 weeks (Baseline vs. Follow Up)]
  • Visual Processing [Срок оценки: 12 weeks (Baseline vs. Follow Up)]
  • Processing Speed [Срок оценки: 12 weeks (Baseline vs. Follow Up)]
  • Learning [Срок оценки: 12 weeks (Baseline vs. Follow Up)]
  • Memory [Срок оценки: 12 weeks (Baseline vs. Follow Up)]
  • MIND Scores [Срок оценки: 12 weeks (Baseline vs. Follow Up)]
Вторичные конечные точки (6)
  • Recruitment Rates [Срок оценки: Throughout the recruitment process]
  • Refusal Rates [Срок оценки: Throughout the recruitment process.]
  • Retention rates [Срок оценки: Throughout the intervention (weeks 1-12)]
  • Attrition rates [Срок оценки: Throughout the intervention (weeks 1-12)]
  • Adherence/Compliance Rates [Срок оценки: Throughout the intervention (weeks 1-12)]
  • Participant Experience and Burden [Срок оценки: Throughout the intervention (weeks 1-12)]

Критерии участия

Критерии включения

  • Individuals aged 18-64 years old
  • Self-reported diagnosis of Multiple sclerosis (MS)
  • 20/20 or corrected vision
  • No other neurodegenerative disease diagnosis
  • Stable disease-modifying therapy (DMT) within 6 months
  • Not Pregnant or lactating
  • No food allergies or intolerances
  • Able to consume study meals
  • Not enrolled in another dietary, exercise, or medication study during the study
  • Access to a computer/laptop with internet

Критерии исключения

  • Individuals younger than 18 or older than 64 years old
  • No self-reported diagnosis of Multiple sclerosis (MS)
  • Not 20/20 or uncorrected vision
  • Other neurodegenerative disease diagnosis
  • Disease modifying therapy (DMT) less than 6 months
  • Pregnant or lactating
  • Food allergies or intolerances
  • Not able to consume study meals
  • Enrolled in another dietary, exercise, or medication study during the study
  • No access to a computer/laptop with internet

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
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Illinois Urbana-Champaign — Urbana

Публикации

  • Martell SG, Holthaus TA, Verma S, Adamson B, Motl RW, Khan NA. Mediterranean-DASH intervention for neurodegenerative delay (MIND) diet intervention in persons with multiple sclerosis: A feasibility, randomized controlled trial. Nutr Res. 2026 May 28;152:11-25. doi: 10.1016/j.nutres.2026.05.006. Online ahead of print. PMID 42314522

Идентификаторы

NCT: NCT06450977 · REMIND

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