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

Part of paid clinical trials in Elizabethton, Tennessee.

Sponsor
The University of Tennessee, Knoxville
Study ID
NCT07625605
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Nov 20, 2023
Status verified
May 2026
Primary completion
May 21, 2025
Completion
May 21, 2025

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Healthy controls
    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).
  • Experimental: Participants with a neurodegenerative disease (amyotrophic lateral sclerosis or Parkinson's disease)
    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).

Primary Outcome Measure

MIND Diet Score (MDS) [ Time Frame: From baseline to the end of 8 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Gary E Shealy Memorial ALS ClinicElizabethtonTennessee37643-
The Cole Center for Parkinson's & Movement DisordersKnoxvilleTennessee37922-
University NeurologyKnoxvilleTennessee37920-

Find similar trials in Elizabethton, TN

By research site
Gary E Shealy Memorial ALS Clinic· Elizabethton, TNThe Cole Center for Parkinson's & Movement Disorders· Knoxville, TNUniversity Neurology· Knoxville, TN

Related Studies