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Could a Brain-Healthy diet help fight ALS and Parkinson's?

NCT ID NCT07625605

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether people with ALS or Parkinson's disease, along with healthy volunteers, could follow the MIND diet — a mix of the Mediterranean and DASH diets thought to protect the brain. Over several weeks, 43 participants received a cookbook, educational materials, and weekly tips. They tracked what they ate and provided stool and blood samples to see how the diet affected their gut bacteria and overall health. The goal was to see if the diet is practical and whether it might improve symptoms or slow disease progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MIND diet (a hybrid of the Mediterranean and DASH diets)
What this could lead to
If the MIND diet proves beneficial, it could offer a simple, low-cost way to help manage symptoms and slow progression of ALS and Parkinson's disease.
What could go wrong
This was a small, early feasibility study with no control group, so any benefits seen may not be due to the diet. Dietary changes can be hard to maintain long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

43 people

The number who actually took part.

Started

Nov 2023

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Gary E Shealy Memorial ALS Clinic

    Elizabethton, Tennessee, 37643, United States

  • The Cole Center for Parkinson's & Movement Disorders

    Knoxville, Tennessee, 37922, United States

  • University Neurology

    Knoxville, Tennessee, 37920, United States

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