The Meals Study for Amyotrophic Lateral Sclerosis and Parkinson's Disease (Meals)
28 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
43
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Tennessee
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Elizabethton, Tennessee, Estados Unidos, 37643
- Gary E Shealy Memorial ALS Clinic
-
Knoxville, Tennessee, Estados Unidos, 37920
- University Neurology
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Knoxville, Tennessee, Estados Unidos, 37922
- The Cole Center for Parkinson's & Movement Disorders
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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).
|
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.
Otros nombres:
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Experimental: 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).
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
MIND Diet Score (MDS)
Periodo de tiempo: 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).
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From baseline to the end of 8 weeks
|
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Gut microbiome
Periodo de tiempo: 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
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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.
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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
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Metabolomics and lipidomics for plasma and stool specimens
Periodo de tiempo: 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.
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Data will be analyzed by standard pipelines like MetaboAnalyst for relative abundances (peak area/intensity) of metabolites and lipids.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Biomarkers from plasma
Periodo de tiempo: Blood collection will occur at baseline (day 1) and upon study completion, an average of 7 weeks.
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Biomarkers of systemic inflammation, intestinal permeability, and metabolism will be quantified using ELISAs or multiplexing measured in units of concentration (pg/mL).
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Blood collection will occur at baseline (day 1) and upon study completion, an average of 7 weeks.
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Weight
Periodo de tiempo: Prior to enrollment, an average of 3 months; baseline; and upon study completion, an average of 7 weeks.
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Weight, measured in pounds (lb) and converted to kilograms (kg).
Weight prior to enrollment will be abstracted from the medical record.
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Prior to enrollment, an average of 3 months; baseline; and upon study completion, an average of 7 weeks.
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Height
Periodo de tiempo: baseline
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Height will be abstracted from the subject's medical record and recorded in inches, then converted to centimeters.
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baseline
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ALS hand grip strength
Periodo de tiempo: baseline and upon completion of the study, an average of 7 weeks
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pounds (lbs)
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baseline and upon completion of the study, an average of 7 weeks
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Unified Parkinson's Disease Rating Scale (UPDRS) for PD
Periodo de tiempo: baseline (day 1) and upon study completion, an average of 7 weeks.
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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.
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baseline (day 1) and upon study completion, an average of 7 weeks.
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ALS functional rating score-revised (ALSFRS-R)
Periodo de tiempo: baseline (day 1) and upon study completion, an average of 7 weeks
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total score ranges from 48 (normal function) to 0 (severe impairment)
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baseline (day 1) and upon study completion, an average of 7 weeks
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blood pressure
Periodo de tiempo: baseline and upon study completion, an average of 7 weeks
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mm/Hg
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baseline and upon study completion, an average of 7 weeks
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Hoehn and Yahr (modified H&Y) score for PD
Periodo de tiempo: 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
|
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body mass index (BMI)
Periodo de tiempo: baseline and upon study completion, an average of 7 weeks
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weight and height will be combined to report BMI in kg/m^2
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baseline and upon study completion, an average of 7 weeks
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Rate of weight change for ALS participants
Periodo de tiempo: 1) the clinical visit prior to enrollment, an average of 3 months, 2) baseline, and 3) upon study completion, an average of 7 weeks
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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.
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1) the clinical visit prior to enrollment, an average of 3 months, 2) baseline, and 3) upon study completion, an average of 7 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Katherine Hope Morgan, PhD, MSN, FNP-BC, RN, University of Tennessee
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de noviembre de 2023
Finalización primaria (Actual)
21 de mayo de 2025
Finalización del estudio (Actual)
21 de mayo de 2025
Fechas de registro del estudio
Enviado por primera vez
4 de noviembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Neuromusculares
- Enfermedades metabólicas
- Enfermedades neurodegenerativas
- Enfermedades de la médula espinal
- Proteinopatías TDP-43
- Deficiencias de proteostasis
- Enfermedad de la neuronas motoras
- Enfermedades Nutricionales y Metabólicas
- La esclerosis lateral amiotrófica
Otros números de identificación del estudio
- 5081
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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