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

28 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

43

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Tennessee
      • Elizabethton, Tennessee, Stati Uniti, 37643
        • Gary E Shealy Memorial ALS Clinic
      • Knoxville, Tennessee, Stati Uniti, 37920
        • University Neurology
      • Knoxville, Tennessee, Stati Uniti, 37922
        • The Cole Center for Parkinson's & Movement Disorders

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Comportamentale: 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.
Altri nomi:
  • Mediterranean-DASH Intervention to Delay Neurodegeneration
  • Mediterranean-DASH Hybrid diet
  • Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention to Delay Neurodegeneration
Sperimentale: 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).
Comportamentale: 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.
Altri nomi:
  • Mediterranean-DASH Intervention to Delay Neurodegeneration
  • Mediterranean-DASH Hybrid diet
  • Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention to Delay Neurodegeneration

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
MIND Diet Score (MDS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Biomarkers from plasma
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: baseline
Height will be abstracted from the subject's medical record and recorded in inches, then converted to centimeters.
baseline
ALS hand grip strength
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The University of Tennessee, Knoxville

Collaboratori

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

Investigatori

  • Investigatore principale: Katherine Hope Morgan, PhD, MSN, FNP-BC, RN, University of Tennessee

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 novembre 2023

Completamento primario (Effettivo)

21 maggio 2025

Completamento dello studio (Effettivo)

21 maggio 2025

Date di iscrizione allo studio

Primo inviato

4 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 5081

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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