MedTrace Logo

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

NCT07625605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-06-04

No results posted yet for this study

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)

Interventions

BEHAVIORAL

The MIND diet

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.

Sponsors & Collaborators

  • University of Tennessee

    collaborator OTHER

  • University of Tennessee Medical Center

    collaborator OTHER

  • East Tennessee State University

    collaborator OTHER

  • The University of Tennessee, Knoxville

    lead OTHER

Principal Investigators

  • Katherine Hope Morgan, PhD, MSN, FNP-BC, RN · University of Tennessee

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2025-05-21
Completion
2025-05-21

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07625605 on ClinicalTrials.gov