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Amyotrophic Lateral Sclerosis (ALS)MealsNCT07625605

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

A study testing The MIND diet in people with Amyotrophic Lateral Sclerosis (ALS) and Parkinson's Disease (PD), run by The University of Tennessee, Knoxville at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
What is being tested?
The MIND diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
3 sitesUnited States
Study dates
20 Nov 2023to 21 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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
  • 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

Who cannot join

  • 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
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  • Unable to masticate or swallow.
  • 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.
  • 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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Gary E Shealy Memorial ALS Clinic

    Elizabethton, Tennessee, 37643

  • University Neurology

    Knoxville, Tennessee, 37920

  • The Cole Center for Parkinson's & Movement Disorders

    Knoxville, Tennessee, 37922

Other trials in United States

About this study

Official 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)

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:

Read more
  • 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.
Being tested
The MIND diet
Keywords
Mediterranean-DASH Intervention to Delay Neurodegeneration, MIND diet, microbiome, metabolome, dietary educational intervention
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The MIND dietBehavioural

    Also called Mediterranean-DASH Intervention to Delay Neurodegeneration, Mediterranean-DASH Hybrid diet, Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention to Delay Neurodegeneration

    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.

Study groups in NCT07625605
Study groupRoleWhat they receive
Healthy controlsExperimentalThe 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).
Receives: Behavioral: The MIND diet
Participants with a neurodegenerative disease (amyotrophic lateral sclerosis or Parkinson's disease)ExperimentalPeople 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).
Receives: Behavioral: The MIND diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MIND Diet Score (MDS)

    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).

    Measured: From baseline to the end of 8 weeks

  2. Gut microbiome

    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.

    Measured: 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

  3. Metabolomics and lipidomics for plasma and stool specimens

    Data will be analyzed by standard pipelines like MetaboAnalyst for relative abundances (peak area/intensity) of metabolites and lipids.

    Measured: 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.

Secondary outcomes (10)

  1. Biomarkers from plasma

    Biomarkers of systemic inflammation, intestinal permeability, and metabolism will be quantified using ELISAs or multiplexing measured in units of concentration (pg/mL).

    Measured: Blood collection will occur at baseline (day 1) and upon study completion, an average of 7 weeks.

  2. Weight

    Weight, measured in pounds (lb) and converted to kilograms (kg). Weight prior to enrollment will be abstracted from the medical record.

    Measured: Prior to enrollment, an average of 3 months; baseline; and upon study completion, an average of 7 weeks.

  3. Height

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

    Measured: baseline

  4. ALS hand grip strength

    pounds (lbs)

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

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

    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.

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

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

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

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

  7. blood pressure

    mm/Hg

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

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

    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.

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

  9. body mass index (BMI)

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

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

  10. Rate of weight change for ALS participants

    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.

    Measured: 1) the clinical visit prior to enrollment, an average of 3 months, 2) baseline, and 3) upon study completion, an average of 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study start20 Nov 2023
  3. Primary completion21 May 2025
  4. Study completion21 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07625605
Sponsor's protocol ID
5081
Acronym
Meals
Status last verified
May 2026
First submitted
4 Nov 2025
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The MIND diet in people with Amyotrophic Lateral Sclerosis (ALS) and Parkinson&#39;s Disease (PD), run by The University of Tennessee, Knoxville at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MIND Diet Score (MDS) (time frame: From baseline to the end of 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07625605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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