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COMPLETED
NCT07625605
NA

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

Sponsor: The University of Tennessee, Knoxville

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2023-11-20

Completion Date

2025-05-21

Last Updated

2026-06-04

Healthy Volunteers

Yes

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.

Locations (3)

Gary E Shealy Memorial ALS Clinic

Elizabethton, Tennessee, United States

University Neurology

Knoxville, Tennessee, United States

The Cole Center for Parkinson's & Movement Disorders

Knoxville, Tennessee, United States