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Completed

NCT Number: NCT07625605

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

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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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Parkinson's Disease (PD) Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gary E Shealy Memorial ALS Clinic, Elizabethton, Tennessee, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

The MIND diet

Behavioral

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.

Other names: Mediterranean-DASH Intervention to Delay Neurodegeneration, Mediterranean-DASH Hybrid diet, Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention to Delay Neurodegeneration

Primary outcomes

  1. MIND Diet Score (MDS)

    Time frame: 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).

  2. Gut microbiome

    Time frame: 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.

  3. Metabolomics and lipidomics for plasma and stool specimens

    Time frame: 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.

Secondary outcomes

  1. Biomarkers from plasma

    Time frame: 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).

  2. Weight

    Time frame: 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.

  3. Height

    Time frame: baseline

    Height will be abstracted from the subject's medical record and recorded in inches, then converted to centimeters.

  4. ALS hand grip strength

    Time frame: baseline and upon completion of the study, an average of 7 weeks

    pounds (lbs)

  5. Unified Parkinson's Disease Rating Scale (UPDRS) for PD

    Time frame: 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.

  6. ALS functional rating score-revised (ALSFRS-R)

    Time frame: baseline (day 1) and upon study completion, an average of 7 weeks

    total score ranges from 48 (normal function) to 0 (severe impairment)

  7. blood pressure

    Time frame: baseline and upon study completion, an average of 7 weeks

    mm/Hg

  8. Hoehn and Yahr (modified H&Y) score for PD

    Time frame: 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.

  9. body mass index (BMI)

    Time frame: baseline and upon study completion, an average of 7 weeks

    weight and height will be combined to report BMI in kg/m^2

  10. Rate of weight change for ALS participants

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

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

Registry information

Official study title

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)

Acronym: Meals

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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