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

28 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

43

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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).
Behawioralne: 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.
Inne nazwy:
  • Mediterranean-DASH Intervention to Delay Neurodegeneration
  • Mediterranean-DASH Hybrid diet
  • Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention to Delay Neurodegeneration
Eksperymentalny: 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).
Behawioralne: 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.
Inne nazwy:
  • Mediterranean-DASH Intervention to Delay Neurodegeneration
  • Mediterranean-DASH Hybrid diet
  • Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention to Delay Neurodegeneration

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
MIND Diet Score (MDS)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Biomarkers from plasma
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline
Height will be abstracted from the subject's medical record and recorded in inches, then converted to centimeters.
baseline
ALS hand grip strength
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The University of Tennessee, Knoxville

Współpracownicy

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

Śledczy

  • Główny śledczy: Katherine Hope Morgan, PhD, MSN, FNP-BC, RN, University of Tennessee

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 listopada 2023

Zakończenie podstawowe (Rzeczywisty)

21 maja 2025

Ukończenie studiów (Rzeczywisty)

21 maja 2025

Daty rejestracji na studia

Pierwszy przesłany

4 listopada 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 maja 2026

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 5081

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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