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The Meals Study for Amyotrophic Lateral Sclerosis and Parkinson's Disease (Meals)

2026年5月28日 更新者：Katherine Morgan、The University of Tennessee, Knoxville

Assessing the Feasibility of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Dietary Pattern for Amyotrophic Lateral Sclerosis and Parkinson's Disease Treatment (Meals Study)

Brief summary template

The goal of this trial is to test the feasibility and efficacy of the Mediterranean-DASH Intervention for Neurodegenerative Delay (the MIND diet) in people living with amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD) and healthy controls. The main question[s] it aims to answer are:

  • How feasibile is our educational dietary intervention, which teaches participants with ALS, PD, and healthy controls to eat by the neuroprotective MIND dietary pattern?
  • How does the MIND dietary pattern affect the gut microbiome, metabolome, and lipidome in people with a neurodegenerative disease (ALS or PD) and healthy controls?
  • Does the MIND diet affect clinical measures of ALS and PD?
  • Does the MIND diet affect human biomarkers of systemic inflammation, metabolism, and neurodegeneration?

Participants will:

  • Receive a MIND diet cookbook, a folder with educational handouts, and weekly emails with links to educational videos about the MIND diet.
  • Complete a food diary, a MIND diet tracker, and a weekly questionnaire about their experience of eating by the MIND diet.
  • Collect stool specimens at the beginning, middle, and end of the study.
  • Undergo venipuncture at the beginning and end of the study.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

43

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Tennessee
      • Elizabethton、Tennessee、アメリカ、37643
        • Gary E Shealy Memorial ALS Clinic
      • Knoxville、Tennessee、アメリカ、37920
        • University Neurology
      • Knoxville、Tennessee、アメリカ、37922
        • The Cole Center for Parkinson's & Movement Disorders

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria for Participants with ALS:

  • Meet the El Escorial Criteria for definite, probable, or possible ALS:

    • Definite ALS is defined as presence of upper motor neuron (UMN) and lower motor neuron (LMN) signs in the bulbar region and at 2 of the other spinal regions
    • Probable ALS is defined as presence of UMN and LMN in at least 2 regions with UMN signs rostral to LMN signs; probable ALS supported by laboratory results is defined as presence of UMN in 1 region with electromyographic evidence of LMN involvement in another region
    • Possible ALS is defined as presence of UMN and LMN in 1 region or UMN in 2 or 3 regions (monomelic ALS, progressive bulbar palsy, and primary lateral sclerosis)
  • Voluntarily participate and able to consent
  • Have internet access
  • Willing to communicate by telephone or teleconferencing, and email
  • Minimum age of 30 years old
  • Able to masticate (chew) and swallow at the time of the study
  • Willing to return to the clinic eight weeks after enrolling for a regularly scheduled visit and post intervention data collection, or if they are not patients of the clinical sites, then they are willing to come to the clinic twice for study activities (once at enrollment and once upon exiting).
  • Patient (and their caregiver, if needed) must be willing and able (in the Investigator's opinion) to comply with all study requirements

Exclusion Criteria for Participants with ALS:

  • Patients that require a special diet (celiac/gluten free, vegetarian, or vegan)
  • Antibiotic use in past 6 months
  • History of bowel diseases or cancer (e.g., irritable bowel syndrome, celiac sprue, Crohn's
  • Younger than age 30
  • Unable to provide consent
  • Feeding by tube feed or primarily liquid diets
  • Unable to masticate or swallow.

Inclusion Criteria for Participants with PD:

  • Meet clinical criteria for PD per the MDS clinical criteria (Postuma et al, Movement Disorders,
  • 2015) as determined by the treating Movement Disorder specialist
  • Hoehn Yar < 2.5, as determined by the treating Movement Disorder Specialist.
  • Be 50 to 80 years of age upon enrollment.
  • Levodopa daily equivalents of no more than 500 a day
  • Subjects are within five years of the onset of symptoms at time of study enrollment.
  • Participants agree not to change PD medications during the 7-week dietary intervention.
  • Voluntarily participate and able to consent
  • Able to masticate (chew) and swallow at the time of the study
  • Have internet access
  • Willing to communicate by telephone or teleconferencing, and email

Exclusion Criteria for Participants with PD:

  • May not be taking medications concerning for a drug induced parkinsonism two years prior to
  • study entry such as antipsychotics, metoclopramide (Reglan), prochlorperazine (Compazine),
  • promethazine (Phenergan) or amiodarone
  • The movement disorder specialist must find no red flags for concern for atypical or Parkinson's Plus per the MDS diagnostic criteria (Postuma et al)
  • Patients that require a special diet (celiac/gluten free, vegetarian, or vegan)
  • Antibiotic use in past 6 months
  • History of bowel diseases or cancer (e.g., irritable bowel syndrome, celiac sprue, Crohn's Disease, colorectal cancer)
  • Unable to provide consent or struggling with major cognitive concerns as determined by the
  • treating Movement Disorder specialist
  • Feeding by tube feed or primarily liquid diets
  • Unable to masticate or swallow.

