NCT07625605Completed
The Meals Study for Amyotrophic Lateral Sclerosis and Parkinson's Disease
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)
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 4 Nov 2025
- Start date
- 20 Nov 2023
- Primary completion date
- 21 May 2025
- Lead sponsor
- The University of Tennessee, Knoxville
- NCT number
- NCT07625605
What you commit to
- Study type: Interventional
- Participants enrolled: 43
- From 20 Nov 2023 to the primary completion date, 21 May 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- May not be taking medications concerning for a drug induced parkinsonism two years prior to
Other illness
- History of bowel diseases or cancer (e.g., irritable bowel syndrome, celiac sprue, Crohn's
- 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)
- History of bowel diseases or cancer (e.g., irritable bowel syndrome, celiac sprue, Crohn's Disease, colorectal cancer)
- treating Movement Disorder specialist
- History of bowel diseases or cancer (e.g., irritable bowel syndrome, celiac sprue, Crohn's Disease, colorectal cancer)
- Diagnosis with any neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, peripheral neuropathies).
Age
- Younger than age 30
- Younger than age 30
Other
- Patients that require a special diet (celiac/gluten free, vegetarian, or vegan)
- Antibiotic use in past 6 months
- Unable to provide consent
- Feeding by tube feed or primarily liquid diets
- Unable to masticate or swallow.
- study entry such as antipsychotics, metoclopramide (Reglan), prochlorperazine (Compazine),
- promethazine (Phenergan) or amiodarone
- Patients that require a special diet (celiac/gluten free, vegetarian, or vegan)
- Antibiotic use in past 6 months
- Unable to provide consent or struggling with major cognitive concerns as determined by the
- 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
- Unable to consent
- Feeding by tube feed or primarily liquid diets
Who the study is looking for
- 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
- 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
Age in the registry: 30 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gary E Shealy Memorial ALS Clinic Coordinator of this site? Confirm its status | Elizabethton | United States | Unknown status |
| University Neurology Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| The Cole Center for Parkinson's & Movement Disorders Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.