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

NCT07625605 | Completed

• 1 other identifier: 5081
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Amyotrophic Lateral Sclerosis (ALS); Parkinson's Disease (PD)

Keywords

Mediterranean-DASH Intervention to Delay Neurodegeneration; MIND diet; microbiome; metabolome; dietary educational intervention

Outcome Measures

Primary Outcomes (3)

• 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).

  From baseline to the end of 8 weeks

• 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.

  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

• 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.

  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)

• Biomarkers from plasma

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

• Weight

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

• Height

  baseline

• ALS hand grip strength

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

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

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

Study Arms (2)

Healthy controls

EXPERIMENTAL

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).

Behavioral: The MIND diet

Participants with a neurodegenerative disease (amyotrophic lateral sclerosis or Parkinson's disease)

EXPERIMENTAL

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).

Behavioral: The MIND diet

Interventions

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.

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

Healthy controls; Participants with a neurodegenerative disease (amyotrophic lateral sclerosis or Parkinson's disease)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Meet clinical criteria for PD per the MDS clinical criteria (Postuma et al, Movement Disorders,
• \) 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

Sponsors & Collaborators

• University of Tennessee: collaborator
• East Tennessee State University: collaborator
• The University of Tennessee, Knoxville: lead
• University of Tennessee Medical Center: collaborator

Study Sites (3)

Gary E Shealy Memorial ALS Clinic

Elizabethton, Tennessee, 37643, United States

Location

University Neurology

Knoxville, Tennessee, 37920, United States

Location

The Cole Center for Parkinson's & Movement Disorders

Knoxville, Tennessee, 37922, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Katherine Hope Morgan, PhD, MSN, FNP-BC, RN

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: June 4, 2026
• Study Start: November 20, 2023
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)