Inclusion Criteria for Healthy Controls:

  • Voluntarily participate and able to consent
  • Able to speak, read, and write English
  • Internet access,
  • Willing to communicate by telephone or teleconferencing, and email
  • Minimum age of 30 years
  • Able to masticate (chew) and swallow at the time of the study
  • Willing to visit the clinic two times to complete study activities
  • Patient (and their caregiver, if needed) must be willing and able (in the Investigator's opinion) to
  • comply with all study requirements

Exclusion Criteria for Healthy Controls:

  • Healthy people who require a special diet (celiac/gluten free, vegetarian, or vegan)
  • Antibiotic use in past 6 months
  • History of bowel diseases or cancer (e.g., irritable bowel syndrome, celiac sprue, Crohn's Disease, colorectal cancer)
  • Younger than age 30
  • Unable to consent
  • Feeding by tube feed or primarily liquid diets
  • Diagnosis with any neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, peripheral neuropathies).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Healthy controls
The control arm follows the same dietary educational intervention as the neurodegenerative arm. In the first week (week 0), baseline data, stool and blood samples, and dietary data is collected. The dietary educational intervention begins after baseline and comprises weeks 1-7. During these weeks, participants learn about the MIND diet, keep dietary records, and complete weekly questionnaires. The dietary education intervention consists of a brief meeting with a study team member, weekly emails, instructional videos, handouts, and a MIND diet cookbook. Stool is collected at baseline, and weeks 4 and 7. Venipuncture is performed in week 0 and 7 (before and after the intervention).
行動：The MIND diet
Participants meet briefly in person with a study team member to receive study materials (e.g., a MIND diet cookbook, a folder, olive oil, and stool collection kits) and an introduction to the MIND dietary pattern. Instruction includes recognizing the 10 healthy food categories (green leafy vegetables, other vegetables, berries, beans & legumes, poultry, seafood, whole grains, nuts, wine, and olive oil as the primary oil) and the 5 food categories that are to be limited (sweets, butter/margarine, red meats, eggs, and cheese). Participants receive weekly emails with links to educational videos about the MIND diet, handouts about the MIND diet food categories, serving/portion sizes, and weekly questionnaires. Participants keep food diaries a minimum of three days per week, and complete a daily MIND diet tracker, which reinforces learning the MIND dietary pattern.
他の名前：
  • Mediterranean-DASH Intervention to Delay Neurodegeneration
  • Mediterranean-DASH Hybrid diet
  • Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention to Delay Neurodegeneration
実験的：Participants with a neurodegenerative disease (amyotrophic lateral sclerosis or Parkinson's disease)
People who have been diagnosed with either ALS or PD will enroll in an 8-week study. In the first week (week 0), baseline data, stool and blood samples, and dietary data will be collected. The dietary educational intervention begins after baseline and comprises weeks 1-7. During these weeks, participants learn about the MIND diet, keep dietary records, and complete weekly questionnaires. The dietary education intervention consists of a brief meeting with a study team member, weekly emails, instructional videos, handouts, and a MIND diet cookbook. Stool is collected at baseline, and weeks 4 and 7. Venipuncture is performed in week 0 and 7 (before and after the intervention).
行動：The MIND diet
Participants meet briefly in person with a study team member to receive study materials (e.g., a MIND diet cookbook, a folder, olive oil, and stool collection kits) and an introduction to the MIND dietary pattern. Instruction includes recognizing the 10 healthy food categories (green leafy vegetables, other vegetables, berries, beans & legumes, poultry, seafood, whole grains, nuts, wine, and olive oil as the primary oil) and the 5 food categories that are to be limited (sweets, butter/margarine, red meats, eggs, and cheese). Participants receive weekly emails with links to educational videos about the MIND diet, handouts about the MIND diet food categories, serving/portion sizes, and weekly questionnaires. Participants keep food diaries a minimum of three days per week, and complete a daily MIND diet tracker, which reinforces learning the MIND dietary pattern.
他の名前：
  • Mediterranean-DASH Intervention to Delay Neurodegeneration
  • Mediterranean-DASH Hybrid diet
  • Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention to Delay Neurodegeneration

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
MIND Diet Score (MDS)
時間枠：From baseline to the end of 8 weeks
The MIND Diet Score (MDS) originally included 10 "brain-healthy" food categories, and 5 "unhealthy" food categories. Zero is equivalent to no adherence to the MIND diet and 15 is the highest possible adherence. The MDS is calculated for each week of the study. In this study, the maximum score will be 13, since we did not collect daily measures of olive oil and wine (2 out of 15 categories of healthy foods).
From baseline to the end of 8 weeks
Gut microbiome
時間枠：Stool is collected at three time points and analyzed by metagenomic sequencing: at baseline, 4 weeks after beginning the intervention, and 7 weeks after beginning the intervention
A metagenomic approach will be utilized to sequence the total DNA from participants' stool samples. Standard metagenomic pipelines will be used to identify the microbiome composition and determine their relative abundances (e.g., percentages, relative abundance). Associations between the MIND Diet Score (MDS) and gut microbiome will be tested.
Stool is collected at three time points and analyzed by metagenomic sequencing: at baseline, 4 weeks after beginning the intervention, and 7 weeks after beginning the intervention
Metabolomics and lipidomics for plasma and stool specimens
時間枠：Stool will be collected during baseline (days 1-7), during the 4th week of intervention (days 21-28), and during week 7 (days 42-49). Blood will be collected at baseline (day 1) and through study completion, an average of 7 weeks.
Data will be analyzed by standard pipelines like MetaboAnalyst for relative abundances (peak area/intensity) of metabolites and lipids.
Stool will be collected during baseline (days 1-7), during the 4th week of intervention (days 21-28), and during week 7 (days 42-49). Blood will be collected at baseline (day 1) and through study completion, an average of 7 weeks.

二次結果の測定

結果測定
メジャーの説明
時間枠
Biomarkers from plasma
時間枠：Blood collection will occur at baseline (day 1) and upon study completion, an average of 7 weeks.
Biomarkers of systemic inflammation, intestinal permeability, and metabolism will be quantified using ELISAs or multiplexing measured in units of concentration (pg/mL).
Blood collection will occur at baseline (day 1) and upon study completion, an average of 7 weeks.
Weight
時間枠：Prior to enrollment, an average of 3 months; baseline; and upon study completion, an average of 7 weeks.
Weight, measured in pounds (lb) and converted to kilograms (kg). Weight prior to enrollment will be abstracted from the medical record.
Prior to enrollment, an average of 3 months; baseline; and upon study completion, an average of 7 weeks.
Height
時間枠：baseline
Height will be abstracted from the subject's medical record and recorded in inches, then converted to centimeters.
baseline
ALS hand grip strength
時間枠：baseline and upon completion of the study, an average of 7 weeks
pounds (lbs)
baseline and upon completion of the study, an average of 7 weeks
Unified Parkinson's Disease Rating Scale (UPDRS) for PD
時間枠：baseline (day 1) and upon study completion, an average of 7 weeks.
A 4-part, 0-199 point scale used to measure Parkinson's severity, where higher scores indicate greater impairment and a score of 0 indicated normal. UPDRS inventories mental state, daily activities, motor function, and treatment complications.
baseline (day 1) and upon study completion, an average of 7 weeks.
ALS functional rating score-revised (ALSFRS-R)
時間枠：baseline (day 1) and upon study completion, an average of 7 weeks
total score ranges from 48 (normal function) to 0 (severe impairment)
baseline (day 1) and upon study completion, an average of 7 weeks
blood pressure
時間枠：baseline and upon study completion, an average of 7 weeks
mm/Hg
baseline and upon study completion, an average of 7 weeks
Hoehn and Yahr (modified H&Y) score for PD
時間枠：baseline and upon study completion, an average of 7 weeks

A clinician-rated scale assessed by the movement disorder specialist to assess the progression of PD from Stage 1.0 - Stage 5.0). Each stage is described as follows.

Stage 1.0: Symptoms affect only one side of the body (unilateral). Stage 1.5: Unilateral and axial (midline/neck/trunk) involvement. Stage 2.0: Bilateral involvement (both sides) without balance impairment. Stage 2.5: Mild bilateral disease with recovery on the pull test (test of postural stability).

Stage 3.0: Mild to moderate bilateral disease, some postural instability, but physically independent.

Stage 4.0: Severe disability; however, still able to walk or stand unassisted. Stage 5.0: Confinement to a wheelchair or bed unless assisted.
baseline and upon study completion, an average of 7 weeks
body mass index (BMI)
時間枠：baseline and upon study completion, an average of 7 weeks
weight and height will be combined to report BMI in kg/m^2
baseline and upon study completion, an average of 7 weeks
Rate of weight change for ALS participants
時間枠：1) the clinical visit prior to enrollment, an average of 3 months, 2) baseline, and 3) upon study completion, an average of 7 weeks
Rate and direction of weight change per unit of time (e.g., change in weight (lbs)/weeks) will be collected from the ALS patients' medical records prior to the intervention and during the intervention to compare the rate of change before the study and during the intervention.
1) the clinical visit prior to enrollment, an average of 3 months, 2) baseline, and 3) upon study completion, an average of 7 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

The University of Tennessee, Knoxville

協力者

University of Tennessee
East Tennessee State University
University of Tennessee Medical Center

捜査官

  • 主任研究者：Katherine Hope Morgan, PhD, MSN, FNP-BC, RN、University of Tennessee

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年11月20日

一次修了 (実際)

2025年5月21日

研究の完了 (実際)

2025年5月21日

試験登録日

最初に提出

2025年11月4日

QC基準を満たした最初の提出物

2026年5月28日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年5月28日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 5081

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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